Cleared Traditional

K940564 - IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION

K940564 is an FDA 510(k) clearance for IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, manufactured by Dako Diagnostics , Ltd.. The device is a Class 1 Microbiology device with product code LJC cleared through the Traditional 510(k) pathway after a 707-day FDA review.

K940564 · Dako Diagnostics , Ltd. · Microbiology device
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Jan 1996
Decision
707d
Days
Class 1
Risk

K940564 is an FDA 510(k) clearance for the IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION. Classified as Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (product code LJC), Class I - General Controls.

Submitted by Dako Diagnostics , Ltd. (Cambridgeshire, GB). The FDA issued a Cleared decision on January 11, 1996 after a review of 707 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Dako Diagnostics , Ltd. devices

FDA 510(k) Submission Details - K940564

510(k) Number K940564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1994
Decision Date January 11, 1996
Days to Decision 707 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
605d slower than avg
Panel avg: 102d · This submission: 707d
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 K940564.
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
CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY
K935393 · Bio-Rad Laboratories, Inc. · Sep 1994