Cleared Traditional

STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. (K860140) - FDA 510(k) Clearance

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

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
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 20
Devices cleared under the same product code (LAN) and FDA review panel - the closest regulatory comparables to K860140.
TDM N-ACETYLPROCAINAMIDE
K060738 · Roche Diagnostics Corp. · Aug 2006
DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
K032564 · Dade Behring, Inc. · Oct 2003
AXSYM N-ACETYLPROCAINAMIDE
K955422 · Abbott Laboratories · Apr 1996
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