(24 days)
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).
Lactate Dehydrogenase-SL Assay
This document is a 510(k) clearance letter from the FDA for a medical device called "Lactate Dehydrogenase-SL Assay". It does not describe acceptance criteria, the results of a study to prove the device meets acceptance criteria, or any of the other specific details requested in the prompt.
The letter states that the FDA has reviewed the 510(k) notification and determined that the device is substantially equivalent to legally marketed predicate devices. This means that the device is considered safe and effective for its intended use based on its similarity to existing devices.
To provide the information requested in the prompt, a study report or a different section of the 510(k) submission that details the performance data would be needed. This document only provides the regulatory clearance.
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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 (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 requlation (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 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
(Optional Format 1-2-96)
§ 862.1440 Lactate dehydrogenase test system.
(a)
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.(b)
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.