TRIAGE STATMETER

• 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: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: K041696 , K080635 , K182719 , K220046

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.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 3 1998

John F. Bruni, Ph.D. Director, Clinical and Regulatory Affairs Biosite Diagnostics 11030 Roselle Street San Diego, California 92121

K973547 Re : Triage® Meter Requlatory Class: I Product Code: KHO, DDR, JHX, MMI Dated: December 17, 1997 Received: December 22, 1997

Dear Dr. Bruni:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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j 10(k) Number if known) j

evice Name: Triage® StatMeter

Indications for Use:

A

. '.

1999 - 1

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

973847

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 4973547

Prescription Use

OR

Over-The Counter Use_

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Regulation Number and Section

§ 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.