Hemoglobin A1C Reagent Set
FDA 510(k) K031539 · Pointe Scientific, Inc.,
510(k) numberK031539
Submission
- Device name
- Hemoglobin A1C Reagent Set
- Applicant
- Pointe Scientific, Inc.,
Lincoln Park, MI, US - Received
- May 16, 2003
- Decision date
- August 6, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K070757 | Microprotein Reagent SetJGP · Traditional | 12/04/2007SE |
| K062118 | Pointe 360CFR · Traditional | 07/13/2007SE |
| K070251 | Carbon Dioxide Liquid Stable ReagentKHS · Traditional | 04/30/2007SE |
| K070207 | Multi-Analyte Chemistry CalibratorJIX · Abbreviated | 04/13/2007SE |
| K070504 | Ammonia/Alcohol Control SetJJY · Abbreviated | 04/11/2007SE |
| K061377 | Apolipoprotein A1 and Apolipoprotein B Reagents and CalibratorsMSJ · Traditional | 03/28/2007SE |
| K051646 | Ise Diluent, 1N KCL, Internal Reference and Ise Standards Low and HighJGS · Traditional | 10/07/2005SE |
| K040391 | Total Bilirubin Reagent SetCIG · Traditional | 06/02/2004SE |
| K023860 | Microalbumin Reagent Set and CalibratorsDDZ · Traditional | 04/28/2003SE |
| K024006 | G6PDH, GLUCOSE-6-PHOSHATE DehydrogenaseJBF · Traditional | 03/31/2003SE |
Questions and answers
When was Hemoglobin A1C Reagent Set cleared by the FDA?
Hemoglobin A1C Reagent Set (K031539) received a 510(k) decision of Substantially Equivalent on August 6, 2003, 82 days after the submission was received.
What is the product code of K031539?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.