DMA TRIGLYCERIDES PROCEDURES

K971113 · Data Medical Associates, Inc. · CDT · May 29, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971113
• Device Name: DMA TRIGLYCERIDES PROCEDURES
• Applicant: Data Medical Associates, Inc.
• Product Code: CDT · Clinical Chemistry
• Decision Date: May 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1705
• Device Class: Class 1

Intended 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 metabolism, 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 Story

In vitro diagnostic assay for quantitative triglyceride measurement in human serum or plasma. Uses GPO (glycerol-3-phosphate oxidase) enzymatic method. Performed in clinical laboratory settings by trained personnel. Input: patient serum or plasma sample. Output: quantitative triglyceride concentration (mg/dL). Results assist clinicians in diagnosing and managing lipid metabolism disorders, diabetes, and assessing coronary heart disease risk.

Clinical Evidence

Bench testing only. Performance characteristics: Linearity up to 1800 mg/dL; within-run precision C.V. 0.4-0.7%; run-to-run precision C.V. 1.7-4.0%; sensitivity 1.0 mg/dL. Interference data provided for bilirubin (>4.5 mg/dL) and hemoglobin (>190 mg/dL).

Technological Characteristics

Enzymatic GPO (glycerol-3-phosphate oxidase) assay. In vitro diagnostic reagent kit. Shelf-life 14 months at 2-8°C. No electronic components, software, or connectivity.

Indications for Use

Indicated for quantitative determination of triglycerides in human serum or plasma for patients with diabetes mellitus, nephrosis, liver obstruction, lipid metabolism disorders, endocrine disorders, or for coronary heart disease risk assessment.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}

K971113
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.

| Linearity | to 1800 mg/dL |
| --- | --- |
| Precision | |
| Within-Run | (Within Normal Range) C.V. of approximately 0.4%
(Above Normal Range) C.V. of approximately 0.7% |
| Run-to-Run | (Within Normal Range) C.V. of approximately 4%
(Above Normal Range) C.V. of approximately 1.7% |
| Shelf-life | 14 months (at 2-8°C) |
| 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 |

5

{1}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 29 1997
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

C. H. Morris, Ph.D.
Vice President, Scientific and Government Affairs
Data Medical Associates, Inc.
845 Avenue G East
Arlington, Texas 76011

Re: K971113
DMA Triglyceride Procedure
Regulatory 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 Regulations, Title 21, Parts 800 to 895. A 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.

{2}

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 [phone].

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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}

12:57 817 648 2461 DATA RET. ASS'T. 004/006

# DMA Triglyceride (GPO) Procedure

510(k) Number (if known): K971113

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 metabolism, 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.

## CASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑ (Per 21 CFR 801.109)
or
Over-The-Counter Use ☐