(63 days)
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No
The summary describes a standard in vitro diagnostic assay for triglycerides, with no mention of AI or ML.
No
The device is an in vitro diagnostic (IVD) intended for the quantitative determination of Triglycerides, which is used for diagnosis and assessment of risk, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders" and provides "valuable information for the assessment of coronary heart disease risk." Furthermore, the "Device Description" section states that the procedure is "intended for in vitro diagnostic use."
No
The device description explicitly states it is an "in vitro diagnostic use for the quantitative determination of triglycerides in human serum or plasma," indicating it is a laboratory assay that likely involves reagents and physical measurement, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device is for the "quantitative determination of Triglycerides in serum and plasma" and that these measurements are "used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders." This clearly indicates a diagnostic purpose using biological samples.
- Device Description: The description states "DMA's Triglyceride (GPO) Procedure is intended for in vitro diagnostic use for the quantitative determination of triglycerides in human serum or plasma." This directly labels the device as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
For the quantitative determination of Triglycerides in serum and plasma. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid merabolism, or various endocrine disorders. Elevated serum triglyceride levels are seen in primary disorders of lipid metabolism or hyperlipoproteinemia secondary to known diseases. Furthermore, in conjunction with high-density lipoprotein and total serum cholesterol, a triglyceride determination provides valuable information for the assessment of coronary heart disease risk. The clinical significance and management of hyperlipoproteinemia depends on the triglyceride distribution among the major serum lipoproteins.
Product codes
CDT
Device Description
DMA's Triglyceride (GPO) Procedure is intended for in vitro diagnostic use for the quantitative determination of triglycerides in human serum or plasma. It is quite similar to many other assays which have long been used for this purpose.
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
DMA's Triglyceride (GPO) Procedure has been shown to have the following performance characteristics:
Linearity: to 1800 mg/dL
Precision:
Within-Run (Within Normal Range) C.V. of approximately 0.4%
Within-Run (Above Normal Range) C.V. of approximately 0.7%
Run-to-Run (Within Normal Range) C.V. of approximately 4%
Run-to-Run (Above Normal Range) C.V. of approximately 1.7%
Shelf-life: 14 months (at 2-8℃)
Sensitivity: (0.001A) 1.0 mg/dL
Interferences:
Bilirubin Significant above 4.5 mg/dL
Hemoglobin Significant above 190 mg/dL
Expected Values: 36 - 173 mg/dL
Key Metrics
Linearity, Precision (Within-Run C.V., Run-to-Run C.V.), Shelf-life, Sensitivity, Interferences (Bilirubin, Hemoglobin), Expected Values
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1705 Triglyceride test system.
(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.(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.
0
1971 MAY 29, 1997
Safety and Effectiveness Summary
DMA's Triglyceride (GPO) Procedure is intended for in vitro diagnostic use for the quantitative determination of triglycerides in human serum or plasma. It is quite similar to many other assays which have long been used for this purpose.
DMA's Triglyceride (GPO) Procedure has been shown to have the following performance characteristics.
to 1800 mg/dL Linearity Precision Within-Run (Within Normal Range) C.V. of approximately 0.4% (Above Normal Range) C.V. of approximately 0.7%
(Within Normal Range) C.V. of approximately 4% Run-to-Run (Above Normal Range) C.V. of approximately 1.7% Shelf-life 14 months (at 2-8℃) Sensitivity (0.001A) 1.0 mg/dL Interferences Bilirubin Significant above 4.5 mg/dL Hemoglobin Significant above 190 mg/dL Expected Values 36 - 173 mg/dL
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized caduceus, which is a symbol often associated with healthcare, overlaid with three human profiles facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 9 1997
C. H. Morris, Ph.D. · Vice President, Scientific and Government Affairs....
- Data Medical Associates, Inc. 845 Avenue G East
76011 Arlington, Texas
Re: K971113 DMA Triglyceride Procedure Requlatory Class: I Product Code: CDT Dated: March 25, 1997 Received: March 27, 1997
Dear Dr. Morris:
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 Requlations, Title 21, Parts 800 to 895. ಗ್ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Register. 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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Page 2
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 (770) 488-7655.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene regalacion Shorion" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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
3
DMA Triglyceride (GPO) Procedure
510(k) Number (if known): K971113
22817 649 2461
12: ""
:9797
Device Name: Triglyceride, Lipase Hydrolysis/Glycerol Kinase Enzyme. Trade Name: DMA Triglyceride (GPO) Procedure
Indications for Use: For the quantitative determination of Triglycerides in serum and plasma. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid merabolism, or various endocrine disorders. Elevated serum triglyceride levels are seen in primary disorders of lipid metabolism or hyperlipoproteinemia secondary to known diseases. Furthermore, in conjunction with high-density lipoprotein and total serum cholesterol, a triglyceride determination provides valuable information for the assessment of coronary heart disease risk. The clinical significance and management of hyperlipoproteinemia depends on the triglyceride distribution among the major serum lipoproteins.
EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
(Division Sign-On
Division of Clinical Laboratory Devices
510(k) Number K971113
Prescription Use (Per 21 CFR 801.109)
Or
Over-The-Counter Use