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.

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.

AI/ML Overview

The provided document describes the DMA's Triglyceride (GPO) Procedure, an in vitro diagnostic device for the quantitative determination of triglycerides in human serum or plasma.

Here's an analysis of its acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Linearity	Not explicitly stated, but typically a range of concentration over which the method gives results proportional to the concentration of the analyte.	to 1800 mg/dL
Precision
Within-Run (Within Normal Range)	Not explicitly stated, but target CVs are typically low for precision.	C.V. of approximately 0.4%
Within-Run (Above Normal Range)	Not explicitly stated.	C.V. of approximately 0.7%
Run-to-Run (Within Normal Range)	Not explicitly stated.	C.V. of approximately 4%
Run-to-Run (Above Normal Range)	Not explicitly stated.	C.V. of approximately 1.7%
Shelf-life	Not explicitly stated, but typical for diagnostic reagents.	14 months (at 2-8°C)
Sensitivity (0.001A)	Not explicitly stated, but typically the lowest concentration of an analyte that the method can reliably detect.	1.0 mg/dL
Interferences
Bilirubin	Not explicitly stated, but typically a threshold below which interference is insignificant.	Significant above 4.5 mg/dL
Hemoglobin	Not explicitly stated.	Significant above 190 mg/dL
Expected Values	Not explicitly defined as 'acceptance criteria' but rather as a reference range.	36 - 173 mg/dL

Note on Acceptance Criteria: The document does not explicitly state pre-defined acceptance criteria for each performance characteristic. Instead, it "has been shown to have the following performance characteristics". For a 510(k) submission, the comparison is often made against a predicate device, and the implicit acceptance criteria are that the new device's performance is comparable or non-inferior to the predicate.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). This level of detail is typically found in the full 510(k) submission, not the summary letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For an in vitro diagnostic device like this, "ground truth" for method performance characteristics (linearity, precision, sensitivity, interferences) is typically established through reference methods, certified calibrators, and control materials, rather than expert interpretation of results. Clinical correlation for "expected values" would involve studies with patient populations, but the details are not available here.

4. Adjudication method for the test set

This is not applicable to the type of performance characteristics described for this in vitro diagnostic device. Adjudication methods (like 2+1, 3+1) are typically used for studies involving expert interpretation of medical images or clinical outcomes, where there might be inter-reader variability.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the DMA Triglyceride (GPO) Procedure is an in vitro diagnostic assay for chemical analysis, not an AI-assisted diagnostic tool that would involve human readers interpreting output.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a laboratory assay, not an algorithm, and its performance is inherently "standalone" in the sense that it produces a quantitative result directly. There isn't a human-in-the-loop component in the direct measurement process of this assay.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance characteristics described:

Linearity, Precision, Sensitivity: Ground truth is established using certified reference materials, calibrators, and control samples with known triglyceride concentrations, or comparisons against a recognized reference method.
Interferences: Ground truth is established by spiking samples with known concentrations of interfering substances (bilirubin, hemoglobin) and observing the impact on triglyceride measurements compared to unspiked controls or reference methods.
Expected Values: Ground truth for these values would typically come from clinical studies on specific populations to establish reference ranges, often derived statistically from a healthy population.

The document does not provide specifics on how these ground truths were established, only that the device "has been shown to have" these characteristics.

8. The sample size for the training set

The concept of a "training set" is primarily relevant for machine learning or AI models. This is an in vitro diagnostic assay, not an AI model, so there isn't a "training set" in that context. The development and optimization of the assay would involve various experiments and optimizations, but these are not referred to as "training sets."

9. How the ground truth for the training set was established

As there is no "training set" in the context of an AI/ML model for this device, this question is not applicable. The development of the assay would involve standard laboratory practices for developing and validating chemical assays.

Summary

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1971 MAY 29, 1997

Safety and Effectiveness Summary

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

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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

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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)

Over-The-Counter Use

Regulation Number and Section

§ 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.