(204 days)
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Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description is very basic.
No.
The device is used to determine a physiological parameter (lactate threshold) for optimization of conditioning, not for treating or diagnosing any disease or condition.
No
Explanation: The device is intended for use by healthy athletes to determine their lactate threshold for optimizing exercise conditioning, not for diagnosing diseases or medical conditions.
Unknown
The summary does not provide enough information about the device's components or how it measures lactic acid to determine if it is software-only. It is described as a "lactic acid test system," which could imply hardware components are involved.
Based on the provided information, yes, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "lactic acid test system intended for use by healthy athletes for the determination of their lactate threshold." This involves analyzing a biological sample (presumably blood, although not explicitly stated, lactic acid testing typically uses blood) to gain information about a physiological state.
- Device Description: It's described as a "lactic acid test system." This further supports the idea that it's designed to perform a test on a biological sample.
Key characteristics of IVDs are that they are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. While the intended use here is for performance optimization in healthy individuals rather than diagnosing a disease, it still involves analyzing a biological sample to gain physiological information.
The fact that it's used by athletes and coaches for performance optimization doesn't exclude it from being an IVD. Many IVDs are used for monitoring physiological parameters in various contexts.
N/A
Intended Use / Indications for Use
LacTest™I is a lactic acid test system intended for use by healthy athletes for the determination of their lactate threshold. Lactate threshold is an important physiological parameter that reflects an individual's capacity for sustained exercise. It has been used by coaches and trainers of elite athletes in a wide range of sports that involve aerobic exercise, to optimize the conditioning of the athlete.
Product codes
KHP
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthy athletes, coaches and trainers of elite athletes
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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
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§ 862.1450 Lactic acid test system.
(a)
Identification. A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).(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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched, symbolizing protection and care.
DEC 17 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
James B. Johnston, Ph.D. . Executive Vice President JWT, Inc. 115 Research Drive Bethlehem, Pennsylvania 18015-3715
Re : K971944 LacTest™ I Brand Lactic Acid Test System Regulatory Class: II Product Code: KHP Dated: October 23, 1997 Received: October 27, 1997
Dear Dr. Johnston:
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. ਸੇ 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 regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 regulation (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 Ditman
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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VI. STATEMENT OF INDICATIONS FOR USE:
510(k) Number (if known): K97 1944
Device Name: LacTest™I
Indications for use:
LacTest™I is a lactic acid test system intended for use by healthy athletes for the determination of their lactate threshold. Lactate threshold is an important physiological parameter that reflects an individual's capacity for sustained exercise. It has been used by coaches and trainers of elite athletes in a wide range of sports that involve aerobic exercise, to optimize the conditioning of the athlete.
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Sign-Off)
of Clinical Laboratory Devices
Number 97/944