idea-010 · viability deck
Every slide states a condition that would have to be true, then reports where it stands using the candidate file's own claim and its own confidence tag. A deck never upgrades a tag, invents a number, or recommends anything, and there is no ask slide.
The chair: the investor, and the practice administrator who has to decide whether insourcing a potassium and a creatinine makes or loses money per patient.
How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-010.md. The number is the claim's position in its ## Claims list, and the tag is copied from that file as it stood on 2026-09-29 and never adjusted here. [no claim] means nothing in the file speaks to the condition. Claims 63–64 were appended by this deck's build. No number appears here that is not in a claim, and there is no ask slide. See docs/deck-spec.md.
What changed since the last build, and what it does not change: on 2026-09-29 two money claims moved to verified. claim 14verified now carries the 2026 CLFS (clinical laboratory fee schedule) national limitation amounts: $4.76 for 84132 and $5.12 for 82565. claim 16verified carries the Medicare fee-for-service volume of the two standalone codes. That puts a number on the revenue side of the per-test question for the first time. The cost side is still blank. The Verified Composite and Gate Check sections of the candidate file are dated 2026-08-25, before these tags moved. This deck neither quotes nor re-derives them.
Would have to be true: For an office-performed potassium and creatinine, Medicare Part B (Medicare Part B) (and Medicare Advantage (Medicare Advantage) and commercial payers for their members) would have to pay the clinic out of the Clinical Laboratory Fee Schedule. The clinic would have to be a physician-office lab billing on its own CLIA (Clinical Laboratory Improvement Amendments) certificate, and it would have to buy the strips out of practice operating expense.
Where it stands: The fee-schedule half is now verified. The codes are paid from the CLFS and not the Physician Fee Schedule, at $4.76 (84132) and $5.12 (82565) as 2026 Medicare national limitation amounts, and the claim notes that commercial rates differ claim 14verified. Whether the clinic captures that payment when it insources a test it used to send out has no connector reading the billing-entitlement rules claim 37unconfirmed. Whether the target clinics are physician-office sites or hospital-owned departments billing on the hospital's institutional claim is unchecked claim 57unverified. Whether Medicare Advantage and commercial payers pay at or above the CLFS amounts is unchecked claim 58unverified. That the clinic is the direct purchaser is an assumption claim 44unconfirmed. The file also carries a German route, outside the US launch jurisdiction and unchecked claim 56unverified.
What would settle it: claim 37unconfirmed needs a reimbursement analyst reading the Medicare Claims Processing Manual on who bills a test performed in a certificate-of-waiver office lab. claim 57unverified needs CMS (Centers for Medicare & Medicaid Services) Provider of Services and CLIA laboratory files cross-referenced to cardiology and nephrology practice locations. claim 58unverified needs negotiated rates for 84132 and 82565 from payers' Transparency-in-Coverage files.
If it's false: If most target clinics are hospital-owned departments, the verified CLFS rate is the wrong number: the hospital, not the clinic, is paid, and the purchasing decision moves to the health system (desirability deck, Slide 3). If the clinic cannot capture the payment, insourcing earns it nothing and Factor 2's payment leg does no work.
Would have to be true: Three things would each have to land. (1) CPT (Current Procedural Terminology) 84132 and 82565 would have to exist with descriptors that fit capillary whole blood from a strip, so no new code is needed. (2) Both would have to be separately payable when reported from one strip and one drop, with the QW modifier where the site bills under a waiver. (3) No Medicare coverage policy would have to restrict point-of-care potassium testing.
Where it stands:
unconfirmed because that cache is the article export, which does not cover NCD text
claim 15unconfirmed.
What would settle it: Descriptors: a human-attached AMA CPT Professional or licensed vendor feed. Bundling and QW: NCCI edit tables plus the CMS CLIA waived-test transmittal, both human-attached. Billability of a suppressed result: a reimbursement analyst reading CLFS billing rules on tests with no reportable value. Coverage: the CMS Medicare Coverage Database with NCD text, read for stance.
If it's false: If only one of the two codes is paid per strip, revenue per strip falls to one of the two figures. If a suppressed result is not billable, every invalid result is a strip the clinic paid for and cannot bill, and the invalid-result rate (feasibility deck, Slide 4) becomes a cost term on Slide 7.
