SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL

K042443 · Arkray, Inc. · CHH · Nov 24, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042443
• Device Name: SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL
• Applicant: Arkray, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Nov 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

The SpotChem EZ Total Cholesterol, HDL and Triglyceride test and panel system are an in vitro diagnostic procedures intended to measure Total Cholesterol/HDL Triglyceride quantitatively in human serum and plasma on the SpotChem EZ analyzer. Total Cholesterol measurements are used the diagnosis and treatment of lipid and lipoprotein metabolism disorders. HDL-Cholesterol measurements are used the diagnosis and treatment of lipid and lipoprotein metabolism disorders. 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

SpotChem EZ system performs quantitative in vitro diagnostic analysis of human serum and plasma samples. Device measures Total Cholesterol, HDL, and Triglycerides. System consists of analyzer and individual/panel test reagents. Used in clinical settings by healthcare professionals. Provides quantitative results to assist clinicians in diagnosing and managing lipid metabolism disorders, diabetes, and endocrine conditions. Benefits patient through rapid, point-of-care assessment of lipid profiles.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance characteristics for in vitro diagnostic measurement.

Technological Characteristics

In vitro diagnostic analyzer for quantitative lipid measurement. Uses serum/plasma samples. Photometric/colorimetric sensing principle. Standalone benchtop analyzer.

Indications for Use

Indicated for quantitative measurement of Total Cholesterol, HDL, and Triglycerides in human serum and plasma for patients requiring diagnosis and treatment of lipid/lipoprotein metabolism disorders, diabetes mellitus, nephrosis, liver obstruction, or endocrine 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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged in a circular fashion around the symbol. The logo is black and white.

NOV 2 4 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Helen Landicho, RAC Director of Regulatory Affairs Polymedco, Inc. 510 Furnace Dock Rd. Cortlandt Manor, NY 10567

k042443 Re:

> Trade/Device Name: The SpotChem EZ Total Cholesterol, HDL and triglyceride Individual Tests and Panel Tests Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: CHN, CDT, LBS Dated: September 8,2004 Received: September 9,2004

Dear Ms. Landicho:

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" (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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Seain M Cooper, US DVM.

Jean M. Cooper, MS. 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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## Indications for Use

510(k) Number (if known): K042443

Device Name:

The SpotChem EZ Total Cholesterol, HDL and triglyceride Individual Tests and Panel Tests

Indications For Use:

The SpotChem EZ Total Cholesterol, HDL and Triglyceride test and panel system are an in vitro diagnostic procedures intended to measure Total Cholesterol/HDL Triglyceride quantitatively in human serum and plasma on the SpotChem EZ analyzer.

Total Cholesterol measurements are used the diagnosis and treatment of lipid and lipoprotein metabolism disorders.

HDL-Cholesterol measurements are used the diagnosis and treatment of lipid and lipoprotein metabolism disorders.

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.

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

Over-The-Counter Use (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 Diagnostic Devices (OIVD)

Carol Buman
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K642443

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