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Fluometer for the measurement of fluorescence in various assay systems. General fluorometer.

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The provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device named "Triage® Meter" and later referred to as "Triage® StatMeter."

The letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• Outlines general control provisions the device is subject to, such as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
• Mentions that the device may require a CLIA complexity categorization and provides contact information for the CDC.
• Refers to labeling regulations and contact information for the Office of Compliance.
• Provides general information on responsibilities under the Act.
• States the "Indications for Use" for the Triage® StatMeter, which is a "Fluometer for the measurement of fluorescence in various assay systems" and a "General fluorometer."

None of these sections detail specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or describe any studies (like a clinical trial or analytical validation study) that were performed to demonstrate that the device met such criteria. The document is a regulatory clearance letter, not a technical report detailing performance specifics.

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