Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1685](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1685) → CEE — Radioimmunoassay, Thyroxine-Binding Globulin # CEE · Radioimmunoassay, Thyroxine-Binding Globulin _Clinical Chemistry · 21 CFR 862.1685 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE ## Overview - **Product Code:** CEE - **Device Name:** Radioimmunoassay, Thyroxine-Binding Globulin - **Regulation:** [21 CFR 862.1685](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1685) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## 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](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K952284.md) | AMERLITE TBG ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | Jul 26, 1995 | SESE | | [K930010](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K930010.md) | ACCESS THYROID UPTAKE ASSAY | Bio-Rad Laboratories, Inc. | Jun 7, 1993 | SESE | | [K910677](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K910677.md) | IMMULITE(TM) T-UPTAKE | Cirrus Diagnostics, Inc. | Apr 29, 1991 | SESE | | [K905777](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K905777.md) | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT | Immunotech Corp. | Jan 30, 1991 | SESE | | [K900240](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K900240.md) | DELFIA TBG KIT | Pharmacia, Inc. | Mar 30, 1990 | SESE | | [K896991](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K896991.md) | ENZYMUN TEST(R) TBK | Boehringer Mannheim Corp. | Mar 1, 1990 | SESE | | [K893469](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K893469.md) | AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT | Amersham Corp. | Aug 15, 1989 | SESE | | [K885034](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K885034.md) | T-UPTAKE MICROASSAY | Diamedix Corp. | Feb 2, 1989 | SESE | | [K884201](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K884201.md) | FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT | Cyberfluor, Inc. | Dec 14, 1988 | SESE | | [K874658](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K874658.md) | TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) | Technicon Instruments Corp. | Dec 18, 1987 | SESE | | [K862109](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K862109.md) | ENZYMUN TEST TBG | Boehringer Mannheim Corp. | Jun 30, 1986 | SESE | | [K861735](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K861735.md) | TIPSEP-TBG ASSAY | Nuclear Diagnostics, Inc. | Jun 13, 1986 | SESE | | [K842167](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K842167.md) | TBG RIA | Syncor Intl. Corp. | Jul 9, 1984 | SESE | | [K842010](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K842010.md) | THYROXINE-BINDING GLOBULIN RADIOUMMU | Nichols Institute Diagnostics | Jun 25, 1984 | SESE | | [K841024](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K841024.md) | VENTREZYME T4U IMMUNOASSAY T4U | Ventrex Laboratories, Inc. | May 9, 1984 | SESE | | [K822684](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K822684.md) | ENDAB THYROID UPTAKE | Immunotech Corp. | Oct 8, 1982 | SESE | | [K820252](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K820252.md) | TBG DIAGNOSTIC KIT | Diagnostic Reagents, Inc. | May 5, 1982 | SESE | | [K810967](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K810967.md) | IN-VITRO TBG RADIOIMMUNOASSAY TEST | Clinical Assays, Inc. | Apr 23, 1981 | SESE | | [K800204](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K800204.md) | RIA PHASE TBG | Boehringer Mannheim Corp. | Mar 19, 1980 | SESE | | [K781225](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE/K781225.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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