EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT

Q: Who is the manufacturer of EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT?

Medica Corp. filed the 510(k) submission for EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT (K080874).

Q: What is the FDA product code for EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT?

CIX. It is classified under 21 CFR 862.1035 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K080874 · Medica Corp. · CIX · Feb 20, 2009 · Clinical Chemistry

Device Facts

Record ID	K080874
Device Name	EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT
Applicant	Medica Corp.
Product Code	CIX · Clinical Chemistry
Decision Date	Feb 20, 2009
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1035
Device Class	Class 2

Intended Use

The EasyRA Albumin (ALB) reagent is intended for the quantitative determination of Albumin in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. The EasyRA Alkaline Phosphatase (ALP) reagent is intended for the quantitative determination of Alkaline Phosphatase in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of Alkaline Phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases. The EasyRA Aspartate Aminotranferase (AST) reagent is intended for the quantitative determination of the enzyme Aspartate Aminotranferase in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of Aspartate Aminotranferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. The EasyRA Carbon Dioxide (CO2) reagent is intended for the quantitative measurement of Carbon Dioxide (CO2) in human serum, Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The Carbon Dioxide calibrator establishes points of reference that are used in the determination of values in the measurement of Bicarbonate/Carbon dioxide on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's CO2 reagent. The EasyRA CREA reagent is a device intended to measure creatinine levels in serum. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. The EasyRA CK reagent is a device intended to measure creatinine kinase activity in serum. Measurements of CK are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Device Story

System consists of liquid, ready-to-use reagents for quantitative colorimetric chemistry analysis on Medica EasyRA Chemistry Analyzer. Input: human serum samples. Operation: reagents react with analytes (enzymatic or non-enzymatic); analyzer measures absorbance changes via spectrophotometry (Beer's Law). Output: quantitative concentration values for ALB, ALP, AST, CO2, CREA, and CK. Used in clinical laboratories by trained personnel. Results assist clinicians in diagnosing/monitoring liver, kidney, heart, and muscle diseases and acid-base status.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing of analytical performance characteristics.

Technological Characteristics

Quantitative colorimetric chemistry reagents. Dual or single reagent systems. Sensing principle: spectrophotometric absorbance measurement (Beer's Law). Energy source: integrated into EasyRA analyzer. Storage: 2–8 °C. Connectivity: proprietary to Medica EasyRA Analyzer. Standards: CLSI EP5-A2, EP6-A, EP9-A2, EP17-A.

Indications for Use

Indicated for quantitative determination of Albumin, Alkaline Phosphatase, Aspartate Aminotransferase, Carbon Dioxide, Creatinine, and Creatine Kinase in human serum for diagnosis and treatment of liver, kidney, bone, parathyroid, intestinal, heart, and muscle diseases, and acid-base balance disorders. Prescription use only.

Regulatory Classification

Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Related Devices

K123802 — EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT · Medica Corp. · Mar 1, 2013
K101090 — EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS · Medica Corp. · May 20, 2011
K101088 — EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT · Medica Corp. · Apr 4, 2011
K080823 — EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT · Medica Corp. · Nov 17, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. # DEPARTMENT OF HEALTH & HUMAN SERVICES Medica Corporation c/o Photios Makris, Ph.D., Director QA/RA 5 Oak Park Drive Bedford, MA 01730 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 # Re: k080874 Trade/Device Name: EasyRA Albumin Reagent, EasyRA Alkaline Phosphatase Reagent, EasyRA Aspartate Aminotransferase Reagent, EasyRA Carbon Dioxide Reagent, EasyRA Carbon Dioxide Calibrator, EasyRA Creatinine Reagent, EasyRA Creatine Kinase Reagent Regulation Number: 21 CFR862.1035 Regulation Name: Albumin Test System Regulatory Class: Class II Product Code: CIX, CJE, CIT, KHS, JIT, JFY, CGS Dated: February 11, 2009 Received: February 12, 2009 FEB 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 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). 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. {1}------------------------------------------------ Page - 2 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Corg C. He Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use #### K080874 510(k) Number (if known): Device Name: Indications For Use: Device Name: Indications For Use: ## EasyRA Albumin Reagent The EasyRA Albumin (ALB) reagent is intended for the quantitative determination of Albumin in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. EasyRA Alkaline Phosphatase Reagent The EasyRA Alkaline Phosphatase (ALP) reagent is intended for the quantitative determination of Alkaline Phosphatase in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of Alkaline Phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases. Device Name: Indications For Use: ## EasyRA Aspartate Aminotransferase Reagent EasyRA Carbon Dioxide Reagent with changes in body acid-base balance. EasyRA Carbon Dioxide Calibrator The EasyRA Aspartate Aminotranferase (AST) reagent is intended for the quantitative determination of the enzyme Aspartate Aminotranferase in human serum, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurement of Aspartate Aminotranferase measurements are used in the diagnosis and treatment of certain types of liver and heart diseases. The EasyRA Carbon Dioxide (CO2) reagent is intended for the quantitative measurement of Carbon Dioxide (CO2) in human serum, Bicarbonate/carbon dioxide measurements arc used in the diagnosis and treatment of numerous potentially serious disorders associated determination of values in the measurement of Bicarbonate/Carbon dioxide on the EasyRA Device Name: Indications For Use: Device Name: Indications For Use: Device Name: Indications For Use: EasyRA Creatinine Reagent The EasyRA CREA reagent is a device intended to measure creatinine levels in serum. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. The Carbon Dioxide calibrator establishes points of reference that are used in the clinical chemistry analyzer when used in conjunction with Medica's CO2 reagent. Device Name: Indications For Use: EasyRA Creatinine Kinase Reagent The EasyRA CK reagent is a device intended to measure creatinine kinase activity in serum. Measurements of CK are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 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) Ruth Chesler Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 88874 510(k) < Page 11 of 218