VITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI

FDA Premarket Approval P000044 S020

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for revision of the intended use to include use of the vitros 5600 integrated system and vitros 3600 immunodiagnostic system with the vitros hbsag assay and the vitros hbsag confirmatory kit. These devices, as modified, will be marketed under the trade name vitros immunodiagnostic products hbsag reagent pack, vitros immunodiagnostic products hbsag calibrator and vitros immunodiagnostic products hbsag confirmatory kit and is indicated for: vitros immunodiagnostic products hbsag reagent pack:for the in vitro qualitative detection of hepatitis b surface antigen (hbsag) in human serum andplasma (heparin, edta, and sodium citrate) using the vitros eci/eciq immunodiagnosticsystems, the vitros 3600 immunodiagnostic system and the vitros 5600 integrated system. Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute and chronic hepatitis b. In addition, this assaymay be used to screen for hepatitis b infection in pregnant women to identify neonates who are at high risk of acquiring iibv during the perinatal period. Vitros immunodiagnostic products hbsag calibralor: for use in the calibration of the vitros eci/eciq immunodiagnostic systems, the vitros3600 immunodiagnostic system and the vitros 5600 integrated system for the in vitroqualitative detection of hepatitis b surface antigen (hbsag) in human serum and plasma using vitros hbsag reagent packs. The vitros hbsag calibrator has been validated for use only on the vitros eci/eciq immunodiagnostic systems, the vitros 3600 immunodiagnosticsystem and the vitros 5600 integrated system with the vitros immunodiagnostic productsanti-hbc reagent packs. (see approval order for additional approval information)

DeviceVITROS IMMUNODIAGNOSTIC PRODUCT HBSAG REAGENT PACK & CALIBRATOR & VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONFIRMATORY KI
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantOrtho-Clinical Diagnostics, Inc.
Date Received2009-02-02
Decision Date2009-10-23
PMAP000044
SupplementS020
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr. rochester, NY 14626-5101

Supplemental Filings

Supplement NumberDateSupplement Type
P000044Original Filing
S040 2019-05-21 30-day Notice
S039 2018-10-16 Normal 180 Day Track No User Fee
S038 2018-02-21 Normal 180 Day Track No User Fee
S037 2018-01-09 Normal 180 Day Track No User Fee
S036 2017-10-17 30-day Notice
S035 2017-05-30 30-day Notice
S034 2016-03-02 30-day Notice
S033 2015-10-29 30-day Notice
S032 2015-08-10 30-day Notice
S031 2015-06-25 30-day Notice
S030 2012-10-17 30-day Notice
S029 2012-01-30 30-day Notice
S028 2011-10-05 Real-time Process
S027 2011-08-19 30-day Notice
S026 2011-04-28 30-day Notice
S025 2010-10-18 30-day Notice
S024 2010-08-06 30-day Notice
S023 2009-12-01 Normal 180 Day Track No User Fee
S022 2009-09-30 30-day Notice
S021 2009-03-06 30-day Notice
S020 2009-02-02 Normal 180 Day Track
S019 2008-11-13 Normal 180 Day Track No User Fee
S018 2008-05-15 30-day Notice
S017 2008-01-23 30-day Notice
S016 2007-03-21 30-day Notice
S015 2007-03-12 30-day Notice
S014 2006-08-08 30-day Notice
S013 2006-05-25 Real-time Process
S012 2006-05-12 30-day Notice
S011 2006-03-15 30-day Notice
S010 2005-11-18 30-day Notice
S009 2005-10-26 30-day Notice
S008 2005-09-02 30-day Notice
S007 2005-07-13 30-day Notice
S006 2005-04-08 Special (immediate Track)
S005 2004-11-15 30-day Notice
S004 2004-10-26 30-day Notice
S003 2003-03-06 30-day Notice
S002 2001-05-29 30-day Notice
S001 2001-05-04 30-day Notice

NIH GUDID Devices

Device IDPMASupp
10758750002764 P000044 030
10758750001088 P000044 030
10758750001071 P000044 030
10758750001064 P000044 030

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