Who is the manufacturer of EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT?

Medica Corp. filed the 510(k) submission for EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT (K080823).

What is the FDA product code for EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT?

JFJ. It is classified under 21 CFR 862.1070 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT?

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

Who can help prepare an FDA 510(k) submission like EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC 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.

EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT

K080823 · Medica Corp. · JFJ · Nov 17, 2008 · Clinical Chemistry

Device Facts

Record ID	K080823
Device Name	EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
Applicant	Medica Corp.
Product Code	JFJ · Clinical Chemistry
Decision Date	Nov 17, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1070
Device Class	Class 2

Intended Use

The EasyRA amylase Reagent (AMY) is for the measurement of a-Amylase in serum using the "EasyRA chemistry analyzer". Amylase measurements are used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) and other pancreatic disorders. For in vitro diagnostic use only. The EasyRA Blood Urea Nitrogen (BUN) Reagent is for the measurement of urea in serum using the "EasyRA chemistry analyzer". Urea measurements in serum are used for the diagnosis and treatment of certain renal and metabolic diseases. For in vitro diagnostic use only. The EasyRA Glucose hexokinase (GLU-H) Reagent is for the measurement of glucose in serum using the "EasyRA chemistry analyzer". Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. . For in vitro diagnostic use only. The EasyRA Triglyceride (TRIG) Reagent is for the measurement of triglycerides in serum using the "EasyRA chemistry analyzer". Triglyceride measurements are used in the diagnosis and treatment of diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders. For in vitro diagnostic use only. The EasyRA Uric Acid (URIC) Reagent is for the measurement of uric acid in serum using the "EasyRA chemistry analyzer". Uric Acid measurements are used in the diagnosis and treatment of renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. For in vitro diagnostic use only.

Device Story

Reagents for use on Medica EasyRA chemistry analyzer; measure amylase, BUN, glucose, triglycerides, and uric acid in human serum. Reagents provided in ready-to-use plastic wedges. Analyzer performs enzymatic reactions; monitors absorbance changes spectrophotometrically (Beer's Law). Used in clinical laboratory settings by trained personnel. Output provides quantitative analyte concentration; assists clinicians in diagnosing/treating conditions like pancreatitis, diabetes, renal failure, and lipid metabolism disorders. Benefits include rapid, automated diagnostic testing.

Clinical Evidence

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

Technological Characteristics

Liquid, ready-to-use reagents in plastic wedges. Enzymatic reaction principles (e.g., hexokinase, urease, lipase, uricase). Detection via spectrophotometry at specific wavelengths (340 nm to 700 nm). Designed for use on Medica EasyRA chemistry analyzer. Storage 2–8 °C.

Indications for Use

Indicated for patients requiring quantitative measurement of amylase, BUN, glucose, triglycerides, or uric acid in serum to aid in the diagnosis and treatment of pancreatic, renal, metabolic, or lipid disorders.

Regulatory Classification

Identification

An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Related Devices

K080874 — EASYRA ALB REAGENT AND EASYRA ALP REAGENT, MODEL 10218/10214, EASYRA AST REAGENT, MODEL 10206, EASYRA CO2 REAGENT · Medica Corp. · Feb 20, 2009
K101090 — EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS · Medica Corp. · May 20, 2011
K100187 — EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT · Medica Corp. · May 5, 2010
K110675 — EASYRA UREA NITROGEN AND CREATININE REAGENTS · Medica Corp. · Apr 21, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Medica Corporation c/o Photios Makris, Ph.D. Director of Regulatory Affairs/Quality Assurance 5 Oak Park Drive Bedford, MA 01730 NOV 1 7 2008 Re: k080823 Trade/Device Name: EasyRA Amylase Reagent, EasyRA Blood Urea Nitrogen (Bun) Reagent, EasyRA Glucose-Hexokinase Reagent, EasyRA Triglyceride Reagent, EasyRA Uric Acid Reagent Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase Test System Regulatory Class: II Product Code: JFJ, CDQ, CFR, CDT, KNK Dated: November 03, 2008 Received: November 04, 2008 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 not 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 Prt 820). {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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Jean m. Coopus, M.S., D.v.M. Yéan 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 {2}------------------------------------------------ ## Indication for Use 510(k) Number (if known): K080823 | Device Name: | EasyRA Amylase Reagent | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications For Use: | The EasyRA amylase Reagent (AMY) is for the measurement of a-Amylase in serum using the "EasyRA chemistry analyzer". Amylase measurements are used for the diagnosis and treatment of pancreatitis (inflammation of the pancreas) and other pancreatic disorders. For in vitro diagnostic use only. | | Device Name: | EasyRA Blood Urea Nitrogen Reagent | | Indications For Use: | The EasyRA Blood Urea Nitrogen (BUN) Reagent is for the measurement of urea in serum using the "EasyRA chemistry analyzer". Urea measurements in serum are used for the diagnosis and treatment of certain renal and metabolic diseases. For in vitro diagnostic use only. | | Device Name: | EasyRA Glucose-Hexokinase Reagent | | Indications For Use: | The EasyRA Glucose hexokinase (GLU-H) Reagent is for the measurement of glucose in serum using the "EasyRA chemistry analyzer". Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma. . For in vitro diagnostic use only. | | Device Name: | EasyRA Triglyceride Reagent | | Indications For Use: | The EasyRA Triglyceride (TRIG) Reagent is for the measurement of triglycerides in serum using the "EasyRA chemistry analyzer". Triglyceride measurements are used in the diagnosis and treatment of diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders. For in vitro diagnostic use only. | | Device Name: | EasyRA Uric Acid Reagent | | Indications For Use: | The EasyRA Uric Acid (URIC) Reagent is for the measurement of uric acid in serum using the "EasyRA chemistry analyzer". Uric Acid measurements are used in the diagnosis and treatment of renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. 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 (OIVD) Carol Benson Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) /<6>\gamma08\gamma-3