ACE Hemoglobin A1c (HbA1c) Reagent
FDA 510(k) K170623 · Alfa Wassermann Diagnostic Technologies, LLC
510(k) numberK170623
Submission
- Device name
- ACE Hemoglobin A1c (HbA1c) Reagent
- Applicant
- Alfa Wassermann Diagnostic Technologies, LLC
West Caldwell, NJ, US - Received
- March 1, 2017
- Decision date
- February 27, 2018
- 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 |
| K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzerLCP · Special | Abbott Rapid Diagnostics | 11/21/2017SE |
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| K122757 | Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent, Ace Triglycerides ReagentCHH · Traditional | 10/05/2012SE |
| K113389 | Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine ReagentCDN · Traditional | 08/10/2012SE |
| K113437 | Ace Hemoglobin Alc(Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace…LCP · Traditional | 08/06/2012SE |
| K113374 | Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace…CIX · Traditional | 07/13/2012SE |
| K113262 | Ace Cholesterol Reagent, Ace Hdl-C Reagent, Ace Ldl-C Reagent-C, Ace-Trislycerides ReagentCHH · Traditional | 07/03/2012SE |
| K113438 | Ace Direct Totaliron-Binding Capacity (Tibc) Reagent, Ace Serum Iron Reagent, Ace Lipase…JMO · Traditional | 06/01/2012SE |
Questions and answers
When was ACE Hemoglobin A1c (HbA1c) Reagent cleared by the FDA?
ACE Hemoglobin A1c (HbA1c) Reagent (K170623) received a 510(k) decision of Substantially Equivalent on February 27, 2018, 363 days after the submission was received.
What is the product code of K170623?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.