510(k) K170940
K170940 is an FDA 510(k) premarket notification submitted by Centers For Disease Control and Prevention (CDC) for the device "Rickettsia Real-time PCR Assay". The FDA issued a decision of Substantially Equivalent on June 29, 2017. The device falls under product code PVQ (Rickettsia Spp. Nucleic Acid Based Detection Assay), a Class II device regulated under 21 CFR 866.3316. Centers For Disease Control and Prevention (CDC) has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 29, 2017
- Date Received
- March 30, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rickettsia Spp. Nucleic Acid Based Detection Assay
- Device Class
- Class II
- Regulation Number
- 866.3316
- Review Panel
- MI
- Submission Type
An in vitro diagnostic test for the detection of Rickettsia spp. nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure. Test results are used in conjunction with other diagnostic assays and clinical observations to aid in the diagnosis infection, in accordance with criteria defined by the appropriate public health authorities in the Federal government.