Cleared Traditional

K853548 - STRATUS PROCAINAMIDE FLUOROMETRIC ENZYM...

K853548 · American Dade · Chemistry device
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Sep 1985
Decision
23d
Days
-
Risk

K853548 is an FDA 510(k) clearance for the STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on September 18, 1985 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel. 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 K853548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date September 18, 1985
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 56
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