Browse hierarchy: [Clinical Toxicology (TX)](/submissions/TX) → [Subpart D — Clinical Toxicology Test Systems](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems) → [21 CFR 862.3320](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3320) → LAR — Enzyme Immunoassay, Procainamide # LAR · Enzyme Immunoassay, Procainamide _Clinical Toxicology · 21 CFR 862.3320 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR ## Overview - **Product Code:** LAR - **Device Name:** Enzyme Immunoassay, Procainamide - **Regulation:** [21 CFR 862.3320](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/862.3320) - **Device Class:** 2 - **Review Panel:** [Clinical Toxicology](/submissions/TX) - **3rd-party reviewable:** yes ## Identification A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 25) Showing 20 most recent of 25 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K060773](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K060773.md) | ONLINE TDM PROCAINAMIDE | Roche Diagnostics Corp. | Aug 23, 2006 | SESE | | [K032573](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K032573.md) | DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 | Dade Behring, Inc. | Oct 31, 2003 | SESE | | [K010812](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K010812.md) | EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 | Syva Co., Dade Behring, Inc. | Apr 13, 2001 | SESE | | [K971716](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K971716.md) | PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | Jun 27, 1997 | SESE | | [K963306](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K963306.md) | CEDIA N-ACETYLPROCAINAMIDE ASSAY | Boehringer Mannheim Corp. | Oct 29, 1996 | SESE | | [K962099](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K962099.md) | CEDIA PROCAINAMIDE ASSAY | Boehringer Mannheim Corp. | Aug 27, 1996 | SESE | | [K962463](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K962463.md) | PROCAINAMIDE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | Aug 14, 1996 | SESE | | [K955444](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K955444.md) | ABBOTT AXSM PROCAINAMIDE ASSAY | Abbott Laboratories | Apr 2, 1996 | SESE | | [K951434](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K951434.md) | OPUS PROCAINAMIDE | Behring Diagnostics, Inc. | Jul 3, 1995 | SESE | | [K942847](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K942847.md) | COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR | Roche Diagnostic Systems, Inc. | Dec 2, 1994 | SESE | | [K934762](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K934762.md) | OPUS PROCAINAMIDE TEST SYSTEM | Pb Diagnostic Systems, Inc. | Jul 20, 1994 | SESE | | [K922914](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K922914.md) | EMIT 2000 PROCAINAMIDE CALIBRATORS | Syva Co. | Aug 24, 1992 | SESE | | [K873350](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K873350.md) | EASY-TEST EMIT PROCAINAMIDE (PROC) #16648 | Em Diagnostic Systems, Inc. | Sep 29, 1987 | SESE | | [K860141](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K860141.md) | STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO. | American Dade | Feb 11, 1986 | SESE | | [K852320](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K852320.md) | COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR | Roche Diagnostic Systems, Inc. | Jul 9, 1985 | SESE | | [K851061](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K851061.md) | EMIT QST PROCAINAMIDE ASSAY | Syva Co. | Apr 12, 1985 | SESE | | [K834464](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K834464.md) | TDX PROCAINAMIDE | Abbott Laboratories | Feb 3, 1984 | SESE | | [K833384](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K833384.md) | PROCAINAMIDE ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | Dec 27, 1983 | SESE | | [K832718](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K832718.md) | EMIT CAD PROCAINAMIDE ASSAY | Syva Co. | Sep 12, 1983 | SESE | | [K831400](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR/K831400.md) | AMES TDA PROCAINAMIDE TEST | Miles Laboratories, Inc. | Jun 2, 1983 | SESE | ## Top Applicants - Syva Co. — 8 clearances - Abbott Laboratories — 2 clearances - Boehringer Mannheim Corp. — 2 clearances - Roche Diagnostic Systems, Inc. — 2 clearances - American Dade — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LAR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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