Cleared Special

K221119 - RCRP Flex reagent cartridge (FDA 510(k) Clearance)

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

K221119 · Siemens Healthcare Diagnostics, Inc. · Immunology device
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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.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

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
229d slower than avg
Panel avg: 104d · This submission: 333d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.