OLYMPUS TRIGLYCERIDE TEST SYSTEM

K063804 · Olympus America, Inc. · CDT · Mar 23, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063804
• Device Name: OLYMPUS TRIGLYCERIDE TEST SYSTEM
• Applicant: Olympus America, Inc.
• Product Code: CDT · Clinical Chemistry
• Decision Date: Mar 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1705
• Device Class: Class 1

Intended Use

System reagent for the quantitative determination of triglyceride concentrations in human serum and plasma on OLYMPUS analyzers. Measurements of triglyceride are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Device Story

Olympus Triglyceride Test System is an in vitro diagnostic reagent for quantitative triglyceride measurement. Input: human serum or plasma samples. Principle: coupled enzymatic reactions; microbial lipases hydrolyze triglycerides to glycerol and fatty acids; glycerol kinase and glycerol phosphate oxidase produce hydrogen peroxide; peroxidase reacts with 4-aminophenazone and MADB to form a chromophore. Output: absorbance measured at 660/800 nm, proportional to triglyceride concentration. Used in clinical laboratories on Olympus AU-series analyzers (AU400/AU600/AU640/AU2700/AU5400). Healthcare providers use results to assess lipid metabolism and cardiovascular disease risk. Includes Data Check Parameters to flag grossly lipemic samples that may cause erroneous results.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (n=80 per instrument group, CVs < 3%). Linearity confirmed 10-1000 mg/dL. Analytical specificity tested per CLSI EP7-A for bilirubin, hemolysate, and ascorbate. Method comparison (n=148) against predicate showed high correlation (r=1.000). Matrix comparison (n=40-41) confirmed equivalence between serum, EDTA plasma, and Lithium-Heparin plasma.

Technological Characteristics

Two-liquid ready-to-use enzymatic reagent. Principle: coupled enzymatic reaction (lipase/GK/GPO/POD) with MADB indicator. Detection: spectrophotometric absorbance at 660/800 nm. Compatible with Olympus AU-series automated analyzers. Standards: CLSI EP5-A2, EP9-A, EP7-A, EP14-A. Traceability: NIST SRM 1951b.

Indications for Use

Indicated for quantitative determination of triglyceride concentrations in human serum and plasma. Used in diagnosis/treatment of patients with diabetes mellitus, nephrosis, liver obstruction, lipid metabolism disorders, endocrine disorders, and assessment of atherosclerosis and coronary artery disease risk.

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.

Predicate Devices

• Olympus triglyceride reagent (k961274)

Submission Summary (Full Text)

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### Triglyceride 510(k)

Ko63804

### Section 2 - 510(k) Summary

- As required by 21 CFR 807.87 (h) -

MAR 2 3 2007

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

...

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| 1. Submitter name, address, contact | Olympus America<br>3131 W Royal Lane<br>Irving, TX 75063 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | 972-619-4710 |
| Fax: | 972-556-0365 |
| Contact Person: | Bev Harding |
| Date Prepared: | December 18, 2006 |
| 2. Device name | |
| Proprietary Name: | Olympus Triglyceride Reagent |
| Common Name: | Triglyceride Reagent |
| Classification Name: | Triglyceride Test System, |
| 3. Predicate device | |
| Reagent: | Olympus Triglyceride OSR6x33 (K961274) |
| 4. Device description | This Olympus Triglyceride procedure is based on a series of coupled enzymatic reactions. The triglycerides in the sample are hydrolyzed by a combination of microbial lipases to give glycerol and fatty acids. The glycerol is phosphorylated by adenosine triphosphate (ATP) in the presence of glycerol kinase (GK) to produce glycerol-3-phosphate. The glycerol-3-phosphate is oxidized by molecular oxygen in the presence of GPO (glycerol phosphate oxidase) to produce hydrogen peroxide (H2O2) and dihydroxyacetone phosphate. The formed H2O2 reacts with 4-aminophenazone and N,N-bis(4-sulfobutyl)-3,5-dimethylaniline, disodium salt (MADB) in the presence of peroxidase (POD) to produce a chromophore, which is read at 660/800nm. The increase in absorbance at 660/800 nm is proportional to the triglyceride content of the sample. |

Triglycerides + 3 H2O Lipase → Glycerol + 3 Fatty Acids

Glycerol + ATP GK,Mg2+→ Glycerol-3-phosphate + ADP

Glycerol-3-phosphate + O2 GPO→ H2O2 + Dihydroxyacetone phosphate

2 H2O2 + MADB + 4AAP Peroxidase → Blue Dye + OH + H2O

| 5. Intended use | System reagent for the quantitative determination of Triglyceride concentrations in human serum and plasma on OLYMPUS analyzers. |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------|
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# Triglyceride 510(k)

