1,25-DIHYDROXY VITAMIN D EIA

K051110 · Immunodiagnostic Systems , Ltd. · MRG · Jul 6, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051110
• Device Name: 1,25-DIHYDROXY VITAMIN D EIA
• Applicant: Immunodiagnostic Systems , Ltd.
• Product Code: MRG · Clinical Chemistry
• Decision Date: Jul 6, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1825
• Device Class: Class 2

Intended Use

The IDS 1,25-Dihydroxy Vitamin D kit is a complete assay system intended for 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.

Device Story

The IDS 1,25-Dihydroxy Vitamin D EIA is an in vitro diagnostic assay system used in clinical laboratories. It processes human serum or plasma samples to measure 1,25-dihydroxyvitamin D levels. The device utilizes an immunoextraction step to purify the analyte, followed by an enzyme immunoassay (EIA) for quantitation. The output is a quantitative measurement of 1,25D, which clinicians use alongside other clinical and laboratory data to assess 1,25D deficiency in patients with renal disease. The device is intended for professional use by laboratory personnel.

Clinical Evidence

No clinical data provided in the document; the submission relies on bench-level performance characteristics of the assay system.

Technological Characteristics

The device is an enzyme immunoassay (EIA) system. It utilizes immunoextraction for sample purification followed by EIA for quantitation. It is designed for in vitro diagnostic use in human serum or plasma.

Indications for Use

Indicated for the assessment of 1,25-dihydroxyvitamin D (1,25D) deficiency associated with renal disease in adult populations using human serum or plasma.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)