Attention: Mr. Christopher Bentsen
6565 185th Avenue NE
Redmond, WA 98052
Product code: MZF
Dear Mr. Bentsen:
The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has completed its review of your premarket approval (PMA) application for the GS HIV Combo Ag/Ab EIA. The GS HIV Combo Ag/Ab EIA is an enzyme immunoassay kit for the simultaneous qualitative detection of HIV-1 p24 antigen and antibodies to HIV-1 (groups M and O) and HIV-2 in human serum or plasma. This kit is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2, including acute or primary infection. The assay may also be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection in pediatric subjects (i.e., children as young as two years of age). The GS HIV Combo Ag/Ab EIA is intended for manual use and with the Bio-Rad EVOLIS™ Automated Microplate System. The GS HIV Combo Ag/Ab EIA is not intended for routine use in the screening of blood or plasma donors; however, it can be used as a blood donor screening assay in urgent situations where traditional licensed blood donor screening tests are unavailable or their use is impractical.
We are pleased to inform you that the PMA is approved. You may begin commercial distribution of the device in accordance with the conditions of approval described below.
The sale and distribution of this device are restricted to prescription use in accordance with 21 CFR 801.109 and under section 515(d)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (the Act). The device is further restricted under section 515(d)(1)(B)(ii) of the Act insofar as the labeling must specify the specific training or experience practitioners need in order to use the device. FDA has determined that these restrictions on sale and distribution are necessary to provide reasonable assurance of the safety and effectiveness of the device. Your device is therefore a restricted device subject to the requirements in sections 502(q) and (r) of the Act, in addition to the many other FDA requirements governing the manufacture, distribution, and marketing of devices.
Expiration dating for this device has been established and approved at:
- 12 months for the GS HIV Combo Ag/Ab EIA at the intended storage conditions of 2 oC to 8 oC.
Continued approval of this PMA is contingent upon the submission of periodic reports, required under 21 CFR 814.84, at intervals of one year from the date of approval of the original PMA. Two copies of this report, identified as "Annual Report" (please use this title even if the specified interval is more frequent than one year) and bearing the applicable PMA reference number, should be submitted to the address below. The Annual Report should indicate the beginning and ending date of the period covered by the report and should include the information required by 21 CFR 814.84.
In addition to the above, and in order to provide continued reasonable assurance of the safety and effectiveness of the device, the Annual Report must include, separately for each model number (if applicable), the number of devices sold and distributed during the reporting period, including those distributed to distributors. The distribution data will serve as a denominator and provide necessary context for FDA to ascertain the frequency and prevalence of adverse events, as FDA evaluates the continued safety and effectiveness of the device.
Before making any change affecting the safety or effectiveness of the device, you must submit a PMA supplement or an alternate submission (30-day notice) in accordance with 21 CFR 814.39. All PMA supplements and alternate submissions (30-day notice) must comply with the applicable requirements in 21 CFR 814.39. For more information, please refer to the FDA guidance document entitled "Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process" at: (www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089274.htm).
In accordance with the Medical Device Reporting (MDR) regulation, 21 CFR 803.50 and 21 CFR 803.52, you are required to report adverse events for this device. Manufacturers of medical devices, including in vitro diagnostic devices, are required to report to FDA no later than 30 calendar days after the day they receive or otherwise become aware of information, from any source, that reasonably suggests that one of their marketed devices:
1. May have caused or contributed to a death or serious injury; or
2. Has malfunctioned and such device or similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
In accordance with the recall requirements specified in 21 CFR 806.10, you are required to submit a written report to FDA of any correction or removal of this device initiated by you to: (1) reduce a risk to health posed by the device; or (2) remedy a violation of the Act caused by the device which may present a risk to health, with certain exceptions specified in 21 CFR 806.10(a)(2). Additional information on recalls is available at: www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm.
CBER does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. CBER will notify the public of its decision to approve your PMA by making available, among other information, a summary of the safety and effectiveness data upon which the approval is based. The information can be found at: http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/
PremarketApprovalsPMAs/ucm089793.htm. Written requests for this information can also be made to the Dockets Management Branch, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The written request should include the PMA number or docket number. Within 30 days from the date that this information is placed on the Internet, any
interested person may seek review of this decision by submitting a petition for review under section 515(g) of the Act and requesting either a hearing or review by an independent advisory committee. FDA may, for good cause, extend this 30-day filing period.
Failure to comply with any post-approval requirement constitutes a ground for withdrawal of approval of a PMA. The introduction or delivery for introduction into interstate commerce of a device that is not in compliance with its conditions of approval is a violation of law.
You are reminded that, as soon as possible and before commercial distribution of your device, you must submit an amendment to this PMA submission with copies of all approved labeling in final printed form. Final printed labeling that is identical to the labeling approved in draft form will not routinely be reviewed by FDA staff when accompanied by a cover letter stating that the final printed labeling is identical to the labeling approved in draft form. If the final printed labeling is not identical, any changes from the final draft labeling should be highlighted and explained in the amendment.
All required documents should be submitted in triplicate, unless otherwise specified, to the address below and should reference the above PMA number to facilitate processing. One of those three copies may be an electronic copy (eCopy), in an electronic format that FDA can process, review and archive (general information): http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/
PremarketSubmissions/ucm134508.htm; clinical and statistical data: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/
Office of Blood Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
If you have any questions concerning this approval order, please contact Vasantha Kumar at (301) 827-6142.
Office of Blood Research and Review
Center for Biologics
Evaluation and Research