(76 days)
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.
Not Found
This a 510(k) summary for "The SpotChem EZ Total Cholesterol, HDL and Triglyceride Individual Tests and Panel Tests". The document focuses on the regulatory clearance for this in vitro diagnostic device and does not contain detailed information about acceptance criteria, specific study designs, or performance metrics in the format requested.
Therefore, I cannot provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The document is a regulatory letter of substantial equivalence and does not include the detailed technical study information.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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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§ 862.1175 Cholesterol (total) test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.