Cleared Traditional

K041658 - BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2...

K041658 is the FDA 510(k) clearance for BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2... by Bio-Rad Laboratories, Inc.. It is a Class 2 Immunology device (product code LKJ) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K041658 · Bio-Rad Laboratories, Inc. · Immunology device
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Dec 2004
Decision
185d
Days
Class 2
Risk

K041658 is an FDA 510(k) clearance for the BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MO.... Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on December 20, 2004 after a review of 185 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 Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K041658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2004
Decision Date December 20, 2004
Days to Decision 185 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 104d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKJ Antinuclear Antibody, Antigen, 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 - LKJ Antinuclear Antibody, Antigen, Control

All 25
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K041658.
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K024223 · Bio-Rad · Jan 2003
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K024226 · Bio-Rad · Jan 2003