PMA P030024S010
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P030024
- Supplement
- S010
- Product code
- LOM
- Decision date
- 2009-09-11
- Classification
- Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Approval order statement
- APPROVAL FOR THE REVISION OF THE INTENDED USE TO INCLUDE USER OF THE VITROS 5600 INTEGRATED SYSTEM AND VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WITH THE ANTI-HBC ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CALIBRATOR AND IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK: FOR THE IN VITRO QUALITATIVE DETECTION OF TOTAL ANTIBODY (LGG AND IGM) TO HEPATITIS B CORE ANTIGEN(TOTAL ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA AND CITRATE) AND NEONATESERUM USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THELABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B, OR RECOVERY FROM HEPATITIS B INFECTION. THE PRESENCE OF ANTI-HBC MAY BE USED AS AN AID IN THE DETERMINATION OF EXPOSURE TOHBV INFECTION FOR INDIVIDUALS PRIOR TO HBV VACCINATION.VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CALIBRATOR:FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM FOR THE IN VITROQUALITATIVE DETECTION OF TOTAL ANTIBODY (IGG AND IGM) TO HEPATITIS B VIRUS CORE ANTIGEN (TOTAL ANTI HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA AND CITRATE) AND NEONATE SERUMUSING VITROS ANTI-HBC IGM REAGENT PACKS. THE VITROS ANTI-HBC CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS ECI/ECIQIMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600INTEGRATED SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACKS.
Current openFDA PMA Record#
- Device
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR
- Applicant
- Ortho-Clinical Diagnostics
- PMA number
- P030024
- Supplement
- S010
- Product code
- LOM
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Decision date
- 2009-09-11
- Decision code
- APPR
- Date received
- 2009-02-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE REVISION OF THE INTENDED USE TO INCLUDE USER OF THE VITROS 5600 INTEGRATED SYSTEM AND VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WITH THE ANTI-HBC ASSAY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CALIBRATOR AND IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK: FOR THE IN VITRO QUALITATIVE DETECTION OF TOTAL ANTIBODY (LGG AND IGM) TO HEPATITIS B CORE ANTIGEN(TOTAL ANTI-HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA AND CITRATE) AND NEONATESERUM USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM.ASSAY RESULTS, IN CONJUNCTION WITH OTHER SEROLOGICAL AND CLINICAL INFORMATION, MAY BE USED FOR THELABORATORY DIAGNOSIS OF INDIVIDUALS WITH ACUTE OR CHRONIC HEPATITIS B, OR RECOVERY FROM HEPATITIS B INFECTION. THE PRESENCE OF ANTI-HBC MAY BE USED AS AN AID IN THE DETERMINATION OF EXPOSURE TOHBV INFECTION FOR INDIVIDUALS PRIOR TO HBV VACCINATION.VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CALIBRATOR:FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600 INTEGRATED SYSTEM FOR THE IN VITROQUALITATIVE DETECTION OF TOTAL ANTIBODY (IGG AND IGM) TO HEPATITIS B VIRUS CORE ANTIGEN (TOTAL ANTI HBC) IN HUMAN ADULT AND PEDIATRIC SERUM AND PLASMA (EDTA AND CITRATE) AND NEONATE SERUMUSING VITROS ANTI-HBC IGM REAGENT PACKS. THE VITROS ANTI-HBC CALIBRATOR HAS BEEN VALIDATED FOR USE ONLY ON THE VITROS ECI/ECIQIMMUNODIAGNOSTIC SYSTEMS, THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM AND THE VITROS 5600INTEGRATED SYSTEM WITH THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACKS.