Cleared Traditional

ANTI-CHLAMYDIA TRACHOMATIS KIT (K842658) - FDA 510(k) Clearance

Class I Immunology device.

K842658 · Amico Lab, Inc. · Immunology device
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Oct 1984
Decision
83d
Days
Class 1
Risk

K842658 is an FDA 510(k) clearance for the ANTI-CHLAMYDIA TRACHOMATIS KIT. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Amico Lab, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1984 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3120 - the FDA immunology 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 Amico Lab, Inc. devices

Submission Details

510(k) Number K842658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1984
Decision Date October 01, 1984
Days to Decision 83 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 104d · This submission: 83d
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 34
Devices cleared under the same product code (LJP) and FDA review panel - the closest regulatory comparables to K842658.
PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST
K900870 · Diagnostic Products Corp. · Apr 1990
PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1
K895839 · Diagnostic Products Corp. · Feb 1990
MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT.
K872903 · Syva Co. · Aug 1987
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST
K864888 · Syva Co. · Feb 1987
MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST
K852779 · Syva Co. · Sep 1985
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT
K842623 · Syva Co. · Aug 1984