(35 days)
The Diazyme Homocysteine Enzymatic Assay is intended for the in vitro quantitative determination of total L-homocysteine in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
Not Found
I am sorry, but after reviewing the provided document, I cannot find the specific information required to complete the table and answer all the questions regarding the acceptance criteria, study details, and ground truth establishment for the Diazyme Homocysteine Enzymatic Assay.
The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed predicate devices. While it mentions the "Indications for Use," it does not provide details about:
- Specific acceptance criteria values.
- The study design, results, or device performance against those criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Details about experts, adjudication methods, or ground truth establishment.
- Information on MRMC studies or standalone algorithm performance.
Therefore, I cannot extract the requested information from this document.
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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 stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is positioned to the right of the department's name, which is written in a circular fashion around the logo.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 3 2006
Mr. Roland Strickland Quality Assurance Manager Diazyme Laboratories 3550 General Atomics Court San Diego, CA 92121
Re: K061296
Trade/Device Name: Diazyme Homocysteine Enzymatic Assay for Cobas Integra® Regulation Number: 21 CFR8862.1377 Regulation Name: Urinary homocystine (nonquantitative) test system Regulatory Class: Class II Product Code: LPS Dated: May 23, 2006 Received: May 26, 2006
Dear Mr. Strickland:
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,
Alberto Gutierrez
Alberto Gutierrez, Ph.D. 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): K061296
Device Name: Diazyme Homocysteine Enzymatic Assay for Cobas Integra®
Indications for Use:
The Diazyme Homocysteine Enzymatic Assay is intended for the in vitro quantitative determination of total L-homocysteine in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
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)
G.C.
Division
Device
10/06/2021
510(K)
Page 1 of 1
§ 862.1377 Urinary homocystine (nonquantitative) test system.
(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.