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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: LBS FDA class 1

    Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl

    Clinical Chemistry

    View full classification →

    This test method uses LDL and VLDL precipitation followed by cholesterol measurement via the esterase-oxidase enzymatic method to quantify HDL cholesterol in serum samples for cardiovascular risk assessment. It is classified as FDA Class 1, subject only to general controls, with no premarket notification required. The product code is LBS, regulated under 21 CFR 862.1475, in the Clinical Chemistry specialty. No special risk flags apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HDL-Cholesterol Gen.4
    Direct HDL Cholesterol (HDL)
    CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
    VITROS CHEMISTRY PRODUCTS DHDL SLIDES
    NMR LIPOPROFILE (R) TEST AND NMR PROFILER
    ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
    EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT
    POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC
    HDL CHOLESTEROL (HDLX) ASSAY
    APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
    HDL CHOLESTEROL REAGENT, MODEL 10211
    DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
    CHOLESTRAK HDL CHOLESTEROL HOME TEST
    ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118)
    PREVU POINT OF CARE SKIN STEROL TEST
    AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
    ULTRA HDL
    ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
    HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
    HDL-EX SEIKEN ASSAY KIT
    VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE
    SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747
    SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
    DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR
    HDL-CHOLESTEROL PLUS 2ND GENERATION
    PICCOLO HDL TEST SYSTEM
    ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR
    JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
    CHOLESTEROL 1, 2, 3
    OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
    OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
    ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
    MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
    LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
    HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
    DIRECT HDL-CHOLESTEROL REAGENT
    HDLC PRECIPITATING REAGENT
    DIRECT HDL
    DIRECT HDL-CHOLESTROL LIQUID
    CARESIDE HDL-CHOLESTEROL
    HDL
    RDI HOMOGENEOUS HDL CHOLESTEROL TEST
    EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5)
    LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR
    ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
    N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
    BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
    ACE HDL-C REAGENT
    BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL
    CHOLESTECH LDX SYSTEM

    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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