Cleared Special

Diazyme Human Kappa Free Light Chain Assay (K181438) - FDA 510(k) Clearance

Also marketed or referenced as:
Diazyme Human Lambda Free Light Chain Assay

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K181438 · Diazyme Laboratories, Inc. · Immunology device
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Jun 2018
Decision
25d
Days
Class 2
Risk

K181438 is an FDA 510(k) clearance for the Diazyme Human Kappa Free Light Chain Assay. Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Diazyme Laboratories, Inc. (Poway, US). The FDA issued a Cleared decision on June 26, 2018 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Diazyme Laboratories, Inc. devices

Submission Details

510(k) Number K181438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2018
Decision Date June 26, 2018
Days to Decision 25 days
Submission Type Special
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 104d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 19
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K181438.
N Latex FLC kappa, N Latex FLC lambda
K190879 · Siemens Healthcare Diagnostics Products GmbH · May 2019
N Latex FLC kappa assay, N Latex FLC lambda assay
K182098 · Siemens Healthcare Diagnostics Products GmbH · Nov 2018
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
K173732 · The Binding Site Group , Ltd. · Aug 2018
IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG
K964260 · Beckman Instruments, Inc. · Feb 1997
BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
K902484 · Beckman Instruments, Inc. · Jun 1990
BECKMAN LAMBDA LIGHT CHAIN REAGENT
K884597 · Beckman Instruments, Inc. · Dec 1988