CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA

K080623 · Jas Diagnostics, Inc. · CHH · Nov 17, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080623
• Device Name: CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
• Applicant: Jas Diagnostics, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Nov 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

For the quantitative measurement of triglycerides in serum. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus. nephrosis, liver obstruction and other diseases involving lipid metabolism or various endocrine disorders. For in-vitro use only. For the quantitative measurement of Total cholesterol in serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. For in-vitro use only.

Device Story

JAS Diagnostics Cholesterol Oxidase and Triglycerides reagents are in-vitro diagnostic kits for serum analysis. Cholesterol reagent uses cholesterol oxidase to convert cholesterol to cholest-4-en-3-one hydrogen peroxide; triglycerides reagent uses lipase, glycerol kinase, and glycerophosphate oxidase to produce hydrogen peroxide. Both assays utilize peroxidase to react with 4-aminoantipyrine and phenolic compounds to yield a red quinoneimine dye. Absorbance is measured at 540-550 nm on Synchron CX systems. The intensity of the red color is proportional to the analyte concentration. Used in clinical laboratories by technicians to provide quantitative lipid profiles, assisting physicians in diagnosing and managing metabolic and endocrine disorders.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench testing and regulatory classification.

Technological Characteristics

In-vitro diagnostic reagents for cholesterol and triglyceride quantification. Utilizes enzymatic assay principles (Cholesterol Oxidase and Glycerol Kinase).

Indications for Use

Indicated for quantitative measurement of triglycerides and total cholesterol in serum. Used for diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, lipid metabolism disorders, and endocrine disorders. For in-vitro diagnostic use.

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with stylized lines representing its wings and body.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## NOV 1 7 2008

JAS Diagnostics, Inc. c/o Mr. Samuel Burgos Quality Assurance Manager 7220 NW 58th Street Miami, FL 33166

k080623 Re:

> Trade Name: Cholesterol Oxidase JAS; Glycerol Kinase Triglycerides Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) Test System Regulatory Class: Class I, subject to the limitation to exemption in 21 CFR 862.9(c)(4) Product Codes: CHH, CDT Dated: October 16, 2008 Received: October 23, 2008

Dear Mr. Burgos:

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.

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 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 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 note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 tolli the [phone] or [phone] or at its Internet consumer http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Yéan 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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## Indication for Use

510(k) Number (if known): k080623

Device Name: Triglycerides

Indication For Use:

For the quantitative measurement of triglycerides in serum. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus. nephrosis, liver obstruction and other diseases involving lipid metabolism or various endocrine disorders. For in-vitro use only.

V Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Digital Sign Off

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

510(k) k090623

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## Indication for Use

510(k) Number (if known): k080623

Device Name: Cholesterol Oxidase

Indication For Use:

For the quantitative measurement of Total cholesterol in serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. For in-vitro use only.

V Prescription Use _ (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

signature

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

510(k) k080623