K Number
K111650
Device Name
IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS...
Date Cleared
2011-09-06

(85 days)

Product Code
Regulation Number
862.1660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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. 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.
Device Description
Not Found
More Information

Not Found

Not Found

No
The document describes control and calibration materials for an automated analyzer, with no mention of AI or ML in the intended use or any other section.

No
The provided text describes diagnostic devices (controls, verifiers, and calibrators) used to monitor the accuracy and quality of assays, not therapeutic devices that treat or prevent disease.

No
This device is described as a control set, calibration verifier, or calibration verifiers, intended to monitor the accuracy and quality or verify the calibration and assay range of other assays. It does not directly diagnose a patient's condition.

No

The device description is not available, but the intended use clearly describes physical components (Control Set, Calibration Verifiers) used with an automated analyzer. These are not software-only components.

Based on the provided text, these devices are IVDs (In Vitro Diagnostics).

Here's why:

  • Intended Use: The intended use statements explicitly state that these devices are for "medical purposes" and are used in conjunction with specific "Assays" (like the CTX-I (Crosslaps) Assay and the 25-Hydroxy Vitamin D Assay) performed on an "Automated Analyser." These assays are designed to measure substances in biological samples (implied by the nature of the analytes like Crosslaps and Vitamin D).
  • Purpose: The devices are used to "monitor the accuracy and quality" or "verify the calibration and assay range" of these assays. This is a core function of quality control and calibration materials used in IVD testing.

IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While these specific devices aren't directly diagnosing a disease, they are essential components used with IVD assays to ensure the reliability and accuracy of the diagnostic results. They are part of the overall IVD system.

N/A

Intended Use / Indications for 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 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.

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.

Product codes

JJX

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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).

1

Page 2 -

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 (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 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 (800) 638-2041 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

2

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)

Page 1 of _3

3

INDICATIONS FOR USE

K numberK111650
DeviceIDS-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)___ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Page 2 of _3

. ".

4

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

・・

ﻟﻰ ﺍ Page 3 of _

...