(244 days)
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No
The summary describes an automated system for a specific immunoassay (Vitamin D), controls, and calibrators. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the analytical performance of the assay on an automated platform.
No.
The device is an in-vitro diagnostic assay used to determine 1,25 dihydroxyvitamin D levels, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is intended for the "determination of 1,25 dihydroxyvitamin D levels in serum and plasma," and these results are "used in the assessment of vitamin D sufficiency," which indicates a diagnostic purpose.
No
The description clearly indicates the device is an assay and associated controls/calibrators used on an automated system, implying chemical reagents and hardware components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is for the "determination of 1,25 dihydroxyvitamin D levels in serum and plasma". Serum and plasma are biological specimens taken from the human body.
- Purpose: The results are used in the "assessment of vitamin D sufficiency", which is a medical purpose related to diagnosing or monitoring a health condition.
- Control Set and Calibration Verifier: The control set and calibration verifier are also described as being used for quality control and calibration verification of the assay, which are essential components of an in vitro diagnostic system.
The definition of an IVD generally includes 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. This device clearly fits within this definition.
N/A
Intended Use / Indications for Use
The IDS-iSYS 1,25 Dihydroxy Vitamin D assay is intended for the determination of 1,25 dihydroxyvitamin D levels in serum and plasma on the IDS-iSYS Multi-Discipline Automated System. Results of the 1.25 Dihydroxy Vitamin D are used in the assessment of vitamin D sufficiency.
The IDS-iSYS 1,25 Dihydroxy Vitamin D Control Set is used for quality control of the IDS-iSYS 1,25 Dihydroxy Vitamin D assay on the IDS-iSYS Multi-Discipline Automated System
The IDS-iSYS 1,25 Dihydroxy Vitamin D Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS 1,25 Dihydroxy Vitamin D assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
Product codes
MRG, JJX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1825 Vitamin D test system.
(a)
Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.(b)
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 18, 2013
Immunodiagnostic Systems Ltd. C/O Mick Fenton 10 DIDCOT WAY, BOLDON BUSINESS PARK, BOLDON, TYNE AND WEAR UNITED KINGDOM NE35 9PD
Re: K123253
Trade/Device Name: IDS iSYS 1,25 Dihydroxy Vitamin D IDS iSYS 1.25 Dihydroxy Vitamin D Control Set IDS iSYS 1,25 Dihydroxy Vitamin D Calibration Verifier Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: 11 Product Code: MRG, JJX
Dated: June 06, 2013 Received: June 11, 2013
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. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2-Mr. Fenton
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Carol C. Benson -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
2
Indications for Use Form
510(k) Number (if known): K123253
Device Name:
IDS iSYS 1,25 Dihydroxy Vitamin D IDS iSYS 1.25 Dihydroxy Vitamin D Control Set IDS iSYS 1,25 Dihydroxy Vitamin D Calibration Verifiers
Indications for Use:
The IDS-iSYS 1,25 Dihydroxy Vitamin D assay is intended for the determination of 1,25 dihydroxyvitamin D levels in serum and plasma on the IDS-iSYS Multi-Discipline Automated System. Results of the 1.25 Dihydroxy Vitamin D are used in the assessment of vitamin D sufficiency.
The IDS-iSYS 1,25 Dihydroxy Vitamin D Control Set is used for quality control of the IDS-iSYS 1,25 Dihydroxy Vitamin D assay on the IDS-iSYS Multi-Discipline Automated System
The IDS-iSYS 1,25 Dihydroxy Vitamin D Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS 1,25 Dihydroxy Vitamin D assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
Prescription Use × (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung W. Johan -S
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K123253 510(k)