Cobas C 501 Tina-Quant HBA1CDX GEN.3 Assay
FDA 510(k) K121610 · Roche Diagnostics Operations
510(k) numberK121610
Submission
- Device name
- Cobas C 501 Tina-Quant HBA1CDX GEN.3 Assay
- Applicant
- Roche Diagnostics Operations
Indianapolis, IN, US - Received
- June 1, 2012
- Decision date
- August 8, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDJ – Hemoglobin A1c Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1373
- Specialty
- Clinical Chemistry
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
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|---|---|---|---|
| K252749 | Medconn 8K Glycated Hemoglobin Test SystemPDJ · Traditional | Shanghai Medconn Medical Technology Co., Ltd. | 01/06/2026SE |
| K250073 | Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ · Traditional | Tosoh Bioscience, Inc. | 10/03/2025SE |
| K242911 | Medconn Glycated Hemoglobin Test systemPDJ · Traditional | Shanghai Medconn Medical Technology Co., Ltd. | 06/20/2025SE |
| K220999 | Hipro Glycosylated Hemoglobin (HbA1c) Test SystemPDJ · Traditional | Shijiazhuang Hipro Biotechnology Co., Ltd. | 09/12/2024SE |
| K200904 | Tosoh Automated Glycohemoglobin Analyzer HLC-723G8PDJ · Traditional | Tosoh Bioscience, Inc. | 08/05/2021SE |
| K200256 | ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssayPDJ · Special | Siemens Healthcare Diagnostics, Inc. | 07/02/2021SE |
| K193053 | Tina-quant Hemoglobin A1cDx Gen.3PDJ · Traditional | Roche Diagnostics Operations (Rdo) | 03/26/2020SE |
| K182651 | HbA1c AdvancedPDJ · Traditional | Beckman Coulter Ireland, Inc. | 01/16/2019SE |
| K182988 | Afinion HbA1c Dx on Afinion 2PDJ · Special | Alere Technologies AS | 11/29/2018SE |
| K173909 | Dimension Hemoglobin A1c AssayPDJ · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/13/2018SE |
More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241220 | Tina-quant Lipoprotein(a) Gen.2 MolarityDFC · Traditional | 01/24/2025SE |
| K233454 | ONLINE TDM MethotrexateLAO · Traditional | 02/20/2024SE |
| K163633 | cobas HbA1c Test, cobas b 101 systemLCP · Traditional | 07/28/2017SE |
| K131366 | Accu-Chek Aviva Expert Blood Glucose Monitoring SystemLFR · Traditional | 10/11/2013SE |
| K131029 | Accu-Chek Aviva Plus Test StripNBW · Special | 08/09/2013SE |
| K113072 | Tina-Quant Albumin GEN.2DCF · Traditional | 05/14/2012SE |
Questions and answers
When was Cobas C 501 Tina-Quant HBA1CDX GEN.3 Assay cleared by the FDA?
Cobas C 501 Tina-Quant HBA1CDX GEN.3 Assay (K121610) received a 510(k) decision of Substantially Equivalent on August 8, 2013, 433 days after the submission was received.
What is the product code of K121610?
The FDA product code is PDJ – Hemoglobin A1c Test System, a Class II (moderate risk) device regulated under 21 CFR 862.1373.