Tina-Quant Albumin GEN.2
FDA 510(k) K113072 · Roche Diagnostics Operations
510(k) numberK113072
Submission
- Device name
- Tina-Quant Albumin GEN.2
- Applicant
- Roche Diagnostics Operations
Indianapolis, IN, US - Received
- October 17, 2011
- Decision date
- May 14, 2012
- 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 |
| K101089 | Easyra Micro-Albumin Reagent and CalibratorDCF · Traditional | Medica Corp. | 07/13/2011SE |
| K101203 | Tina-Quant Albumin Gen 2DCF · Traditional | Roche Diagnostics | 09/10/2010SE |
| 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 |
|---|---|---|
| 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 |
| K121610 | Cobas C 501 Tina-Quant HBA1CDX GEN.3 AssayPDJ · Traditional | 08/08/2013SE |
Questions and answers
When was Tina-Quant Albumin GEN.2 cleared by the FDA?
Tina-Quant Albumin GEN.2 (K113072) received a 510(k) decision of Substantially Equivalent on May 14, 2012, 210 days after the submission was received.
What is the product code of K113072?
The FDA product code is DCF – Albumin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5040.