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510(k) Data Aggregation
Device Name
VISTA ANTIGEN SALMONELLA O GROUP DManufacturer
Date Cleared
1997-08-25
(60 days)
Product Code
Regulation Number
866.3550Type
TraditionalPanel
MicrobiologyAge Range
All
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) premarket notification approval letter for the VISTA™ Antigen Salmonella O Group D device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
The letter primarily covers:
- The FDA's determination of substantial equivalence for the device.
- Regulatory classifications and general controls applicable to the device.
- Contact information for further regulatory guidance.
- An enclosure indicating the device's indications for use: "Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum."
Therefore, I cannot provide the requested information based on the given document.
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