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.
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Describe your device and the Research Assistant searches 510(k)s, compares intended use, and drafts a predicate shortlist — with citations.
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Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test
Immunology
The Human Leukocyte Antigen (HLA) Typing Companion Diagnostic Test is a prescription genotyping or phenotyping assay intended as an aid in identifying patients with specific HLA alleles or antigens who may benefit from a particular therapeutic product or who may be at increased risk for serious adverse reactions to a corresponding therapeutic product. HLA typing is critical for pharmacogenomic decision-making in drug therapy and organ transplantation. Classified as FDA Class 2 under regulation 866.5960, it requires 510(k) clearance in the Immunology specialty. The device is not an implant and not life-sustaining.
No 510(k) clearances found for "QUK". Try a different K-number, product code, or device name.
What 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.