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- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
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Assay, Genotype, Hiv Drug Resistance, In Vitro
- Page Type
- Product Code
- Definition
- Hiv-1 drug resistance genotyping
- Regulation Medical Specialty
- Immunology
- Review Panel
- Immunology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 866.3950
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 866.3950 In vitro human immunodeficiency virus (HIV) drug resistance genotype assay
§ 866.3950 In vitro human immunodeficiency virus (HIV) drug resistance genotype assay.
(a) Identification. The in vitro HIV drug resistance genotype assay is a device that consists of nucleic acid reagent primers and probes together with software for predicting drug resistance/susceptibility based on results obtained with these primers and probes. It is intended for use in detecting HIV genomic mutations that confer resistance to specific antiretroviral drugs, as an aid in monitoring and treating HIV infection.
(b) Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay.” See § 866.1(e) for the availability of this guidance document.
[72 FR 44382, Aug. 8, 2007]