(174 days)
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No
The summary describes a reagent and analyzer for measuring calcium levels, which is a standard laboratory test and does not mention any AI or ML components.
No
The device is intended for diagnostic purposes (measuring calcium levels for diagnosis and treatment of various diseases), not for providing therapy or treatment itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany".
No
The device is a reagent, which is a chemical substance used in a laboratory test. This is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure the total calcium level in serum and plasma". Serum and plasma are biological samples taken from the human body.
- Purpose: The purpose of the measurement is for "diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany". This indicates the results are used for medical purposes related to a patient's health.
- Method: The measurement is performed "using the Eon 100 Analyzer", which is a laboratory instrument designed to analyze biological samples.
These characteristics align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of a potential recipient with a potential donor, or to monitor therapeutic measures.
N/A
Intended Use / 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).
Product codes
CJY
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
Prescription Use
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized eagle. The eagle is depicted with its wings spread, symbolizing protection and service. The overall design is simple and conveys a sense of authority and responsibility.
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
2
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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