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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name human immunodeficiency virus (hiv) viral load monitoring test
510(k) Number BK231025
Tradename Aptima HIV-1 Quant Dx Assay
Device Name Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test
Original Applicant
HOLOGIC INC
10210 genetic center dr
san diego,  CA  92121
Regulation Number866.3958
Classification Product Code
QUM  
Date Received11/08/2023
Decision Date 08/06/2024
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Clinical Chemistry
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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