Cleared Traditional

K083602 - KAPPA LIGHT CHAINS

K083602 is an FDA 510(k) clearance for KAPPA LIGHT CHAINS, manufactured by SENTINEL CH. SpA. The device is a Class 2 Immunology device with product code DFH cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K083602 · SENTINEL CH. SpA · Immunology device
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Sep 2009
Decision
272d
Days
Class 2
Risk

K083602 is an FDA 510(k) clearance for the KAPPA LIGHT CHAINS. Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by SENTINEL CH. SpA (Milan, IT). The FDA issued a Cleared decision on September 3, 2009 after a review of 272 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 SENTINEL CH. SpA devices

FDA 510(k) Submission Details - K083602

510(k) Number K083602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2008
Decision Date September 03, 2009
Days to Decision 272 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
168d slower than avg
Panel avg: 104d · This submission: 272d
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 54
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K083602.
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator
K153394 · Diazyme Laboratories · Nov 2016
Optilite FreeLite Kappa Free Kit, Optilite Freelite Lambda Free Kit
K150658 · The Binding Site Group , Ltd. · Aug 2015
HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER
K120056 · The Binding Site Group , Ltd. · Apr 2013
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL
K082503 · Siemens Healthcare Diagnostics · Dec 2008
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
K070900 · The Binding Site, Ltd. · Nov 2007
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
K062372 · The Binding Site, Ltd. · Jun 2007