Cleared Traditional

CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT (K864128) - FDA 510(k) Clearance

Class I Microbiology device.

K864128 · Diagnostic Technology, Inc. · Microbiology device
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Apr 1987
Decision
190d
Days
Class 1
Risk

K864128 is an FDA 510(k) clearance for the CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Diagnostic Technology, Inc. (Hauppauge, US). The FDA issued a Cleared decision on April 29, 1987 after a review of 190 days - an extended review cycle.

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 Technology, Inc. devices

Submission Details

510(k) Number K864128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1986
Decision Date April 29, 1987
Days to Decision 190 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 102d · This submission: 190d
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 11
Devices cleared under the same product code (LJP) and FDA review panel - the closest regulatory comparables to K864128.
PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1
K895839 · Diagnostic Products Corp. · Feb 1990
ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST
K881500 · Ortho Diagnostic Systems, Inc. · Apr 1988
MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT.
K872903 · Syva Co. · Aug 1987
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST
K864888 · Syva Co. · Feb 1987
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST
K853738 · Ortho Diagnostic Systems, Inc. · Dec 1985
MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST
K852779 · Syva Co. · Sep 1985