Cleared Traditional

K962558 - CHLAMYDIA IGG ELISA TEST SYSTEM

K962558 is an FDA 510(k) clearance for CHLAMYDIA IGG ELISA TEST SYSTEM, manufactured by Armkel, LLC. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K962558

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.

LJC Device Classification - Class 1, General Controls

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 52
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
IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION
K940564 · Dako Diagnostics , Ltd. · Jan 1996
ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY
K935807 · Bio-Rad Laboratories, Inc. · May 1995