Radioimmunoassay, Thyroxine-Binding Globulin
The Thyroxine-Binding Globulin Radioimmunoassay is a clinical chemistry device that uses radiolabeled immunoassay methods to measure the concentration of thyroxine-binding globulin (TBG) in serum, used in the interpretation of thyroid hormone levels and investigation of abnormal total thyroid hormone results due to TBG abnormalities. It is classified as FDA Class 2 (moderate risk), though it is exempt from 510(k) premarket notification. The product code is CEE, regulated under 21 CFR 862.1685, within the Clinical Chemistry medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- CEE
- Device Class
- FDA class 2
- Regulation Number
- 862.1685
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 25 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K952284 | AMERLITE TBG ASSAY | Jul 26, 1995 | Substantially Equivalent | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
| K930010 | ACCESS THYROID UPTAKE ASSAY | Jun 07, 1993 | Substantially Equivalent | BIO-RAD LABORATORIES, INC. |
| K910677 | IMMULITE(TM) T-UPTAKE | Apr 29, 1991 | Substantially Equivalent | CIRRUS DIAGNOSTICS, INC. |
| K905777 | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT | Jan 30, 1991 | Substantially Equivalent | IMMUNOTECH CORP. |
| K900240 | DELFIA TBG KIT | Mar 30, 1990 | Substantially Equivalent | PHARMACIA, INC. |
| K896991 | ENZYMUN TEST(R) TBK | Mar 01, 1990 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K893469 | AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT | Aug 15, 1989 | Substantially Equivalent | AMERSHAM CORP. |
| K885034 | T-UPTAKE MICROASSAY | Feb 02, 1989 | Substantially Equivalent | DIAMEDIX CORP. |
| K884201 | FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT | Dec 14, 1988 | Substantially Equivalent | CYBERFLUOR, INC. |
| K874658 | TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) | Dec 18, 1987 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K862109 | ENZYMUN TEST TBG | Jun 30, 1986 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K861735 | TIPSEP-TBG ASSAY | Jun 13, 1986 | Substantially Equivalent | NUCLEAR DIAGNOSTICS, INC. |
| K842167 | TBG RIA | Jul 09, 1984 | Substantially Equivalent | SYNCOR INTL. CORP. |
| K842010 | THYROXINE-BINDING GLOBULIN RADIOUMMU | Jun 25, 1984 | Substantially Equivalent | NICHOLS INSTITUTE DIAGNOSTICS |
| K841024 | VENTREZYME T4U IMMUNOASSAY T4U | May 09, 1984 | Substantially Equivalent | VENTREX LABORATORIES, INC. |
| K822684 | ENDAB THYROID UPTAKE | Oct 08, 1982 | Substantially Equivalent | IMMUNOTECH CORP. |
| K820252 | TBG DIAGNOSTIC KIT | May 05, 1982 | Substantially Equivalent | DIAGNOSTIC REAGENTS, INC. |
| K810967 | IN-VITRO TBG RADIOIMMUNOASSAY TEST | Apr 23, 1981 | Substantially Equivalent | CLINICAL ASSAYS, INC. |
| K800204 | RIA PHASE TBG | Mar 19, 1980 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K781225 | GLOBULIN TEST, HUMAN THYROXINE BINDING | Aug 31, 1978 | Substantially Equivalent | HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
| K780671 | 125 I-T3 UPTAKE REAGENT | Jun 06, 1978 | Substantially Equivalent | RADIOIMMUNOASSAY, INC. |
| K780486 | STIKSEP-T3 KIT | Apr 28, 1978 | Substantially Equivalent | NUCLEAR DIAGNOSTICS, INC. |
| K772183 | THYROID BINDING GLOBULIN | Dec 20, 1977 | Substantially Equivalent | CORNING MEDICAL & SCIENTIFIC |
| K771341 | SPINSEP-TBG | Aug 10, 1977 | Substantially Equivalent | NUCLEAR DIAGNOSTICS, INC. |
| K760134 | PROCEDURE, RA, THYROXINE BINDING PROTEIN | Jul 20, 1976 | Substantially Equivalent | BIO-RAD |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.