The EasyRA Albumin (ALB) reagent is intended for the quantitative determination of Albumin in human serum, 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.

The EasyRA Alkaline Phosphatase (ALP) reagent is intended for the quantitative determination of Alkaline Phosphatase in human serum, 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.

The EasyRA Aspartate Aminotranferase (AST) reagent is intended for the quantitative determination of the enzyme Aspartate Aminotranferase in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of Aspartate Aminotranferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.

The EasyRA Carbon Dioxide (CO2) reagent is intended for the quantitative measurement of Carbon Dioxide (CO2) in human serum, Bicarbonate/carbon dioxide measurements arc used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

The Carbon Dioxide calibrator establishes points of reference that are used in the determination of values in the measurement of Bicarbonate/Carbon dioxide on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's CO2 reagent.

The EasyRA CREA reagent is a device intended to measure creatinine levels in serum. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes.

The EasyRA CK reagent is a device intended to measure creatinine kinase activity in serum. Measurements of CK are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for various EasyRA reagents (Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Carbon Dioxide, Creatinine, Creatine Kinase) and a Carbon Dioxide Calibrator.

The document primarily states that the FDA has determined these devices are substantially equivalent to legally marketed predicate devices, allowing them to be marketed. It lists the indications for use for each reagent but does not detail any performance studies, acceptance criteria, or specific data from such studies.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for a test set.
Number and qualifications of experts for ground truth.
Adjudication method.
MRMC comparative effectiveness study results.
Standalone performance results.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Summary

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Image /page/0/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Medica Corporation c/o Photios Makris, Ph.D., Director QA/RA 5 Oak Park Drive Bedford, MA 01730

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: K080874

Trade/Device Name: EasyRA Albumin Reagent, EasyRA Alkaline Phosphatase Reagent, EasyRA Aspartate Aminotransferase Reagent, EasyRA Carbon Dioxide Reagent, EasyRA Carbon Dioxide Calibrator, EasyRA Creatinine Reagent, EasyRA Creatine Kinase Reagent Regulation Number: 21 CFR862.1035 Regulation Name: Albumin Test System Regulatory Class: Class II Product Code: CIX, CJE, CIT, KHS, JIT, JFY, CGS Dated: February 11, 2009 Received: February 12, 2009

FEB 2009

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). 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.

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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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Corg C. He

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

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Indications for Use

K080874 510(k) Number (if known):

Device Name: Indications For Use:

Device Name:

Indications For Use:

EasyRA Albumin Reagent

EasyRA Alkaline Phosphatase Reagent The EasyRA Alkaline Phosphatase (ALP) reagent is intended for the quantitative determination of Alkaline Phosphatase in human serum, 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.

Device Name: Indications For Use:

EasyRA Aspartate Aminotransferase Reagent

EasyRA Carbon Dioxide Reagent

with changes in body acid-base balance.

EasyRA Carbon Dioxide Calibrator

The EasyRA Carbon Dioxide (CO2) reagent is intended for the quantitative measurement

of Carbon Dioxide (CO2) in human serum, Bicarbonate/carbon dioxide measurements arc used in the diagnosis and treatment of numerous potentially serious disorders associated

determination of values in the measurement of Bicarbonate/Carbon dioxide on the EasyRA

Device Name: Indications For Use:

Device Name: Indications For Use: EasyRA Creatinine Reagent The EasyRA CREA reagent is a device intended to measure creatinine levels in serum. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes.

The Carbon Dioxide calibrator establishes points of reference that are used in the

clinical chemistry analyzer when used in conjunction with Medica's CO2 reagent.

Device Name: Indications For Use:

EasyRA Creatinine Kinase Reagent The EasyRA CK reagent is a device intended to measure creatinine kinase activity in serum. Measurements of CK are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

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)

Ruth Chesler

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 88874

510(k) <

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Regulation Number and Section

§ 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.