(174 days)
Vital Diagnostics Eon Calcium Reagent is a device intended to measure the total calcium level in serum and plasma using the Eon 100 Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
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The provided document is a 510(k) premarket notification letter from the FDA regarding "Eon Calcium Reagent." This document is a regulatory approval letter for an in vitro diagnostic (IVD) reagent intended to measure calcium levels in serum and plasma. The information requested (acceptance criteria, study details, sample sizes, ground truth establishment, etc.) is typically found in the scientific documentation submitted as part of the 510(k) application, not in the approval letter itself. Regulatory letters primarily acknowledge substantial equivalence and outline ongoing regulatory responsibilities.
Therefore,Based on the provided FDA 510(k) approval letter (K120626) for the "Eon Calcium Reagent," none of the requested information regarding specific acceptance criteria, device performance tables, study details (sample sizes, provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone performance, or ground truth establishment for either test or training sets is present.
The document is purely an FDA approval letter stating that the device is substantially equivalent to legally marketed predicate devices for the indicated use of measuring total calcium levels in serum and plasma. It does not contain the technical or clinical study data that would detail how the device's performance was evaluated against specific acceptance criteria.
To answer your questions, one would need access to the actual 510(k) submission document, which contains the analytical and clinical performance studies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Vital Diagnostics (Manufacturing) Pty, Ltd. c/o Melita Lambiris 189-199 Browns Rd Noble Park, Australia 3174
Re: K120626
Trade Name: Eon Calcium Reagent Regulation Number: 21 CFR §862.1145 Regulation Name: Calcium Test System Regulatory Class: Class II Product Codes: CJY Dated: July 4, 2012 Received: July 6, 2012
Dear Melita Lambiris:
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 (1 wr ), it nay of be ac yound in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. your device 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 mean that I Dr mas mass statutes and regulations administered by other Federal agencies. or the Act of any 1 outs all the Act's requirements, including, but not limited to: registration 1 ou mast compty what an this; labeling (21 CFR Parts 801 and 809); medical device and fishing (21 GFR 807), as other elated adverse events) (21 CFR 803); and good reporting (reporting of nequirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
AUG 22 2012
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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/ResourcesforYou/Industry/default.htm
Sincerely yours,
Courtney 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): K120626
Device Name: Eon Calcium Reagent
Indications for Use:
Vital Diagnostics Eon Calcium Reagent is a device intended to measure the total calcium level in serum and plasma using the Eon 100 Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Prescription Use × Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign, Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120626
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§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.