IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...

K111650 · Immunodiagnostic Systems , Ltd. · JJX · Sep 6, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111650
• Device Name: IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...
• Applicant: Immunodiagnostic Systems , Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 6, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The IDS-iSYS CTX-I (CrossLaps) Control Set is intended for medical purposes for use in the IDS-iSYS CTX-I (Crosslaps) Assay on the IDS-iSYS Multi-Discipline Automated Analyser to monitor the accuracy and quality of the IDS-iSYS CTX-I (Crosslaps) Assay. The IDS-iSYS CTX-I (CrossLaps) Calibrator Verifier is a device intended for medical purposes for use in the quantitative verification of calibration and assay range of the IDS-iSYS CTX-I (Crosslaps®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer. The IDS-iSYS 25-Hydroxy Vitamin D Calibration Verifiers are intended for use in the quantitative verification of calibration and assay range of the IDS-iSYS 25 Hydroxy Vitamin D Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.

Device Story

IDS-iSYS CTX-I (Crosslaps) Control Set, IDS-iSYS 25-Hydroxy Vitamin D Calibration Verifiers, and IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers are quality control and calibration verification materials. Used in clinical laboratory settings on the IDS-iSYS Multi-Discipline Automated Analyzer. Controls monitor assay accuracy and quality; verifiers confirm calibration and assay range. These materials ensure the performance of the automated analyzer system, allowing clinicians to rely on accurate diagnostic results for patient management.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time closed vial, open vial, and on-board) confirmed performance within 10% of reference material concentrations. Value assignment performed via triplicate testing across multiple IDS-iSYS analyzers.

Technological Characteristics

Liquid, bovine serum albumin or equine serum/buffer-based matrix. Contains <0.1% sodium azide. Multi-level packaging (2.5 mL or 1 mL vials). Designed for use on IDS-iSYS Multi-Discipline Automated Analyzer. Stability validated per CEN 13640.

Indications for Use

Indicated for use by clinical laboratory professionals to monitor assay accuracy and verify calibration/assay range for IDS-iSYS CTX-I and 25-Hydroxy Vitamin D assays on the IDS-iSYS Multi-Discipline Automated Analyzer.

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, with flowing lines representing its wings and body.

Food and Drug Administration 10903 New Hampshire Avenue lver Spring, MD 20993

SECT 8 2011

Immunodiagnostic Systems Itd. c/o Mick Fenton Regulator Affairs Officer ! 0 Didcot way Bolden Business Park Boldon, Tyne & Wear, NE35 9PD, UK

> Re: k111650 Trade Name: IDS-iSYS CTX-I (Crosslaps®) Calibration Verifiers, IDS-iSYS 25 Hydroxy Vitamin D Calibration Verifiers, and IDS-iSyS CTX-I (Crosslaps®) Control Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Codes: JJX Dated: June 8, 2011 Received: June 13, 2011

#### 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 affectingyour 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 (2) CFR Part 801), please contact the Office of In Viro 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 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/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours,

z

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

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## INDICATIONS FOR USE

K number K11650 Device IDS-iSYS CTX-I (Crosslaps) Control Set The IDS-iSYS CTX-I (CrossLaps) Control Set is intended for medical purposes for use in the IDS-iSYS CTX-I (Crosslaps) Assay on the IDS-iSYS Multi-Discipline Automated Analyser to monitor the

accuracy and quality of the IDS-iSYS CTX-I (Crosslaps) 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)

દિવેલા ગુજરાત રાજ્યના

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

111650 510(k)

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## INDICATIONS FOR USE

| K number | K111650 |
|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | IDS-iSYS 25-Hydroxy Vitamin D Calibration Verifiers |
| | The IDS-iSYS 25-Hydroxy Vitamin D Calibration Verifiers are intended for use in the quantitative verification of calibration and assay range of the IDS-iSYS 25-Hydroxy Vitamin D Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer. |

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)

Butt chal ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

1116650 510(k)___ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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#### INDICATIONS FOR USE

K number K111650

Device

# IDS-iSYS CTX-I (Crosslaps) Calibration Verifiers

The IDS-iSYS CTX-I (CrossLaps) Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration and assay range of the IDS-iSYS CTX-I (CrossLaps®) Assay 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)

: ・

Rute Chen

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

510(k) (((50

・・

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