Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7470](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7470) → LCP — Assay, Glycosylated Hemoglobin # LCP · Assay, Glycosylated Hemoglobin _Hematology · 21 CFR 864.7470 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP ## Overview - **Product Code:** LCP - **Device Name:** Assay, Glycosylated Hemoglobin - **Regulation:** [21 CFR 864.7470](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7470) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) ## Identification A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 249) Showing 20 most recent of 249 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K221326](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K221326.md) | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | Nov 22, 2024 | SESE | | [K231465](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K231465.md) | Q-Pad Test System | Qurasense | Dec 6, 2023 | SESE | | [K214117](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K214117.md) | Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer | Abbott Diagnostics Technologies AS | Sep 27, 2023 | SESE | | [K192987](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K192987.md) | Aina HbA1c Monitoring System 2 | Jana Care, Inc. | Mar 26, 2020 | SESE | | [K192369](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K192369.md) | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. | Oct 29, 2019 | SESE | | [K183230](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K183230.md) | OneDraw A1C Test System | Drawbridge Health, Inc. | Aug 15, 2019 | SESE | | [K181915](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K181915.md) | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. | Apr 12, 2019 | SESE | | [K180509](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K180509.md) | Quo-Test A1c System | Ekf-Diagnostic GmbH | Feb 16, 2019 | SESE | | [K173127](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K173127.md) | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) | Skyla Corporation H.S.P.B | Sep 25, 2018 | SESE | | [K170623](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K170623.md) | ACE Hemoglobin A1c (HbA1c) Reagent | Alfa Wassermann Diagnostic Technologies, LLC | Feb 27, 2018 | SESE | | [K171650](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K171650.md) | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | Abbott Rapid Diagnostics | Nov 21, 2017 | SESE | | [K170147](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K170147.md) | Lucica Glycated Albumin-L | Asahi Kasei Pharma Corporation | Oct 12, 2017 | SESE | | [K163633](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K163633.md) | cobas HbA1c Test, cobas b 101 system | Roche Diagnostics Operations | Jul 28, 2017 | SESE | | [K161533](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K161533.md) | A1C EZ Glycohemoglobin Analysis System | Biohermes Co., Ltd. | Jun 16, 2017 | SESE | | [K162281](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K162281.md) | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | Sebia | Feb 17, 2017 | SESE | | [K160762](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K160762.md) | Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set | Diazyme Laboratories | Nov 21, 2016 | SESE | | [K142664](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K142664.md) | URight Hemoglobin A1c system, FORA A1c System | Taidoc Technology Corporation | Jan 29, 2016 | SESE | | [K140827](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K140827.md) | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set | Sd Biosensor, Inc. | Sep 30, 2015 | SESE | | [K151809](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K151809.md) | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer | Alere Technologies AS | Sep 25, 2015 | SESE | | [K141944](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K141944.md) | HOME ACCESS AIC TEST | Home Access Health Corp. | Mar 13, 2015 | SESE | ## Top Applicants - Helena Laboratories — 19 clearances - Bio-Rad — 15 clearances - Bio-Rad Laboratories, Inc. — 8 clearances - Abbott Laboratories — 7 clearances - Isolab, Inc. — 7 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com