Cleared Traditional

K862320 - DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM (FDA 510(k) Clearance)

Class I Microbiology device.

K862320 · Difco Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1986
Decision
62d
Days
Class 1
Risk

K862320 is an FDA 510(k) clearance for the DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on August 19, 1986 after a review of 62 days - a notably fast clearance cycle.

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: 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 Difco Laboratories, Inc. devices

Submission Details

510(k) Number K862320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1986
Decision Date August 19, 1986
Days to Decision 62 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 102d · This submission: 62d
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.