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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Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
Microbiology
The Nucleic Acid Amplification Test for the Quantitation of BK Virus (BKV) DNA is an in vitro diagnostic device intended to quantitate BKV DNA in human samples as an aid in managing BKV infection in transplant patients, where serial measurements can indicate the need for treatment changes and assess viral response. Results must be interpreted by a qualified healthcare professional in conjunction with clinical signs and relevant laboratory findings, and must not be the sole basis for patient management decisions. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 866.3183 in the Microbiology specialty. It carries product code QMI and is not an implant and not life-sustaining.
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.