Assay, Direct, Nucleic Acid Amplification, Q Fever
The Assay, Direct, Nucleic Acid Amplification, Q Fever (product code OVF) consists of nucleic acid primers and probes intended for the amplification and identification of Coxiella burnetii directly from clinical specimens, aiding in the diagnosis of Q Fever and providing epidemiological information on this disease. The assay uses nucleic acid amplification methods rather than the traditional antisera or antigens described in the regulation. As an FDA Class 1 device under regulation 866.3500, it is subject only to general controls and falls within the Microbiology specialty. The device is not an implant and is not life-sustaining.
Basic Information
- Product Code
- OVF
- Device Class
- FDA class 1
- Regulation Number
- 866.3500
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
These reagents are nucleic acid primers and probes intended for the amplification and identification of Coxiella burnetii directly from clinical specimens. The identification aids in the diagnosis of Q Fever and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera or antigens.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K103207 | JBAIDS Q FEVER DETECTION KIT | May 20, 2011 | Substantially Equivalent | IDAHO TECHNOLOGY, INC. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.