Cleared Traditional

K942847 - COBAS-FP REAGENT FOR PROCAINAMIDE/CALIB...

K942847 is the FDA 510(k) clearance for COBAS-FP REAGENT FOR PROCAINAMIDE/CALIB... by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (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

Submission Details

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.

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 22
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
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