Atlas FDA

IMMULITE 2000 ANTI-CCP IGG ASSAY

FDA 510(k) clearance K121576 · decided 2013-04-04

Clearance details

K-number
K121576
Device name
IMMULITE 2000 ANTI-CCP IGG ASSAY
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2012-05-30
Decision date
2013-04-04
Days to decision
309 days
Clearance type
Traditional
Product code
NHX
Device class
2
Regulation number
866.5775
Medical specialty
Immunology
Advisory committee
Immunology
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials. (K153551)Axis-Shield Diagnostics Limited2016-08-04
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 (K143754)Inova Diagnostics, Inc.2015-09-21
MULTI-ANALYTE DETECTION SYSTEMS (K112810)Bio-Rad Laboratories2011-10-26
AXIS-SHIELD ANTI-CCP (K110296)Axis-Shield Diagnostics, Ltd.2011-08-18
CCPOINT (K093908)Euro-Diagnostica AB2010-12-01
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K093954)Bio-Rad Laboratories2010-08-24
THERATEST EL-ANTI-CCP/2 (K090753)Theratest Laboratories, Inc.2010-03-05
IMMUNOSCAN CCPLUS (K091657)Euro-Diagnostica AB2009-11-19
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 (K083868)Axis-Shield Diagnostics, Ltd.2009-09-25
ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP (K081338)Roche Diagnostics2008-09-11
QUANTA LITE CCP3.1 IGG/IGA ELISA (K072944)Inova Diagnostics, Inc.2008-03-05
EUROIMMUN ANTI-CCP ELISA (K070789)Euroimmun Us, LLC2007-12-31

Recalls involving this device

No recalls on record reference this clearance.

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