Cleared Traditional

K934762 - OPUS PROCAINAMIDE TEST SYSTEM

K934762 is an FDA 510(k) clearance for OPUS PROCAINAMIDE TEST SYSTEM, manufactured by Pb Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code LAR cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K934762 · Pb Diagnostic Systems, Inc. · Toxicology device
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Jul 1994
Decision
289d
Days
Class 2
Risk

K934762 is an FDA 510(k) clearance for the OPUS PROCAINAMIDE TEST SYSTEM. Classified as Enzyme Immunoassay, Procainamide (product code LAR), Class II - Special Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 289 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pb Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K934762

510(k) Number K934762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1993
Decision Date July 20, 1994
Days to Decision 289 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 87d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LAR Device Classification - Class 2, Special Controls

Product Code LAR Enzyme Immunoassay, Procainamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - LAR Enzyme Immunoassay, Procainamide

All 24
Devices cleared under the same product code (LAR) and FDA review panel - the closest regulatory comparables to K934762.
ABBOTT AXSM PROCAINAMIDE ASSAY
K955444 · Abbott Laboratories · Apr 1996
OPUS PROCAINAMIDE
K951434 · Behring Diagnostics, Inc. · Jul 1995
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR
K942847 · Roche Diagnostic Systems, Inc. · Dec 1994
EMIT 2000 PROCAINAMIDE CALIBRATORS
K922914 · Syva Co. · Aug 1992
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648
K873350 · Em Diagnostic Systems, Inc. · Sep 1987
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.
K860141 · American Dade · Feb 1986