VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
FDA premarket approval P030024/S007 · decided 2008-02-12
Approval details
- PMA number
- P030024
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK AND CALIBRATOR
- Generic name
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Applicant
- Ortho-Clinical Diagnostics
- Date received
- 2007-12-10
- Decision date
- 2008-02-12
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LOM
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR THE ADDITION OF A NEW PROCESS STEP TO IDENTIFY AND DILUTE SAMPLES WITH HIGH RESULT SIGNAL-TO-CUTOFF RATIO (S/C) ABOVE THE NORMAL NEGATIVE POPULATION AND THE CHANGES INVOLVED IN ADDING THIS NEW PROCESS. THESE CHANGES ARE AN UPDATE TO THE MAGNETIC CARD AND TO THE LABELING OF THE VITROS ANTI-HBC REAGENT PACK TO SUPPORT THE IDENTIFICATION, DILUTION AND TESTING OF THE HIGH NEGATIVE SAMPLES.
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