IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET

K091849 · Immunodiagnostic Systems, Inc. · MRG · Jun 25, 2010 · Clinical Chemistry

Device Facts

• Record ID: K091849
• Device Name: IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET
• Applicant: Immunodiagnostic Systems, Inc.
• Product Code: MRG · Clinical Chemistry
• Decision Date: Jun 25, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1825
• Device Class: Class 2

Intended Use

The IDS-iSYS Multi-Discipline Automated Analyzer is a discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use. The IDS-iSYS 25-Hydroxy Vitamin D Assay is intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum on the IDS-iSYS Multi-Discipline Automated Analyzer. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population. The kit is for in vitro diagnostic use only. The IDS-iSYS 25-Hydroxy Vitamin D Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the IDS-iSYS 25-Hydroxy Vitamin D Assay.

Device Story

The IDS-iSYS system is a discrete, continuous-loading chemiluminescent immunoassay analyzer. It processes human serum samples to quantify 25-hydroxyvitamin D levels. The device performs automated sample pretreatment to denature Vitamin D Binding Protein, followed by neutralization and incubation with acridinium-labeled anti-25-OH D antibodies and magnetic particles. A magnet captures the particles; after washing and trigger reagent addition, the system measures emitted light, which is inversely proportional to the analyte concentration. The analyzer is intended for clinical laboratory use. Results are provided to clinicians to aid in assessing patient vitamin D status. The system includes integrated software for calibration, quality control monitoring, and data management.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (CLSI EP5-A2), linearity (CLSI EP6-A2), and method comparison (CLSI EP9-A2) against the predicate RIA. Method comparison across 348 samples showed correlation coefficients (r) of 0.94–0.96. Analytical sensitivity (LoD) is 3.6 ng/mL; functional sensitivity is 6 ng/mL. Specificity testing confirmed 100% cross-reactivity for 25-hydroxyvitamin D3, D2, and 24,25-dihydroxyvitamin D3. Interference testing identified bias with hemolysis and icterus, leading to labeling contraindications for such specimens.

Technological Characteristics

Chemiluminescent immunoassay; automated discrete continuous loading analyzer; in vitro diagnostic use; human serum sample matrix.

Indications for Use

Indicated for quantitative determination of 25-hydroxyvitamin D and other hydroxylated metabolites in human serum to assist clinicians in assessing vitamin D sufficiency in adult populations.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle-like emblem with three stylized lines representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. The seal is printed in black and white.

Immunodiagnostic Systems, Inc. c/o Mr. Ken Gibbs 17029 East Enterprise Drive, Suite 1 Fountain Hills, Arizona 85268

Re: k091849

Trade/Device Name: IDS-iSYS 25-Hydroxy Vitamin D Assay Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D Test System Regulatory Class: Class II Product Code: MRG, JJX, JJE Dated: June 21, 2010 Received: June 22, 2010

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

JUN ? 5 2010

Dear Mr. Gibbs:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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 a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.goy/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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. Harper, Ph.D. 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): K091849

IDS-iSYS 25-Hydroxy Vitamin D Assay Device Name:

Indications For Use: The IDS-iSYS Multi-Discipline Automated Analyser is a discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use

> The IDS-iSYS 25-Hydroxy Vitamin D Assay is intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum on the IDS-iSYS Multi-Discipline Automated Analyser. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.

The kit is for in vitro diagnostic use only.

The IDS-iSYS 25-Hydroxy Vitamin D Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the IDS-iSYS 25-Hydroxy Vitamin D Assay.

Prescription Use × (Part 21 CFR 801 Subpart D)

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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)

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091849