EON CHOLESTEROL REAGENT

K120202 · Vital Diagnostics Pty., Ltd. · CHH · Jul 27, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120202
• Device Name: EON CHOLESTEROL REAGENT
• Applicant: Vital Diagnostics Pty., Ltd.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Jul 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

Eon Cholesterol Reagent is an in vitro diagnostic device intended for the quantitative determination of total cholesterol in human plasma and serum using the Eon 100 Clinical Chemistry Analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Device Story

Eon Cholesterol Reagent is an in vitro diagnostic reagent used with the Eon 100 Clinical Chemistry Analyser. It measures total cholesterol levels in human plasma and serum samples. The device is intended for use by healthcare professionals in clinical laboratory settings to assist in diagnosing and managing lipid and lipoprotein metabolism disorders. The analyzer processes the sample with the reagent to provide a quantitative cholesterol concentration, which clinicians use to assess patient health and guide therapeutic decisions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent for quantitative cholesterol determination. Designed for use with the Eon 100 Clinical Chemistry Analyser. Operates via standard clinical chemistry enzymatic assay principles.

Indications for Use

Indicated for the quantitative determination of total cholesterol in human plasma and serum to aid in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the seal is a stylized graphic of three overlapping human figures.

10903 New Hampshire Avenue Silver Spring, MD 20993

Vital Diagnostics Pty Ltd c/o Melita Lambiris 189 - 199 Browns Road Noble Park, Victoria 3174 Australia .

JUL 2 7 2012

Re: k120202

> Trade Name: Eon Cholesterol Reagent Regulation Number: 21 CFR §862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I, meets limitations per 21 CFR 862.9(c)(4) Product Codes: CHH Dated: June 13, 2012 Received: June 21, 2012

Dear Melita Lambiris:

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 approval approvisions 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 (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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. 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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Cynthia H. Joiner, Ph.D.

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

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): k120202

Device Name:

Eon Cholesterol Reagent

Indications for Use:

Eon Cholesterol Reagent is an in vitro diagnostic device intended for the quantitative determination of total cholesterol in human plasma and serum using the Eon 100 Clinical Chemistry Analyser. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Prescription Use × . (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

Q. Rute Chm

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 120202