IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D

K123253 · Immunodiagnostic Systems , Ltd. · MRG · Jun 18, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123253
• Device Name: IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D
• Applicant: Immunodiagnostic Systems , Ltd.
• Product Code: MRG · Clinical Chemistry
• Decision Date: Jun 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1825
• Device Class: Class 2

Intended Use

The IDS-iSYS 1,25 Dihydroxy Vitamin D assay is intended for the quantitative determination of 1,25 dihydroxyvitamin D levels in serum and plasma on the IDS-iSYS Multi-Discipline Automated System. Results of the 1,25 Dihydroxy Vitamin D are used in the assessment of vitamin D sufficiency. The IDS-iSYS 1,25 Dihydroxy Vitamin D Control Set is used for quality control of the IDS-iSYS 1,25 Dihydroxy Vitamin D assay on the IDS-iSYS Multi-Discipline Automated System. The IDS-iSYS 1,25 Dihydroxy Vitamin D Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS 1,25 Dihydroxy Vitamin D assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.

Device Story

The IDS iSYS 1,25 Dihydroxy Vitamin D assay is an in vitro diagnostic test performed on the IDS-iSYS Multi-Discipline Automated System. It measures 1,25 dihydroxyvitamin D levels in serum and plasma samples. The system automates the assay process, providing quantitative results used by clinicians to assess a patient's vitamin D status. The device includes a control set for quality assurance and calibration verifiers to ensure the accuracy of the automated analyzer. It is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics of the assay on the IDS-iSYS platform.

Technological Characteristics

Competitive chemiluminescent immunoassay. Components: mouse monoclonal anti-1,25D antibody (immunopurification), biotinylated sheep anti-1,25D antibody, acridinium ester conjugate, streptavidin-coated magnetic particles. Automated on IDS-iSYS system. Reagents contain bovine serum albumin, sodium azide (<1.0%), and sheep proteins. Calibration: 2-point, user-initiated every 14 days. Sterilization: not specified. Connectivity: standalone automated analyzer.

Indications for Use

Indicated for the quantitative determination of 1,25-dihydroxyvitamin D in serum and plasma for the assessment of vitamin D sufficiency in adults. For prescription use only.

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.

Predicate Devices

• Immunodiagnostic Systems Gamma-B 1, 25-Dihydroxy Vitamin D and Control Set (k042519)
• Immunodiagnostic Systems Gamma-B 1,25-Dihydroxy Vitamin D Calibration Verifiers (k122141)

Submission Summary (Full Text)

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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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 18, 2013

Immunodiagnostic Systems Ltd. C/O Mick Fenton 10 DIDCOT WAY, BOLDON BUSINESS PARK, BOLDON, TYNE AND WEAR UNITED KINGDOM NE35 9PD

Re: K123253

Trade/Device Name: IDS iSYS 1,25 Dihydroxy Vitamin D IDS iSYS 1.25 Dihydroxy Vitamin D Control Set IDS iSYS 1,25 Dihydroxy Vitamin D Calibration Verifier Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: 11 Product Code: MRG, JJX

Dated: June 06, 2013 Received: June 11, 2013

Dear Mr. Fenton:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2-Mr. Fenton

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

#### 510(k) Number (if known): k123253

Device Name:

IDS iSYS 1,25 Dihydroxy Vitamin D IDS iSYS 1.25 Dihydroxy Vitamin D Control Set IDS iSYS 1,25 Dihydroxy Vitamin D Calibration Verifiers

Indications for Use:

The IDS-iSYS 1,25 Dihydroxy Vitamin D assay is intended for the determination of 1,25 dihydroxyvitamin D levels in serum and plasma on the IDS-iSYS Multi-Discipline Automated System. Results of the 1.25 Dihydroxy Vitamin D are used in the assessment of vitamin D sufficiency.

The IDS-iSYS 1,25 Dihydroxy Vitamin D Control Set is used for quality control of the IDS-iSYS 1,25 Dihydroxy Vitamin D assay on the IDS-iSYS Multi-Discipline Automated System

The IDS-iSYS 1,25 Dihydroxy Vitamin D Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS 1,25 Dihydroxy Vitamin D assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.

Prescription Use × (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

## Yung W. Johan -S

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

k123253 510(k)