Cleared Special

K033865 - IDEIA PCE CHLAMYDIA

K033865 is an FDA 510(k) clearance for IDEIA PCE CHLAMYDIA, manufactured by Dakocytomation, Ltd.. The device is a Class 1 Microbiology device with product code LJC cleared through the Special 510(k) pathway after a 40-day FDA review.

K033865 · Dakocytomation, Ltd. · Microbiology device
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Jan 2004
Decision
40d
Days
Class 1
Risk

K033865 is an FDA 510(k) clearance for the IDEIA PCE CHLAMYDIA. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Dakocytomation, Ltd. (Ely, Cambridgeshire, GB). The FDA issued a Cleared decision on January 21, 2004 after a review of 40 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033865

510(k) Number K033865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2003
Decision Date January 21, 2004
Days to Decision 40 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 102d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

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 65
Devices cleared under the same product code (LJC) and FDA review panel - the closest regulatory comparables to K033865.
CT OIA
K032330 · Thermo Biostar, Inc. · Mar 2004
CHLAMYDIA IGG ELISA TEST SYSTEM
K033079 · Trinity Biotech USA · Nov 2003
MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA
K982210 · Dade Behring, Inc. · Jul 1998
CHLAMYDIA IGG ELISA TEST SYSTEM
K962558 · Armkel, LLC · Feb 1997
ACCESS CHLAMYDIA ASSAY
K960850 · Bio-Rad Laboratories, Inc. · Feb 1997
VIDAS CHLAMYDIA BLOCKING ASSAY
K955627 · Biomerieux Vitek, Inc. · Oct 1996
K033865 · IDEIA PCE CHLAMYDIA
Download PDF Dakocytomation, Ltd.