LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30

K974859 · Diagnostic Chemicals , Ltd. · CFJ · Jan 22, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974859
• Device Name: LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: CFJ · Clinical Chemistry
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1440
• Device Class: Class 2

Intended Use

For the quantitative determination of Lactate Dehydrogenase in serum. For IN VITRO diagnostic use. Elevated levels of lactate dehydrogenase are clinically significant and can be found in disease states which result in cell damage. Myocardial infarcts, liver disease, megaloblastic anemias, renal disease, progressive muscular dystrophy and some malignancies all produce elevated lactate dehydrogenase values in serum (1).

Device Story

The Lactate Dehydrogenase-SL Assay is an in vitro diagnostic reagent kit for the quantitative measurement of LDH in serum. It utilizes the lactate-to-pyruvate (LDH-L) enzymatic reaction method, consistent with Wacker et al. and International Federation of Clinical Chemists (IFCC) recommendations. The assay employs lactate as the substrate and nicotinamide adenine dinucleotide (NAD) as the indicator coenzyme. The reaction is monitored spectrophotometrically. The device is intended for use in clinical laboratory settings by trained laboratory personnel. Results are used by physicians to assess cell damage associated with various clinical conditions, including myocardial infarction and liver disease, aiding in clinical decision-making and patient management.

Clinical Evidence

No clinical data provided. The submission relies on established biochemical methodology (LDH-L reaction) and adherence to IFCC-recommended reaction conditions for analytical performance.

Technological Characteristics

In vitro diagnostic reagent kit; enzymatic spectrophotometric assay; LDH-L (lactate to pyruvate) reaction principle; utilizes lactate substrate and NAD coenzyme; intended for use with clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of Lactate Dehydrogenase (LDH) in human serum to assist in the diagnosis and monitoring of disease states associated with cell damage, including myocardial infarction, liver disease, megaloblastic anemias, renal disease, progressive muscular dystrophy, and certain malignancies.

Regulatory Classification

Identification

A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Reference Devices

• Wacker et.al. method
• Wroblewski and LaDue method
• Amador et.al. method
• Gay et.al. method

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JAN 2 2 1998

Karen Callbeck, R.T.B.Sc. Regulatory Affairs Coordinator Diaqnostic Chemicals Limited West Royalty Industrial Park Charlottetown, PE Canada C1E, 1B0

K974859 Re: Lactate Dehydrogenase-SL Assay Requlatory Class: II Product Code: CFJ December 18, 1997 Dated: December 29, 1997 Received:

Dear Ms. Callbeck:

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, Druq, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially.equivalent-determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 requlation (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 Gutman

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):

Device Name: Lactate Dehydrogenase-SL Assay

## Indications for Use:

For the quantitative determination of Lactate Dehydrogenase in serum. For IN VITRO diagnostic use. Elevated levels of lactate dehydrogenase are clinically significant and can be found in disease states which result in cell damage. Myocardial infarcts, liver disease, megaloblastic anemias, renal disease, progressive muscular dystrophy and some malignancies all produce elevated lactate dehydrogenase values in serum (1).

974859

Wacker et.al. (2) published a method for the measurement of lactate dehydrognase (LDH) utilizing lactate as the substrate and nicotinamide adenine dinucleotide (NAD) as the indicator coenzyme. The use of the reverse reaction, pyruvate to lactate (LDH-P), has been described by Wroblewski and LaDue (3). Amador et.al. (4) claim the lactate to pyruvate (LDH-L) method is the method of choice because of the greater linearity of the reaction and improved stability of the reagents involved. The LDH-L reaction has been further studied by-Gay et.al. (5) and the optimum reaction conditions outlined. This procedure uses the LDH-L method of Wacker in accordance with the recomendations of the International Federation of Clinical Chemists (6).

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices

Division of Clinical Laboratory Devices
510(k) Number k974859

Prescription Use (Per 21 CFR 801.109

OR

Over-The-Counter Use

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