Cleared Traditional

K852320 - COBAS FP REAGEN FOR PROCAINAMIDE & PRO ...

K852320 is the FDA 510(k) clearance for COBAS FP REAGEN FOR PROCAINAMIDE & PRO ... by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code LAR) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K852320 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jul 1985
Decision
39d
Days
Class 2
Risk

K852320 is an FDA 510(k) clearance for the COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR. Classified as Enzyme Immunoassay, Procainamide (product code LAR), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on July 9, 1985 after a review of 39 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K852320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1985
Decision Date July 09, 1985
Days to Decision 39 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 87d · This submission: 39d
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 K852320.
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
EMIT QST PROCAINAMIDE ASSAY
K851061 · Syva Co. · Apr 1985
TDX PROCAINAMIDE
K834464 · Abbott Laboratories · Feb 1984
PROCAINAMIDE ANALYTICAL TEST PACK
K833384 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983