BEUDAMED
    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: LJC FDA class 1

    Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

    Microbiology

    View full classification →

    An enzyme-linked immunosorbent assay (ELISA) for the Chlamydiae group is a laboratory diagnostic test used to detect antibodies to Chlamydia species in patient specimens, supporting the serological diagnosis of chlamydial infections in the microbiology laboratory. The device is FDA Class 1, the lowest risk category, subject to general controls. It carries product code LJC and is regulated under 21 CFR 866.3120 within the Microbiology specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CT OIA
    IDEIA PCE CHLAMYDIA
    CHLAMYDIA IGG ELISA TEST SYSTEM
    MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
    CHLAMYDIA IGG ELISA TEST SYSTEM
    ACCESS CHLAMYDIA ASSAY
    VIDAS CHLAMYDIA BLOCKING ASSAY
    IMX SELECT CHLAMYDIA
    IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION
    CHLAMYDIA OIA
    QUICKVUE(R) CHLAMYDIA TEST
    ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY
    CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY
    SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT
    MICRO TRAK XL SYSTEM
    SYVA MICROTRAK CHLAMYDIA EIA
    MICROTRAK(R) II CHLAMYDIA EIA ASSAY
    ORTHO CHLAMYDIA ANTIGEN ELISA TEST
    SEROELISA(TM) CHLAMYDIA IGA TEST KIT
    SEROLISA CHLAMYDIA IGG TEST KIT
    VIDAS CHLAMYDIA ASSAY, MODIFICATION
    ANTIGENZ CHLAMYDIA
    VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST
    CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
    ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION
    SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION
    CHLAMYDIA SYSTEM SOFTWARE (CSS)
    ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
    QUIDEL CHLAMYDIA POSITIVE CONTROL
    SYVA MICROTRAK EIA ACCESSORY REAGENTS
    ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA
    CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
    QUIDEL CHLAMYDIA TEST
    PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT
    KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET
    VISUWELL(R) CHLAMYDIA
    CHLAMYDIAZYME DIAGNOSTIC KIT
    ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG
    ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT
    CLEARVIEW CHLAMYDIA
    MODIFIED ELISA FOR CHLAMYDIA
    KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)
    CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY
    ABBOTT TESTPACK CHLAMYDIA
    CHLAMYDIAZYME BLOCKING REAGENT
    MICROTRAK CHLAMYDIA EIA
    CHLAMYDIAZYME/COMMANDER INSTRUMENTATION
    MODIFIED IDEIA CHLAMYDIA TEST
    PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
    KODAK SURECELL CHLAMYDIA TEST KIT

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump