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.
Gram-Positive Bacteria And Their Resistance Markers
Microbiology
The Gram-Positive Bacteria and Their Resistance Markers device is a qualitative multiplexed in vitro diagnostic device intended to detect and identify gram-positive bacteria and antibiotic resistance markers in positive blood cultures, enabling rapid identification of bloodstream pathogens. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is PAM, with regulation number 866.3365 under the Microbiology medical specialty.
510(k) Clearances
6 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.