510(k) K103207
K103207 is an FDA 510(k) premarket notification submitted by Idaho Technology, Inc. for the device "JBAIDS Q FEVER DETECTION KIT". The FDA issued a decision of Substantially Equivalent on May 20, 2011. The device falls under product code OVF (Assay, Direct, Nucleic Acid Amplification, Q Fever), a Class I device regulated under 21 CFR 866.3500. Idaho Technology, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2011
- Date Received
- November 1, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Direct, Nucleic Acid Amplification, Q Fever
- Device Class
- Class I
- Regulation Number
- 866.3500
- Review Panel
- MI
- Submission Type
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.