OCTEIA 25-HYDROXY VITAMIN D

K021163 · Immunodiagnostic Systems , Ltd. · MRG · May 10, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021163
• Device Name: OCTEIA 25-HYDROXY VITAMIN D
• Applicant: Immunodiagnostic Systems , Ltd.
• Product Code: MRG · Clinical Chemistry
• Decision Date: May 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1825
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The IDS OCTEIA® 25-Hydroxy Vitamin D kit is a enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. For In Vitro Diagnostic Use Only.

Device Story

The OCTEIA 25-Hydroxy Vitamin D kit is an enzyme immunoassay (EIA) used for the quantitative measurement of 25-hydroxyvitamin D and its metabolites in human serum or plasma. The device is intended for in vitro diagnostic use in clinical laboratory settings. It assists healthcare providers in assessing a patient's vitamin D status, which informs clinical decisions regarding vitamin D supplementation or treatment of deficiencies. The assay provides a quantitative result that reflects the patient's vitamin D levels.

Clinical Evidence

No clinical data provided; device is an in vitro diagnostic assay evaluated via bench testing.

Technological Characteristics

Enzyme immunoassay (EIA) kit for quantitative analysis of 25-hydroxyvitamin D in serum or plasma. In vitro diagnostic device.

Indications for Use

Indicated for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in human serum or plasma for the assessment of vitamin D sufficiency in patients.

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/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAY 1 0 2002

Immunodiagnostic Systems Limited c/o Mr. R. Kent Donohue Senior Staff Engineer Conformity Assessment Services Underwriters Laboratories Inc. ® 12 Laboratory Drive Research Triangle Park, NC 27709

Re: k021163

> Trade/Device Name: OCTEIA® 25-Hydroxy Vitamin D Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: Class II Product Code: MRG Dated: May 2, 2002 Received: May6, 2002

Dear Mr. Donohue:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and i additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K_02 || 3

OCTEIA® 25-Hydroxy Vitamin D Device Name:

Indications For Use:

The IDS OCTEIA® 25-Hydroxy Vitamin D kit is a enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency.

For In Vitro Diagnostic Use Only.

Ran Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 0911103 510(k) Number _

PRESCRIPTION USE

OTC

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