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.
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-Discipline 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 hGH Assay (IDS-iSYS hGH) when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, indicating that the devices listed are substantially equivalent to previously marketed devices. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily addresses the regulatory approval process and includes "Indications for Use" for three specific devices:

IDS-iSYS IGFBP-3 Control Set: Intended for medical purposes to monitor the accuracy and quality of the IDS-iSYS IGFBP-3 Assay on the IDS-iSYS Multi-Discipline Automated Analyser.
IDS-iSYS IGFBP-3 Calibration Verifiers: Intended for medical purposes for quantitative verification of calibration of the IDS-iSYS IGFBP-3 Assay on the IDS-iSYS Multi-Discipline Automated Analyzer.
IDS-iSYS hGH Calibration Verifiers: Intended for medical purposes for quantitative verification of calibration of the hGH Assay (IDS-iSYS hGH) on the IDS-iSYS Multi-Discipline Automated Analyzer.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than performance studies.

Summary

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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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Page 2

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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

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

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
.0 2

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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 formedical purposes for use in the quantitative verification of calibrationof the IDS-iSYS IGFBP-3 Assay when performed on the IDS-iSYSMulti-Discipline Automated Analyzer.

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

2 of 3

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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.

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

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.