Would have to be true: The addressable market would have to be the product of four separately evidenced factors: the number of US HF/CKD patients in active RAASi/MRA titration, times the potassium tests each receives per year at a titration visit, times a net strip price the clinic will pay, times the share of clinics that switch. No single headline number stands in for them.
Where it stands:
What would settle it: Population: a primary claims analysis (Medicare Part D plus diagnosis codes, or a published cohort) counting RAASi/MRA starts and dose changes. Rate: a human reading the guideline. Price: an internal bill-of-materials estimate for the floor (Slide 7). Share: PECOS/Provider Enrollment by specialty for the denominator, plus a licensed POC-diagnostics report or a practice survey for switching.
If it's false: If the population in active titration is small, or the per-patient cadence is only a handful of tests in the first month, then even the $9.88 ceiling times a real volume cannot carry a strip-manufacturing business. Factor 3 stays at the floor, and the TAM kill condition becomes evaluable in the wrong direction.
Would have to be true: Four things would have to be done before the first strip is billed. The three-channel strip would have to be developed. A dual 510(k) (premarket notification) and CLIA waiver by application would have to be completed across two generic types, including multi-site untrained-operator studies. Strip manufacturing would have to be scaled up. And both the capital and the calendar that sequence takes would have to fall within what a device company can raise and survive. No dollar or month figure is in any claim, and none is estimated here.
Where it stands: The pathway is real. FDA (US Food and Drug Administration) operates a Dual 510(k) and CLIA Waiver by Application route and issued a final guidance on it. That settles that the route exists, not the study package it requires claim 8verified. The file records capital intensity and time-to-revenue as this candidate's honest principal weakness, and asserts no figure claim 26unconfirmed. Calendar to first commercial dollar claim 50unconfirmed, capital required claim 51unconfirmed, and the lag from a clinic's first purchase to its first paid CLFS claim claim 52unconfirmed are all business estimates with no connector. What the waiver study package requires is carried in the feasibility deck (Slide 3) claim 66unverified. The OTC home-use submission, which is the obvious extension, adds a lay human-factors package on top claim 54unconfirmed.
What would settle it: A human reading the named FDA guidance ("Recommendations for Dual 510(k) and CLIA Waiver by Application Studies") to size the study package. Then an internal development plan with costed bench, analytical and waiver studies, plus a manufacturing scale-up quote. These are Tier 3 human estimates that no public source prices.
If it's false: If capital to first dollar exceeds what can be raised on the evidence this file carries, the razor/razorblade revenue shape the Scores table credits never starts. Factor 7 stays low whatever Slides 1–3 show.
Would have to be true: The defensible assets would have to be real and ownable: the hemolysis-detection-and-suppression logic, the potassium-selective membrane chemistry at whole-blood ionic strength, and the strip manufacturing yield curve. And incumbents that already own high-volume strip manufacturing and ISE chemistry would have to be unable to replicate them quickly.
Where it stands: The moat claim is the Generator's judgement. The patent leg is blocked by a missing PatentsView key, and the yield-curve leg cannot be documented by any lookup claim 24unconfirmed. No patent search has been performed, so the FTO (freedom to operate) field is unexamined, not clear claim 25unconfirmed. Whether the core suppression function is free of in-force claims is carried in the feasibility deck (Slide 7) claim 68unverified.
What would settle it: A prior-art and assignee sweep (Patents Public Search or Espacenet, on the CPC classes and assignees named in the file), then connectors patent once PATENTSVIEW_API_KEY is set. The file names the highest-value single query: art on hemolysis detection used to flag or suppress a co-located electrolyte result. The yield-curve leg is Tier 3 diligence.
If it's false: If the suppression logic is already claimed, or is obvious to an incumbent, the moat reduces to manufacturing yield. The Scores table notes that yield describes the incumbents' moat at least as well as this candidate's. Factor 5 has nothing to stand on.
Would have to be true: The incumbents in potassium testing (Nova Biomedical, Abbott Point of Care, Abbott/Abaxis Piccolo, Epocal/Siemens, and the benchtop ISE vendors) would have to be absent from the single-use-strip, single-fingerstick-drop format for a reason that doesn't also stop this device. And clinics would have to prefer that format over a cleared point-of-care analyzer they could already buy.
