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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: LCP FDA class 2

    Assay, Glycosylated Hemoglobin

    Hematology

    View full classification →

    Glycosylated hemoglobin assay is a laboratory test system used in hematology and diabetes management to measure the proportion of hemoglobin that has been glycated, providing an indication of average blood glucose levels over the preceding two to three months. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is LCP, regulated under 21 CFR 864.7470, in the Hematology specialty. No special risk flags apply.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Nova Allegro HbA1c Assay, Nova Allegro Analyzer
    Q-Pad Test System
    Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer
    Aina HbA1c Monitoring System 2
    PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
    OneDraw A1C Test System
    PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
    Quo-Test A1c System
    skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
    ACE Hemoglobin A1c (HbA1c) Reagent
    Alere Afinion HbA1c and ACR on Afinion 2 analyzer
    Lucica Glycated Albumin-L
    cobas HbA1c Test, cobas b 101 system
    A1C EZ Glycohemoglobin Analysis System
    CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
    Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
    URight Hemoglobin A1c system, FORA A1c System
    SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
    Alere Afinion HbA1c, Alere Afinion AS100 Analyzer
    HOME ACCESS AIC TEST
    A1c iGear System
    DIAZYME GLYCATED SERUM PROTEIN POC TEST KIT
    HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM
    UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT
    VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
    A1C GEAR SYSTEM
    MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS
    ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR
    VARIANT(TM) II TURBO HBA1C KIT - 2.0
    VARIANT II HEMOGLOBIN A1C PROGRAM (NEW), VARIANT II HEMOGLOBIN TESTING SYSTEM WITH CDM SOFTWARE, CDM SOFTWARE
    ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
    CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
    VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM
    GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY
    LABONACHECK A1C
    UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT
    HEMOCUE HBA1C 501
    ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT
    EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
    TINA-QUANT HBA1C GEN.2
    PREMIER HB9210 HBA1C ANALYZER
    ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
    AVIE A1C TEST SYSTEM
    ELITECH CLINICAL SYSTEMS HBA1C REAGENT, ELITECH CLINCAL SYSTEM HBA1C CALIBRATOR SET, ELITECH CLINICAL
    DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
    DIMENSIONS HB1C KIT, MODEL DF105A
    AFINION ANALYZER
    DIMENSION VISA HBA1C, MODEL K3105A
    TQ HBA1C GEN3
    ST AIA PACK HBA1C

    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

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