Aptima HCV Quant Dx Assay

FDA Premarket Approval P160023 S016

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 to add an alternate cleaning method for the sample shields and target capture reagent (tcr) adapters used on the panther/panther fusion instruments.

DeviceAptima HCV Quant Dx Assay
Generic NameAssay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
ApplicantHOLOGIC, INC.
Date Received2019-12-23
Decision Date2020-01-21
PMAP160023
SupplementS016
Product CodeMZP 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address HOLOGIC, INC. 10210 Genetic Center Dr san Diego, CA 92121

Supplemental Filings

Supplement NumberDateSupplement Type
P160023Original Filing
S017 2020-02-12 30-day Notice
S016 2019-12-23 Real-time Process
S015 2019-06-21 Normal 180 Day Track
S014 2019-05-21 30-day Notice
S013 2019-04-19 30-day Notice
S012 2019-03-27 30-day Notice
S011 2019-03-18 Real-time Process
S010 2019-02-21 30-day Notice
S009 2018-12-31 Real-time Process
S008 2018-11-29 30-day Notice
S007 2018-10-03 30-day Notice
S006 2018-08-31 30-day Notice
S005 2018-07-09 30-day Notice
S004 2018-05-09 135 Review Track For 30-day Notice
S003 2018-04-20 30-day Notice
S002 2018-03-12 30-day Notice
S001 2017-08-28 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
15420045506800 P160023 000
15420045506794 P160023 000
15420045506787 P160023 000
15420045506800 P160023 000
15420045506794 P160023 000
15420045506787 P160023 000

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