(90 days)
The revogene™ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The revogene™ is capable of automated lysis and dilution of samples originating from various clinical specimen types. revogene™ performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR.
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The provided text is a 510(k) premarket notification letter from the FDA to GENEPOC INC. regarding their Revogene device. It details the regulatory classification, general controls, and indications for use of the device.
However, the document does not contain the specific information required to answer your request about acceptance criteria and the study proving the device meets those criteria. Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Details on the sample size used for the test set or its data provenance.
- The number or qualifications of experts used for ground truth establishment.
- Information on adjudication methods.
- Details on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- The type of ground truth used.
- Sample size for the training set or how its ground truth was established.
The document is purely administrative, confirming the FDA's substantial equivalence determination and outlining regulatory obligations. It does not delve into the technical performance studies or the clinical trials typically associated with proving a device meets acceptance criteria.
§ 862.2570 Instrumentation for clinical multiplex test systems.
(a)
Identification. Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document.