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 862.1445](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1445) → CFE — Electrophoretic, Lactate Dehydrogenase Isoenzymes # CFE · Electrophoretic, Lactate Dehydrogenase Isoenzymes _Clinical Chemistry · 21 CFR 862.1445 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE ## Overview - **Product Code:** CFE - **Device Name:** Electrophoretic, Lactate Dehydrogenase Isoenzymes - **Regulation:** [21 CFR 862.1445](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1445) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## Identification A lactate dehydrogenase isoenzymes test system is a device intended to measure the activity of lactate dehydrogenase isoenzymes (a group of enzymes with similar biological activity) in serum. Measurements of lactate dehydrogenase isoenzymes are used in the diagnosis and treatment of liver diseases, such as viral hepatitis, and myocardial infarction. ## 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 28) Showing 20 most recent of 28 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K100307](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K100307.md) | GELSCAN, MODEL 1206 | Sebia | Aug 31, 2010 | SESE | | [K022455](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K022455.md) | SPIFE LD-12 KIT, MODEL 3338 | Helena Laboratories | Oct 1, 2002 | SESE | | [K020467](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K020467.md) | SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 | Helena Laboratories | Mar 29, 2002 | SESE | | [K970477](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K970477.md) | HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT | Sebia | Mar 10, 1997 | SESE | | [K940224](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K940224.md) | CARDIO REP LD | Helena Laboratories | Aug 17, 1994 | SESE | | [K921455](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K921455.md) | ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD | E.I. Dupont DE Nemours & Co., Inc. | Apr 29, 1992 | SESE | | [K905861](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K905861.md) | ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH | E.I. Dupont DE Nemours & Co., Inc. | Feb 6, 1991 | SESE | | [K894081](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K894081.md) | ROCHO ISOMUNE - LD | Roche Diagnostic Systems, Inc. | Aug 31, 1989 | SESE | | [K892818](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K892818.md) | REP(TM) LD-2 STAT KIT, CAT. NO. 3078 | Helena Laboratories | Jun 20, 1989 | SESE | | [K874145](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K874145.md) | TITAN GEL REP LDH-6 HV | Helena Laboratories | Nov 24, 1987 | SESE | | [K874142](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K874142.md) | TITAN GEL REP LDH-30 HV | Helena Laboratories | Nov 24, 1987 | SESE | | [K874143](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K874143.md) | TITAN GEL REP LDH-12 HV | Helena Laboratories | Nov 23, 1987 | SESE | | [K873386](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K873386.md) | TITAN GEL LDH REP SYSTEM | Helena Laboratories | Oct 20, 1987 | SESE | | [K861750](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K861750.md) | CK/LD BUFFER (CAT. NO. 5808) | Helena Laboratories | May 29, 1986 | SESE | | [K850210](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K850210.md) | ISOENZYME TEST LD-1 | Sclavo, Inc. | Mar 29, 1985 | SESE | | [K842669](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K842669.md) | TITAN GEL ISO DOT LDH KIT | Helena Laboratories | Nov 9, 1984 | SESE | | [K841433](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K841433.md) | CORNING LACTATE DEHYDROPHORETIC ASSAY | Corning Medical & Scientific | May 16, 1984 | SESE | | [K832314](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K832314.md) | CARDIZYME PLUS LD #65094/93 | Em Industries, Inc. | Sep 1, 1983 | SESE | | [K830872](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K830872.md) | TITAN GEL LDH ISO-ENZYME CONTROL | Helena Laboratories | Apr 12, 1983 | SESE | | [K802628](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K802628.md) | PARAGON ELECTROPHORESIS LACTATE REAG.KIT | Beckman Instruments, Inc. | Dec 11, 1980 | SESE | ## Top Applicants - Helena Laboratories — 11 clearances - Corning Medical & Scientific — 3 clearances - Electrophoresis Corp. of America — 3 clearances - E.I. Dupont DE Nemours & Co., Inc. — 2 clearances - Sebia — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE) **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