Tina-Quant Albumin Gen 2
FDA 510(k) K101203 · Roche Diagnostics
510(k) numberK101203
Submission
- Device name
- Tina-Quant Albumin Gen 2
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- April 29, 2010
- Decision date
- September 10, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DCF – Albumin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5040
- Specialty
- Immunology
Other 510(k)s with product code DCF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153560 | Optilite Low Level Albumin KitDCF · Traditional | The Binding Site Group , Ltd. | 08/25/2016SE |
| K143118 | Human Microalbumin kit for use on SPAPLUSDCF · Traditional | The Binding Site Group , Ltd. | 05/26/2015SE |
| K142346 | Urine/CSF Albumin, Urine/CSF Albumin CalibratorDCF · Traditional | Beckman Coulter Ireland, Inc. | 10/15/2014SE |
| K121045 | Human Albumin CSF KitDCF · Traditional | The Binding Site Group , Ltd. | 06/19/2013SE |
| K113072 | Tina-Quant Albumin GEN.2DCF · Traditional | Roche Diagnostics Operations | 05/14/2012SE |
| K101089 | Easyra Micro-Albumin Reagent and CalibratorDCF · Traditional | Medica Corp. | 07/13/2011SE |
| K100853 | Cobas 8000 Modular Series AnalyzerDCF · Special | Roche Diagnostics Corp. | 09/09/2010SE |
| K091486 | K-Assay Microalbumin and K-Assay Microalbumin CalibratorDCF · Traditional | Kamiya Biomedical Co. | 04/29/2010SE |
| K082251 | Synchron Systems Microalbumin (Ma) Reagent, Model 475100DCF · Traditional | Beckman Coulter, Inc. | 04/08/2009SE |
| K061990 | Dimension Vista Microalbumin Flex Reagent Cartridge; Protein 3 Calibrator; Protein 3…DCF · Traditional | Dade Behring, Inc. | 09/19/2006SE |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261686 | Elecsys Phospho-Tau (217P) PlasmaSET · Traditional | 08/19/2026SE |
| K252323 | cobas pulse blood glucose monitoring systemPZI · Dual Track | 06/12/2026SE |
| K252431 | Elecsys CalcitoninJKR · Traditional | 04/24/2026SE |
| K252280 | Elecsys Anti-SARS-CoV-2 SQVP · Traditional | 04/13/2026SE |
| K260049 | Elecsys Anti-HBc IgMSEI · Traditional | 04/07/2026SE |
| K260048 | Elecsys Anti-HAV IgMLOL · Traditional | 04/07/2026SE |
| K260046 | Elecsys Anti-HBc IISEI · Traditional | 04/07/2026SE |
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | 04/02/2026SE |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutionsCFR · Traditional | 02/12/2026SE |
Questions and answers
When was Tina-Quant Albumin Gen 2 cleared by the FDA?
Tina-Quant Albumin Gen 2 (K101203) received a 510(k) decision of Substantially Equivalent on September 10, 2010, 134 days after the submission was received.
What is the product code of K101203?
The FDA product code is DCF – Albumin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5040.