Cleared Traditional

K862354 - MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPE...

K862354 is the FDA 510(k) clearance for MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPE... by Synbiotics Corp.. It is a Class 1 Microbiology device (product code LJP) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K862354 · Synbiotics Corp. · Microbiology device
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Sep 1986
Decision
101d
Days
Class 1
Risk

K862354 is an FDA 510(k) clearance for the MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Synbiotics Corp. (San Diego, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 101 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 Synbiotics Corp. devices

Submission Details

510(k) Number K862354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1986
Decision Date September 29, 1986
Days to Decision 101 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 102d · This submission: 101d
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.

Regulatory Peers - LJP Antiserum, Fluorescent, Chlamydia Trachomatis

All 19
Devices cleared under the same product code (LJP) and FDA review panel - the closest regulatory comparables to K862354.
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST
K864888 · Syva Co. · Feb 1987
PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM
K864663 · Kallestad Diag, A Div. of Erbamont, Inc. · Feb 1987
PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM
K863681 · Kallestad Laboratories, Inc. · Dec 1986
DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM
K862320 · Difco Laboratories, Inc. · Aug 1986
CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT
K860179 · Difco Laboratories, Inc. · Mar 1986
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST
K853738 · Ortho Diagnostic Systems, Inc. · Dec 1985