Cleared Traditional

K852319 - COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS

K852319 is an FDA 510(k) clearance for COBAS FP REAGENTS FOR NAPA AND NAPA CAL..., manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code LAN cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K852319 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jun 1985
Decision
25d
Days
Class 2
Risk

K852319 is an FDA 510(k) clearance for the COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS. Classified as Enzyme Immunoassay, N-acetylprocainamide (product code LAN), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on June 25, 1985 after a review of 25 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

FDA 510(k) Submission Details - K852319

510(k) Number K852319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1985
Decision Date June 25, 1985
Days to Decision 25 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
62d faster than avg
Panel avg: 87d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LAN Device Classification - Class 2, Special Controls

Product Code LAN Enzyme Immunoassay, N-acetylprocainamide
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 - LAN Enzyme Immunoassay, N-acetylprocainamide

All 19
Devices cleared under the same product code (LAN) and FDA review panel - the closest regulatory comparables to K852319.
MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR
K871680 · Roche Diagnostic Systems, Inc. · Jun 1987
STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.
K860140 · American Dade · Feb 1986
STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I
K853547 · American Dade · Sep 1985
EMIT QST N-ACETYLPROCAINAMIDE ASSAY
K851060 · Syva Co. · Apr 1985
N-ACETYLPROCAINAMIDE ACA-ANALYTICAL
K833378 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983
N-ACETYLPROCAINAMIDE ASSAY FOR COBAS
K832098 · Syva Co. · Aug 1983