Atlas FDA

TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323

FDA 510(k) clearance K003064 · decided 2001-05-01

Clearance details

K-number
K003064
Device name
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2000-10-02
Decision date
2001-05-01
Days to decision
211 days
Clearance type
Traditional
Product code
DDG
Device class
2
Regulation number
866.5880
Medical specialty
Immunology
Advisory committee
Immunology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Roche Diagnostics Corp.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Access sTfR (K240987)Beckman Coulter, Inc.2024-07-03
Transferrin (K190495)Biosystems S.A.2020-03-16
Tina-quant Transferrin ver.2 (urine application) (K182095)Roche Diagnostics Operations (Rdo)2018-11-05
TRANSFERRIN KIT FOR USE ON THE SPAPLUS (K120236)The Binding Site Group , Ltd.2013-02-13
ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 (K080634)Beckman Coulter, Inc.2008-08-11
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA (K081299)Siemens Healthcare Diagnostics, Inc.2008-08-08
TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS (K063086)Thermo Electron OY2007-08-08
TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C (K063766)Good Biotech Corp.2007-04-23
DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H (K063663)Dade Behring, Inc.2007-03-21
DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H (K063322)Dade Behring, Inc.2007-01-24
N ANTISERA TO HUMAN TRANSFERRIN (K053075)Dade Behring, Inc.2006-03-16
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN (K042477)Ortho-Clinical Diagnostics, Inc.2004-11-19

Recalls involving this device

RecordFirmDate
Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c sys recall (Z-0009-2009)Roche Diagnostics Corp.2008-10-09

PMA approvals by this applicant

RecordFirmDate
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043)Roche Diagnostics Corp.2025-05-27
ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044)Roche Diagnostics Corp.2025-05-27
Elecsys Anti-HBc II (P100031/S033)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc II (P100032/S023)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110031/S027)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110022/S034)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBs (P010054/S048)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025)Roche Diagnostics Corp.2024-11-22