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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Reagents, 2019-Novel Coronavirus Nucleic Acid
Unknown
Reagents for 2019-Novel Coronavirus Nucleic Acid detection are nucleic acid-based in vitro diagnostic devices for the detection of SARS-CoV-2 (2019-nCoV) and/or the diagnosis of 2019-nCoV infection in human clinical specimens. These devices are classified as Not Classified (Class N), reviewed by the Microbiology panel, with no regulation number assigned; this classification reflects emergency authorization status during the COVID-19 public health emergency. The product code is QJR. The devices are not implants and are not flagged as life-sustaining.
No 510(k) clearances found for "QJR". 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.