Albumin, Antigen, Antiserum, Control
FDA product code DCF · Class II (moderate risk) · 21 CFR 866.5040 · Immunology
37510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Kallestad Diag, A Div. of Erbamont, Inc. 4
- The Binding Site Group , Ltd. 3
- Technicon Instruments Corp. 2
- Roche Diagnostics Corp. 2
- Dade Behring, Inc. 2
- Behring Diagnostics, Inc. 2
- Unipath , Ltd. 2
- Beckman Instruments, Inc. 2
- Orion Corp. 1
- Wampole Laboratories 1
- Cooper Biomedical, Inc. 1
- Intl. Diagnostic Technology 1
- Dako Corp. 1
- The Binding Site, Ltd. 1
- International Enzymes, Inc. 1
- Roche Diagnostic Systems, Inc. 1
- Ortho Diagnostics, Inc. 1
- Beckman Coulter Ireland, Inc. 1
- Diagnostic Chemicals , Ltd. 1
- Polymedco, Inc. 1
510(k) clearances
| 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 |
| 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 |
| K053553 | Nycocard U-Albumin and U-Albumin ControlDCF · Traditional | Polymedco, Inc. | 03/09/2006SE |
| K051191 | DCL Microalbumin Assay, Model 252-20DCF · Traditional | Diagnostic Chemicals , Ltd. | 07/05/2005SE |
| K042643 | Vitros Chemistry Product Malb Reagent, Calibrator Kit 24, Malb Performance Verifiers I…DCF · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/18/2004SE |
| K033525 | Dimension Microalbumin (Malb) Flex Reagent Cartridge Method, Calibrator, Models DF114…DCF · Traditional | Dade Behring, Inc. | 01/12/2004SE |
| K972929 | N Antiserum to Human AlbuminDCF · Traditional | Behring Diagnostics, Inc. | 10/20/1997SE |
| K964695 | Immage Immunochemistry System Albumin (Alb) ReagentDCF · Traditional | Beckman Instruments, Inc. | 04/29/1997SE |
| K961824 | Cobas Integra Reagent Cassettes for Albumin, Hbalc and DigoxinDCF · Traditional | Roche Diagnostic Systems, Inc. | 07/23/1996SE |
| K953927 | Linical Protein Vi Calibration Verifiers Levels A-E for Beckman Array Protein SystemDCF · Traditional | International Enzymes, Inc. | 09/15/1995SE |
| K914391 | Albumin Test Rid KitDCF · Traditional | The Binding Site, Ltd. | 12/10/1991SE |
| K900167 | Turbiquant Immunoglobulin & Albumin KitDCF · Traditional | Behring Diagnostics, Inc. | 01/22/1990SE |
| K896059 | Modified QM300 Albumin Antibody PackDCF · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 11/06/1989SE |
| K895808 | Technicon DPA-1(TM) System Serum AlbuminDCF · Traditional | Technicon Instruments Corp. | 10/17/1989SE |
| K882153 | Technicon DPA-1(TM) SystemDCF · Traditional | Technicon Instruments Corp. | 08/04/1988SE |
| K882082 | QM300 Albumin Antibody PackDCF · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 07/08/1988SE |
| K881127 | QM300 Calibrator D PackDCF · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 04/21/1988SE |
| K881126 | QM300 Albumin Antibody PackDCF · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 04/06/1988SE |
| K875161 | Mat (TM) Microalbumin TestDCF · Traditional | Wampole Laboratories | 02/17/1988SE |
| K873862 | Albumin in SerumDCF · Traditional | Unipath , Ltd. | 10/20/1987SE |
| K873861 | Albumin in UrineDCF · Traditional | Unipath , Ltd. | 10/13/1987SE |
| K862671 | Microalbuminuria AssayDCF · Traditional | Orion Corp. | 09/18/1986SE |
| K851285 | Radial Immunodiffusion Plates CSF Igg & CSF AlbumiDCF · Traditional | Cooper Biomedical, Inc. | 06/17/1985SE |
| K812496 | Immunogl. Frct. of Rabbit Antiser.-AlbumDCF · Traditional | Dako Corp. | 09/23/1981SE |
| K802404 | Ortho Bovine Albumin Solution 30% ProteDCF · Traditional | Ortho Diagnostics, Inc. | 10/23/1980SE |
| K780913 | Additional Reagents Kits for Imm. SystemDCF · Traditional | Beckman Instruments, Inc. | 06/22/1978SE |
| K771771 | Quan. Color. Deter. of Serum AlbuminDCF · Traditional | Stanbio Laboratory | 10/07/1977SE |
| K761225 | Low Level Human Albumin Test KitsDCF · Traditional | Intl. Diagnostic Technology | 04/07/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0739-2020 Class II | 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute…Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine… | Ortho Clinical Diagnostics Inc | 10/14/2019Terminated |
| Z-2124-2017 Class II | Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when…Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the… | Beckman Coulter Inc. | 04/24/2017Terminated |
| Z-1831-2013 Class II | uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2…Product fails to meet the accuracy at the low end of the measuring range. | Wako Life Sciences, Inc. | 04/30/2013Terminated |