EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS

K101090 · Medica Corp. · CJE · May 20, 2011 · Clinical Chemistry

Device Facts

• Record ID: K101090
• Device Name: EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
• Applicant: Medica Corp.
• Product Code: CJE · Clinical Chemistry
• Decision Date: May 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Intended Use

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 Aminotransferase (AST) reagent is intended for the quantitative determination of the enzyme Aspartate Aminotransferase 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.

Device Story

Reagents for use with Medica EasyRA Chemistry Analyzer; intended for quantitative in vitro diagnostic measurement of ALP, AST, and amylase in human serum and plasma. Clinical laboratory personnel load reagents into the analyzer; system performs automated photometric analysis. Output provides enzyme concentration levels to clinicians; results assist in diagnosis and monitoring of liver, bone, cardiac, and pancreatic conditions. Benefits include rapid, automated clinical chemistry testing for patient management.

Clinical Evidence

No clinical data provided; substantial equivalence established through bench testing and performance verification on the Medica EasyRA Chemistry Analyzer.

Technological Characteristics

Liquid ready-to-use reagents in plastic wedges. ALP: HEDTA buffer, 2-Amino-2-methyl-1-propanol, MgCl2, ZnSO4, 4-Nitrophenyl Phosphate. AST: Tris buffer, L-Aspartate, rabbit muscle LDH, porcine muscle MDH, alpha-Ketoglutarate, NADH. Amylase: MES buffer, 2-chloro-4-nitrophenol-alpha-D-maltotrioside, NaCl, calcium acetate, potassium thiocyanate, sodium azide. Spectrophotometric detection at 340nm or 405nm. Standalone operation on Medica EasyRA Chemistry Analyzer.

Indications for Use

Indicated for quantitative determination of ALP, AST, and amylase in human serum and plasma for diagnosis/treatment of liver, bone, parathyroid, intestinal, heart, and pancreatic diseases in clinical laboratory settings.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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:<br>Indication For Use: | EasyRA Alkaline phosphatase Reagent<br>The EasyRA Alkaline phosphatase (ALP) reagent is intended for the<br>quantitative determination of alkaline phosphatase in human serum and<br>plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical<br>laboratories. Measurement of alkaline phosphatase or its isoenzymes are<br>used in the diagnosis and treatment of liver, bone, parathyroid and<br>intestinal diseases. For in vitro diagnostic use only. |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name:<br>Indication For Use: | EasyRA Aspartate Aminotransferase Reagent<br>The EasyRA Aspartate Aminotranferase (AST) reagent is intended for<br>the quantitative determination of the enzyme Aspartate Aminotranferase<br>in human serum and plasma, using the MEDICA "EasyRA Chemistry<br>Analyzer" in clinical laboratories. Measurement of alkaline phosphatase<br>measurements are used in the diagnosis and treatment of certain types of<br>liver and heart diseases. For in vitro diagnostic use only. |
| Device Name:<br>Indication For Use: | EasyRA Amylase Reagent<br>The EasyRA Amylase (AMY) reagent is intended for the quantitative<br>determination of amylase in human serum and plasma, using the<br>MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. a-<br>Amylase in serum/plasma is used for the diagnosis and treatment of<br>pancreatitis (inflammation of the pancreas) and other pancreatic<br>disorders. 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)

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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