IDS-ISYS IFG-I CONTROL SET

K110412 · Immunodiagnostic Systems , Ltd. · JJX · Mar 16, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110412
• Device Name: IDS-ISYS IFG-I CONTROL SET
• Applicant: Immunodiagnostic Systems , Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 16, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The IDS-iSYS IGF-I Controls Set is a quality control material device intended for medical purposes for use in the IDS-iSYS Insulin like Growth Factor-I (IGF-I) Assay on the IDS-iSYS Multi-Discipline Automated Analyser to monitor the accuracy and quality of the IDS-iSYS IGF-I Assay. For prescription use only

Device Story

IDS-iSYS IGF-I Controls Set is an in vitro diagnostic quality control material; consists of lyophilized bovine serum albumin in buffer matrix with human recombinant IGF-I and sodium azide preservative. Used in clinical laboratory settings by trained personnel to monitor accuracy/quality of IDS-iSYS IGF-I Assay on IDS-iSYS Multi-Discipline Automated Analyzer. Device requires reconstitution with distilled/deionized water. Provides three levels of control (30, 250, 900 ng/mL) to verify assay performance against established target ranges. Healthcare providers use control results to validate assay batch reliability; ensures accurate patient IGF-I measurement.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) confirm 12-month shelf life at 2-8°C and stability of reconstituted material (3 hours on-analyzer; 7 weeks at -20°C) with 90-110% recovery. Traceability established to WHO International Standard (NIBSC code: 02/254).

Technological Characteristics

Lyophilized bovine serum albumin in buffer matrix; contains human recombinant IGF-I and <0.1% sodium azide. Three levels of control (30, 250, 900 ng/mL). Reconstitution required with 1.0 mL distilled/deionized water. Traceable to WHO International Standard (NIBSC 02/254). Stability tested per CEN 13640.

Indications for Use

Indicated for use as a quality control material to monitor the accuracy and quality of the IDS-iSYS IGF-I Assay on the IDS-iSYS Multi-Discipline Automated Analyser.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

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 graphic of three horizontal lines that curve upwards, resembling a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.

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

Immunodiagnostic Systems Ltd. c/o Mick Fenton 10 Didcot Way Boldon Business Park Boldon, Tyne & Wear, NE35 9PD, UK

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Re: k110412

Trade/Device Name: IDS-iSYS IGF-I Controls Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: February 9, 2011 Received: February 14, 2011

Dear Ms. 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.

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.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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

CA

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): K110412

Device Name:

IDS-iSYS IGF-I Controls Set

Indications for Use:

The IDS-iSYS IGF-I Controls Set is a quality control material device intended for medical purposes for use in the IDS-iSYS Insulin like Growth Factor-I (IGF-I) Assay on the IDS-iSYS Multi-Discipline Automated Analyser to monitor the accuracy and quality of the IDS-iSYS IGF-I Assay.

Prescription Use X (Part 21 CFR 801 Subpart D) 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)

Signature

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k110412