Cleared Traditional

APPLELISA CHLAMYDIA TRACHOMATIS ANTI (K843120) - FDA 510(k) Clearance

Class I Microbiology device.

K843120 · Apple Diagnostic Products · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1984
Decision
35d
Days
Class 1
Risk

K843120 is an FDA 510(k) clearance for the APPLELISA CHLAMYDIA TRACHOMATIS ANTI. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Apple Diagnostic Products (Mchenry, US). The FDA issued a Cleared decision on September 12, 1984 after a review of 35 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 Apple Diagnostic Products devices

Submission Details

510(k) Number K843120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1984
Decision Date September 12, 1984
Days to Decision 35 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 102d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
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 - LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)

All 66
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K843120.
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
K982210 · Dade Behring, Inc. · Jul 1998
IMX SELECT CHLAMYDIA
K936054 · Abbott Laboratories · May 1996
SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT
K926090 · Syva Co. · Sep 1993
MICRO TRAK XL SYSTEM
K921747 · Syva Co. · Oct 1992
SYVA MICROTRAK CHLAMYDIA EIA
K920503 · Syva Co. · Sep 1992
MICROTRAK(R) II CHLAMYDIA EIA ASSAY
K921462 · Syva Co. · Sep 1992