(117 days)
Not Found
None
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as a "Fluometer for the measurement of fluorescence in various assay systems" and a "General fluorometer". Its intended use is measurement, not treatment or diagnosis of a disease or condition, which is characteristic of therapeutic devices.
No
The device is a general fluorometer used for measuring fluorescence in various assay systems, which is typically a research or laboratory instrument, not a device used for diagnosing medical conditions in patients.
No
The provided 510(k) summary describes a "Fluometer for the measurement of fluorescence," which is inherently a hardware device designed to measure light. There is no mention of software as the primary or sole component.
Based on the provided information, it is unlikely that this device is an IVD. Here's why:
- Intended Use: The intended use is described as a "Fluometer for the measurement of fluorescence in various assay systems. General fluorometer." This description is very broad and doesn't specify a particular diagnostic purpose or the analysis of human specimens for diagnostic information.
- Lack of Specificity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic results for specific diseases or conditions.
- General Purpose: The term "General fluorometer" suggests a device used for a wide range of applications, not necessarily limited to in vitro diagnostics.
What makes a device an IVD?
An In Vitro Diagnostic (IVD) device is defined as a medical device that is intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes.
In conclusion: While a fluorometer could be used as part of an IVD system (e.g., in a fluorescence-based immunoassay for detecting a specific analyte in blood), the description provided here for the "Fluometer" itself does not indicate that its intended use is specifically for in vitro diagnostic purposes. It appears to be a general laboratory instrument.
N/A
Intended Use / Indications for Use
Fluometer for the measurement of fluorescence in various assay systems. General fluorometer.
Product codes
KHO, DDR, JHX, MMI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 (770) 488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
2
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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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_
(Optional Format 1-2-96) ਿ
.