Studybox Research Tool
CLIA Waiver Precedent Finder
Every test FDA has CLIA-waived, searchable by analyte: who got there, when, with which specimens, and by which route.
Precedents
Tool
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| Waived | Company | Test system | Specimen | Route | FDA record |
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How to read it
Two Routes to a CLIA Waiver.
- Waiver by application (CW): the test was cleared first, then the maker ran a separate CLIA waiver study with untrained operators at intended-use sites and applied for the waiver.
- Waived at 510(k) (K): the waiver came with the clearance. Usually that means a dual 510(k) and CLIA waiver submission, one combined study. Tests cleared for home or over-the-counter use are waived automatically, so those are hidden by default.
- What precedent tells you: how many tests for your analyte are already waived, whether makers got there in one combined study or two, and which specimens FDA has accepted. The FDA record linked on each row has the details, and many link to a decision summary describing the study.
→ Planning a waiver study?
Estimate positives, enrollment, sites and weeks with the IVD Study Planner, or talk to the Studybox team. The team has run dual 510(k)/CLIA waiver studies for flu, RSV, Strep A, STI and PT/INR tests.
Source: FDA CLIA database download. Relabels of an already-waived test (FDA "CR" records) are left out so each row is an original waiver decision. Informational only; confirm on FDA's record.