(238 days)
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No
The summary describes reagents for a chemistry analyzer and does not mention any AI or ML capabilities.
No
The device is described as a reagent for in vitro diagnostic use, measuring substances in serum for diagnosis and treatment of conditions, not for directly treating or preventing disease in a patient.
Yes
The document explicitly states that the EasyRA chemistry analyzer and its reagents are used for "diagnosis and treatment" of various conditions, such as "pancreatitis", "renal and metabolic diseases", and "carbohydrate metabolism disorders". The phrase "For in vitro diagnostic use only" further confirms its diagnostic purpose.
No
The device description is not provided, but the intended use clearly describes reagents for use with a "chemistry analyzer," which is a hardware device. The reagents themselves are also physical components.
Yes, based on the provided information, these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Explicit Statement: Each reagent description explicitly states "For in vitro diagnostic use only." This is a clear indication of their intended purpose.
- Intended Use: The intended use for each reagent is to measure specific substances (amylase, urea, glucose, triglycerides, uric acid) in serum. Serum is a biological sample taken from the body.
- Diagnostic Purpose: The measurements are stated to be used for the "diagnosis and treatment" of various diseases and conditions (pancreatitis, renal and metabolic diseases, diabetes mellitus, etc.). This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Use with a Specific Analyzer: The reagents are intended for use with the "EasyRA chemistry analyzer," which is a laboratory instrument used for performing chemical tests on biological samples. This further supports their role in a diagnostic workflow.
Therefore, the EasyRA amylase Reagent, EasyRA Blood Urea Nitrogen (BUN) Reagent, EasyRA Glucose hexokinase (GLU-H) Reagent, EasyRA Triglyceride (TRIG) Reagent, and EasyRA Uric Acid (URIC) Reagent are all IVDs.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
JFJ, CDQ, CFR, CDT, KNK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 862.1070 Amylase test system.
(a)
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).(b)
Classification. Class II.
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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).
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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 (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) /\gamma08\gamma-3