Cleared Traditional

RESPIRASTICK ENZYME IMMUNOASSAY TEST (K862475) - FDA 510(k) Clearance

Class I Microbiology device.

K862475 · Orion Diagnostica, Inc. · Microbiology device
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Sep 1986
Decision
78d
Days
Class 1
Risk

K862475 is an FDA 510(k) clearance for the RESPIRASTICK ENZYME IMMUNOASSAY TEST. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Orion Diagnostica, Inc. (Somerset, US). The FDA issued a Cleared decision on September 16, 1986 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - the FDA microbiology 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 Orion Diagnostica, Inc. devices

Submission Details

510(k) Number K862475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1986
Decision Date September 16, 1986
Days to Decision 78 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 102d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTY Antigens, All Groups, Streptococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GTY Antigens, All Groups, Streptococcus Spp.

All 43
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