(42 days)
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.
Not Found
This is a 510(k) premarket notification for in vitro diagnostic reagents, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study design for AI performance, sample sizes, expert ground truth, adjudication methods, and MRMC studies is not applicable to this document. The document primarily focuses on establishing substantial equivalence for the EasyRA BUN Reagent and EasyRA CREA Reagent to predicate devices.
{0}------------------------------------------------
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).
{1}------------------------------------------------
Page 2 -
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 (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
Enclosure
{2}------------------------------------------------
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)
(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 (OVD)
Apr
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110675
§ 862.1770 Urea nitrogen test system.
(a)
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.(b)
Classification. Class II.