(350 days)
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No
The summary describes reagents for a chemistry analyzer and does not mention any AI or ML capabilities.
No
The device is an in vitro diagnostic reagent used for quantitative determination of substances in human samples for diagnosis and treatment of diseases, not for direct therapeutic intervention.
Yes
The "EasyRA Chemistry Analyzer" is intended for measurements (e.g., Albumin, Total Calcium) that are "used in the diagnosis and treatment of numerous diseases." This explicitly states its role in diagnosis.
No
The 510(k) summary describes chemical reagents intended for use with a specific chemistry analyzer hardware device, not a standalone software product.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The intended use sections for the Albumin and Total Calcium reagents explicitly state "For in vitro diagnostic use only."
- Intended Use: The reagents are intended for the quantitative determination/measurement of substances (Albumin, Total Calcium, Magnesium, Inorganic Phosphorus) in human serum and plasma. This is a core function of IVD devices, which are used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Clinical Laboratories: The intended user/care setting is "clinical laboratories," which is where IVD testing is performed.
- Diagnosis and Treatment: The intended use descriptions clearly state that the measurements are used in the diagnosis and treatment of various diseases and conditions. This aligns with the purpose of IVD devices.
While the "Device Description" is not found, the intended use and the explicit "For in vitro diagnostic use only" statements are sufficient to classify these reagents as IVDs.
N/A
Intended Use / Indications for Use
EasyRA Albumin Reagent
The EasyRA albumin reagent is intended for the quantitative determination of Albumin (ALB) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. For in vitro diagnostic use only.
EasyRA Calcium Reagent
The EasyRA total calcium reagent is intended for the quantitative measurement of Total Calcium (Ca) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety if bone diseases, chronic renal disease and tetany. For in vitro diagnostic use only.
EasyRA Magnesium Reagent
The EasyRA magnesium reagent is intended for the quantitative measurement of Magnesium (Mg) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison's disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders.
EasyRA inorganic phosphorous Reagent
This reagent is intended for the quantitative measurement of Inorganic Phosphorous (PHOS) in human serum and plasma. Phosphorus measurements are used in the diagnosis and treatment of parathyroid gland, kidney diseases, and vitamin D imbalance.
Product codes (comma separated list FDA assigned to the subject device)
CIX, CJY, JGJ, CEO
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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§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.
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Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure. The emblem is black and white and has a simple, modern design.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Medica Corporation c/o Dr. Photios Makris Director OA/RA 5 Oak Park Drive Bedford, MA 01730
Re: K101088
Trade Name: EasyRA Albumin Reagent, EasyRA Calcium Reagent, Easy RA Magnesium Reagent, Easy RA Inorganic Phosphorus Reagent Regulation Number: 21 CFR §862.1035 Regulation Name: Albumin Test System Regulatory Class: Class II Product Codes: CIX, CJY, JGJ, CEO - 1 2011 Dated: March 30, 2011 Received: March 31, 2011
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); 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 Parts 801 and 809), 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
Courtney Harper, 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): | ____________________ |
|---|---|
| Device Name: | EasyRA Albumin Reagent |
| Indications For Use: | The EasyRA albumin reagent is intended for the quantitative determination of Albumin (ALB) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. For in vitro diagnostic use only. |
| Device Name: | EasyRA Calcium Reagent |
| Indications For Use: | The EasyRA total calcium reagent is intended for the quantitative measurement of Total Calcium (Ca) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety if bone diseases, chronic renal disease and tetany. For in vitro diagnostic use only. |
| Device Name: | EasyRA Magnesium Reagent |
| Indications For Use: | The EasyRA magnesium reagent is intended for the quantitative measurement of Magnesium (Mg) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison's disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders. |
| Device Name: | EasyRA inorganic phosphorous Reagent |
| Indications For Use: | This reagent is intended for the quantitative measurement of Inorganic Phosphorous (PHOS) in human serum and plasma. Phosphorus measurements are used in the diagnosis and treatment of parathyroid gland, kidney diseases, and vitamin D imbalance. |
| Prescription Use | |
| (Part 21 CFR 801 Subpart D) | X |
| 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
f C Benson
Office of In Vitro Diagnostic Device
)
510(k) K101088
Evaluation and Safety
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