Cleared Special

K190879 - N Latex FLC kappa, N Latex FLC lambda (FDA 510(k) Clearance)

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

K190879 · Siemens Healthcare Diagnostics Products GmbH · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
29d
Days
Class 2
Risk

K190879 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 May 3, 2019 after a review of 29 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 Siemens Healthcare Diagnostics Products GmbH devices

Submission Details

510(k) Number K190879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2019
Decision Date May 03, 2019
Days to Decision 29 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 104d · This submission: 29d
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 62
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