(326 days)
Not Found
Not Found
No
The document describes reagents for a chemistry analyzer and does not mention any AI or ML capabilities.
No.
The device is used for quantitative determination of various substances in human serum, which is an in vitro diagnostic (IVD) purpose, not a therapeutic one. It aids in diagnosis and treatment, but does not directly treat.
Yes
The "EasyRA Chemistry Analyzer" is intended for the quantitative determination of various substances in human serum, and the measurements are explicitly stated to be "used in the diagnosis and treatment of numerous diseases." This directly indicates its role in the diagnostic process.
No
The device described is a reagent kit intended for use with a specific chemistry analyzer (MEDICA "EasyRA Chemistry Analyzer"). Reagents are chemical substances used in laboratory tests and are not software-only devices.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagents are for the quantitative determination of various substances (Albumin, Alkaline Phosphatase, Aspartate Aminotranferase, Carbon Dioxide, Creatinine, Creatinine Kinase) in human serum. This involves testing biological samples in vitro (outside the body).
- Clinical Laboratories: The intended use specifies that the device is used in clinical laboratories, which is a typical setting for IVD testing.
- Diagnosis and Treatment: The intended use also clearly states that the measurements are used in the diagnosis and treatment of various diseases. This is a core purpose of IVD devices.
- Reagents and Analyzer: The description mentions both reagents and a chemistry analyzer, which are components commonly used in IVD systems for performing tests on biological samples.
The definition of an IVD device generally includes reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems intended for use in the in vitro examination of specimens derived from the human body for the purpose of providing information for diagnostic, monitoring, or compatibility purposes. The provided information aligns perfectly with this definition.
N/A
Intended Use / 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.
EasyRA Aspartate Aminotransferase Reagent
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.
EasyRA Carbon Dioxide Reagent
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 with changes in body acid-base balance.
EasyRA Carbon Dioxide Calibrator
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.
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.
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.
Product codes
CIX, CJE, CIT, KHS, JIT, JFY, CGS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1035 Albumin test system.
(a)
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.(b)
Classification. Class II.
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)