(396 days)
The EasyRA Alkaline phosphatase (ALP) reagent is intended for the quantitative determination of alkaline phosphatase in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases. For in vitro diagnostic use only.
The EasyRA Aspartate Aminotranferase (AST) reagent is intended for the quantitative determination of the enzyme Aspartate Aminotranferase in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of alkaline phosphatase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. For in vitro diagnostic use only.
The EasyRA Amylase (AMY) reagent is intended for the quantitative determination of amylase in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. a-Amylase in serum/plasma is used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) and other pancreatic disorders. For in vitro diagnostic use only.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them in the format you requested. The document is a 510(k) clearance letter from the FDA for several "EasyRA" reagents. It focuses on the substantial equivalence determination and the indications for use of these diagnostic reagents.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test sets, data provenance, training sets, or how ground truth was established for these.
- Information on the number or qualifications of experts used for ground truth, or adjudication methods.
- Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
The document is a regulatory approval, not a scientific study report. Therefore, I cannot fulfill your request based on the provided input.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Medica Corporation c/o Dr. Photios Makris Director of Regulatory Affairs 5 Oak Park Drive Bedford, MA 01730
MAY 2 0 2011
K101090 Re:
Trade Name: EasyRA Alkaline Phosphatase Reagent, EasyRA Aspartate Aminotransferase Reagent, EasyRA Amylase Reagent Regulation Number: 21 CFR § 862.1050 Regulation Name: Alkaline phosphatase or isoenzymes test system Regulatory Class: Class II Product Code: CJE, CIT, JFJ Dated: May 11, 2011 Received: May 16, 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/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) 796-7100 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
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Enclosure
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Indication for Use
510(k) Number (if known): K101090
| Device Name:Indication For Use: | EasyRA Alkaline phosphatase ReagentThe EasyRA Alkaline phosphatase (ALP) reagent is intended for thequantitative determination of alkaline phosphatase in human serum andplasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinicallaboratories. Measurement of alkaline phosphatase or its isoenzymes areused in the diagnosis and treatment of liver, bone, parathyroid andintestinal diseases. For in vitro diagnostic use only. |
|---|---|
| Device Name:Indication For Use: | EasyRA Aspartate Aminotransferase ReagentThe EasyRA Aspartate Aminotranferase (AST) reagent is intended forthe quantitative determination of the enzyme Aspartate Aminotranferasein human serum and plasma, using the MEDICA "EasyRA ChemistryAnalyzer" in clinical laboratories. Measurement of alkaline phosphatasemeasurements are used in the diagnosis and treatment of certain types ofliver and heart diseases. For in vitro diagnostic use only. |
| Device Name:Indication For Use: | EasyRA Amylase ReagentThe EasyRA Amylase (AMY) reagent is intended for the quantitativedetermination of amylase in human serum and plasma, using theMEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. a-Amylase in serum/plasma is used for the diagnosis and treatment ofpancreatitis (inflammation of the pancreas) and other pancreaticdisorders. For in vitro diagnostic use only. |
Prescription Use _ X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K101090
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.