Primus A1CARE Assay
FDA 510(k) K062658 · Primus Corp.
510(k) numberK062658
Submission
- Device name
- Primus A1CARE Assay
- Applicant
- Primus Corp.
Kansas City, MO, US - Received
- September 6, 2006
- Decision date
- November 26, 2007
- 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 |
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| 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 |
|---|---|---|
| K013787 | Nycocard CRPDCK · Traditional | 05/14/2002SE |
| K014084 | Nycocard CRP ControlDCK · Traditional | 01/07/2002SE |
| K993131 | Nycocard HBA1C Glycosylated Hemoglobin AssayLCP · Traditional | 05/22/2000SE |
| K994045 | Primus Liquid Calibrator for GHB/A1C Level 1 and Level 2LCP · Special | 12/21/1999SE |
| K992921 | Primus Liquid Control for Ghb/Alc Level I and Level IILCP · Traditional | 11/12/1999SE |
| K955283 | Primus Variant System PVS99GKA · Traditional | 03/01/1996SE |
| K942009 | Primus Rapid Gel 100 Glycated Hemoglobin AssayLCP · Traditional | 09/14/1994SE |
| K940008 | Glycated Protein CalibratorsJIS · Traditional | 05/09/1994SE |
| K940142 | Glycated Protein ControlsJJX · Traditional | 04/26/1994SE |
| K936204 | Glycated Hemoglobin CalibratorsLCP · Traditional | 03/22/1994SE |
Questions and answers
When was Primus A1CARE Assay cleared by the FDA?
Primus A1CARE Assay (K062658) received a 510(k) decision of Substantially Equivalent on November 26, 2007, 446 days after the submission was received.
What is the product code of K062658?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.