(237 days)
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No
The provided text describes a standard clinical chemistry analyzer that performs quantitative measurements of specific analytes using established methods. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No
The device is a clinical analyzer designed for laboratory use to measure various substances in human serum, which aids in diagnosis and treatment but does not directly provide therapy.
Yes
The device is described as making "direct quantitative measurements" of various substances, and these measurements are "used in the diagnosis and treatment of diseases" or to "monitor electrolyte balance." This indicates its role in identifying or characterizing disease states.
No
The device description clearly identifies the EasyRA clinical analyzer as a physical instrument designed for laboratory use, which performs direct quantitative measurements on human serum samples. This indicates it is a hardware device, not software-only.
Based on the provided text, the EasyRA clinical analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for "clinical laboratory use, making direct quantitative measurements of Na (sodium), K (potassium), Cl (chloride), Li (lithium) and Glucose (Trinder method) in human serum samples." This involves testing samples taken from the human body (in vitro) to provide information for diagnosis and treatment.
- Indications for Use: The indications for use clearly link the measurements to the "diagnosis and treatment" of various diseases and conditions (electrolyte imbalance, low/high blood potassium, electrolyte and metabolic disorders, carbohydrate metabolism disorders, mental disturbances). This is a core function of IVD devices.
- Device Description: The device description reinforces that it's for "clinical laboratory use" and performs "direct quantitative measurements" on "human serum samples."
The definition of an IVD device generally involves instruments, reagents, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The EasyRA analyzer fits this description perfectly by analyzing human samples to provide diagnostic information.
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Intended Use / Indications for Use
The EasyRA clinical analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na (sodium), K (potassium), Cl (chloride), Li (lithium) and Glucose (Trinder method) in human serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.
Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.
Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lithium measurements are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
Product codes
CGA, JGS, CEM, CGZ, JIH, JJE, JIT, JJY
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 laboratory 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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§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a flowing, abstract design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Medica Corporation c/o Dr. Photios Makris Director of Regulatory Affairs 5 Oak Park Drive Bedford. MA 01730
AUG 3 0 2007
Re: K070057 Trade/Device Name: EasyRa Clinical Chemistry Analyzer Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, JGS, CEM, CGZ, JIH, JJE, JIT, JJY Dated: August 8, 2007 Received: August 9, 2007
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. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. 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 (K070057):
Device Name:
Indications For Use:
The EasyRA clinical analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na (sodium), K (potassium), Cl (chloride), Li (lithium) and Glucose (Trinder method) in human serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.
Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.
Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lithium measurements are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
Prescription Use J
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 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. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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