Cleared Traditional

K864128 - CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CO...

K864128 is an FDA 510(k) clearance for CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CO..., manufactured by Diagnostic Technology, Inc.. The device is a Class 1 Microbiology device with product code LJP cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K864128 · Diagnostic Technology, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K864128

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 102d · This submission: 190d
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 26
Devices cleared under the same product code (LJP) and FDA review panel - the closest regulatory comparables to K864128.
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
MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST
K870946 · Serono Diagnostics, Inc. · Apr 1987
CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS
K864662 · American Micro Scan · Mar 1987
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST
K864888 · Syva Co. · Feb 1987