(185 days)
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No
The summary describes a standard blood lactate testing system with a meter and test strips, and there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
No
The device is intended for the determination of Lactate in whole blood, which is a diagnostic function to monitor a biochemical indicator and evaluate physical performance, not to treat a condition.
Yes
The device is described as being used for the "determination of Lactate in whole blood" to evaluate "biochemical indicator of Lactic Acidosis" and "evaluate physical performance or to establish a proper intensity of exercise for athletes." This indicates it's used to identify or monitor a physiological condition, which is a diagnostic purpose.
No
The device description explicitly states that the system consists of a "Lactate Pro™ Blood Lactate Test Meter" and "Lactate ProTM Test Strip," which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the determination of Lactate in whole blood, which is a biological sample taken from the body. This is a key characteristic of an IVD.
- Device Description: The system consists of a meter and test strips, which are typical components of an IVD system used for analyzing biological samples.
- Anatomical Site: The analysis is performed on "whole blood," which is a biological specimen.
- Intended User / Care Setting: While it mentions use by individuals and athletes, it also explicitly states it can be used in the "clinical setting," which is a common environment for IVD use.
- Predicate Devices: The listed predicate devices (Boehringer Mannheim ACCUSPORT and YSI MODEL 2300 STAT PLUS) are also IVD devices used for lactate measurement. This further supports the classification of the Lactate Pro™ System as an IVD.
The definition of an IVD generally includes devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Lactate Pro™ System fits this definition by analyzing whole blood to provide information related to lactic acidosis and physical performance.
N/A
Intended Use / Indications for Use
The Lactate ProTM System is intended for the determination of Lactate in whole blood. The system is designed for the determination of blood Lactate by individuals with biochemical indicator of Lactic Acidosis. And evaluate physical performance or to establish a proper intensity of exercise for athletes. The system can be used in the clinical setting.
Product codes
KHP
Device Description
The Lactate ProTM System consists of Lactate ProTM Blood Lactate Test Meter, Lactate ProTM Test Strip.
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
whole blood
Indicated Patient Age Range
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Intended User / Care Setting
individuals with biochemical indicator of Lactic Acidosis.
The system can be used in the clinical setting. The system can be used in the home and in the clinical setting.
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
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)
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.
0
SEP 1 1 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
Lactate ProTM System
I . General Information
| Common Name of the Device: | Test for Lactate in whole blood
Blood Lactate test meter |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name of the Device: | Lactate ProTM Test Strip
Lactate ProTM Blood Lactate Test Meter |
| Classification Information: | Lactate test system, 21 CFR 862.1450,
Class I, KHP (Lactate Oxidase, Lactic Acid)
Colorimeter photometer for clinical use, 21
CFR 862.2300, Class I |
| Submitter's Name/Address | KDK CORPORATION, Administration
Division
Kazuo Iketaki
Deputy General Manager
57 NISHIAKETA-CHO, HIGASHI-KUJO,
MINAMI-KU
KYOTO
601-8045 JAPAN |
II . Indications for Use
The Lactate Pro™ System is intended for the determination of Lactate in whole blood. The system is designed for the determination of blood Lactate by individuals with biochemical indicator of Lactic Acidosis. And evaluate physical performance or to establish a proper intensity of exercise for athletes. The system can be used in the clinical setting.
III . Device Description
The Lactate Pro™ System consists of Lactate Pro™ Blood Lactate Test Meter, Lactate ProTM Test Strip.
IV . Substantial Equivalence
Lactate Pro™ System is used for the determination of blood Lactate by individuals with biochemical indicator of Lactic Acidosis. And as Lactate concentration increases in blood during exercises due to the lack of oxygen, Lactate can be measured to evaluate physical performance or to establish a proper intensity of exercises for athletes.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the first profile being the most prominent.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 1 1998
Kazuo Iketaki Deputy General Manager KDK Corporation 57 Nishi Aketa-Cho Hiqashi-Kujo, Minami-Ku Kyoto 601, Japan
- K980908 Re : Lactate Pro™ System Regulatory Class: I Product Code: KHP Dated: Auqust 21, 1998 Received: August 24, 1998
Dear Mr. Iketaki:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬ 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 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 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
3
510(k) Number (if known):__unknown
Device Name: Lactate Pro™Test Strips, Lactate Pro™ Blood Lactate Test Meter Indications For Use:
The Lactate Pro™ System is intended for the determination of Lactate in whole blood. The system is designed for the determination of blood Lactate by individuals with biochemical indicator of Lactic Acidosis. And evaluate physical performance or to establish a proper intensity of exercise for athletes. The system can be used in the home and in the clinical setting.
(Predicate Devices) Boehringer Mannheim ACCUSPORT YSI, INC. YSI MODEL 2300 STAT PLUS
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) | |
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K981901 |