Cleared Traditional

K853738 - ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST

K853738 is the FDA 510(k) clearance for ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST by Ortho Diagnostic Systems, Inc.. It is a Class 1 Microbiology device (product code LJP) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K853738 · Ortho Diagnostic Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1985
Decision
91d
Days
Class 1
Risk

K853738 is an FDA 510(k) clearance for the ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on December 6, 1985 after a review of 91 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K853738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1985
Decision Date December 06, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 102d · This submission: 91d
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 16
Devices cleared under the same product code (LJP) and FDA review panel - the closest regulatory comparables to K853738.
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
MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST
K852779 · Syva Co. · Sep 1985
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT
K842623 · Syva Co. · Aug 1984
MICRO TRAK CHLAMYDIA TRACHOMATIS DIRECT
K832077 · Syva Co. · Sep 1983