Vitros Immunodiagnostic Products Anti-Hbe Reagent Pack/Anti-Hbe Calibrator/Anti Hbe Controls

FDA premarket approval P100001 · Qualitative and Quantitative Hepatitis B Virus Antibody assays

PMA numberP100001

Approval

Applicant
Ortho-Clinical Diagnostics
Received
January 29, 2010
Decision date
July 20, 2011 (APRL)
Supplements
17, latest January 24, 2023
Product code
SEI – Qualitative And Quantitative Hepatitis B Virus Antibody Assays

Official FDA PMA record

Approval order statement

APPROVAL FOR THE VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK, CALIBRATOR AND CONTROLS. THIS DEVICE IS INDICATED FOR: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK FOR THE IN VITRO QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B E ANTIGEN (ANTI-HBE) IN HUMAN ADULT AND PEDIATRIC (2 TO 21 YEARS OLD) SERUM FROM INDIVIDUALS WHO HAVE SYMPTOMS OF CHRONIC HEPATITIS AND THOSE WHO HAVE RECOVERED FROM HBV INFECTION, USING THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS. FURTHER ASSESSMENT OF HBV INFECTION (BIOCHEMICAL, SEROLOGICAL AND/OR NUCLEIC ACID TESTING) IS REQUIRED TO DEFINE THE SPECIFIC DISEASE STATE. VITROS ANTI-HBE TEST PERFORMANCE HAS NOT BEEN ESTABLISHED FOR THE MONITORING OF HBV DISEASE OR THERAPY. VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CALIBRATOR FOR USE IN THE CALIBRATION OF THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS WHEN USED WITH THE VITROS ANTI-HBE TEST FOR THE IN VITRO QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS B E ANTIGEN (ANTI-HBE). VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE CONTROLS FOR USE IN MONITORING THE PERFORMANCE OF THE VITROS ANTI-HBE TEST WHEN USED ON THE VITROS ECI/ECIQ IMMUNODIAGNOSTIC SYSTEMS.