DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE

K961919 · Data Medical Associates, Inc. · JPZ · Jul 1, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961919
• Device Name: DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
• Applicant: Data Medical Associates, Inc.
• Product Code: JPZ · Clinical Chemistry
• Decision Date: Jul 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1360
• Device Class: Class 1

Intended Use

For in-vitro diagnostic use. For the quantitative determination of gamma glutamyltransferase in serum.

Device Story

Colorimetric assay for quantitative determination of GGT in serum; utilizes enzymatic reaction where GGT catalyzes transfer of glutamyl group from L-g-glutamyl-3-carboxy-4-nitroanilide to glycylglycine; produces 5-amino-2-nitrobenzoate; rate of increase in absorbance at 405 nm proportional to GGT activity; used in clinical laboratory settings; results interpreted by clinicians to differentiate hepatobiliary disease from skeletal disease.

Clinical Evidence

Bench testing only. Performance validated through linearity (up to 2000 U/L), precision (within-run CV 1.7-4.6%; run-to-run CV 0.9-7.3%), analytical sensitivity (3.8-4.0 U/L), and interference studies (bilirubin, hemoglobin, lipemia). Shelf-life established at 19 months at 2-8°C.

Technological Characteristics

Colorimetric enzymatic assay. Reagents include L-g-glutamyl-3-carboxy-4-nitroanilide and glycylglycine. Detection via spectrophotometry at 405 nm. In-vitro diagnostic reagent kit.

Indications for Use

Indicated for quantitative determination of gamma glutamyltransferase (GGT) in serum to aid in the diagnosis of chronic alcoholism, diabetes, neurological disorders, and liver diseases, including obstructive jaundice, cholangitis, and cholecystitis.

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.

Predicate Devices

• Gamma Glutamyl Transferase Procedure, Sigma Diagnostics

Submission Summary (Full Text)

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JUL 1 1996
K961919
Data Medical Associates, Inc. • 845 Avenue G East • Arlington, TX 76011 • 817/640-0965

# 510(k) Summary

Submitter: Data Medical Associates, Inc.
845 Avenue G East
Arlington, TX 76011
817-640-0965

Contact Name: C. H. Morris, Ph.D.
Vice President, Scientific and Government Affairs

510(k) Number: 961919

Date Summary Prepared: 6/20/96

Device Name: Colorimetric Method, Gamma Glutamyltransferase

Predicate Device: Gamma Glutamyl Transferase Procedure, Sigma Diagnostics, St. Louis, Missouri.

Device Description: The method is based on the reaction wherein gamyl glutamyltransferase catalyzes the transfer of the glutamyl group from L-g-glutamyl-3-carboxy-4-nitroanilide to glycylglycine with the formation of g-glutamylglycylglycine and 5-amino-2-nitrobenzoate. The rate of increase of 5-amino-2-nitrobenzene, which absorbs light at 405 nM, is proportional to the gamma glutamyltransferase activity in the sample.

Intended Use: For in-vitro diagnostic use. For the quantitative determination of gamma glutamyltransferase in serum.

Elevated serum gamma glutamyltransferase (GGT) is found in chronic alcoholism, diabetes, certain neurological disorders, and all forms of liver disease. It is more sensitive than alkaline phosphatase, the transaminases, and leucine aminopeptidase (LAP) in detecting obstructive jaundice, cholangitis, and cholecystitis; its rise occurs earlier than these other enzymes and persists longer. Moderate increases are seen with infectious hepatitis, and normal levels are seen in skeletal disease. Serum GGT levels can therefore be used to differentiate skeletal or hepatobiliary disease.

The intended use is the same as the predicate device.

IN TEXAS: 800/633-5338
OUTSIDE TEXAS: 800/433-7224
FAX: [phone]

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Material comparison with predicate device:

| | DMA | Sigma |
| --- | --- | --- |
| L-g-Glutamyl-3-Carboxy-4-Nitroanilide | 4.39 mmol/L | 4.36 mmol/L |
| Glycylglycine | 60 mmol/L | 60 mmol/L |
| Preservative | yes | yes |
| Surfactant | yes | no |
| Buffer | no | yes |
| Stabilizer | no | yes |
| Fillers | no | yes |

Non Clinical Test Comparison:

| Linearity | to 2000 U/L |
| --- | --- |
| Precision | |
| Within-Run | (at approximately 12 U/L) C.V. of 4.6%
(at approximately 51 U/L) C.V. of 2.5%
(at approximately 1100 U/L) C.V. of 3.1%
(at approximately 1870 U/L) C.V. of 1.7% |
| Run-to-Run | (at approximately 12 U/L) C.V. of 7.3%
(at approximately 50 U/L) C.V. of 3.7%
(at approximately 1090 U/L) C.V. of 1.4%
(at approximately 1880 U/L) C.V. of 0.9% |
| Shelf-Life | 19 months at 2°-8°C |
| Sensitivity (0.001A)
(Analytical) | 4.0 U/L
3.8 U/L |
| Interferences | |
| Bilirubin | no interference to 17.8 mg/dL bilirubin |
| Hemoglobin | (at approximately 82 U/L GGT) no interference up to 321 mg/dL hemoglobin |
| Lipemia | (at approximately 25 U/L GGT) no interference up to 877 mg/dL triglyceride
(at approximately 80 U/L GGT) no interference up to 482 mg/dL triglyceride |
| Expected Values | 9-55 U/L |

Conclusion: Based upon the comparative testing with the predicate device consisting of the principle of the test, comparison of reagents, and performance characteristics of stability, linearity, expected values, precision, sensitivity and correlation, all found in the body of the submission, it is concluded by the submitter that the proposed device is substantially equivalent to the predicate device.