Cleared Traditional

COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR (K942847) - FDA 510(k) Clearance

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

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 24
Devices cleared under the same product code (LAR) and FDA review panel - the closest regulatory comparables to K942847.
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
EMIT 2000 PROCAINAMIDE CALIBRATORS
K922914 · Syva Co. · Aug 1992
COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR
K852320 · Roche Diagnostic Systems, Inc. · Jul 1985