Cleared Traditional

K182098 - N Latex FLC kappa assay

K182098 is an FDA 510(k) clearance for N Latex FLC kappa assay, manufactured by Siemens Healthcare Diagnostics Products GmbH. The device is a Class 2 Immunology device with product code DFH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K182098

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.

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 53
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
K201496 · Siemens Healthcare Diagnostics Products GmbH · Oct 2021
N Latex FLC kappa, N Latex FLC lambda
K193047 · Siemens Healthcare Diagnostics Products GmbH · Jul 2021
N Latex FLC kappa, N Latex FLC lambda
K190879 · Siemens Healthcare Diagnostics Products GmbH · May 2019
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit
K173732 · The Binding Site Group , Ltd. · Aug 2018
Diazyme Human Kappa Free Light Chain Assay
K181438 · Diazyme Laboratories, Inc. · Jun 2018
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