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.

Device Description

The Lactate Pro™ System consists of Lactate Pro™ Blood Lactate Test Meter, Lactate ProTM Test Strip.

AI/ML Overview

The provided text does not contain a study that proves the device meets specific acceptance criteria. Instead, it is a 510(k) premarket notification letter from the FDA, granting clearance for the Lactate Pro™ System based on substantial equivalence to predicate devices. It discusses the device's indications for use and classification but does not include detailed performance data or acceptance criteria that a clinical study would typically provide.

Therefore, for items 1-9, the answer will largely be "Not applicable" or "Information not provided in the document."

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in this document.	Not specified in this document.

The document is a marketing clearance letter, not a performance study report. It does not detail specific acceptance criteria for accuracy, precision, or other performance metrics, nor does it present the results of such testing for the Lactate Pro™ System. The FDA's clearance is based on a determination of substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Information not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Information not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Information not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a blood lactate test system, not an AI-powered diagnostic imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Information not provided in the document. As a blood lactate test system, its standalone performance would typically refer to its accuracy and precision against a reference method, not an algorithm's performance. The document does not contain this data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Information not provided in the document. For a blood lactate meter, ground truth would typically be established by a laboratory reference method (e.g., a laboratory analyzer). The document does not specify this.

8. The sample size for the training set

Not applicable. This device is a measurement system, not a machine learning algorithm that requires a training set in the conventional sense. Any internal calibration data or development data are not discussed.

9. How the ground truth for the training set was established

Not applicable. See reasoning for point 8.

Summary

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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 bloodBlood Lactate test meter
Trade Name of the Device:	Lactate ProTM Test StripLactate 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, 21CFR 862.2300, Class I
Submitter's Name/Address	KDK CORPORATION, AdministrationDivisionKazuo IketakiDeputy General Manager57 NISHIAKETA-CHO, HIGASHI-KUJO,MINAMI-KUKYOTO601-8045 JAPAN

II . Indications for Use

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.

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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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Page 2

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

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510(k) Number (if known):__unknown

Device Name: Lactate Pro™Test Strips, Lactate Pro™ Blood Lactate Test Meter Indications For Use:

(Predicate Devices) Boehringer Mannheim ACCUSPORT YSI, INC. YSI MODEL 2300 STAT PLUS

No. K951331 No. K913806

(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)

Over-The-Counter Use
	(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K981901

Regulation Number and Section

§ 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.