(45 days)
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No
The device description details a standard enzymatic reaction and photometric measurement, with no mention of AI or ML algorithms for analysis or interpretation.
No
This device is an in-vitro diagnostic device used for quantitative determination of gamma glutamyltransferase in serum, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in-vitro diagnostic use."
No
The device description clearly outlines a chemical reaction and measurement of light absorption, indicating a physical in-vitro diagnostic test kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in-vitro diagnostic use."
- Nature of the Test: The device performs a quantitative determination of gamma glutamyltransferase in serum, which is a laboratory test performed on a biological sample (serum) outside of the body to diagnose or monitor a medical condition. This is the definition of an in vitro diagnostic test.
- Device Description: The description details a chemical reaction used to measure an analyte (gamma glutamyltransferase) in a sample, further confirming its IVD nature.
The other sections like "Mentions image processing," "Mentions AI," "Input Imaging Modality," "Anatomical Site," "Indicated Patient Age Range," "Intended User / Care Setting," and the details about training and test sets are not relevant to determining if a device is an IVD. The performance studies and key metrics are also typical for IVD devices to demonstrate their analytical performance.
N/A
Intended Use / Indications for 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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 approximatley 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 approximatley 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
Key Metrics
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Predicate Device(s)
Gamma Glutamyl Transferase Procedure, Sigma Diagnostics, St. Louis, Missouri.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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Image /page/0/Picture/0 description: The image shows a close-up of a document with some text. The text "JUL 1" is visible on the right side of the image. The rest of the text is illegible.
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.
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 approximatley 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 approximatley 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 | ||
| Interrferences | ||
| 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 linearity, expected values, precision, sensitivity and correlation, all found in the body of the misure), enposed "tarabon" by the submitter that the proposed device is substantially equivalent to the predicate device.