Cleared Traditional

K942847 - COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR

K942847 is an FDA 510(k) clearance for COBAS-FP REAGENT FOR PROCAINAMIDE/CALIB..., manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code LAR cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K942847 · Roche Diagnostic Systems, Inc. · Toxicology device
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Dec 1994
Decision
169d
Days
Class 2
Risk

K942847 is an FDA 510(k) clearance for the COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR. Classified as Enzyme Immunoassay, Procainamide (product code LAR), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 2, 1994 after a review of 169 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 Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K942847

510(k) Number K942847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1994
Decision Date December 02, 1994
Days to Decision 169 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
82d slower than avg
Panel avg: 87d · This submission: 169d
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 K942847.
PROCAINAMIDE ENZYME IMMUNOASSAY
K962463 · Diagnostic Reagents, Inc. · Aug 1996
ABBOTT AXSM PROCAINAMIDE ASSAY
K955444 · Abbott Laboratories · Apr 1996
OPUS PROCAINAMIDE
K951434 · Behring Diagnostics, Inc. · Jul 1995
OPUS PROCAINAMIDE TEST SYSTEM
K934762 · Pb Diagnostic Systems, Inc. · Jul 1994
EMIT 2000 PROCAINAMIDE CALIBRATORS
K922914 · Syva Co. · Aug 1992
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648
K873350 · Em Diagnostic Systems, Inc. · Sep 1987