(89 days)
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No
The summary describes in vitro diagnostic reagents for a chemistry analyzer, focusing on quantitative measurements of cholesterol and triglycerides. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an in vitro diagnostic reagent used to measure specific blood components (HDL, LDL, cholesterol, triglycerides) on a chemistry analyzer. Its purpose is to assist in diagnosis and treatment, not to directly treat a patient.
Yes
The text explicitly states that the reagents "can assist in the diagnosis and treatment of patients" and that the measurements "are used in the diagnosis and treatment of lipid disorders".
No
The 510(k) summary describes chemical reagents intended for use with a chemistry analyzer, not a software-only device.
Yes, based on the provided information, these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that these reagents are for the "quantitative determination" of various substances (HDL Cholesterol, LDL Cholesterol, Total Cholesterol, Triglycerides) in "human serum and plasma." This indicates they are used to analyze samples taken from the human body.
- "For in vitro diagnostic use only": Each intended use statement concludes with this phrase, which is a clear indicator that the device is intended for diagnostic testing performed outside of the living body (in vitro).
- Clinical Context: The intended uses describe how the measurements obtained are used in the "diagnosis and treatment" of various diseases and conditions (coronary heart disease, lipid disorders, atherosclerosis, liver and renal diseases, diabetes mellitus, nephrosis, liver obstruction, endocrine disorders). This aligns with the purpose of IVDs, which is to provide information for diagnostic purposes.
- Clinical Laboratories: The intended user is specified as "clinical laboratories," which are the typical settings where in vitro diagnostic testing is performed.
Therefore, the combination of analyzing human samples, being used for diagnostic purposes, and the explicit "for in vitro diagnostic use only" statement confirms that these devices are IVDs.
N/A
Intended Use / Indications for Use
The EasyRA HDL Cholesterol reagent is intended for the quantitative determination of High Density Lipoprotein Cholesterol in human serum and plasma on the Medica EasyRA Chemistry Analyzer. The Medica EasyRA HDL-Cholesterol reagent can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. For in vitro diagnostic use only.
The EasyRA LDL Cholesterol reagent is intended for the quantitative determination of Low Density Lipoprotein Cholesterol in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. The LDL Cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only.
The EasyRA CHOL reagent is intended for the quantitative determination of total cholesterol in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Total cholesterol measurements are used to screen for elevated cholesterol as a risk factor in coronary artery disease. For in vitro diagnostic use only.
The EasyRA TRIG reagent is intended for the quantitative measurement of triglycerides in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism and various endocrine disorders. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
LBS, MRR, CHH, CDT
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
clinical laboratories
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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§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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Medica Corporation c/o Photios Makris, Ph.D. 5 Oak Park Drive Bedford, MA 01730
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
JUL 1 2 2011
Re: K111036
Trade/Device Name: EasyRA High Density Lipoproteins (HDL) Cholesterol Reagent, EasyRA Low Density Lipoproteins (LDL) Cholesterol Reagent, EasyRA Cholesterol (CHOL) Reagent, EasyRA Triglycerides (TRIG) Reagent Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein Test System Regulatory Class: Class I, meets limitations per 21 CFR 862.9(c)(4) Product Code: LBS, MRR, CHH, CDT Dated: April 12, 2011 Received: April 14, 2011
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 class II (Special Controls), 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K111036
| Device Name: | EasyRA High Density Lipoproteins (HDL) Cholesterol Reagent |
|---|---|
| Indications For Use: | The EasyRA HDL Cholesterol reagent is intended for the quantitative determination of High Density Lipoprotein Cholesterol in human serum and plasma on the Medica EasyRA Chemistry Analyzer. The Medica EasyRA HDL-Cholesterol reagent can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. For in vitro diagnostic use only. |
| Device Name: | EasyRA Low Density Lipoproteins (LDL) cholesterol Reagent |
| Indications For Use: | The EasyRA LDL Cholesterol reagent is intended for the quantitative determination of Low Density Lipoprotein Cholesterol in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. The LDL Cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only. |
| Device Name: | EasyRA Cholesterol (CHOL) Reagent |
| Indications For Use: | The EasyRA CHOL reagent is intended for the quantitative determination of total cholesterol in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Total cholesterol measurements are used to screen for elevated cholesterol as a risk factor in coronary artery disease. For in vitro diagnostic use only. |
| Device Name: | EasyRA Triglycerides (TRIG) Reagent |
| Indications For Use: | The EasyRA TRIG reagent is intended for the quantitative measurement of triglycerides in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism and various endocrine disorders. For in vitro diagnostic use only. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Congurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Sary ensim
Division Sign-Off
Office of In Vitro Diagnostic Device
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Evaluation and Safety
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