Cleared Traditional

K850158 - CHLAMYDIA FLUORO-KIT 1680

K850158 is an FDA 510(k) clearance for CHLAMYDIA FLUORO-KIT 1680, manufactured by Clinical Sciences, Inc.. The device is a Class 1 Microbiology device with product code LJP cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K850158 · Clinical Sciences, Inc. · Microbiology device
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Mar 1985
Decision
65d
Days
Class 1
Risk

K850158 is an FDA 510(k) clearance for the CHLAMYDIA FLUORO-KIT 1680. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Clinical Sciences, Inc. (Whippany, US). The FDA issued a Cleared decision on March 21, 1985 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Clinical Sciences, Inc. devices

FDA 510(k) Submission Details - K850158

510(k) Number K850158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1985
Decision Date March 21, 1985
Days to Decision 65 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
37d faster than avg
Panel avg: 102d · This submission: 65d
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 K850158.
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST
K853738 · Ortho Diagnostic Systems, Inc. · Dec 1985
MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST
K852779 · Syva Co. · Sep 1985
SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT
K851033 · Syncor Intl. Corp. · Jun 1985
SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST
K844582 · Syncor Intl. Corp. · Jan 1985
AMIZYME-C TRACHOMATIS TEST KIT
K842525 · Amico Lab, Inc. · Oct 1984
ANTI-CHLAMYDIA TRACHOMATIS KIT
K842658 · Amico Lab, Inc. · Oct 1984