EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT

K100187 · Medica Corp. · CGA · May 5, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100187
• Device Name: EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT
• Applicant: Medica Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: May 5, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EasyRA Glucose Trinder (GLU-T) Reagent is for the measurement of glucose in serum and plasma using the "EasyRA chemistry analyzer". Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. . For in vitro diagnostic use only. The EasyRA Glucose Hexokinase (GLU-H) Reagent is for the measurement of glucose in serum and plasma using the "EasyRA chemistry analyzer". Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. . For in vitro diagnostic use only.

Device Story

EasyRA Glu-T and Glu-H reagents are in vitro diagnostic reagents used with the EasyRA chemistry analyzer. These reagents facilitate the quantitative measurement of glucose in human serum and plasma samples. The system is intended for use by clinical laboratory professionals to assist in the diagnosis and management of carbohydrate metabolism disorders. The analyzer processes samples using the reagents to produce glucose concentration values, which are then reviewed by clinicians to inform patient care decisions regarding metabolic health.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics typical for glucose test systems.

Technological Characteristics

Reagents for glucose measurement using Trinder (glucose oxidase/peroxidase) and Hexokinase enzymatic methods. Designed for use on the EasyRA chemistry analyzer. In vitro diagnostic use only.

Indications for Use

Indicated for measurement of glucose in serum and plasma for diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. For in vitro diagnostic use.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with its wings spread and stylized in a flowing, curved design.

Medica Corp. c/o Photios Makris Director of Regulatory Affairs 5 Oak Park Drive, Bedford, MA 01730

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

MAY 0 5 2010

Re: k100187

Trade/Device Name: EasyRA Glu-T Reagent, EasyRA Glu-H Reagent Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: CFR, CGA Dated: April 6, 2010 Received: April 7, 2010

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 Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. 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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

CA

Courtney C. 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): K100187

| Device Name: | EasyRA Glucose-Trinder Reagent |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | The EasyRA Glucose Trinder (GLU-T) Reagent is for the measurement of glucose in serum and plasma using the "EasyRA chemistry analyzer". Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. . |
| | For in vitro diagnostic use only. |
| Device Name: | EasyRA Glucose-Hexokinase Reagent |
| Indications For Use: | The EasyRA Glucose Hexokinase (GLU-H) Reagent is for the measurement of glucose in serum and plasma using the "EasyRA chemistry analyzer". Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. . |
| | For in vitro diagnostic use only. |

Prescription Use × (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)

Division Sign-

Office of In Vitro Diagnostic Device Evaluation and Safely

510(k) k 0018

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