Cleared Traditional

K962558 - CHLAMYDIA IGG ELISA TEST SYSTEM

K962558 is the FDA 510(k) clearance for CHLAMYDIA IGG ELISA TEST SYSTEM by Armkel, LLC. It is a Class 1 Microbiology device (product code LJC) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K962558 · Armkel, LLC · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
238d
Days
Class 1
Risk

K962558 is an FDA 510(k) clearance for the CHLAMYDIA IGG ELISA TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Armkel, LLC (Frederick, US). The FDA issued a Cleared decision on February 24, 1997 after a review of 238 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Armkel, LLC devices

Submission Details

510(k) Number K962558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1996
Decision Date February 24, 1997
Days to Decision 238 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 102d · This submission: 238d
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 46
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K962558.
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
K982210 · Dade Behring, Inc. · Jul 1998
ACCESS CHLAMYDIA ASSAY
K960850 · Bio-Rad Laboratories, Inc. · Feb 1997
VIDAS CHLAMYDIA BLOCKING ASSAY
K955627 · Biomerieux Vitek, Inc. · Oct 1996
IMX SELECT CHLAMYDIA
K936054 · Abbott Laboratories · May 1996
ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY
K935807 · Bio-Rad Laboratories, Inc. · May 1995
QUICKVUE(R) CHLAMYDIA TEST
K946276 · Quidel Corp. · May 1995