Cleared Traditional

K842525 - AMIZYME-C TRACHOMATIS TEST KIT

K842525 is an FDA 510(k) clearance for AMIZYME-C TRACHOMATIS TEST KIT, manufactured by Amico Lab, Inc.. The device is a Class 1 Immunology device with product code LJP cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K842525 · Amico Lab, Inc. · Immunology device
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Oct 1984
Decision
95d
Days
Class 1
Risk

K842525 is an FDA 510(k) clearance for the AMIZYME-C TRACHOMATIS TEST 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 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Amico Lab, Inc. devices

FDA 510(k) Submission Details - K842525

510(k) Number K842525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1984
Decision Date October 01, 1984
Days to Decision 95 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 105d · This submission: 95d
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 K842525.
SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT
K851033 · Syncor Intl. Corp. · Jun 1985
CHLAMYDIA FLUORO-KIT 1680
K850158 · Clinical Sciences, Inc. · Mar 1985
SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST
K844582 · Syncor Intl. Corp. · Jan 1985
ANTI-CHLAMYDIA TRACHOMATIS KIT
K842658 · Amico Lab, Inc. · Oct 1984
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT
K842623 · Syva Co. · Aug 1984
MICRO TRAK CHLAMYDIA TRACHOMATIS DIRECT
K832077 · Syva Co. · Sep 1983