(65 days)
The IDS 1,25-Dihydroxy Vitamin D EIA kit is a complete assay system intended for the purification of 1,25-dihydroxyvitamin D (1,25D) in human serum or plasma by immunoextraction followed by quantitation by enzymeimmunoassay. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of 1,25D deficiency associated with renal disease in adult populations. For In Vitro Diagnostic Use Only.
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The provided text is a letter from the FDA regarding a 510(k) premarket notification for a device. It does not contain information about acceptance criteria, device performance, study details (like sample size, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment for either training or test sets. Therefore, I cannot generate the requested table and study description from this input.
The document primarily focuses on:
- Granting substantial equivalence for the "1, 25-Dihydroxy Vitamin D EIA" device.
- Listing the regulation number, name, and product code.
- Stating the intended use of the device: "to assist the clinician in the assessment of 1,25D deficiency associated with renal disease in adult populations" in conjunction with other clinical and laboratory data.
- Providing information about regulatory requirements and contacts.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Paul Puntin Head of Quality & Regulatory Affairs Immunodiagnostic Systems Limited 10 Didcot Way Boldon Business Park Boldon, Tyne & Wear NE35 9PD UK
Re: K051110
Trade/Device Name: 1, 25-Dihydroxy Vitamin D EIA Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: Class II Product Code: MRG Dated: April 22, 2005 Received: May 2, 2005
Dear Mr. Puntin:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave ro rowed your we 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 connineroo prior colassified 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.
JUL 6 - 2005
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 n may 60 below 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 r hat 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) I his icher witi anow you to ogen maxing of substantial equivalence of your device to a legally premarked predication. "The I Driving of Sostion 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, If you desire specific information accuration of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the v tro Diagnostic Do Moo Branding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou inay of amall 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. Benam
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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8.0 INDICATIONS FOR USE
510(k) Number (if known): KQ5 | | ID
Device Name:
1,25-Dihydroxy Vitamin D EIA
Indications For Use:
The IDS 1,25-Dihydroxy Vitamin D EIA kit is a complete assay system intended for the purification of 1,25-dihydroxyvitamin D (1,25D) in human serum or plasma by immunoextraction followed by quantitation by enzymeimmunoassay. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of 1,25D deficiency associated with renal disease in adult populations.
For In Vitro Diagnostic Use Only.
Kemal
(Division Sign-Off)
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_005 1110
Image /page/2/Picture/9 description: The image shows the phrase "Prescription Use" followed by the text "(Part 21 CFR 801 Subpart D)". There is a large X over a horizontal line to the right of the text. The text is in black font and the X is also in black.
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)
§ 862.1825 Vitamin D test system.
(a)
Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.(b)
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.