(131 days)
Not Found
No
The device is a set of calibration verifiers for an in vitro diagnostic assay, consisting of liquid vials with specific concentrations of a substance. The description focuses on the chemical composition and stability testing, with no mention of AI or ML.
No
The device is described as "Calibration Verifiers" for an "Assay," indicating its use for verification and calibration of an in vitro diagnostic test, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for in vitro diagnostic use." The "Device Description" also mentions its use for verifying the IDS-iSYS CTX-I (CrossLaps ®) Assay, which is a diagnostic assay.
No
The device description clearly states it consists of physical vials containing liquid, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "verification of the IDS-iSYS CTX-I (CrossLaps ®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer." This indicates it's used in a laboratory setting to assess the performance of another diagnostic assay.
- Intended User / Care Setting: It states "For in vitro diagnostic use; for prescription use." This directly identifies it as an IVD and indicates it's used in a clinical laboratory environment under the direction of a healthcare professional.
- Device Description: The description details the composition of the device, which are liquid vials containing specific concentrations of a human analyte (CTX-I) in a matrix (horse serum). This is typical for calibration or verification materials used in diagnostic testing.
- Performance Studies: The document describes performance studies related to traceability, value assignment, and stability. These are standard types of studies performed on IVD devices to ensure their accuracy and reliability.
- Predicate Device: The mention of a predicate device with a K number (K111650) and the same name ("IDS-iSYS CTX-I (Crosslaps ®) Calibration Verifiers") strongly suggests this is a submission for a device that is substantially equivalent to a previously cleared IVD.
All of these factors point to this device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The IDS-iSYS CTX-1 (CrossLaps ®) Calibration Verifiers is a device intended for the verification of the IDS-iSYS CTX-I (CrossLaps ®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers consists of one set of four vials, 2.5 mL each in liquid form, containing horse serum with
§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that forms the shape of a bird in flight. The graphic is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2015
IMMUNODIAGNOSTIC SYSTEMS LTD. ROMA YOUNG, REGULATORY AFFAIRS OFFICER 10 DIDCOT WAY, BOLDEN BUSINESS PARK BOLDON, TYNE & WEAR, NE35 9PD UNITED KINGDOM
Re: K143324
Trade/Device Name: IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJX Dated: January 29, 2015 Received: February 6, 2015
Dear Roma Young:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For: Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K143324
Device Name
IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers
Type of Use (Select one or both, as applicable)
Indications for Use (Describe)
The IDS-iSYS CTX-1 (CrossLaps ®) Calibration Verifiers is a device intended for the verification 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) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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510(k) SUMMARY
- According to the requirements of 21CFR807.92, the following Introduction information provides sufficient detail to understand the basis for a determination of substantial equivalence.
- Submitter Immunodiagnostic Systems Ltd 10 Didcot Way Boldon Business Park Boldon Tyne and Wear NE35 9PD United Kingdom
- Contact Person: Roma Young Phone: +44 191 5190660 Fax: +44 191 5190760 Email: roma.young@idsplc.com
- Secondary Contact: Mick Fenton Phone: +44 191 5190660 Fax: +44 191 5190760 Email: michael.fenton@idsplc.com
- March 23rd, 2015 Date Prepared:
- Device Name: Proprietary names: IDS-iSYS CTX-I (Crosslaps®) Calibration Verifiers Common names: As above
- Classification: 21CFR862.1660 (Class I, Reserved)
Product Code: JJX
- The IDS-iSYS CTX-I (CrossLaps®) Calibration Verifiers consists of Device Description: one set of four vials, 2.5 mL each in liquid form, containing horse serum with