Cleared Traditional

K860140 - STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYM...

K860140 is the FDA 510(k) clearance for STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYM... by American Dade. It is a Class 2 Toxicology device (product code LAN) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K860140 · American Dade · Toxicology device
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Feb 1986
Decision
23d
Days
Class 2
Risk

K860140 is an FDA 510(k) clearance for the STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.. Classified as Enzyme Immunoassay, N-acetylprocainamide (product code LAN), Class II - Special Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on February 6, 1986 after a review of 23 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 American Dade devices

Submission Details

510(k) Number K860140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1986
Decision Date February 06, 1986
Days to Decision 23 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
64d faster than avg
Panel avg: 87d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 18
Devices cleared under the same product code (LAN) and FDA review panel - the closest regulatory comparables to K860140.
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
MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR
K871680 · Roche Diagnostic Systems, Inc. · Jun 1987
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
EMIT QST N-ACETYLPROCAINAMIDE ASSAY
K851060 · Syva Co. · Apr 1985