Cleared Traditional

K871680 - MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR

K871680 is an FDA 510(k) clearance for MODIFIED COBAS FP REAGENTS FOR NAPA AND..., 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 40-day FDA review.

K871680 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jun 1987
Decision
40d
Days
Class 2
Risk

K871680 is an FDA 510(k) clearance for the MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR. 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 8, 1987 after a review of 40 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 - K871680

510(k) Number K871680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1987
Decision Date June 08, 1987
Days to Decision 40 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
47d faster than avg
Panel avg: 87d · This submission: 40d
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 K871680.
OPUS NAPA
K934705 · Pb Diagnostic Systems, Inc. · Nov 1993
EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT
K922915 · Syva Co. · Aug 1992
EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649
K873349 · Em Diagnostic Systems, Inc. · Sep 1987
STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.
K860140 · American Dade · Feb 1986
STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I
K853547 · American Dade · Sep 1985
COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS
K852319 · Roche Diagnostic Systems, Inc. · Jun 1985