Cleared Traditional

K212379 - N Latex FLC kappa

K212379 is an FDA 510(k) clearance for N Latex FLC kappa, 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 212-day FDA review.

K212379 · Siemens Healthcare Diagnostics Products GmbH · Immunology device
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Mar 2022
Decision
212d
Days
Class 2
Risk

K212379 is an FDA 510(k) clearance for the N Latex FLC kappa, N Latex FLC lambda. 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 March 2, 2022 after a review of 212 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 Siemens Healthcare Diagnostics Products GmbH devices

FDA 510(k) Submission Details - K212379

510(k) Number K212379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2021
Decision Date March 02, 2022
Days to Decision 212 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
108d slower than avg
Panel avg: 104d · This submission: 212d
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 K212379.
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
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay
K220001 · Diazyme Laboratories, Inc. · Aug 2022
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