Cleared Traditional

K834242 - ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS

K834242 is the FDA 510(k) clearance for ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS by Apple Diagnostic Products. It is a Class 1 Immunology device (product code LJP) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K834242 · Apple Diagnostic Products · Immunology device
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Mar 1984
Decision
87d
Days
Class 1
Risk

K834242 is an FDA 510(k) clearance for the ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS. Classified as Antiserum, Fluorescent, Chlamydia Trachomatis (product code LJP), Class I - General Controls.

Submitted by Apple Diagnostic Products (Mchenry, US). The FDA issued a Cleared decision on March 2, 1984 after a review of 87 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 Apple Diagnostic Products devices

Submission Details

510(k) Number K834242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1983
Decision Date March 02, 1984
Days to Decision 87 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 104d · This submission: 87d
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 23
Devices cleared under the same product code (LJP) and FDA review panel - the closest regulatory comparables to K834242.
AMIZYME-C TRACHOMATIS TEST KIT
K842525 · Amico Lab, Inc. · Oct 1984
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
MICRO TRAK CHLAMYDIA TRAC CONTROL SLID
K832078 · Syva Co. · Sep 1983
MICRO TRAK CHLAMYDIA TRACHOMATIS CULT
K823010 · Syva Co. · Dec 1982