(24 days)
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,
Not Found
The provided document K112788 is a 510(k) clearance letter for the Medica Corp. EasyLyte Na/K/Ca/pH Analyzer. It does not contain detailed information about acceptance criteria or the specific study details proving the device meets those criteria.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study reports with acceptance criteria in the format requested.
Therefore, many of the requested points cannot be answered from the provided text.
However, based on the information provided, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided document. The document is a 510(k) clearance letter, which confirms substantial equivalence to a predicate device but does not detail the specific performance metrics or acceptance criteria used in the underlying studies.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not present in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not present in the provided document. The EasyLyte Na/K/Ca/pH Analyzer is an in-vitro diagnostic device, so the ground truth would typically be established by a reference method or laboratory.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable as the EasyLyte Na/K/Ca/pH Analyzer is an in-vitro diagnostic device for measuring electrolytes and pH, not an AI-assisted diagnostic imaging device requiring human reader interpretation in an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable in the context of an AI-driven standalone algorithm. The device itself is a standalone analyzer for in-vitro diagnostic testing, meaning its performance is evaluated based on its own measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not explicitly stated in the provided document. For an in-vitro diagnostic device like this, the ground truth would typically be established by a well-characterized reference measurement method or a validated laboratory standard.
8. The sample size for the training set:
This information is not present in the provided document. The device is not described as a machine learning/AI model that would have a "training set" in the conventional sense. Its development would involve calibration and validation data, but not a training set in the AI context.
9. How the ground truth for the training set was established:
This information is not present in the provided document due to the nature of the device (see point 8).
In summary, the provided document is a regulatory clearance letter and does not contain the detailed technical study information required to answer most of your questions about acceptance criteria and study design. Such details would typically be found in the 510(k) submission itself or accompanying technical documentation, which is not part of this public clearance letter.
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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
Page 1 of 1
§ 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.