Cleared Traditional

K853547 - STRATUS N-ACETYLPROCAINAMIDE FLUOROMETR...

K853547 is the FDA 510(k) clearance for STRATUS N-ACETYLPROCAINAMIDE FLUOROMETR... by American Dade. It is a Class 2 Chemistry device (product code LAN) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K853547 · American Dade · Chemistry device
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Sep 1985
Decision
21d
Days
Class 2
Risk

K853547 is an FDA 510(k) clearance for the STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I. 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 September 16, 1985 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - the FDA in vitro diagnostics and chemistry 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 K853547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date September 16, 1985
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
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 Chemistry 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 K853547.
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-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.
K860140 · American Dade · Feb 1986
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
N-ACETYLPROCAINAMIDE ACA-ANALYTICAL
K833378 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983