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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: CHH FDA class 1

    Enzymatic Esterase--Oxidase, Cholesterol

    Clinical Chemistry

    View full classification →

    The Enzymatic Esterase-Oxidase, Cholesterol test system (product code CHH) is an in-vitro diagnostic device used in clinical chemistry to measure total cholesterol in serum or plasma using an enzymatic esterase-oxidase coupled reaction, one of the most commonly used methods for lipid panel testing. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1175 in the Clinical Chemistry medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
    Cholesterol2
    VITROS XT Chemistry Products TRIG-CHOL Slides
    Extended Lipid Panel Assay
    Mission Lipid Panel Monitoring System
    Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
    CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System
    Cholesterol
    AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL
    PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
    ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
    EON CHOLESTEROL REAGENT
    ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT
    ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
    HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE
    S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)
    CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
    EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT
    PTS PANELS CHOL+HDL PANEL TEST STRIPS
    VAP-NT CHOLESTEROL TEST
    ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE
    SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL
    COBAS INTEGRA CHOLESTEROL GEN. 2
    PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
    PTS PANELS LIPID PANEL TEST STRIPS
    PTS PANELS LIPID PANEL TEST STRIPS
    BIOSCANNER PLUS; LIPID PANEL TEST STRIPS
    BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM
    RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY
    RESOLUTION CHOLESTEROL MONITOR
    ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS
    PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR
    SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
    RLP CHOLESTEROL IMMUNOSEPARATION ASSAY
    CHOLESITE TEST SYSTEM
    MTM BIOSCANNER C TEST STRIPS
    CHOLESTRON PRO II CHOLESTEROL TEST
    HICHEM CHOLESTEROL REAGENT KIT
    ENA-C-T TOTAL CHOLESTEROL TEST MODEL F 20000, (PHYSICIAN DIRECTED USE)
    CARESIDE ANALYZER
    MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
    CHOL
    CHOL
    INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
    COBAS INTEGRA HDL-CHOLESTEROL DIRECT
    CHOLESTEROL RAPID LIQUID REAGENT
    CHOLESTEROL REAGENT
    SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
    PARAMAX CHOLESTEROL REAGENT
    CHOL OR CHOLESTEROL

    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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