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July 3, 2012 Approval Letter, OraQuick In-Home HIV Test

OraSure Technologies, Inc.
Attention: Ms. Tiffany Miller
220 East First Street
Bethlehem, PA 18015-1389

Device: OraQuick® In-Home HIV Test
Filed: January 9, 2012
Amended: January 9, 2012
January 27, 2012
February 17, 2012
March 5, 2012
March 21, 2012
April 18, 2012
April 20, 2012
May 29, 2012
June 5, 2012
June 20, 2012
July 3, 2012

Dear Ms. Miller:

The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) for the OraQuick® In-Home HIV Test. The OraQuick® In-Home HIV Test is a single-use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in human oral fluid specimens. The OraQuick® In-Home HIV Test is intended as an over-the-counter (OTC) test for consumer use as an aid in the diagnosis of infection with HIV-1 and HIV-2.

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.

Expiration dating for this device has been established and approved at 30 months.

Continued approval of this PMA is contingent upon the submission of periodic reports, required under 21 CFR 814.84, at intervals of one year (unless otherwise specified) 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.

In addition to the Annual Report requirements, you must provide the following data in post-approval study reports (PAS). Two (2) copies, identified as "PMA Post-Approval Study Report" and bearing the applicable PMA reference number, should be submitted to the address below.

  1. In order to validate changes made to the OraQuick® In-Home HIV Test labeling after completion of the clinical trials, you must conduct a study to assess comprehension of the labeling in both English and Spanish. These studies will follow the same label comprehension study design as in your clinical trials and include intended use populations that speak only English, only Spanish, and are bilingual (English and Spanish). You must submit the results of these studies within six months of the approval of the PMA.
  2. You will conduct surveillance of the Consumer Support Center usage to collect information on the number of individuals reporting positive results, negative results and unknown results, as well as demographic information that does not breach caller confidentiality.  Within two months you must submit a protocol for this surveillance, and provide this surveillance information annually in PMA Post-Approval Study Reports.
  3. You will provide a certificate of translation for all final labeling printed in Spanish.

Be advised that the failure to conduct any such study in compliance with the good clinical laboratory practices in 21 CFR part 58 (if a non-clinical study subject to part 58) or the institutional review board regulations in 21 CFR part 56 and the informed consent regulations in 21 CFR part 50 (if a clinical study involving human subjects) may be grounds for FDA withdrawal of approval of the PMA.

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.

You are reminded that many FDA requirements govern the manufacture, distribution, and marketing of devices. For example, 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.

Additional information on MDR, including how, when, and where to report, is available at: www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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 Federal Food, Drug, and Cosmetic Act (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/
. 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/
; clinical and statistical data: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/

Office of Blood Research and Review
Center for Biologics Evaluation and Research
Food and Drug Administration
Suite 200N
1401 Rockville Pike
Rockville, MD 20852-1448

If you have any questions concerning this approval order, please contact Dr. Vasantha Kumar at (301) 827-6142.

Sincerely yours,


Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics
Evaluation and Research

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