Quo-Test A1c System
FDA 510(k) K180509 · Ekf-Diagnostic GmbH
510(k) numberK180509
Submission
- Device name
- Quo-Test A1c System
- Applicant
- Ekf-Diagnostic GmbH
Barleben, DE - Received
- February 27, 2018
- Decision date
- February 16, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Dual Track 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 |
| 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 |
| K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzerLCP · Special | Abbott Rapid Diagnostics | 11/21/2017SE |
More from Abbott Rapid Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K200909 | Hemo Control (optional Add Pack Hemo Control DM)GKR · Special | 06/12/2020SE |
| K172173 | DiaSpect Tm, DiaSpect Tm CuvettesGKR · Traditional | 04/06/2018SE |
| K110393 | Ekf- Diagnostic Hemo_Control Hemoglobin Measurement System; Ekf-Diagnostic Hemoglobin…GKR · Special | 03/04/2011SE |
| K031898 | Ekf Diagnostic Hemo Control Hemoglobin Measurement SystemGKR · Traditional | 09/24/2003SE |
Questions and answers
When was Quo-Test A1c System cleared by the FDA?
Quo-Test A1c System (K180509) received a 510(k) decision of Substantially Equivalent on February 16, 2019, 354 days after the submission was received.
What is the product code of K180509?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.