Rickettsia Spp. Nucleic Acid Based Detection Assay
The Rickettsia Spp. Nucleic Acid Based Detection Assay is a microbiology in vitro diagnostic device that detects Rickettsia species nucleic acids in specimens from individuals with signs or symptoms of rickettsial infection and epidemiological risk factors consistent with potential exposure, used in conjunction with other diagnostic assays and clinical observations to aid in diagnosis. It is classified as FDA Class II under regulation 21 CFR 866.3316, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PVQ and it falls under the Microbiology medical specialty. It is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- PVQ
- Device Class
- FDA class 2
- Regulation Number
- 866.3316
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
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.
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 |
|---|---|---|---|---|
| K170940 | Rickettsia Real-time PCR Assay | Jun 29, 2017 | Substantially Equivalent | Centers for Disease Control and Prevention (CDC) |
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.