Atlas FDA

ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP

FDA 510(k) clearance K081338 · decided 2008-09-11

Clearance details

K-number
K081338
Device name
ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2008-05-13
Decision date
2008-09-11
Days to decision
121 days
Clearance type
Traditional
Product code
NHX
Device class
2
Regulation number
866.5775
Medical specialty
Immunology
Advisory committee
Immunology
Location
Indianapolis, IN, 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
IMMULITE 2000 ANTI-CCP IGG ASSAY (K121576)Siemens Healthcare Diagnostics, Inc.2013-04-04
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
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

RecordFirmDate
Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190 recall (Z-2361-2019)Roche Diagnostics Operations, Inc.2019-08-23
Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160 recall (Z-2362-2019)Roche Diagnostics Operations, Inc.2019-08-23

PMA approvals by this applicant

RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01