IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...

K111938 · Immunodiagnostic Systems , Ltd. · JJX · Feb 14, 2012 · Clinical Chemistry

Device Facts

• Record ID: K111938
• Device Name: IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL...
• Applicant: Immunodiagnostic Systems , Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Feb 14, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The IDS-iSYS IGFBP-3 controls set is a quality control material device intended for medical purposes for use in the IDS-iSYS IGFBP-3 assay on the IDS-iSYS multi discipline automated analyzer to monitor the accuracy and quality of the IDS-iSYS IGFBP-3 assay. The IDS-iSYS IGFBP-3 calibration verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS IGFBP-3 assay when performed on the IDS-iSYS multi-disciplined automated analyzer. The IDS-iSYS hGH calibration verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS hGH assay when performed on the IDS-iSYS multi-disciplined automated analyzer.

Device Story

The IDS-iSYS IGFBP-3 Control Set and Calibration Verifiers (IGFBP-3 and hGH) are in vitro diagnostic materials used to monitor assay performance and verify calibration on the IDS-iSYS Multi-Discipline Automated Analyzer. These products serve as quality control and calibration verification tools for clinical laboratory professionals. By providing known values for comparison, they allow clinicians to assess the accuracy and stability of the IDS-iSYS IGFBP-3 and hGH assays. This ensures the reliability of patient test results, supporting accurate clinical decision-making regarding growth hormone and IGFBP-3 levels. The devices are used in a laboratory environment as part of standard quality assurance workflows.

Clinical Evidence

No clinical data. Bench testing only. Includes stability studies (accelerated and real-time), traceability to international standards (NISBC 93/560 and 98/574), and value assignment validation across multiple analyzer units.

Technological Characteristics

Materials: Bovine serum albumin, phosphate buffer, sodium azide. Form factor: Lyophilized powder or ready-to-use liquid. Energy source: N/A (reagent/control material). Connectivity: N/A (used on IDS-iSYS analyzer). Sterilization: N/A. Software: N/A (assay-specific control material).

Indications for Use

Indicated for use as quality control material and calibration verification material for the IDS-iSYS IGFBP-3 and hGH assays on the IDS-iSYS Multi-Discipline Automated Analyzer. Intended for professional, prescription-only use in clinical laboratory settings to monitor assay accuracy and verify calibration.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

10903 New Hampshire Avenue Silver Spring, MD 20993

IMMUNODIAGNOSTIC SYSTEMS LTD. c/o Mick Fenton 10 Didcot Way Bolden Business Park Boldon, Tyne & Wear United Kingdom NE35 9PD

FEB 1 4 2012

Re: k111938

Trade Name: IDS-iSYS IGFBP-3 Calibration Verifiers, IDS-iSYS IGFBP-3 Control Set, IDS-iSYS hGH Calibration Verifiers Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: January 20, 20112 Received: January 23, 2012

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.

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 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).

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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/Medical

Devices/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/ResourcesforYou/Industry/default.htm

Sincerely yours,

N.

Counney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

K number

Device

## IDS-iSYS IGFBP-3 Control Set

The IDS-iSYS IGFBP-3 Control Set is intended for medical purposes for use in the IDS-iSYS IGFBP-3 Assay on the IDS-iSYS Multi-Discipline Automated Analyser to monitor the accuracy and quality of the IDS-iSYS IGFBP-3 Assay.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Office of in Willo Blag.
Device Evaluation and Safety

510(k) K111938
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# INDICATIONS FOR USE

| K number | K |
|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | IDS-iSYS IGFBP-3 Calibration Verifiers |
| | The IDS-iSYS IGFBP-3 Calibration Verifier is a device intended for<br>medical purposes for use in the quantitative verification of calibration<br>of the IDS-iSYS IGFBP-3 Assay when performed on the IDS-iSYS<br>Multi-Discipline Automated Analyzer. |

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

VD)
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k111938

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#### INDICATIONS FOR USE

K K number

IDS-iSYS hGH Calibration Verifiers Device

> The IDS-iSYS hGH Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the hGH Assay (IDS-iSYS hGH) when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

(VD)

Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

210(K) King38 2