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 862.1100](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1100) → CIT — Nadh Oxidation/Nad Reduction, Ast/Sgot # CIT · Nadh Oxidation/Nad Reduction, Ast/Sgot _Clinical Chemistry · 21 CFR 862.1100 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT ## Overview - **Product Code:** CIT - **Device Name:** Nadh Oxidation/Nad Reduction, Ast/Sgot - **Regulation:** [21 CFR 862.1100](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1100) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## Identification An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. ## 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 139) Showing 20 most recent of 139 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K093883](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K093883.md) | AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT- | Seppim S.A.S. | Sep 20, 2010 | SESE | | [K080485](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K080485.md) | ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS | Diasys Diagnostics Systems GmbH | Dec 4, 2008 | SESE | | [K071525](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K071525.md) | ACTIVATED ASPARTATE AMINOTRANSFERASE | Abbott Laboratories | Mar 19, 2008 | SESE | | [K071580](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K071580.md) | AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL | Thermofisher Scientific OY | Oct 3, 2007 | SESE | | [K071211](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K071211.md) | COBAS C 111 ANALYZER | Roche Diagnostics | Jul 30, 2007 | SESE | | [K060318](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K060318.md) | HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | Horiba Abx | Aug 8, 2006 | SESE | | [K023551](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K023551.md) | WIENER LAB GOT (AST) UV AA LIQUIDA | Wiener Laboratories Saic | Dec 9, 2002 | SESE | | [K013698](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K013698.md) | AST (SGOT) | Jas Diagnostics, Inc. | Dec 21, 2001 | SESE | | [K013145](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K013145.md) | WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. | Wiener Laboratories Saic | Nov 27, 2001 | SESE | | [K010488](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K010488.md) | ATAC PAK AST REAGENT KIT | Elan Holdings, Inc. | Apr 9, 2001 | SESE | | [K001679](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K001679.md) | VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 | Ortho-Clinical Diagnostics, Inc. | Jun 28, 2000 | SESE | | [K993468](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K993468.md) | WAKO L-TYPE GOT TEST | Wako Chemicals USA, Inc. | Dec 16, 1999 | SESE | | [K992136](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K992136.md) | BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS) | Bayer Corp. | Nov 9, 1999 | SESE | | [K992801](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K992801.md) | SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 | Sigma Diagnostics, Inc. | Sep 28, 1999 | SESE | | [K991663](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K991663.md) | AST/SGOT | A.P. Total Care, Inc. | Jun 30, 1999 | SESE | | [K990009](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K990009.md) | CARESIDE AST | Careside, Inc. | Mar 16, 1999 | SESE | | [K983131](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K983131.md) | AST | Abbott Laboratories | Sep 28, 1998 | SESE | | [K981843](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K981843.md) | AST | Abbott Laboratories | Jun 29, 1998 | SESE | | [K981650](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K981650.md) | AST/SGOT LIQUID REAGENT - KINETIC METHOD | Teco Diagnostics | Jun 29, 1998 | SESE | | [K981225](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K981225.md) | ASPARTATE AMINOTRANSFERASE (AST) | Abbott Laboratories | Apr 23, 1998 | SESE | ## Top Applicants - Em Diagnostic Systems, Inc. — 10 clearances - Abbott Laboratories — 8 clearances - Roche Diagnostic Systems, Inc. — 6 clearances - American Monitor Corp. — 5 clearances - Coulter Electronics, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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