EASYRA UREA NITROGEN AND CREATININE REAGENTS

K110675 · Medica Corp. · CDQ · Apr 21, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110675
• Device Name: EASYRA UREA NITROGEN AND CREATININE REAGENTS
• Applicant: Medica Corp.
• Product Code: CDQ · Clinical Chemistry
• Decision Date: Apr 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

EasyRA Urea Nitrogen Reagent: The EasyRA Urea Nitrogen (BUN) Reagent is for the measurement of urea nitrogen in serum and plasma using the “EasyRA chemistry analyzer”. Urea measurements are used for the diagnosis and treatment of certain renal and metabolic diseases. EasyRA CREA Reagent: The EasyRA Creatinine (CREA) Reagent is for the measurement of Creatinine in serum and plasma using the “EasyRA chemistry analyzer”. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis. For in vitro diagnostic use only

Device Story

EasyRA BUN and CREA reagents are liquid, ready-to-use chemistry reagents for the EasyRA clinical chemistry analyzer. The device processes serum or plasma samples via enzymatic colorimetric reactions. For BUN, urease hydrolyzes urea to ammonia/CO2; ammonia reacts with 2-oxoglutarate and NADH analog via glutamate dehydrogenase; decrease in NADH absorbance at 340 nm is proportional to urea concentration. For Creatinine, multistep enzymatic reactions (creatinine amidohydrolase/creatine amidinohydrolase) produce sarcosine, which is oxidized to hydrogen peroxide; peroxide reacts with 4-aminoantipyrene and ESPMT to form a quinoneimine dye; increase in absorbance at 550 nm is proportional to creatinine concentration. Used in clinical laboratories by technicians to provide quantitative results for clinicians to diagnose/monitor renal and metabolic conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics typical for in vitro diagnostic reagents.

Technological Characteristics

Liquid, ready-to-use enzymatic reagents. BUN: urease, glutamate dehydrogenase, NADH analog. Creatinine: creatinine amidohydrolase, creatine amidinohydrolase, sarcosine oxidase, peroxidase. Photometric detection (340 nm for BUN, 550 nm for Creatinine). Analyzed on EasyRA clinical chemistry analyzer. No specific material standards or connectivity mentioned.

Indications for Use

Indicated for the measurement of urea nitrogen and creatinine in serum and plasma to aid in the diagnosis and treatment of renal and metabolic diseases and monitoring of renal dialysis. For in vitro diagnostic use by clinical professionals.

Regulatory Classification

Identification

A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Submission Summary (Full Text)

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Public Health Service

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three parallel, curved lines that converge to the right, resembling a bird in flight. The emblem is a symbol associated with the U.S. Department of Health and Human Services.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

APR 2 1 2011

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

Re: k110675 Trade Name: EasyRA Bun Reagent, EasyRA CREA Reagent Regulation Number: 21 CFR §862.1770 Regulation Name: Urea Nitrogen Test System. Regulatory Class: Class II Product Codes: CDQ, CGX Dated: March 08, 2011 Received: March 10, 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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1f 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

Enclosure

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# Indications for Use

510(k) Number (if known): k110675

Device Name: EasyRA Urea Nitrogen reagent EasyRA Creatinine reagent

Indications For Use:

### EasyRA BUN Reagent:

The EasyRA Urea Nitrogen (BUN) Reagent is for the measurement of urea nitrogen in serum and plasma using the "EasyRA chemistry analyzer". Urea measurements are used for the diagnosis and treatment of certain renal and metabolic diseases.

For in vitro diagnostic use only.

### EasyRA CREA Reagent:

The EasyRA Creatinine (CREA) Reagent is for the measurement of Creatinine in serum and plasma using the "EasyRA chemistry analyzer". Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis.

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 (OVD)

Apr

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

510(k) K110675