BEUDAMED
    Product Code: GKA FDA class 2 21 CFR 864.7415

    Abnormal Hemoglobin Quantitation

    Hematology

    Abnormal Hemoglobin Quantitation (product code GKA) is a hematology assay system used to detect, identify, and quantify variant hemoglobins such as HbS, HbC, HbE, and other structurally abnormal hemoglobin forms, supporting the diagnosis of hemoglobinopathies. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7415 in the Hematology specialty (HE), it is eligible for third-party review.

    View on FDA
    510(k)s
    23
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    15
    Years Active
    43

    Basic Information

    Product Code
    GKA
    Device Class
    FDA class 2
    Regulation Number
    864.7415
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 23 510(k) clearances via K numbers.

    K Number Device Name
    K232027 CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
    K222635 Premier Resolution System
    K192931 V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control
    K180762 CAPI 3 HEMOGLOBIN(E)
    K171664 Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
    K112550 CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
    K112491 SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
    K091283 CAPILLARYS NEONAT HB (PN 2006)
    K082227 MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
    K080911 VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH
    K052291 CAPILLARY'S HEMOGLOBIN(E) (PN 2007)
    K050709 RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
    K051072 BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
    K040146 INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
    K955355 VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
    K955283 PRIMUS VARIANT SYSTEM PVS99
    K954048 VARIANT HEMOGLOBINOPATHY PROGRAM
    K924813 VARIANT SICKLE CELL SHORT PROGRAM
    K834595 PARAGON ACID HEMOGLOBIN REAGENT KIT
    K840011 RESOLVE-HB
    K822123 ISOPROPANOL HEMOGLOBIN STABILITY TEST
    K820573 HELENA HEMOGLOBIN DETECT COLUMN SYS
    K811894 ORTHO SICKLE CELL CONTROLS

    FEI Numbers

    This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.