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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
1401 Rockville Pike
Rockville, MD 20852-1448
November 19, 2001
Mr. Ron Sanyal, M. Pharm., CQE, RAC
Manager, Regulatory Affairs
bioMerieux, Inc.
100 Rodolphe Street
Durham, North Carolina 27712
Re: BP010001/0
Product: NucliSens HIV-1 QT
Device Code: MZF
Date Received: 02-JAN-01
Dear Mr. Sanyal:
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 NucliSens HIV-1 QT. This device is intended for use in conjunction with clinical presentation and other laboratory markers of disease progression for prognostic assessment of HIV-1 infected patients, and for monitoring the effects of anti-retroviral therapy by serial measurements of plasma HIV-1 RNA for pediatric and adult patients with baseline viral loads greater than 93,000 and 28,000 copies of HIV-1 viral RNA/mL respectively. We are pleased to inform you that the PMA is approved subject to the conditions described below and in the "Conditions of Approval" (enclosed). You may begin commercial distribution of the device upon receipt of this letter.
- The lyophilization process must be fully validated during the manufacturing of
the first three commercial lots of the NucliSens® HIV-1 QT test.
- bioMérieux will provide lot release test results for the first three commercial lots of the NucliSens® HIV-1 QT test. Thereafter, lot release data will be submitted to CBER from every third lot of test kits for a period of 12 months under a surveillance program. The need for continued surveillance of this test kit beyond this period will be determined by CBER.
Expiration dating for this device has been approved as 12 months under storage and shipping conditions described in the package insert. The protocol you used to establish this expiration dating is considered an approved protocol for the purpose of extending the expiration dating as provided by 21 CFR 814.39(a)(8).
CBER will publish a notice of its decision to approve your PMA in the FEDERAL REGISTER. The notice will state that a summary of the safety and effectiveness data upon which the approval is based is available to the public upon request. Within 30 days of publication of the notice of approval in the FEDERAL REGISTER, any interested person may seek review of this decision by requesting an opportunity for administrative review, either through a hearing or review by an independent advisory committee, under section 515(g) of the Federal Food, Drug, and Cosmetic Act (the act).
Failure to comply with the conditions of approval invalidates this approval order. Commercial distribution of a device that is not in compliance with these conditions is a violation of the act.
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.
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.
Document Control Center (HFM-99)
Center for Biologics Evaluation and Research
Food and Drug Administration
1401 Rockville Pike
Rockville, Maryland 20852-1448
If you have any questions concerning this approval order, please contact Sayah Nedjar, Ph.D. at (301) 827-3524.
Sincerely yours,
--- signature ---
Hira L. Nakhasi, Ph.D.
Director
Division of Emerging and Transfusion Transmitted Diseases
Office of Blood Research and Review
Center for Biologics Evaluation and Research
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