ST Aia Pack HBA1C
FDA 510(k) K100304 · Tosoh Bioscience, Inc.
510(k) numberK100304
Submission
- Device name
- ST Aia Pack HBA1C
- Applicant
- Tosoh Bioscience, Inc.
South San Franciso, CA, US - Received
- February 3, 2010
- Decision date
- August 27, 2010
- 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 |
| 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 |
|---|---|---|
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ · Traditional | 10/03/2025SE |
| K211199 | ST AIA-PACK BNP AssayNBC · Special | 11/08/2021SE |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8PDJ · Traditional | 08/05/2021SE |
| K160113 | ST AIA-PACK hsE2 Calibrator SetJIT · Traditional | 02/17/2016SE |
| K153417 | ST AIA-PACK PROG III Calibrator SetJIT · Traditional | 12/18/2015SE |
| K150270 | ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH…MRG · Traditional | 10/26/2015SE |
| K143075 | ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetCDZ · Traditional | 07/02/2015SE |
| K143296 | AIA-PACK C-Peptide Control SetJJX · Traditional | 12/16/2014SE |
| K143144 | ST AIA-PACK PROG II Calibrator SetJIT · Traditional | 12/03/2014SE |
| K140648 | ST Aia-Pack C-Peptide II Calibrator SetJIT · Abbreviated | 04/10/2014SE |
Questions and answers
When was ST Aia Pack HBA1C cleared by the FDA?
ST Aia Pack HBA1C (K100304) received a 510(k) decision of Substantially Equivalent on August 27, 2010, 205 days after the submission was received.
What is the product code of K100304?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.