Dri Hemoglobin A1C Assay and Calibrators
FDA 510(k) K053411 · Microgenics Corp.
510(k) numberK053411
Submission
- Device name
- Dri Hemoglobin A1C Assay and Calibrators
- Applicant
- Microgenics Corp.
Fremont Blvd., CA, US - Received
- December 7, 2005
- Decision date
- February 3, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7470
- Specialty
- Hematology
Other 510(k)s with product code LCP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro AnalyzerLCP · Dual Track | Nova Biomedical Corporation | 11/22/2024SE |
| K231465 | Q-Pad Test SystemLCP · Traditional | Qurasense | 12/06/2023SE |
| K214117 | Afinion HbA1c, Afinion 2 and Alere Afinion AS100 AnalyzerLCP · Dual Track | Abbott Diagnostics Technologies AS | 09/27/2023SE |
| K192987 | Aina HbA1c Monitoring System 2LCP · Traditional | Jana Care, Inc. | 03/26/2020SE |
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP · Traditional | Ixensor Co, Ltd. | 10/29/2019SE |
| K183230 | OneDraw A1C Test SystemLCP · Traditional | Drawbridge Health, Inc. | 08/15/2019SE |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP · Traditional | Ixensor Co, Ltd. | 04/12/2019SE |
| K180509 | Quo-Test A1c SystemLCP · Dual Track | Ekf-Diagnostic GmbH | 02/16/2019SE |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent…LCP · Traditional | Skyla Corporation H.S.P.B | 09/25/2018SE |
| K170623 | ACE Hemoglobin A1c (HbA1c) ReagentLCP · Traditional | Alfa Wassermann Diagnostic Technologies, LLC | 02/27/2018SE |
More from Alfa Wassermann Diagnostic Technologies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K243498 | Alinity c Benzodiazepines Reagent KitJXM · Special | 12/11/2024SE |
| K240670 | DRI Ecstasy Plus AssayDKZ · Special | 10/30/2024SE |
| K231020 | Alinity c Tricyclic Antidepressants Reagent KitLFH · Traditional | 11/17/2023SE |
| K231007 | CEDIA Heroin Metabolite (6-AM) AssayDJG · Traditional | 09/27/2023SE |
| K213875 | DRI TM Tricyclics Serum Tox AssayLFH · Traditional | 12/21/2022SE |
| K211973 | DRI Cocaine Metabolite AssayDIO · Traditional | 09/24/2021SE |
| K192943 | CEDIA Heroin Metabolite (6-AM) assayDJG · Traditional | 12/16/2019SE |
| K190968 | CEDIA Benzodiazepine AssayJXM · Traditional | 12/09/2019SE |
| K181499 | DRI Cocaine Metabolite AssayDIO · Traditional | 07/06/2018SE |
| K173963 | DRI Benzodiazepine AssayJXM · Traditional | 02/21/2018SE |
Questions and answers
When was Dri Hemoglobin A1C Assay and Calibrators cleared by the FDA?
Dri Hemoglobin A1C Assay and Calibrators (K053411) received a 510(k) decision of Substantially Equivalent on February 3, 2006, 58 days after the submission was received.
What is the product code of K053411?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.