LACTATE PRO SYSTEM

K980908 · Kdk Corp. · KHP · Sep 11, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980908
• Device Name: LACTATE PRO SYSTEM
• Applicant: Kdk Corp.
• Product Code: KHP · Clinical Chemistry
• Decision Date: Sep 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1450
• Device Class: Class 1

Intended 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.

Device Story

Lactate Pro System measures lactate concentration in whole blood samples. System comprises a portable test meter and disposable test strips. Used in clinical settings and home environments by patients or athletes. Principle of operation involves enzymatic reaction (lactate oxidase) on test strip to quantify blood lactate levels. Output is a numerical lactate concentration value displayed on the meter. Healthcare providers or users utilize this data to monitor lactic acidosis or optimize athletic training intensity. Benefits include rapid, point-of-care assessment of metabolic status during exercise or clinical evaluation.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance specifications consistent with predicate devices.

Technological Characteristics

System utilizes lactate oxidase enzymatic sensing technology. Consists of a handheld meter and disposable test strips. Operates as an in vitro diagnostic device for whole blood analysis. No specific materials, connectivity, or software architecture details provided.

Indications for Use

Indicated for individuals with biochemical indicators of Lactic Acidosis and athletes requiring blood lactate monitoring to evaluate physical performance or establish exercise intensity.

Regulatory Classification

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).

Predicate Devices

• Boehringer Mannheim ACCUSPORT (K951331)
• YSI, INC. YSI MODEL 2300 STAT PLUS (K913806)

Submission Summary (Full Text)

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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 blood<br>Blood Lactate test meter |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name of the Device: | Lactate ProTM Test Strip<br>Lactate ProTM Blood Lactate Test Meter |
| Classification Information: | Lactate test system, 21 CFR 862.1450,<br>Class I, KHP (Lactate Oxidase, Lactic Acid)<br>Colorimeter photometer for clinical use, 21<br>CFR 862.2300, Class I |
| Submitter's Name/Address | KDK CORPORATION, Administration<br>Division<br>Kazuo Iketaki<br>Deputy General Manager<br>57 NISHIAKETA-CHO, HIGASHI-KUJO,<br>MINAMI-KU<br>KYOTO<br>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.

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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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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 regulation (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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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

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 | <span style="text-decoration: underline;">✓</span> |
|----------------------|----------------------------------------------------|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | <span style="text-decoration: underline;"></span> |
|-----------------------------------------|----------------------------------------------------------|
| | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | <span style="text-decoration: underline;">K981901</span> |