Cleared Traditional

K895839 - PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1

K895839 is an FDA 510(k) clearance for PATHODX CHLAMYDIA CULTURE CONFIRMATION ..., manufactured by Diagnostic Products Corp.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K895839

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.

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 30
Devices cleared under the same product code (LJP) and FDA review panel - the closest regulatory comparables to K895839.
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT
K063675 · Diagnostic Hybrids, Inc. · Sep 2007
CHLAMYDIA TRACHOMATIS ANTIGEN TEST
K941714 · Neogenex · Jul 1994
PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST
K900870 · Diagnostic Products Corp. · Apr 1990
FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI
K883352 · Whittaker Bioproducts, Inc. · Oct 1988
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