Cleared Traditional

K153394 - 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 (FDA 510(k) Clearance)

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

K153394 · Diazyme Laboratories · Immunology device
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Nov 2016
Decision
360d
Days
Class 2
Risk

K153394 is an FDA 510(k) clearance for the Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light C.... Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on November 18, 2016 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K153394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2015
Decision Date November 18, 2016
Days to Decision 360 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
256d slower than avg
Panel avg: 104d · This submission: 360d
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 K153394.
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K231290 · The Binding Site, Ltd. · Jan 2024
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2
K210623 · Sebia · Nov 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
K211648 · Diazyme Laboratories, Inc. · Sep 2022