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 862.1405](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1405) → CFP — Radioimmunoassay, Immunoreactive Insulin # CFP · Radioimmunoassay, Immunoreactive Insulin _Clinical Chemistry · 21 CFR 862.1405 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP ## Overview - **Product Code:** CFP - **Device Name:** Radioimmunoassay, Immunoreactive Insulin - **Regulation:** [21 CFR 862.1405](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1405) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## Identification An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. Immunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia. ## Classification Rationale Class I (general 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 27) Showing 20 most recent of 27 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K963911](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K963911.md) | ALPCO/MERCODIA INSULIN ELISA | American Laboratory Products Co., Ltd. | Nov 1, 1996 | SESE | | [K953084](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K953084.md) | ACCESS ULTRASENSITIVE INSULIN ASSAY | Bio-Rad Laboratories, Inc. | Sep 25, 1995 | SESE | | [K920109](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K920109.md) | IMX INSULIN | Abbott Laboratories | May 7, 1992 | SESE | | [K914820](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K914820.md) | DSL INSULIN RIA (DSL 1600) | Diagnostic Systems Laboratories, Inc. | Jan 9, 1992 | SESE | | [K903628](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K903628.md) | AIA-PACK IRI | Tosoh Corp. | Sep 7, 1990 | SESE | | [K901135](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K901135.md) | ENZYMUN TEST(R) INSULIN | Boehringer Mannheim Corp. | Apr 3, 1990 | SESE | | [K896572](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K896572.md) | REP(TM) SPE PLUS-30 PROCEDURES | Helena Laboratories | Jan 11, 1990 | SESE | | [K890837](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K890837.md) | RIA-GNOST INSULIN | Cambridge Medical Technology | Apr 26, 1989 | SESE | | [K851071](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K851071.md) | PHARMACIA INSULIN RIA | Pharmacia, Inc. | Apr 12, 1985 | SESE | | [K841573](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K841573.md) | INSULIN RADIOIMMUNOASSAY KIT | Sorin Biomedica, Fiat, USA, Inc. | May 16, 1984 | SESE | | [K823939](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K823939.md) | WAKO INSULIN TEST | Wako Chemicals USA, Inc. | Jan 28, 1983 | SESE | | [K822509](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K822509.md) | COVALENT COAT RIA KIT | Immuchem Corp. | Sep 28, 1982 | SESE | | [K821861](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K821861.md) | COAT-A-COUNT INSULIN KIT | Diagnostic Products Corp. | Jul 8, 1982 | SESE | | [K821374](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K821374.md) | ENZYMUNE-TEST INSULIN | Icl Scientific | May 28, 1982 | SESE | | [K812227](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K812227.md) | GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY | Clinical Assays, Inc. | Sep 24, 1981 | SESE | | [K811953](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K811953.md) | IMMOPHASE INSULIN (125I) RADIOASSAY | Corning Medical & Scientific | Jul 23, 1981 | SESE | | [K811423](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K811423.md) | VENTRE/SEP | Ventrex Laboratories, Inc. | Jun 9, 1981 | SESE | | [K811144](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K811144.md) | ARIA II INSULIN RIA | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 15, 1981 | SESE | | [K792279](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K792279.md) | AUTOPAK 12 INSULIN TEST DELIVERY SYSTEM | Micromedic Systems | Dec 6, 1979 | SESE | | [K791707](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP/K791707.md) | CENTRIA INSULIN RIA | Ventrex Laboratories, Inc. | Oct 17, 1979 | SESE | ## Top Applicants - Bd Becton Dickinson Vacutainer Systems Preanalytic — 2 clearances - Micromedic Systems — 2 clearances - Ventrex Laboratories, Inc. — 2 clearances - Abbott Laboratories — 1 clearance - American Laboratory Products Co., Ltd. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com