510(k) Predicate Finder
Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.
Let the assistant find your predicates
Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
Free to try · every answer cites its records
Assay, Proliferation, In Vitro, T Lymphocyte
Hematology
The In Vitro T Lymphocyte Proliferation Assay is a diagnostic device that measures constituents of dividing DNA or other pre-division cellular components to classify the ability of T lymphocytes to divide or proliferate in response to specific or non-specific stimulants. It is used to evaluate immune function in patients with normal or abnormally low T-lymphocyte counts, such as those in a natural or induced immunosuppressed state. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NID and regulation 21 CFR 864.5220 in the Hematology specialty (reviewed by the Immunology panel). The device is eligible for third-party review and is not an implant or life-sustaining device.
510(k) Clearances
2 matchesWhat is a Predicate Device?
A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.
Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.
Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.