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 862.1635](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1635) → CEK — Biuret (Colorimetric), Total Protein # CEK · Biuret (Colorimetric), Total Protein _Clinical Chemistry · 21 CFR 862.1635 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK ## Overview - **Product Code:** CEK - **Device Name:** Biuret (Colorimetric), Total Protein - **Regulation:** [21 CFR 862.1635](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1635) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## Identification A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. ## 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 § 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 § 862.9. ## Recent Cleared Devices (20 of 116) Showing 20 most recent of 116 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K992846](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K992846.md) | HICHEM TOTAL PROTEIN REAGENT | Elan Holdings, Inc. | Oct 18, 1999 | SESE | | [K973108](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K973108.md) | TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 | Diagnostic Chemicals , Ltd. | Mar 2, 1998 | SESE | | [K980042](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K980042.md) | CARESIDE TOTAL PROTEIN | Exigent Diagnostics, Inc. | Feb 4, 1998 | SESE | | [K971524](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K971524.md) | TOTAL PROTEIN OR TP | Carolina Liquid Chemistries Corp. | May 16, 1997 | SESE | | [K961864](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K961864.md) | CSF/URINE TOTAL PROTEIN | Teco Diagnostics | Oct 24, 1996 | SESE | | [K955905](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K955905.md) | STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY | Solarcare Technologies Corp,Inc. | May 30, 1996 | SESE | | [K955936](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K955936.md) | TOTAL PROTEIN REAGENT | Derma Media Lab., Inc. | Mar 12, 1996 | SESE | | [K950920](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K950920.md) | DUPONT DIMENSION TOTAL PROTEIN METHOD | Dupont Medical Products | Aug 11, 1995 | SESE | | [K950234](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K950234.md) | TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 | Emd Chemicals, Inc. | Jun 14, 1995 | SESE | | [K950128](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K950128.md) | TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 | Emd Chemicals, Inc. | May 15, 1995 | SESE | | [K943004](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K943004.md) | TOTAL PROTEIN QVET | Prisma Systems | Dec 9, 1994 | SESE | | [K941496](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K941496.md) | SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY | Solarcare, Inc. | Oct 27, 1994 | SESE | | [K942424](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K942424.md) | DMA MICROPROTEIN PROCEDURE | Data Medical Associates, Inc. | Sep 6, 1994 | SESE | | [K934841](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K934841.md) | URINARY/CEREBROSPINAL FLUID PROTEIN | E.I. Dupont DE Nemours & Co., Inc. | Apr 6, 1994 | SESE | | [K935174](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K935174.md) | TOTAL PROTEIN TEST (TPRO) | Em Diagnostic Systems, Inc. | Dec 16, 1993 | SESE | | [K921412](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K921412.md) | MICROPROTEIN REAGENT SET | Sterling Diagnostics, Inc. | Jan 21, 1993 | SESE | | [K924659](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K924659.md) | OLYUMPUS TOTAL PROTEIN REAGENT | Olympus Corp. | Dec 29, 1992 | SESE | | [K922467](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K922467.md) | SYNCHRON TOTAL PROTEIN TEST --MODIFIED | Beckman Instruments, Inc. | Nov 23, 1992 | SESE | | [K923267](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K923267.md) | SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | Sep 9, 1992 | SESE | | [K923266](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK/K923266.md) | NOVA TOTAL PROTEIN MODULE | Nova Biomedical Corp. | Aug 12, 1992 | SESE | ## Top Applicants - Em Diagnostic Systems, Inc. — 10 clearances - Harleco — 6 clearances - Beckman Instruments, Inc. — 4 clearances - Data Medical Associates, Inc. — 4 clearances - Medical Analysis Systems, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CEK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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