Cleared Traditional

K043067 - ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400

K043067 is an FDA 510(k) clearance for ENA IGG BEADCHIP TEST SYSTEM, manufactured by Bioarray Solutions, Ltd.. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K043067 · Bioarray Solutions, Ltd. · Immunology device
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Optimized for regulatory review, auditing and printing
May 2005
Decision
204d
Days
Class 2
Risk

K043067 is an FDA 510(k) clearance for the ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Bioarray Solutions, Ltd. (Warren, US). The FDA issued a Cleared decision on May 31, 2005 after a review of 204 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bioarray Solutions, Ltd. devices

FDA 510(k) Submission Details - K043067

510(k) Number K043067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2004
Decision Date May 31, 2005
Days to Decision 204 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 105d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear Antibody, Antigen And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - LLL Extractable Antinuclear Antibody, Antigen And Control

All 144
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