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K Number
K973547
Device Name
TRIAGE STATMETER
Manufacturer
BIOSITE INCORPORATED
Date Cleared
1998-01-13

(117 days)

Product Code
KHO,DDR,JHX,MMI
Regulation Number
862.2560
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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

Device Description

Not Found

AI/ML Overview

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.

§ 862.2560 Fluorometer for clinical use.

(a)
Identification. A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.