Cleared Traditional

N Latex FLC kappa assay, N Latex FLC lambda assay (K182098) - FDA 510(k) Clearance

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

K182098 · Siemens Healthcare Diagnostics Products GmbH · Immunology device
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Nov 2018
Decision
90d
Days
Class 2
Risk

K182098 is an FDA 510(k) clearance for the N Latex FLC kappa assay, N Latex FLC lambda assay. Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics Products GmbH (Marburg, DE). The FDA issued a Cleared decision on November 1, 2018 after a review of 90 days - within the typical 510(k) review window.

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 Siemens Healthcare Diagnostics Products GmbH devices

Submission Details

510(k) Number K182098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2018
Decision Date November 01, 2018
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 104d · This submission: 90d
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 26
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K182098.
N Latex FLC kappa, N Latex FLC lambda
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N Latex FLC kappa, N Latex FLC lambda
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N Latex FLC kappa, N Latex FLC lambda
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Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
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Diazyme Human Kappa Free Light Chain Assay
K181438 · Diazyme Laboratories, Inc. · Jun 2018
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