KHQ · Radioassay, Triiodothyronine Uptake
Clinical Chemistry · 21 CFR 862.1715 · Class 2
Overview
| Product Code | KHQ |
|---|---|
| Device Name | Radioassay, Triiodothyronine Uptake |
| Regulation | 21 CFR 862.1715 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A triiodothyronine uptake test system is a device intended to measure the total amount of binding sites available for binding thyroid hormone on the thyroxine-binding proteins, thyroid-binding globulin, thyroxine-binding prealbumin, and albumin of serum and plasma. The device provides an indirect measurement of thyrkoxine levels in serum and plasma. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders.
Classification Rationale
Class II. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (20 of 93)
Showing 20 most recent of 93 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K981375 | ACE T UPTAKE REAGENT TU CALIBRATORS | Schiapparelli Biosystems, Inc. | Jun 10, 1998 | SESE |
| K980088 | T-UPTAKE MICROPLATE EIA | Monobind | Feb 4, 1998 | SESE |
| K970539 | CHIRON DIAGNOSTICS ACS:180TU P | Chiron Diagnostics Corp. | Mar 24, 1997 | SESE |
| K964308 | VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) | Johnson & Johnson Clinical Diagnostics, Inc. | Nov 27, 1996 | SESE |
| K961488 | ELECSYS T-UPTAKE ASSAY | Boehringer Mannheim Corp. | Jun 12, 1996 | SESE |
| K954807 | CEDIA T UPTAKE ASSAY | Boehringer Mannheim Corp. | Dec 21, 1995 | SESE |
| K951586 | T-UPTAKE EIA TEST | Diagnostic Reagents, Inc. | May 15, 1995 | SESE |
| K933414 | STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | Nov 22, 1994 | SESE |
| K934312 | AXSYM(TM) T-UPTAKE | Abbott Laboratories | Jun 21, 1994 | SESE |
| K935816 | VIDAS T UPTAKE | Biomerieux Vitek, Inc. | Mar 22, 1994 | SESE |
| K926220 | T3 UPTAKE CHEMILUMINESCENCE ASSAY | Nichols Institute Diagnostics | Nov 17, 1993 | SESE |
| K931294 | IQ TUPTAKE ASSAY | Becton Dickinson Advanced Diagnostics | Jul 22, 1993 | SESE |
| K926443 | COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS | Roche Diagnostic Systems, Inc. | May 20, 1993 | SESE |
| K925257 | CIBA CORNING ACS T UPTAKE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Dec 28, 1992 | SESE |
| K923676 | VISTA THYROXINE UPTAKE ASSAY | Syva Co. | Oct 9, 1992 | SESE |
| K913663 | AIA-PACK T-U | Tosoh Corp. | Sep 30, 1991 | SESE |
| K911912 | SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) | Serono-Baker Diagnostics, Inc. | Sep 18, 1991 | SESE |
| K911093 | CIBA CORNING ACS T UPTAKE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Apr 29, 1991 | SESE |
| K903396 | IL T UPTAKE ASSAY SYSTEM | Instrumentation Laboratory CO | Oct 12, 1990 | SESE |
| K902748 | SEROZYME FREE T3 IMMUNOASSAY | Advanced Magnetics, Inc. | Aug 9, 1990 | SESE |
Top Applicants
- Syva Co. — 5 clearances
- Miles Laboratories, Inc. — 3 clearances
- Ciba Corning Diagnostics Corp. — 3 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 3 clearances
- Amersham Corp. — 3 clearances
