← Product Code [JPZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ) · K961919 # DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE (K961919) _Data Medical Associates, Inc. · JPZ · Jul 1, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K961919 ## Device Facts - **Applicant:** Data Medical Associates, Inc. - **Product Code:** [JPZ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ.md) - **Decision Date:** Jul 1, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1360 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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: 817/649-2461 {1} 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. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K961919](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JPZ/K961919) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com