Where it stands: No cleared strip-and-fingerstick potassium meter was found. After the audit, this rests on a complete enumeration of both product codes under 21 CFR (Title 21 of the Code of Federal Regulations) 862.1600 over thirty years. That enumeration is a Stage 0 scan and cannot confer a tag. The file also records that "no predicate for the potassium channel" is overstated claim 7unconfirmed. A cleared Piccolo potassium test system covering whole blood at a point-of-care location exists. Its CLIA-waived status was never checked, and the narrowed gap is form factor and per-test cost claim 10unconfirmed. The i-STAT CHEM8+ record the Verifier located is an ionized-calcium clearance, so its potassium half is not established claim 9unconfirmed. The named firms are corroborated as active by clearance records, which are pointers only claim 27unconfirmed. The file's own candidate reason for the empty format is the hemolysis mechanism, carried in the feasibility deck claim 22unconfirmed. Whether clinics choose this device over an incumbent analyzer is unchecked claim 49unconfirmed. Whether practices that placed one kept using it for potassium is unchecked claim 59unverified.
What would settle it: The CMS CLIA waived-test transmittal for the Piccolo potassium listing, human-attached. Reagent reorder data at cardiology and nephrology accounts for claim
If it's false: If the format is empty only because the physics of hemolysis defeats it, the empty field is a warning, not white space, and this slide hands off to the feasibility deck's load-bearing condition. If clinics are content with incumbent analyzers, Factor 8 caps as the Generator itself instructed.
Would have to be true: The payment a clinic receives per potassium-and-creatinine test would have to exceed the fully-loaded cost of performing it in the office: strip, meter amortisation, QC (quality control) material, operator time, and the strips consumed by suppressed results that cannot be billed. That would have to hold at the test volume one outpatient HF or nephrology clinic generates. A net strip price below the payment would also have to leave the manufacturer a positive gross margin.
Where it stands: The payment side is now known for Medicare: $4.76 plus $5.12 claim 14verified. The cost side has no source, so the inequality is unresolved claim 36unconfirmed. Whether a strip price below that ceiling leaves manufacturer margin claim 45unconfirmed depends on a three-channel strip's bill of materials at volume claim 46unconfirmed. Meter price or placement claim 47unconfirmed and per-clinic volume claim 48unconfirmed set how many tests carry the fixed costs. The unbillable suppressed strip claim 63unverified makes the invalid-result rate claim 23unconfirmed a cost multiplier.
What would settle it: An internal bill-of-materials and fully-loaded cost-per-reported-result estimate for the strip, set against the CLFS amounts already on file. This is Tier 3 human work, but it needs no strip to exist, no clinician interviewed and no patent searched. A reimbursement analyst's reading on claim 63unverified converts the invalid-result rate into a cost term.
If it's false: If the fully-loaded cost per reported result sits at or above the payment, the clinic loses money on every test it insources. That is the negative economic claim the file wrote against its own interest. No clinic-purchase route survives, and only the health-system value route in the business case, which has its own unchecked study claim 55unconfirmed, remains.
Every condition above that has nothing verified behind its load-bearing half. Four slides cite a verified claim (14, 16 or 8), but in each case the verified part is the known half and the unresolved part is the one the condition turns on. So all seven are listed.
The measure that matters: three verified claims now anchor this deck, and every one of them is a revenue-side or pathway-existence fact. No cost, share, margin or calendar figure in the file is verified.
If only one thing from this chair could be checked: would the fully-loaded cost of producing one reported potassium-and-creatinine result in an outpatient clinic sit below what the clinic is paid for it claim 36unconfirmed? The revenue side is now on file at $4.76 plus $5.12 per Medicare test claim 14verified. The cost side is blank.
This one rather than the others because every other money question multiplies against it. Share, TAM and capital only matter if each test is not a loss to the clinic that runs it. It is also the only load-bearing condition across the three decks that can be taken most of the way before a strip exists. With the payment side verified, what remains is an internal bill-of-materials estimate plus the analyst's reading on whether a suppressed result can be billed.
Naming it is not a recommendation, a gate, or a kill.
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