LIQUID LDH-L REAGENT SET

K973589 · Pointe Scientific, Inc., · CFJ · Oct 8, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973589
• Device Name: LIQUID LDH-L REAGENT SET
• Applicant: Pointe Scientific, Inc.,
• Product Code: CFJ · Clinical Chemistry
• Decision Date: Oct 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1440
• Device Class: Class 2

Intended Use

This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of Lactate dehydrogenase in serum or leomonogram in the for in vitro diagnostic use only. The determination of Lactate dehydrogenase in serum is most commonly performed for the diagnosis and treatment of myocardial infarctions. LD elevations are also observed in liver disease, pernicious anemia, some cases of renal disease, and in cases of skeletal muscle trauma.

Device Story

Liquid LDH-L Reagent Set is an in vitro diagnostic reagent kit used for the quantitative measurement of Lactate dehydrogenase (LDH) in serum samples. The device is intended for use in clinical laboratory settings by qualified technologists. It facilitates the diagnosis and monitoring of conditions such as myocardial infarction, liver disease, pernicious anemia, renal disease, and skeletal muscle trauma. The reagent is used in conjunction with standard laboratory instrumentation to perform biochemical assays. Results are provided to healthcare providers to assist in clinical decision-making regarding patient diagnosis and treatment plans.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent kit for quantitative biochemical analysis of serum LDH. Liquid formulation. Designed for use with standard clinical laboratory instrumentation.

Indications for Use

Indicated for the quantitative determination of Lactate dehydrogenase (LDH) in serum for the diagnosis and treatment of myocardial infarctions, liver disease, pernicious anemia, renal disease, and skeletal muscle trauma. For use by qualified laboratory technologists in a diagnostic laboratory setting.

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.

Submission Summary (Full Text)

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OCT - 8 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

William F. Walters, Jr. .Vice President, Technical Operations Pointe Scientific, Inc. 1025 John A. Papalas Drive Lincoln Park, Michigan 48146

K973589 Re : Liquid LDH-L Reagent Kit Regulatory Class: I Product Code: CFJ Dated: September 16, 1997 Received: September 22, 1997

Dear Mr. Waters:

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, qood 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. ਸੇਂ 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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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 requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (chin 007) chip device may required, 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 described in your six (n) pivalence 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 enc regulation chercred/ (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 at this time

Device Name:_Liquid LDH-L Reagent Set

Indications for use:

This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of Lactate dehydrogenase in serum or leomonogram in the for in vitro diagnostic use only. The determination of Lactate dehydrogenase in serum is most commonly performed for the diagnosis and treatment of myocardial infarctions. LD elevations are also observed in liver disease, pernicious anemia, some cases of renal disease, and in cases of skeletal muscle trauma.

(Division Sign-Off)
Division of Clinical Labormonvic
510(k) Number k973589

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
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| (Per 21 CFR 801.109) | |

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OR

Over-The-Counter Use