(62 days)
Diazyme homocysteine 2 reagent assay is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only. The reagents can assist in the diagnosis and treatment of patients suspected of having hyperhomocyone . Inc creating and homocystinuria. Patients who are taking methotrexate, carbamazepine, phenytoin, nitrovos oxide, anticonvulsants, or 6-azuridine triacetate, may have higher levels of Homocysteine due to metabolic interference with Homocysteine metabolism.
Diazyme homocysteine Calibrators is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Diazyme Laboratories for their Homocysteine 2 Reagent Enzymatic Assay. This document does not contain the detailed study information needed to describe acceptance criteria and device performance in the requested format.
The letter acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices. It lists the trade name, regulation number, regulation name, regulatory class, and product code. It also includes the "Indications for Use" for the device, which describes what the assay is intended to do (quantitative determination of total L-homocysteine in serum or plasma) and for whom (assisting in diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria, including those on certain medications).
However, the document does not provide any specific information regarding:
- Acceptance criteria values or reported device performance metrics. These would typically include sensitivity, specificity, accuracy, precision, etc., with numerical targets and achieved results.
- Study design details:
- Sample size for the test set or training set.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Whether MRMC or standalone studies were performed, or any corresponding effect sizes.
- Type of ground truth used (e.g., pathology, outcomes data).
- How ground truth for the training set was established.
Therefore, I cannot fulfill the request by extracting the specific information about acceptance criteria and study details from the provided text. This document is a regulatory approval letter, not a technical study report.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Diazyme Laboratories c/o Mr. Charles Lu Quality System Manager 12889 Gregg Court Poway, CA 92064
SEP 1 7 2007
K071971 Re:
Trade Name: Diazyme Homocysteine 2 Reagent Enzymatic Assay Regulation Number: 21 CFR 8862.1377 Regulation Name: Urinary Homocysteine (nonquantiative) test system Regulatory Class: Class II Product Code: LPS, JIX Dated: August 20, 2007 Received: August 21, 2007
Dear Mr. Lu:
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 10(x) marketed predicate device results in a classification for your device and than bernetted 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) 276-0490. 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 une (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Jean 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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Indications for Use
510(k) Number (if known):
Image /page/2/Picture/3 description: The image shows a handwritten text string that appears to be "K07 1971". The characters are written in a simple, somewhat stylized manner, with varying stroke thicknesses. The text is clear and legible against the plain background.
Device Name: Diazyme Homocysteine 2 Reagent Enzymatic Assay
Indications for Use: Diazyme homocysteine 2 reagent assay is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only. The reagents can assist in the diagnosis and treatment of patients suspected of having hyperhomocyone . Inc creating and homocystinuria. Patients who are taking methotrexate, carbamazepine, phenytoin, nitrovos oxide, anticonvulsants, or 6-azuridine triacetate, may have higher levels of Homocysteine due to metabolic interference with Homocysteine metabolism.
Device Name: Diazyme Homocysteine Calibrators
Indications for Use: Diazyme homocysteine Calibrators is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only.
Prescription Use X (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)
Page 13 sion Sign-C
ିffice of In Vitro Diagnostic Device I Waluation and Safety
K07/971
§ 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.