Cleared Special

K221119 - RCRP Flex reagent cartridge

K221119 is an FDA 510(k) clearance for RCRP Flex reagent cartridge, manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DCN cleared through the Special 510(k) pathway after a 333-day FDA review.

K221119 · Siemens Healthcare Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
333d
Days
Class 2
Risk

K221119 is an FDA 510(k) clearance for the RCRP Flex reagent cartridge. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on March 17, 2023 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - 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. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K221119

510(k) Number K221119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2022
Decision Date March 17, 2023
Days to Decision 333 days
Submission Type Special
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
228d slower than avg
Panel avg: 105d · This submission: 333d
Pathway characteristics
Modification to existing cleared device.

DCN Device Classification - Class 2, Special Controls

Product Code DCN System, Test, C-reactive Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 - DCN System, Test, C-reactive Protein

All 69
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K221119.
CardioPhase® hsCRP
K232624 · Siemens Healthcare Diagnostic Products GmbH · Nov 2023
Tina-quant C-Reactive Protein IV
K192072 · Roche Diagnostics Operations (Rdo) · Feb 2020
Optilite High Sensitivity C-Reactive Protein Kit
K180099 · The Binding Site Group , Ltd. · Oct 2018
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
K172868 · The Binding Site Group , Ltd. · Feb 2018
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
K171498 · Meso Scale Diagnostics, LLC · Jan 2018
C-Reactive Protein Kit for use on SPAPLUS
K161982 · The Binding Site Group · Apr 2017
K221119 · RCRP Flex reagent cartridge
Download PDF FDA Summary Siemens Healthcare Di…