EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT

K080810 · Medica Corp. · CIG · Dec 10, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080810
• Device Name: EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT
• Applicant: Medica Corp.
• Product Code: CIG · Clinical Chemistry
• Decision Date: Dec 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

The EasyRA DBIL Reagent is for the in vitro measurement of Direct Billirubin in serum specimens of adults on the Medica EasyRA analyzer. Bilirubin measwements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block, EasyRA Bilirubin-Total Reagent Device Name: The EasyRA TBIL Reagent is for the in vitro measurement of Total Bilirubin in Indications For Use: serum specimens of adults on the Medica EasyRA analyzer. Bilirubin measwements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. Device Name: EasyRA Phosphorus Reagent The EasyRA Phosphorus Reagent is for the in vitro measurement of phosphorus Indications For Use: in serum on the Medica EasyRA analyzer. Phosphorus measurements are used in the diagnosis and treatment of parathyroid gland, kidney diseases, and vitamin D imbalance. Device Name: EasyRA Iron Reagent Indications For Use: The EasyRA Iron Reagent is for the in vitro measurement of iron in serum on the Medica EasyRA analyzer. Iron measurements are used in the diagnosis and treatment of iron deficiency anemia, hemochromatosis, and chronic renal disease. Device Name: EasyRA Magnesium Reagent The EasyRA Magnesium Reagent is for the in vitro measurement of phosphorus Indications For Use: 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.

Device Story

Reagent kits for use on Medica EasyRA clinical chemistry analyzer; input: patient serum samples; operation: automated colorimetric/spectrophotometric analysis of chemical reactions within reagent-sample mixture; output: quantitative concentration values for bilirubin (direct/total), phosphorus, iron, and magnesium; used in clinical laboratory settings by trained technicians; results interpreted by physicians to diagnose/monitor liver, metabolic, renal, and hematological conditions; benefits include rapid, automated diagnostic testing for patient management.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and performance validation of reagent assays on the Medica EasyRA analyzer.

Technological Characteristics

Liquid ready-to-use dual-reagent systems. Colorimetric endpoint chemistry. Sensing via spectrophotometric absorbance measurement. Wavelengths: 340 nm (Phosphorus), 520/600 nm (Magnesium), 550 nm (Bilirubin), 600/700 nm (Iron). Requires Medica EasyRA Analyzer. Storage 2-8°C.

Indications for Use

Indicated for in-vitro quantitative measurement of Direct Bilirubin, Total Bilirubin, Inorganic Phosphorus, Iron, and Magnesium in adult human serum to aid in diagnosis/treatment of liver, metabolic, hematological, parathyroid, kidney, and iron-deficiency disorders. Not tested in neonates.

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The text is in blue, with "FDA" in a larger font size than the rest of the text.

June 11, 2018

Medica Corp. Photios Makris Director, QA/RA 5 Oak Park Drive Bedford, MA 01730

Re: K080810

Trade/Device Name: EasyRA Bilirubin-Direct Reagent, EasyRA Bilirubin-Total Reagent, EasyRA Phosphorus-Inorganic Reagent, EasyRA Iron Reagent, EasyRA Magnesium Reagent Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG, CEO, JIY, JGJ Dated: December 5, 2008 Received: December 9, 2008

Dear Photios Makris:

This letter corrects our substantially equivalent letter of December 10, 2008.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indication for Use

## 510(k) Number (if known): K080810

Device Name: EasyRA Bilirubin-Direct Reagent Indication For Use: The EasyRA DBIL Reagent is for the in vitro measurement of Direct Billirubin in serum specimens of adults on the Medica EasyRA analyzer. Bilirubin measwements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block, EasyRA Bilirubin-Total Reagent Device Name: The EasyRA TBIL Reagent is for the in vitro measurement of Total Bilirubin in Indications For Use: serum specimens of adults on the Medica EasyRA analyzer. Bilirubin measwements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. Device Name: EasyRA Phosphorus Reagent The EasyRA Phosphorus Reagent is for the in vitro measurement of phosphorus Indications For Use: in serum on the Medica EasyRA analyzer. Phosphorus measurements are used in the diagnosis and treatment of parathyroid gland, kidney diseases, and vitamin D imbalance. Device Name: EasyRA Iron Reagent Indications For Use: The EasyRA Iron Reagent is for the in vitro measurement of iron in serum on the Medica EasyRA analyzer. Iron measurements are used in the diagnosis and treatment of iron deficiency anemia, hemochromatosis, and chronic renal disease. Device Name: EasyRA Magnesium Reagent The EasyRA Magnesium Reagent is for the in vitro measurement of phosphorus Indications For Use: 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.

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 (OIVD)

Carol C. Benson

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

510(k) K080810