Cleared Traditional

K864662 - CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS (FDA 510(k) Clearance)

Class I Microbiology device.

K864662 · American Micro Scan · Microbiology device
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Mar 1987
Decision
117d
Days
Class 1
Risk

K864662 is an FDA 510(k) clearance for the CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by American Micro Scan (West Sacramento, US). The FDA issued a Cleared decision on March 25, 1987 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3120 - 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 American Micro Scan devices

Submission Details

510(k) Number K864662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1986
Decision Date March 25, 1987
Days to Decision 117 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 102d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJP Antiserum, Fluorescent, Chlamydia Trachomatis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
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.