LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET

K973157 · Pointe Scientific, Inc., · JQB · Oct 10, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973157
• Device Name: LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
• Applicant: Pointe Scientific, Inc.,
• Product Code: JQB · Clinical Chemistry
• Decision Date: Oct 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1360
• Device Class: Class 1

Intended Use

This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative kinetic determination of gamma glutamyl transferase in serum. It is intended for in vitro diagnostic use only. The determination of gamma glutamyl transferase in serum is most commonly performed for the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and secondary liver tumors.

Device Story

Liquid GGT Reagent Set; in vitro diagnostic reagent for quantitative kinetic determination of gamma glutamyl transferase in serum. Used in clinical laboratory settings by qualified technologists. Input: patient serum sample. Principle: kinetic enzymatic assay. Output: quantitative GGT concentration value. Healthcare providers use results to diagnose and monitor liver diseases, specifically alcoholic cirrhosis and secondary liver tumors.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid reagent set for kinetic enzymatic assay. In vitro diagnostic use. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for quantitative kinetic determination of gamma glutamyl transferase in serum for diagnosis and treatment of liver diseases, including alcoholic cirrhosis and secondary liver tumors, in a clinical laboratory setting by qualified technologists.

Regulatory Classification

Identification

A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

OCT 10 1997

Re : K973157 Liquid GGT (Gamma Glutamyl Transferase) Reagent Set Trade Name: Requlatory Class: I Product Code: JQB Dated: Auqust 19, 1997 Received: Auqust 22, 1997

Dear Mr. Walters:

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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirement, 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 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 (301) Additionally, for questions on the promotion and 594-4588. 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

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:_gamma-Glutamy! Transferase (Liquid) Reagent Set

Indications for use:

This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative kinetic determination of gamma glutamyl transferase in serum. It is intended for in vitro diagnostic use only. The determination of gamma glutamyl transferase in serum is most commonly performed for the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and secondary liver tumors.

Image /page/2/Picture/5 description: The image shows a document with the text 'Division of Clinical Laboratory Devices' and '510(k) Number'. There is also a handwritten number 'k973157' on the document. The document appears to be a formal or official record related to clinical laboratory devices.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)