Cleared Traditional

K862354 - MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT

K862354 is an FDA 510(k) clearance for MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPE..., manufactured by Synbiotics Corp.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K862354

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.

LJP Device Classification - Class 1, General Controls

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 31
Devices cleared under the same product code (LJP) and FDA review panel - the closest regulatory comparables to K862354.
PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM
K864663 · Kallestad Diag, A Div. of Erbamont, Inc. · Feb 1987
CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST
K864389 · American Micro Scan · Dec 1986
PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM
K863681 · Kallestad Laboratories, Inc. · Dec 1986
DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM
K862320 · Difco Laboratories, Inc. · Aug 1986
CHLAMYSET ANTIGEN
K853401 · Orion Corp. · Apr 1986
CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT
K860179 · Difco Laboratories, Inc. · Mar 1986