VITROS CHEMISTRY PRODUCTS TRIG SLIDES

K130332 · Ortho-Clinical Diagnostics, Inc. · CDT · May 31, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130332
• Device Name: VITROS CHEMISTRY PRODUCTS TRIG SLIDES
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CDT · Clinical Chemistry
• Decision Date: May 31, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1705
• Device Class: Class 1

Intended Use

For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS® Systems. 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.

Device Story

VITROS Chemistry Products TRIG Slides are in vitro diagnostic test slides used on VITROS Chemistry Systems. The device utilizes an enzymatic endpoint reaction to measure triglyceride concentration in serum or plasma samples. The process involves lipase, glycerol kinase, and L-alpha-glycerophosphate oxidase to catalyze reactions, followed by reflectance spectrophotometry to quantify the analyte. The system is operated by laboratory professionals in clinical settings. The output provides quantitative triglyceride levels, which clinicians use to diagnose and monitor metabolic, endocrine, and lipid-related diseases. The device is a modified version of a previously cleared product, maintaining identical technological principles and performance characteristics.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm performance criteria met following reagent enzyme source change.

Technological Characteristics

In vitro diagnostic lipase assay reagent. Modification: enzyme source changed from Candida Rugosa to Pseudomonas. Fundamental scientific technology unchanged.

Indications for Use

Indicated for patients requiring quantitative measurement of triglyceride concentration in serum or plasma to assist in the diagnosis and treatment of diabetes mellitus, nephrosis, liver obstruction, lipid metabolism disorders, or endocrine disorders.

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)

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# 14130332

## SECTION 6: 510(k) Summary

# MAY 3 1 2013

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#### 510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

| Submitter Information | | |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Name | Ortho-Clinical Diagnostics, Inc. | |
| Address | 100 Indigo Creek Drive | |
| | Rochester, New York 14626 | |
| Phone number | [phone] | |
| Fax number | [phone] | |
| Establishment Registration<br>Number | 1319809 | |
| Name of contact person | Gaozhen Hang | |
| Date prepared | February 8, 2013 | |
| Name of device | | |
| Trade or proprietary name | VITROS Chemistry Products TRIG Slides | |
| Common or usual name | Lipase Hydrolysis/Glycerol Kinase Enzyme,<br>Triglycerides | |
| Classification name | Triglyceride test system | |
| Classification panel | Clinical Chemistry | |
| Regulation | 21 CFR 862.1705 | |
| Product Code(s) | CDT | |
| Legally marketed device(s)<br>to which equivalence is<br>claimed | The VITROS Chemistry Products TRIG Slides<br>(modified) are substantially equivalent to the VITROS<br>Chemistry Products TRIG Slides (current). The FDA<br>cleared the VITROS Chemistry Products TRIG Slides<br>on August 3, 1981 (k812029). | |

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Ortho-Clinical Diagnostics VITROS® Chemistry Product TRIG Slides Special 510(k)

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Ortho-Clinical Diagnostics VITROS® Chemistry Product TRIG Slides Special 510(k) ·

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| Summary of the technological characteristics of the device compared to the<br>predicate device | | |
|------------------------------------------------------------------------------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | New Device [VITROS<br>TRIG Slide (Modified)] | Predicate [VITROS TRIG<br>Slide (Current) [k812029] |
| Intended Use | No Change | For <i>in vitro</i> diagnostic use<br>only.<br>VITROS Chemistry Products<br>TRIG Slides quantitatively<br>measure triglyceride (TRIG)<br>concentration in serum and<br>plasma using VITROS<br>250/350/950/5,1 FS and 4600<br>Chemistry Systems and the<br>VITROS 5600 Integrated<br>System. |
| Basic Principle | No Change | Enzymatic Endpoint test type<br>utilizing reflectance<br>spectrophotometry |
| Concentrations of<br>VITROS TRIG Slide<br>Reactive Ingredients per<br>cm-squared | No Change | Lipase ( <i>Candida rugosa</i> E.C.<br>3.1.1.3) 0.15 U<br>Peroxidase (horseradish root<br>E.C.1.11.1.7) 0.52 U; glycerol<br>kinase ( <i>Cellulomonas</i> sp.,<br>E.C.2.7.1.30) 0.35 U; L-α-<br>glycerophosphate oxidase<br>( <i>Pediococcus</i> sp., E.C.1.1.3.-)<br>0.19 U; Triton X-100 0.62 mg;<br>2-(3,5-dimethoxy-4-<br>hydroxyphenyl)-4,5-bis(4-<br>dimenthylaminophenyl)<br>imidazole (leuco dye) 0.04 mg;<br>and adenosine triphosphate<br>0.14 mg. |
| Sample volume | No Change | 5.5 µL |
| Sample type | No Change | Serum, plasma |
| Assay Range Serum,<br>Plasma | No Change | 10.0-525.0 mg/dL |
| Incubation time and<br>temperature | No Change | 5 minutes at 37°C |

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Ortho-Clinical Diagnostics VITROS® Chemistry Product TRIG Slides Special 510(k)

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#### Summary of design control activities conducted in relation to the device modification

The Ortho-Clinical Diagnostics, Inc. procedure for risk management is based on ISO 14971, Medical Devices - Application of Risk Management to Medical Devices and references CDRH Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management.

The risk analysis method used to assess the impact of the device modification was a Hazard Analysis. The following performance characteristics: accuracy, precision, linearity, potential interferents, long term and on-analyzer stability, limit of detection and specimen type were considered for potential hazards. Validation and verification testing were conducted and the modified device met the pre-determined acceptance criteria for all the performance testing. The modification does not negatively impact the performance of the device or the safety and effectiveness of the device.

#### CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products TRIG Slides (modified) for use with human serum and plasma is substantially equivalent to the predicate (unmodified VITROS TRIG Slides) and is safe and effective for the stated intended use.

Ortho-Clinical Diagnostics VITROS® Chemistry Product TRIG Slides Special 510(k)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized symbol with three curved lines, resembling a person embracing another. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 31, 2013

Ortho-Clinical Diagnostics, Inc. C/O Gaozhen Hang 100 Indigo Creek Drive ROCHESTER NY 14626-5101

Re: K130332

Trade/Device Name: VITROS Chemistry Products TRIG Slide Regulation Number: 21 CFR 862.1705 Regulation Name: Triglyceride test system Regulatory Class: I, meets limitations of exemption per 21 CFR 862.9(c)(4) Product Code: CDT Dated: May 06, 2013 Received: May 09, 2013

Dear Gaozhen Hang:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration .- Please note .- CDRH-does not-evaluate information-related to contract-liability warranties." We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for

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the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol G. Benson -S for

Courtney H. Lias, Ph.D. Director, Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

· Enclosure

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### Indications for Use

| 510(k) Number (if known): | k130332 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

VITROS® Chemistry Products TRIG Slide

Indications for Use: .

Indications for Use:

> For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS® Systems. 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/OR Prescription Use X Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) ___

Ruth A. Chester - S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)_k130332

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