(24 days)
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No
The provided text describes a standard electrolyte analyzer and does not mention any AI or ML capabilities. The device description, mentions of AI/ML, and details about training/test sets are all marked as "Not Found".
No
The EasyLyte Na/K/Ca/pH analyzer is an in-vitro diagnostic device used for testing electrolytes and pH, which provides information for diagnosis and treatment, but does not directly provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "used for the in-vitro diagnostic testing" of various substances, and further details how these measurements are "used in the diagnosis and treatment of" specific diseases and conditions.
No
The device is described as an "analyzer" for in-vitro diagnostic testing of various electrolytes and pH in biological samples. This strongly implies a physical instrument with hardware components for sample handling, measurement, and analysis, not solely software.
Yes, based on the provided information, the EasyLyte Na/K/Ca/pH analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the device is used for "in-vitro diagnostic testing" of specific analytes (Sodium, Potassium, ionized Calcium, and pH) in biological samples (serum, plasma, and whole blood). It also lists the diagnostic purposes for measuring these analytes, which are related to diagnosing and treating various diseases and conditions.
- Sample Type: The device analyzes biological samples (serum, plasma, whole blood), which is characteristic of IVD devices.
- Purpose: The measurements are used for diagnosis and treatment, which is the core function of an IVD device.
The definition of an IVD device generally includes instruments, reagents, and systems intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures. The EasyLyte Na/K/Ca/pH analyzer fits this description.
N/A
Intended Use / Indications for Use
The EasyLyte Na/K/Ca/pH analyzer is used for the in-vitro diagnostic testing of Sodium(Na+), Potassium(K+), and ionized Calcium(Ca++) with pH correction in clinical laboratories by trained technicians.
Sodium test
The sodium (Na+) assay is intended to measure sodium in serum, plasma, and whole blood. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large anounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's discase (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Potassium test
The potassium (K+) assay is intended to measure potassium in serum, plasma, and whole blood. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Calcium-ionized test
The ionized calcium (Ca++) assay is intended to measure the ionized calcium level in serum, plasma, and whole blood. fonized 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). Acidosis (low pH) causes increase and alkalosis (high pH) a decrease in the amount of ionized calcium.
pH test
The sample pH assay is intended to measure the pH of the ionized calcium assay. Measurements of pH are used to calculate the "normalized ionized calcium value" in samples with pH other than 7.40 units.
Product codes
CEM, CHL, JFP, JGS
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 by trained technicians.
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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§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.
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Image /page/0/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. Encircling the caduceus are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Medica Corp. c/o Photios Makris Director Regulatory Affairs 5 Oak Park Drive, Bedford, MA 01730
OCT 20 2011
Re: K112788
Trade/Device Name: EasyLyte Na/K/Ca/pH Analyzer Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium test system. Regulatory Class: II Product Code: CEM, CHL, JFP, JGS Dated: September 23, 2011 Received: September 26, 2011
Dear Mr. 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.
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 Virro 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/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 1951 196-5680 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm.
Sincerely yours.
j
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology 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): K112788
Device Name: EasyLyte Na/K/Ca/pH Analyzer
Indications For Use. The EasyLyte Na/K/Ca/pH analyzer is used for the in-vitro diagnostic testing of Sodium(Na+), Potassium(K+), and ionized Calcium(Ca++) with pH correction in clinical laboratories by trained technicians.
Sodium test
The sodium (Na+) assay is intended to measure sodium in serum, plasma, and whole blood. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large anounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's discase (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Potassium test
The potassium (K+) assay is intended to measure potassium in serum, plasma, and whole blood. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Calcium-ionized test
The ionized calcium (Ca++) assay is intended to measure the ionized calcium level in serum, plasma, and whole blood. fonized 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). Acidosis (low pH) causes increase and alkalosis (high pH) a decrease in the amount of ionized calcium.
pH test
The sample pH assay is intended to measure the pH of the ionized calcium assay. Measurements of pH are used to calculate the "normalized ionized calcium value" in samples with pH other than 7.40 units,
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k-112788
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