HBA1C Enzymatic Assay
FDA 510(k) K050178 · General Atomics
510(k) numberK050178
Submission
- Device name
- HBA1C Enzymatic Assay
- Applicant
- General Atomics
San Diego, CA, US - Received
- January 26, 2005
- Decision date
- June 28, 2005
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K082488 | Diazyme Lp(A) AssayDFC · Traditional | 01/13/2009SE |
| K072977 | Diazyme Apolipoprotein A-1 AssayMSJ · Traditional | 07/16/2008SE |
| K072523 | Diazyme Ldl-Cholesterol Reagent, Calibrator and ControlsLBR · Traditional | 01/22/2008SE |
| K042448 | Diazyme Homocysteine Enzymatic Assay KitJJX · Traditional | 10/29/2004SE |
| K033360 | Diazyme Lithium Enzymatic Assay KitJII · Traditional | 12/23/2003SE |
Questions and answers
When was HBA1C Enzymatic Assay cleared by the FDA?
HBA1C Enzymatic Assay (K050178) received a 510(k) decision of Substantially Equivalent on June 28, 2005, 153 days after the submission was received.
What is the product code of K050178?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.