Cleared Traditional

ADENOLEX (R) LATEX AGGLUTINATION TEST (K864645) - FDA 510(k) Clearance

Class I Microbiology device.

K864645 · Orion Diagnostica, Inc. · Microbiology device
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Jun 1987
Decision
191d
Days
Class 1
Risk

K864645 is an FDA 510(k) clearance for the ADENOLEX (R) LATEX AGGLUTINATION TEST. Classified as Antigens, Cf (including Cf Control), Adenovirus 1-33 (product code GOD), Class I - General Controls.

Submitted by Orion Diagnostica, Inc. (Somerset, US). The FDA issued a Cleared decision on June 4, 1987 after a review of 191 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3020 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Orion Diagnostica, Inc. devices

Submission Details

510(k) Number K864645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1986
Decision Date June 04, 1987
Days to Decision 191 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 102d · This submission: 191d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GOD Antigens, Cf (including Cf Control), Adenovirus 1-33
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3020
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.