EASYRA MG REAGENT, MODEL 10220

K092737 · Medica Corp. · JGJ · Nov 17, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092737
• Device Name: EASYRA MG REAGENT, MODEL 10220
• Applicant: Medica Corp.
• Product Code: JGJ · Clinical Chemistry
• Decision Date: Nov 17, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1495
• Device Class: Class 1

Intended Use

The EasyRA Magnesium Reagent is for the in-vitro quantitative measurement of magnesium in serum on the Medica EasyRA analyzer. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison's disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders. For in vitro diagnostic use only.

Device Story

The EasyRA Magnesium Reagent is an in-vitro diagnostic reagent used with the Medica EasyRA clinical chemistry analyzer. It enables quantitative measurement of magnesium levels in serum samples. The system is intended for use in clinical laboratory settings by trained personnel. The analyzer processes the sample with the reagent to produce a photometric measurement, which is then converted into a concentration value. This output assists clinicians in diagnosing and monitoring conditions related to magnesium imbalance, such as renal failure, alcoholism, and pancreatitis. The device provides objective data to support clinical decision-making regarding patient electrolyte management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In-vitro diagnostic reagent for use on the Medica EasyRA analyzer. Utilizes photometric measurement principles for quantitative serum magnesium analysis. Class I, reserved device.

Indications for Use

Indicated for the quantitative determination of magnesium in human serum or plasma on the EasyRA clinical chemistry analyzer.

Regulatory Classification

Identification

A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

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

Medica Corporation c/o Photios Makris, Ph.D. Director of Regulatory Affairs 5 Oak Park Drive, Bedford, MA 01730, USA

NOV 1 7 2009

k092737 Re:

Trade/Device Name: Magnesium EasyRA Reagent Regulation Number: 21 CFR 862.1495 Regulation Name: Magnesium Test System Regulatory Class: Class I, reserved Product Code: JGJ Dated: October 23, 2009 Received: October 26, 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 conninered prior of the resired 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 r ou may, atterests 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 r lease of acrease 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 or any I odetar states and equirements, 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) I mis letter will anow you to oogin maxing of substantial equivalence of your device to a legally premaince notification "Thesults in a classification for your device and thus, permits your device to proceed to the market.

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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 yours,

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): K092737

Device Name:

EasyRA Magnesium Reagent

Indications For Use:

The EasyRA Magnesium Reagent is for the in-vitro quantitative measurement of magnesium in serum on the Medica EasyRA analyzer. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison's disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders.

For in vitro diagnostic use only.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Coneurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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

510(k) K092737