DDG · Transferrin, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5880 · Class 2
Overview
| Product Code | DDG |
|---|---|
| Device Name | Transferrin, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5880 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 48)
Showing 20 most recent of 48 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240987 | Access sTfR | Beckman Coulter, Inc. | Jul 3, 2024 | SESE |
| K190495 | Transferrin | Biosystems S.A. | Mar 16, 2020 | SESE |
| K182095 | Tina-quant Transferrin ver.2 (urine application) | Roche Diagnostics Operations (Rdo) | Nov 5, 2018 | SESE |
| K120236 | TRANSFERRIN KIT FOR USE ON THE SPAPLUS | The Binding Site Group , Ltd. | Feb 13, 2013 | SESE |
| K080634 | ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 | Beckman Coulter, Inc. | Aug 11, 2008 | SESE |
| K081299 | DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA | Siemens Healthcare Diagnostics, Inc. | Aug 8, 2008 | SESE |
| K063086 | TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS | Thermo Electron OY | Aug 8, 2007 | SESE |
| K063766 | TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C | Good Biotech Corp. | Apr 23, 2007 | SESE |
| K063663 | DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H | Dade Behring, Inc. | Mar 21, 2007 | SESE |
| K063322 | DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H | Dade Behring, Inc. | Jan 24, 2007 | SESE |
| K053075 | N ANTISERA TO HUMAN TRANSFERRIN | Dade Behring, Inc. | Mar 16, 2006 | SESE |
| K042477 | VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN | Ortho-Clinical Diagnostics, Inc. | Nov 19, 2004 | SESE |
| K012393 | TINA-QUANT TRANSFERRIN VER.2 | Roche Diagnostics Corp. | Sep 19, 2001 | SESE |
| K012371 | TINA-QUANT TRANSFERRIN VER.2 | Roche Diagnostics Corp. | Sep 19, 2001 | SESE |
| K011662 | MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL | The Binding Site, Ltd. | Jul 30, 2001 | SESE |
| K003064 | TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323 | Roche Diagnostics Corp. | May 1, 2001 | SESE |
| K002585 | RANDOX TRANSFERRIN | Randox Laboratories, Ltd. | Feb 5, 2001 | SESE |
| K994294 | DIMENSION TRNF FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | Feb 4, 2000 | SESE |
| K993537 | K-ASSAY TRANSFERRIN | Kamiya Biomedical Co. | Nov 30, 1999 | SESE |
| K993162 | WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR | Wako Chemicals USA, Inc. | Nov 12, 1999 | SESE |
Top Applicants
- Dade Behring, Inc. — 5 clearances
- Beckman Instruments, Inc. — 4 clearances
- Roche Diagnostics Corp. — 3 clearances
- Boehringer Mannheim Corp. — 3 clearances
- The Binding Site, Ltd. — 2 clearances
