Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7415](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7415) → GKA — Abnormal Hemoglobin Quantitation # GKA · Abnormal Hemoglobin Quantitation _Hematology · 21 CFR 864.7415 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA ## Overview - **Product Code:** GKA - **Device Name:** Abnormal Hemoglobin Quantitation - **Regulation:** [21 CFR 864.7415](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7415) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) - **3rd-party reviewable:** yes ## Identification An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types. ## Classification Rationale Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. ## Special Controls *Classification.* Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. ## Recent Cleared Devices (20 of 23) Showing 20 most recent of 23 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K232027](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K232027.md) | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | Sebia | Apr 4, 2024 | SESE | | [K222635](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K222635.md) | Premier Resolution System | Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | Aug 4, 2023 | SESE | | [K192931](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K192931.md) | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | Helena Laboratories, Corp. | Apr 19, 2022 | SESE | | [K180762](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K180762.md) | CAPI 3 HEMOGLOBIN(E) | Sebia | Dec 14, 2018 | SESE | | [K171664](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K171664.md) | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | Bio-Rad Laboratories, Inc. | Sep 13, 2017 | SESE | | [K112550](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K112550.md) | CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM | Sebia | May 25, 2012 | SESE | | [K112491](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K112491.md) | SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 | Sebia | May 24, 2012 | SESE | | [K091283](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K091283.md) | CAPILLARYS NEONAT HB (PN 2006) | Sebia | Feb 22, 2010 | SESE | | [K082227](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K082227.md) | MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 | Sebia | Mar 26, 2009 | SESE | | [K080911](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K080911.md) | VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH | Bio-Rad Laboratories Inc., Clinical Systems Divisi | May 2, 2008 | SESE | | [K052291](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K052291.md) | CAPILLARY'S HEMOGLOBIN(E) (PN 2007) | Sebia | Jun 27, 2006 | SESE | | [K050709](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K050709.md) | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 | Wallac OY | Mar 8, 2006 | SESE | | [K051072](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K051072.md) | BIO-RAD VARIANT NBS SICKLE CELL PROGRAM | Bio-Rad Laboratories, Inc. | May 12, 2005 | SESE | | [K040146](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K040146.md) | INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | May 4, 2004 | SESE | | [K955355](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K955355.md) | VARIANT ALPHA-THALASSEMIA SHORT PROGRAM | Bio-Rad | Apr 26, 1996 | SESE | | [K955283](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K955283.md) | PRIMUS VARIANT SYSTEM PVS99 | Primus Corp. | Mar 1, 1996 | SESE | | [K954048](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K954048.md) | VARIANT HEMOGLOBINOPATHY PROGRAM | Bio-Rad | Nov 20, 1995 | SESE | | [K924813](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K924813.md) | VARIANT SICKLE CELL SHORT PROGRAM | Bio-Rad | Jan 14, 1993 | SESE | | [K834595](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K834595.md) | PARAGON ACID HEMOGLOBIN REAGENT KIT | Beckman Instruments, Inc. | May 7, 1984 | SESE | | [K840011](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA/K840011.md) | RESOLVE-HB | Isolab, Inc. | Feb 4, 1984 | SESE | ## Top Applicants - Sebia — 7 clearances - Bio-Rad — 3 clearances - Bio-Rad Laboratories, Inc. — 2 clearances - Helena Laboratories — 2 clearances - Beckman Instruments, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GKA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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