Attention: Mr. Scott Dennis
6565 185th Avenue NE
Redmond, WA 98052
Device: Multispot HIV-1/HIV-2 Rapid Test
Filed: September 27, 2012
Amended: October 24, 2012
December 20, 2012
March 12, 2013
March 13, 2013
Dear Mr. Dennis:
The Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) has completed its evaluation of your premarket approval application (PMA) supplement, which requested approval for modification to the package insert for the Multispot HIV-1/HIV-2 Rapid Test so that it can be used in conjunction with a new HIV diagnostic testing algorithm. Based on the information submitted, the PMA supplement is approved. You may begin commercial distribution of the device as modified by your PMA supplement in accordance with the conditions 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.
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" (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:
- May have caused or contributed to a death or serious injury; or
- 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 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.
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 supplement 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.
Center for Biologics Evaluation and Research
Food and Drug Administration
Suite 200N, HFM-99
1401 Rockville Pike
Rockville, MD 20852-1448
If you have questions concerning this approval order, please contact Dr. Vasantha Kumar at (301) 827-6142.
Hira L. Nakhasi, PhD
Division of Emerging and
Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research