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    K Number
    K072714
    Device Name
    TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Date Cleared
    2008-04-18

    (206 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K052464
    Why did this record match?
    Device Name :

    TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For the quantitative determination of percent hemoglobin A1c in whole blood (or hemolysate derived from whole blood) on Roche clinical chemistry analyzers. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

    Device Description

    With the Tina-Quant Hemoglobin A1c Gen.2 test system, the anticoagulated whole blood specimen is hemolyzed prior to determination of HbA1c by an turbidimetric inhibition immunoassay (TINIA). Liberated hemoglobin (Hb) in the hemolyzed sample is converted to a derivative having a characteristic absorption spectrum and measured bichromatically. The instrument calculates the % HbA1c from the HbA1c/ Hb ratio according to a user selected protocol.

    AI/ML Overview

    Here's a summary of the acceptance criteria and study information for the Tina-Quant® Hemoglobin A1c Gen.2 Test System, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission primarily focuses on modifications to an already cleared device (K052464). The acceptance criteria for the new features or extended parameters are shown below, along with the reported performance where available.

    FeatureAcceptance CriteriaReported Device Performance
    Measuring Range (Integra 800/800 CTS)0.3 - 3.4 g/dL HbA1c (for HbA1c); 4-35 g/dL Hb (for Hb)Modified Device (Integra 800/800 CTS): 0.3 - 3.4 g/dL HbA1c, 4-35 g/dL Hb (This is the expanded range, which is the acceptance criterion itself for this modification). Predicate Device (Integra 800): 0.3-2.6 g/dL HbA1c, 4-35 g/dL Hb
    Endogenous Interferences (Whole blood application only)No significant interference (bias within ± 10%) for:
    • Lipemia (up to 800 mg/dL Intralipid)
    • Bilirubin (up to 30 mg/dL Bilirubin/ditaurobilirubin)
    • Rheumatoid factor (up to 350 IU/mL RF)
    • Glycemia (up to 1000 mg/dL glucose) | Reported: No significant interference (bias within ± 10%) up to:
    • 800 mg/dL Intralipid
    • 30 mg/dL Bilirubin/ditaurobilirubin
    • 350 IU/mL RF
    • 1000 mg/dL Glucose |
      | Anticoagulant (Potassium fluoride/Na2-EDTA) | Reagent-specific criteria:
    • Mean deviation of all samples:
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