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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Placental Alpha Microglobulin-1 Immunoassay
Unknown
The Placental Alpha Microglobulin-1 Immunoassay is a qualitative test intended to detect the presence of placental alpha microglobulin-1 (PAMG-1) in cervicovaginal secretions as an aid to assess the risk of spontaneous preterm delivery within seven days from the time of sample collection in pregnant women with signs and symptoms of early preterm labor. It is classified as a Class 3 device requiring Premarket Approval (PMA) due to the high-risk nature of its intended use in predicting preterm birth; no regulation number has been assigned. The product code is QBB, reviewed by the Clinical Toxicology (TX) panel. It is not an implant and is not life-sustaining.
No 510(k) clearances found for "QBB". 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.