## Section 2 - 510(k) Summary

მ. The following Tables compare the new Olympus Triglyceride OSR6x118 with the Olympus Triglyceride OSR6x33

| Similarities | | |
|-------------------------------|----------------------------------------------------------------|-----------|
| Item | New Olympus Triglyceride | Predicate |
| Measurement | Quantitative | Same |
| Chemical reaction | Enzymatic GPO methodology with Trinder<br>indicator system | Same |
| Sample dilution | Not required | Same |
| Reagent Materials | Lipoprotein Lipase and coupling enzymes<br>and co-factors | Same |
| Traceability | College of American Pathology (CAP)<br>Serum Lipid (RM016) # 2 | Same |
| Reagent storage form | Liquid ready to use | Same |
| Reagent On Board<br>Stability | 30 days on board | Same |
| Calibration | Single Point | Same |
| Calibration Stability | 30 days | Same |
| Quality Controls | 2 Levels | Same |

| Item | New Olympus Triglyceride | Predicate |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | System reagent for the quantitative determination of<br>Triglyceride concentrations in human serum and plasma on<br>OLYMPUS analyzers | System reagent for the<br>quantitative<br>determination of<br>Triglyceride<br>concentrations in<br>human serum on<br>OLYMPUS analyzers |
| Catalogue Number | OSR6x118 | OSR6x33 |
| Specimen Type | Serum and Plasma | Serum |
| Indicator | N,N-bis(4-sulfobutyl)-3,5-dimethylaniline, disodium salt<br>(MADB) | 4-chlorophenol |
| Methodology | Enzymatic endpoint at approximately 660nm | Enzymatic endpoint at<br>approximately 520nm |
| Expected Values | Adults: 48 - 352mg/dL<br><br>Triglyceride<br><150 mg/dL<br>150-199 mg/dL<br>200-499 mg/dL<br>≥500 mg/dL | Adults: 48 -352mg/dL |
| | Risk Classification<br>Normal<br>Borderline High<br>High<br>Very High | |

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# Triglyceride 510(k)

# Section 2 - 510(k) Summary

| Performance Characteristics | | | | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-----------|--------------------------------------------------------------------------------------------------------------------|-----------|
| Item | New Olympus Triglyceride | Predicate | | |
| Precision AU400/400e | Sample | Total CV% | Sample | Total CV% |
| | 1 | 2.58 | 1 | 1.21 |
| | 2 | 2.54 | 2 | 1.67 |
| | 3 | 2.41 | 3 | 1.37 |
| Precision<br>AU600/640/640e | Sample | Total CV% | AU600<br>Sample | Total CV% |
| | 1 | 1.65 | 1 | 1.83 |
| | 2 | 1.41 | 2 | 1.58 |
| | 3 | 1.46 | 3 | 2.80 |
| | | | 4 | 1.13 |
| | | | AU640/640e<br>Sample | Total CV% |
| | | | 1 | 1.00 |
| | | | 2 | 1.00 |
| Precision AU2700/5400 | Sample | Total CV% | Sample | Total CV% |
| | 1 | 2.00 | 1 | 2.50 |
| | 2 | 1.72 | 2 | 2.00 |
| | 3 | 1.78 | 3 | 1.50 |
| | | | 4 | 1.20 |
| Assay Range | 10 - 1000 mg/dL | | 10 - 1000 mg/dL | |
| | Intercept | -0.871 | Intercept | 3.2 |
| Method Comparison | Slope | 1.011 | Slope | 1.010 |
| | R | 1.000 | R | 0.999 |
| Interfering Substances | AU400/400e/600/640/640e/2700/5400<br>Ascorbate ≤ 5% up to 20 mg/dL<br>Bilirubin ≤ 3% up to 40 mg/dL<br>Hemolysis ≤ 3% up to 500 mg/dL | | AU400/400e<br>Ascorbate ≤ 2% up to 20mg/dL<br>Bilirubin ≤ 10% up to 20 mg/dL<br>Hemolysis ≤ 8% up to 500 mg/dL | |
| | | | AU600/640/640e<br>Ascorbate ≤ 1% up to 20mg/dL<br>Bilirubin ≤ 10% up to 32 mg/dL<br>Hemolysis ≤ 7% up to 500 mg/dL | |
| | | | AU2700/5400<br>Ascorbate ≤ 2% up to 20mg/dL<br>Bilirubin ≤ 10% up to 16 mg/dL<br>Hemolysis ≤ 8% up to 500 mg/dL | |

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Olympus America, Inc. c/o Ms. Bev Harding 3131 West Royal Lane Irving, TX 75063-3104

MAR 2 3 2007

k063804 Re:

Trade/Device Name: Olympus Triglyceride Test System Regulation Number: 21 CFR8 862.1705 Regulation Name: Triglyceride test system. Regulatory Class: Class I meets limitations of exemptions, 21 CFR 862.9 (c) (4) Product Code: CDT Dated: March 16, 2007 Received: March 19, 2007

Dear Ms. Harding:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Ilsting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gally marketed predicate device results in a classification for your device and thus, serroot to your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please othe the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloft the [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K063804

Device Name:

Olympus Triglyceride Test System.

Indications for Use:

System reagent for the quantitative determination of Triglyceride concentrations in human serum and plasma on OLYMPUS analyzers

Measurements of triglyceride are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various enocrine disorders, and in the assessment of risk factors for atherosclerosis and coronary artery disease.

Prescription Use (Part 21 CFR 801.Subpart D)

Over-The-Counter Use (Part 21 CFR 801.Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostics Devices (OIVD)

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