Cleared Traditional

CAPILLARY'S IMMUNOTYPING (PN 2100) (K042939) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042939 · Sebia, Inc. · Immunology device
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Jun 2005
Decision
245d
Days
Class 2
Risk

K042939 is an FDA 510(k) clearance for the CAPILLARY'S IMMUNOTYPING (PN 2100). Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Sebia, Inc. (Chelsea, US). The FDA issued a Cleared decision on June 27, 2005 after a review of 245 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 Sebia, Inc. devices

Submission Details

510(k) Number K042939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2004
Decision Date June 27, 2005
Days to Decision 245 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 104d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFH Kappa, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DFH Kappa, Antigen, Antiserum, Control

All 62
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K042939.
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Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
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