Atlas FDA

RCRP Flex reagent cartridge

FDA 510(k) clearance K221119 · decided 2023-03-17

Clearance details

K-number
K221119
Device name
RCRP Flex reagent cartridge
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2022-04-18
Decision date
2023-03-17
Days to decision
333 days
Clearance type
Special
Product code
DCN
Device class
2
Regulation number
866.5270
Medical specialty
Immunology
Advisory committee
Immunology
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
CardioPhase® hsCRP (K232624)Siemens Healthcare Diagnostic Products GmbH2023-11-27
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Optilite High Sensitivity C-Reactive Protein Kit (K180099)The Binding Site Group , Ltd.2018-10-12
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls (K172868)The Binding Site Group , Ltd.2018-02-28
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (K171498)Meso Scale Diagnostics, LLC2018-01-12
C-Reactive Protein Kit for use on SPAPLUS (K161982)The Binding Site Group2017-04-05
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (K113809)Hitachi Chemical Diagnostics, Inc.2012-08-17
PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (K091052)Abaxis, Inc.2010-01-15
C-REACTIVE PROTEIN (LATEX) (K083444)Roche Diagnostics Corp.2009-03-18
PATHFAST HSCRP (K083412)Mitsubishi Kagaku Iatron2009-03-09
S-TEST C-REACTIVE PROTEIN (CRP) (K083040)Alfa Wassermann Diagnostic Technologies, Inc.2009-01-30
ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS (K072658)Siemens Medical Solutions Diagnostics2008-04-01

Recalls involving this device

RecordFirmDate
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. recall (Z-1551-2025)Siemens Healthcare Diagnostics, Inc.2025-04-10

PMA approvals by this applicant

RecordFirmDate
Atellica IM Total PSA II (tPSAII) (P240021)Siemens Healthcare Diagnostics, Inc.2025-12-03
IMMULITE 2000 PSA (P930027/S037)Siemens Healthcare Diagnostics, Inc.2025-10-30
IMMULITE 2000 AFP (P010007/S024)Siemens Healthcare Diagnostics, Inc.2025-10-30
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (P100039/S018)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM Anti-HBe2 (aHBe2) (P200017/S005)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM HBc Total 2 (HBcT2) (P210019/S004)Siemens Healthcare Diagnostics, Inc.2025-10-17
IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S036)Siemens Healthcare Diagnostics, Inc.2025-08-14
ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025)Siemens Healthcare Diagnostics, Inc.2025-07-16