(471 days)
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No
The document describes an in-vitro diagnostic analyzer for measuring electrolytes and ionized calcium. There are no mentions of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the analytical function of the device.
No.
The device is described as an in-vitro diagnostic device intended for testing of certain analytes in human samples, which is for diagnostic purposes, not for therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in-vitro diagnostic testing" and that "Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany".
No
The device is described as an "Analyzer" for in-vitro diagnostic testing, which strongly implies a physical hardware component is involved in the analysis of the samples (serum, plasma, whole blood). The description focuses on the intended use and the analytes measured, not on software functionality.
Yes, based on the provided information, the EasyLyte Na/K/C/Ca Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "in-vitro diagnostic testing" of various electrolytes in human biological samples (serum, plasma, whole blood).
- Nature of Testing: The device performs quantitative determination of analytes (sodium, potassium, chloride, ionized calcium) in samples taken from the human body, but the testing is done outside the body (in vitro). This is the core definition of an IVD.
- Clinical Context: The intended use also mentions that the measurements are used in the "diagnosis and treatment" of various medical conditions, which is a key characteristic of IVD devices used in clinical settings.
Therefore, the information provided clearly indicates that this device falls under the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The EasyLyte Na/K/C/Ca Analyzer is intended for in-vitro diagnostic testing of sodium (Na), Potassium (K), Chloride (CL), and Ionized Calcium (Ca++) without pH correction.
The ionized calcium test on the EasyLyte Na/K/C//Ca analyzer is intended for the quantitative determination of calcium ions (Ca++) in human serum, plasma and whole Blood in clinical laboratories. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany (intermittent muscular contractions or spasms).
Product codes
JFP
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
Clinical laboratories
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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§ 862.1145 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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MEDICA CORPORATION PHOTIOS MAKRIS DIRECTOR OF REGULATORY AFFAIRS 5 OAK PARK DRIVE BEDFORD, MA 01730
December 1, 2016
Re: K152327
Trade/Device Name: EasyLvte Na/K/Cl/Ca Analyzer Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: II Product Code: JFP Dated: August 14, 2015 Received: September 1, 2015
Dear Photios Makris:
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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Indications for Use
510(k) Number (if known) K152327
Device Name EasyLyte Na/K/Cl/Ca analyzer
Indications for Use (Describe)
The EasyLyte Na/K/C/Ca Analyzer is intended for in-vitro diagnostic testing of sodium (Na), Potassium (K), Chloride (CL), and lonized Calcium (Ca++) without pH correction.
The ionized calcium test on the EasyLyte Na/K/C//Ca analyzer is intended for the quantitative determination of calcium ions (Ca++) in human serum, plasma and whole Blood in clinical laboratories. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disease and tetany finternittent muscular contractions or spasms).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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