Cleared Traditional

K895839 - PATHODX CHLAMYDIA CULTURE CONFIRMATION ...

K895839 is the FDA 510(k) clearance for PATHODX CHLAMYDIA CULTURE CONFIRMATION ... by Diagnostic Products Corp.. It is a Class 1 Microbiology device (product code LJP) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K895839 · Diagnostic Products Corp. · Microbiology device
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Feb 1990
Decision
121d
Days
Class 1
Risk

K895839 is an FDA 510(k) clearance for the PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 1, 1990 after a review of 121 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K895839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1989
Decision Date February 01, 1990
Days to Decision 121 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
19d slower than avg
Panel avg: 102d · This submission: 121d
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 15
Devices cleared under the same product code (LJP) and FDA review panel - the closest regulatory comparables to K895839.
PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST
K900870 · Diagnostic Products Corp. · Apr 1990
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
K881500 · Ortho Diagnostic Systems, Inc. · Apr 1988
PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS
K880031 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1988
MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT.
K872903 · Syva Co. · Aug 1987
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