LACTEST I

K971944 · Jwt, Inc. · KHP · Dec 17, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971944
• Device Name: LACTEST I
• Applicant: Jwt, Inc.
• Product Code: KHP · Clinical Chemistry
• Decision Date: Dec 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1450
• Device Class: Class 1

Intended 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.

Device Story

LacTest™I is a lactic acid test system used by healthy athletes, coaches, and trainers to determine lactate threshold. By measuring physiological lactate levels, the device provides data on an individual's capacity for sustained aerobic exercise. This information assists in optimizing athletic conditioning programs. The device is intended for use in sports training environments.

Indications for Use

Indicated for healthy athletes to determine lactate threshold for optimizing aerobic exercise conditioning.

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).

Submission Summary (Full Text)

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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 [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 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