(448 days)
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No
The document describes an in vitro diagnostic assay and associated reagents for measuring PTH levels. 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 a chemical assay performed on an automated analyzer.
No
The device is an in vitro diagnostic assay used for the quantitative determination of PTH in human serum or plasma to aid in the differential diagnosis of calcium metabolism disorders. It does not provide any therapeutic intervention.
Yes
The device is described as an "in vitro diagnostic use only" kit for the quantitative determination of PTH in human serum or plasma. It is explicitly stated that "results are to be use in the differential diagnosis of hypercalcemia and hypocalcemia." This indicates its purpose is to aid in diagnosing medical conditions.
No
The device description is not available, but the intended use clearly describes an "assay" and "kit" for in vitro diagnostic use, which are typically hardware-based components used with an automated analyzer. This strongly suggests it is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The text explicitly states:
- "The IDS-iSYS Intact PTH assay is intended for the quantitative determination of PTH in human serum or plasma..." This indicates it's used to analyze biological samples in vitro (outside the body).
- "Results are to be use in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism." This describes a medical purpose for the results obtained from the in vitro analysis.
- "The kit is for in vitro diagnostic use only." This is a direct and clear statement that the device is intended for in vitro diagnostic purposes.
The descriptions of the Control Set, Calibrator, and Calibration Verifier also support the IVD nature, as these are components typically used to ensure the accuracy and reliability of an in vitro diagnostic assay.
N/A
Intended Use / Indications for Use
The IDS-iSYS Intact PTH assay is intended for the quantitative determination of PTH in human serum or plasma on the IDSiSYS Multi-Discipline Automated Analyzer. Results are to be use in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.
The kit is for in vitro diagnostic use only.
The IDS-iSYS Intact PTH assay Control Set is intended for use as assayed quality control samples to monitor the precision of the IDS-iSYS Intact PTH assay.
The IDS-iSYS Intact PTH Calibrator is intended for the calibration of the IDS-iSYS Intact PTH assay.
The IDS-iSYS iPTH Calibration Verifier is intended for verification of calibration of the IDS-iSYS iPTH Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
Product codes
CEW, JIT, 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
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§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.
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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 Boldon Business Park Boldon, Tyne & Wear, NE35 9PD, UK
FEB 0 3 2012
Re: K103325
Trade Name: IDS-iSYS Intact PTH Regulation Number: 21 CFR §862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Codes: CEW, JIT, JJX Dated: January 17, 2012 Received: January 19, 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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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/Resourcesfor You/Industry/default.htm
Sincerely yours,
Signature
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
510(k) Number (if known):
Device Name:
Indications For Use:
IDS-iSYS Intact PTH assay
The IDS-iSYS Intact PTH assay is intended for the quantitative determination of PTH in human serum or plasma on the IDSiSYS Multi-Discipline Automated Analyzer. Results are to be use in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.
The kit is for in vitro diagnostic use only.
The IDS-iSYS Intact PTH assay Control Set is intended for use as assayed quality control samples to monitor the precision of the IDS-iSYS Intact PTH assay.
The IDS-iSYS Intact PTH Calibrator is intended for the calibration of the IDS-iSYS Intact PTH assay.
The IDS-iSYS iPTH Calibration Verifier is intended for verification of calibration of the IDS-iSYS iPTH Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
:
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Davice Evaluation and Safety
510(k) K103325