CEE · Radioimmunoassay, Thyroxine-Binding Globulin
Clinical Chemistry · 21 CFR 862.1685 · Class 2
Overview
| Product Code | CEE |
|---|---|
| Device Name | Radioimmunoassay, Thyroxine-Binding Globulin |
| Regulation | 21 CFR 862.1685 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A thyroxine-binding globulin test system is a device intended to measure thyroxine (thyroid)-binding globulin (TBG), a plasma protein which binds thyroxine, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
Classification Rationale
Class II (special controls). 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.
Special Controls
*Classification.* Class II (special controls). 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 25)
Showing 20 most recent of 25 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952284 | AMERLITE TBG ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | Jul 26, 1995 | SESE |
| K930010 | ACCESS THYROID UPTAKE ASSAY | Bio-Rad Laboratories, Inc. | Jun 7, 1993 | SESE |
| K910677 | IMMULITE(TM) T-UPTAKE | Cirrus Diagnostics, Inc. | Apr 29, 1991 | SESE |
| K905777 | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT | Immunotech Corp. | Jan 30, 1991 | SESE |
| K900240 | DELFIA TBG KIT | Pharmacia, Inc. | Mar 30, 1990 | SESE |
| K896991 | ENZYMUN TEST(R) TBK | Boehringer Mannheim Corp. | Mar 1, 1990 | SESE |
| K893469 | AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT | Amersham Corp. | Aug 15, 1989 | SESE |
| K885034 | T-UPTAKE MICROASSAY | Diamedix Corp. | Feb 2, 1989 | SESE |
| K884201 | FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT | Cyberfluor, Inc. | Dec 14, 1988 | SESE |
| K874658 | TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) | Technicon Instruments Corp. | Dec 18, 1987 | SESE |
| K862109 | ENZYMUN TEST TBG | Boehringer Mannheim Corp. | Jun 30, 1986 | SESE |
| K861735 | TIPSEP-TBG ASSAY | Nuclear Diagnostics, Inc. | Jun 13, 1986 | SESE |
| K842167 | TBG RIA | Syncor Intl. Corp. | Jul 9, 1984 | SESE |
| K842010 | THYROXINE-BINDING GLOBULIN RADIOUMMU | Nichols Institute Diagnostics | Jun 25, 1984 | SESE |
| K841024 | VENTREZYME T4U IMMUNOASSAY T4U | Ventrex Laboratories, Inc. | May 9, 1984 | SESE |
| K822684 | ENDAB THYROID UPTAKE | Immunotech Corp. | Oct 8, 1982 | SESE |
| K820252 | TBG DIAGNOSTIC KIT | Diagnostic Reagents, Inc. | May 5, 1982 | SESE |
| K810967 | IN-VITRO TBG RADIOIMMUNOASSAY TEST | Clinical Assays, Inc. | Apr 23, 1981 | SESE |
| K800204 | RIA PHASE TBG | Boehringer Mannheim Corp. | Mar 19, 1980 | SESE |
| K781225 | GLOBULIN TEST, HUMAN THYROXINE BINDING | Hyland Therapeutic Div., Travenol Laboratories | Aug 31, 1978 | SESE |
Top Applicants
- Boehringer Mannheim Corp. — 3 clearances
- Nuclear Diagnostics, Inc. — 3 clearances
- Immunotech Corp. — 2 clearances
- Amersham Corp. — 1 clearance
- Bio-Rad — 1 clearance
