Cleared Traditional

AMIZYME-C TRACHOMATIS TEST KIT (K842525) - FDA 510(k) Clearance

Class I Immunology device.

K842525 · Amico Lab, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 104d · This submission: 95d
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 K842525.
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