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.
Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
Microbiology
The HSV-1 and HSV-2 CNS Nucleic-Acid Based Panel is an in vitro diagnostic test for the qualitative detection and differentiation of Herpes Simplex Virus types 1 and 2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of HSV central nervous system infection. It is an FDA Class 2 device regulated under 21 CFR 866.3307, requiring 510(k) clearance, within the Microbiology (MI) specialty. The product code is PGH, and it carries a life-sustaining flag given the critical nature of CNS infection diagnosis. Negative results do not exclude HSV infection and should not be the sole basis for treatment decisions.
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.