Cleared Traditional

OPUS PROCAINAMIDE TEST SYSTEM (K934762) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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.
ONLINE TDM PROCAINAMIDE
K060773 · Roche Diagnostics Corp. · Aug 2006
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
K032573 · Dade Behring, Inc. · Oct 2003
CEDIA N-ACETYLPROCAINAMIDE ASSAY
K963306 · Boehringer Mannheim Corp. · Oct 1996
CEDIA PROCAINAMIDE ASSAY
K962099 · Boehringer Mannheim Corp. · Aug 1996
ABBOTT AXSM PROCAINAMIDE ASSAY
K955444 · Abbott Laboratories · Apr 1996
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR
K942847 · Roche Diagnostic Systems, Inc. · Dec 1994