(16 days)
The SPOTCHEM II Total Bilirubin test is intended to measure the levels of bilirubin in serum, plasma, and whole blood. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
The SPOTCHEM II Total Protein test is intended to measure total protein in serum, plasma, and whole blood. Measurements of total protein are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow, as well as other metabolic and nutritional disorders.
The SPOTCHEM II Albumin test is intended to measure the albumin concentration in serum, plasma, and whole blood. Measurements of albumin are used in the diagnosis and treatment of numerous diseases involving the liver or kidneys.
Not Found
This document is a 510(k) clearance letter from the FDA for Arkray SPOTCHEM II Total Bilirubin, Total Protein, and Albumin Tests. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria, study details, device performance, sample sizes, ground truth establishment, or expert involvement. These details would typically be found in the 510(k) submission itself, or in supporting documentation, which is not included in the provided snippets.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The document is solely a regulatory clearance for marketing the device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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JUN 17 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Arkray, Inc. c/o Ms. Helen Landicho, RAC Director of Regulatory Affairs Polymedco Inc. 510 Furnace Dock Rd. Cortlandt Manor, NY 10567
Re: K051432
Trade/Device Name: Arkray SPOTCHEM II Total Bilirubin, Total Protein and Albumin Tests Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG, CEK, CIX Dated: May 31, 2005 Received: June 3, 2005
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting 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
K051432 510(k) Number (if known):
Device Name: Arkray SPOTCHEM II Total Bilirubin, Total Protein, and Albumin Tests
Indications For Use:
The SPOTCHEM II Total Bilirubin test is intended to measure the levels of bilirubin in serum, plasma, and whole blood. Measurements of the levels of bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
The SPOTCHEM II Total Protein test is intended to measure total protein in serum, plasma, and whole blood. Measurements of total protein are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow, as well as other metabolic and nutritional disorders.
The SPOTCHEM II Albumin test is intended to measure the albumin concentration in serum, plasma, and whole blood. Measurements of albumin are used in the diagnosis and treatment of numerous diseases involving the liver or kidneys.
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)
Acting
(Division Sign-Off)
(Division Sign Off)
Division of Chnical Laboratory Devices
510(k) Number K051432
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§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.