Cleared Traditional

K042939 - CAPILLARY'S IMMUNOTYPING (PN 2100)

K042939 is an FDA 510(k) clearance for CAPILLARY'S IMMUNOTYPING (PN 2100), manufactured by Sebia, Inc.. The device is a Class 2 Immunology device with product code DFH cleared through the Traditional 510(k) pathway after a 245-day FDA review.

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

FDA 510(k) Submission Details - K042939

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
140d slower than avg
Panel avg: 105d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFH Device Classification - Class 2, Special Controls

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 55
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