LCP · Assay, Glycosylated Hemoglobin
Hematology · 21 CFR 864.7470 · Class 2
Overview
| Product Code | LCP |
|---|---|
| Device Name | Assay, Glycosylated Hemoglobin |
| Regulation | 21 CFR 864.7470 |
| Device Class | Class 2 |
| Review Panel | Hematology |
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 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | Nov 22, 2024 | SESE |
| K231465 | Q-Pad Test System | Qurasense | Dec 6, 2023 | SESE |
| K214117 | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 Analyzer | Abbott Diagnostics Technologies AS | Sep 27, 2023 | SESE |
| K192987 | Aina HbA1c Monitoring System 2 | Jana Care, Inc. | Mar 26, 2020 | SESE |
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. | Oct 29, 2019 | SESE |
| K183230 | OneDraw A1C Test System | Drawbridge Health, Inc. | Aug 15, 2019 | SESE |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. | Apr 12, 2019 | SESE |
| K180509 | Quo-Test A1c System | Ekf-Diagnostic GmbH | Feb 16, 2019 | SESE |
| K173127 | 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 | ACE Hemoglobin A1c (HbA1c) Reagent | Alfa Wassermann Diagnostic Technologies, LLC | Feb 27, 2018 | SESE |
| K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | Abbott Rapid Diagnostics | Nov 21, 2017 | SESE |
| K170147 | Lucica Glycated Albumin-L | Asahi Kasei Pharma Corporation | Oct 12, 2017 | SESE |
| K163633 | cobas HbA1c Test, cobas b 101 system | Roche Diagnostics Operations | Jul 28, 2017 | SESE |
| K161533 | A1C EZ Glycohemoglobin Analysis System | Biohermes Co., Ltd. | Jun 16, 2017 | SESE |
| K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | Sebia | Feb 17, 2017 | SESE |
| K160762 | 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 | URight Hemoglobin A1c system, FORA A1c System | Taidoc Technology Corporation | Jan 29, 2016 | SESE |
| K140827 | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set | Sd Biosensor, Inc. | Sep 30, 2015 | SESE |
| K151809 | Alere Afinion HbA1c, Alere Afinion AS100 Analyzer | Alere Technologies AS | Sep 25, 2015 | SESE |
| K141944 | 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
