EASYRA CLINICAL CHEMISTRY ANALYZER

K070057 · Medica Corp. · CGA · Aug 30, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070057
• Device Name: EASYRA CLINICAL CHEMISTRY ANALYZER
• Applicant: Medica Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Aug 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EasyRA clinical analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), Cl- (chloride), Li+ (lithium) and Glucose (Trinder method) in human serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders. 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. Lithium measurements are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

Device Story

EasyRA is a random-access clinical chemistry analyzer for clinical laboratories; processes human serum samples. Inputs: serum samples; reagents. Operation: utilizes photometric (up to 6 wavelengths) and ion-selective electrode (ISE) technologies. Photometric module performs endpoint/rate reactions; ISE module measures voltage changes (Nernst equation) for electrolyte activity. RFID chips on reagent vessels store test parameters (wavelength, reaction time, volumes) to ensure correct method execution. Throughput: 150 tests/hour. Output: quantitative analyte concentrations. Healthcare providers use results for diagnosis and treatment of metabolic/electrolyte disorders and drug monitoring. Benefits: automated, intuitive interface; high-throughput clinical testing.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance characteristics of the clinical chemistry analyzer.

Technological Characteristics

Random-access analyzer; 24 photometric test positions + 4 ISE positions. Photometric sensing via 6-wavelength photometer; potentiometric sensing via ion-selective electrodes. Connectivity: LIS integration, barcode scanning. Reagent management: RFID-tagged vessels. Throughput: 150 tests/hour. Software: Hazard analysis and development processes reviewed. Calibration: Photometric (blanks/kinetic/endpoint) and ISE (Nernst equation/2-point).

Indications for Use

Indicated for clinical laboratory use to measure Na, K, Cl, Li, and Glucose in human serum. Used for diagnosis and treatment of electrolyte imbalances, metabolic disorders, carbohydrate metabolism disorders (diabetes, hypoglycemia, pancreatic islet cell carcinoma), and monitoring lithium dosage for mental disturbances (bipolar disorder).

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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming a flowing, abstract design.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

AUG 3 0 2007

Re: k070057 Trade/Device Name: EasyRa Clinical Chemistry Analyzer Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, JGS, CEM, CGZ, JIH, JJE, JIT, JJY Dated: August 8, 2007 Received: August 9, 2007

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. 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 (k070057):

Device Name:

Indications For Use:

The EasyRA clinical analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na (sodium), K (potassium), Cl (chloride), Li (lithium) and Glucose (Trinder method) in human serum samples. Additionally, other various chemistry assays may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.

Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.

Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.

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.

Lithium measurements are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

Prescription Use J

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 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)

Carol C. Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K070057

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