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    Tool · 510(k)

    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.

    Product Code: JSF FDA class 1

    Culture Media, Single Biochemical Test

    Microbiology

    View full classification →

    The Culture Media, Single Biochemical Test is a microbiology diagnostic medium designed to perform a single defined biochemical test reaction that detects a specific metabolic property of a microorganism, used to confirm the identity of bacterial isolates as part of routine clinical microbiology identification procedures. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JSF and is regulated under 21 CFR 866.2320, within the Microbiology medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    NUTRIENT GELATIN - PRODUCT NUMBER T2860
    LAURYL TRYPTOSE BROTH
    MOELLERS DECARBOXYLASE, LYSINE
    MOELLERS DECARBOXYLASE, ONITHINE
    ACETAMIDE AGAR SLANT
    NITRATE BROTH
    CYSTINE TRYPTIC MEDIUM W/LACTOSE
    CYSTINE TRYPTIC MEDIUM W/ MALTOSE
    MOELLOERS DECARBOXYLASE, ARGININE
    ONPG TEST REAGENT
    CYSTINE TRYPTIC MEDIUM W/SUCROSE
    CYSTINE TRYPTIC MEDIUM W/DEXTROSE
    BRILLIANT GREEN BILE BROTH
    NUTRIENT GELATIN
    BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC
    BIOTIS (TM) STARCH HYDROLYSIS WITH BCP
    CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990
    IAFP UREA AGAR SLANT
    TRYPTONE BROTH, 2%
    DNASE AGAR
    TRYPTONE WATER (1%)
    BIOTIS DECARBOXYLASE MEDIA, ORNITHINE
    BIOTIS DECARBOXYLASE MEDIA, LYSINE
    BIOTIS DECARBOXYLASE MEDIA, ARGININE
    BIOTIS MOTILITY TEST MEDIUM
    CAFFEIC ACID DISK
    ACETATE DIFFERENTIAL AGAR
    SIMMONS CITRATE AGAR
    CYSTINE TRYPTIC AGAR W/SUCROSE
    CYSTINE TRYPTIC AGAR W/LACTOSE
    CYSTINE TRYPTIC AGAR W/DEXTROSE
    CYSTINE TRYPTIC AGAR W/MANNITOL
    CYSTINE TRYPTIC AGAR W/MALTOSE
    PHENOL RED BROTH W/CARBOHYDRATES
    CYSTINE TRYPTIC AGAR W/FRUCTOSE
    DIFFERENTIATION DISKS BILE ESCULIN
    DECARBOXYLASE TEST REAGENT
    HIPPURATE TEST REAGENT
    INDOLE REAGENT
    LYSINE IRON AGAR
    VOGES-PROSKAUER REAGENT B
    VOGES-PROSKAUER REAGENT A
    CHRISTENSEN'S UREA AGAR
    HIPPURATE TEST DISKS
    STREP-A-CHEK
    ZINC DUST SUSPENSION
    OXIDASE TEST STRIPS-OXIDASESURE
    ARGINIE BROTH
    ONPG DISKS
    SPOT TEST NINHYDRIN REAGENTS

    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.

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