(296 days)
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No
The summary describes in vitro diagnostic tests for electrolyte levels using a chemistry analyzer. There is no mention of AI or ML in the intended use, device description, or any other section.
No
This device is for in vitro diagnostic use, intended for quantitative determination of various ions in human samples to aid in diagnosis and treatment, not for direct therapeutic intervention.
Yes
This device performs quantitative determination of various ions (sodium, potassium, chloride, bicarbonate/carbon dioxide) in human samples, and these measurements are explicitly stated as being "used in the diagnosis and treatment of" several diseases and conditions. This aligns with the definition of a diagnostic device.
No
The device description is not provided, but the intended use clearly describes in vitro diagnostic tests performed on a physical chemistry analyzer (MEDICA EasyRA Chemistry Analyzer with the ISE module option). This indicates a hardware component is essential to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the tests are for the quantitative determination of various ions (sodium, potassium, chloride, bicarbonate/carbon dioxide) in human serum, plasma, and urine. These are biological samples taken from the human body.
- Purpose: The measurements are used in the diagnosis and treatment of various diseases and conditions (aldosteronism, diabetes insipidus, electrolyte imbalance, acid-base balance disorders, etc.). This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Setting: The tests are intended for use in "clinical laboratories," which is a typical setting for IVD testing.
- Explicit Statement: Each intended use section concludes with the phrase "For in vitro diagnostic use only." This is a clear and direct statement indicating the device's classification.
N/A
Intended Use / Indications for Use
The EasyRA sodium test is intended for the quantitative determination of sodium ions (Na+) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. For in vitro diagnostic use only.
The EasyRA potassium test is intended for the quantitative determination of potassium ions (K+) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only.
The EasyRA chloride test is intended for the quantitative determination of chloride ions (Cl) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. For in vitro diagnostic use only.
The EasyRA carbon dioxide reagent is intended for the quantitative determination of Bicarbonate/Carbon Dioxide in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JGS, CEM, CGZ, KHS
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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§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.
0
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Medica Corporation c/o Dr. Photios Makris Director OA/RA 5 Oak Park Drive Bedford, MA 01730
Re: K100829
Trade Name: EasyRA Sodium Assay, EasyRA Potassium Assay, Easy RA Chloride Assay, Easy RA Carbon Dioxide Assay, Regulation Number: 21 CFR §862.1665 Regulation Name: Sodium Test System Regulatory Class: Class II Product Codes: JGS, CEM, CGZ, KHS Dated: December 16, 2010 Received: December 17, 2010
JAN 1 4 201
Dear Dr. 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. Come
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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 (OS) regulation (21 CFR Part 820).
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/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 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
C.H. Ph.D.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology 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): K1008299
| Device Name: | EasyRA Sodium assay: |
|---|---|
| Indications For Use: | The EasyRA sodium test is intended for the quantitative determination of sodium ions (Na+) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. For in vitro diagnostic use only. |
| Device Name: | EasyRA Potassium assay: |
| Indications For Use: | The EasyRA potassium test is intended for the quantitative determination of potassium ions (K+) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only. |
| Device Name: | EasyRA Chloride assay: |
| Indications For Use: | The EasyRA chloride test is intended for the quantitative determination of chloride ions (Cl) in human serum, plasma and urine using the MEDICA EasyRA Chemistry Analyzer with the ISE module option in clinical laboratories. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. For in vitro diagnostic use only. |
| Device Name: | EasyRA Carbon Dioxide reagent: |
| Indications For Use: | The EasyRA carbon dioxide reagent is intended for the quantitative determination of Bicarbonate/Carbon Dioxide in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. For in vitro diagnostic use only. |
Prescription Use X (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)
Carol C. Benam
Division Sign-Off
510(k)_
Office of In Vitro Diagnostic Device Page 18 of 146 Evaluation and Safety