(120 days)
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No
The summary describes a reagent, calibrator, and quality control material for a chemistry analyzer, with no mention of AI or ML.
No
All provided information indicates the device is an in-vitro diagnostic (IVD) device used for quantitative determination and measurement of LDL Cholesterol, not for direct therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section states, "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." This clearly indicates a diagnostic purpose.
No
The device described is a reagent, calibrator, and quality control material used with a chemistry analyzer, which are physical components, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the reagent is for the "quantitative determination of Low Density Lipoproteins in human serum." This involves testing a sample taken from the human body (serum) outside of the body (in vitro).
- Purpose: The measurements are used in the "diagnosis and treatment of lipid disorders... atherosclerosis, and various liver and renal diseases." This aligns with the purpose of IVDs, which are used to provide information for diagnosis, monitoring, or treatment.
- Components: The description includes a reagent, calibrator, and quality control material, which are typical components of an IVD system used for laboratory testing.
- Care Setting: The intended user is "clinical laboratories," which is the standard setting for performing in vitro diagnostic tests.
The other components (calibrator and QC material) are also considered part of the IVD system as they are essential for the proper functioning and validation of the diagnostic test.
N/A
Intended Use / Indications for Use
The EasyRA dLDL reagent is intended for the quantitative determination of Low Density Lipoproteins in human serum, 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.
The EasyRA dLDL calibrator facilitates measurements of LDL Cholesterol on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's dLDL reagent. The dLDL calibrator is used to establish a point of reference that is used in the determination of values in the measurement of LDL Cholesterol in human serum.
The EasyRA EasyQC material validates measurements of LDL Cholesterol on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's dLDL reagent and calibrator. The EasyQC is used to estimate test precision and to detect systemic analytical deviations that may arise from reagent or analytical instrument variation.
Product codes
MRR, JIX, JJY
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
human serum
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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract shapes, possibly representing human figures or stylized wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Medica Corp. c/o Dr. Photios Makris Director of Regulatory Affairs/Quality Assurance 5 Oak Park Drive Bedford, MA 01730
JUL 1 7 2009
Re: K090734
Trade Name: EasyRA Direct Low Density Lipoproteins Cholesterol Reagent Regulation Number: 21 CFR §862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, subject to 862.9(c)(4) Product Codes: MRR, JIX, JJY Dated: July 01, 2009 Received: July 02, 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); 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 (OS) regulation (21 CFR Part 820).
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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.
G.C.H.
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
Enclosure
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Indications for Use
510(k) Number (if known): Kogo 734
Device Name: EasyRA direct Low Density Lipoproteins (dLDL) cholesterol Reagent Indications For Use: The EasyRA dLDL reagent is intended for the quantitative determination of Low Density Lipoproteins in human serum, 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. Device Name: EasyRA direct Low Density Lipoproteins (dLDL) cholesterol Calibrator Indications For Use: The EasyRA dLDL calibrator facilitates measurements of LDL Cholesterol on the EasyRA clinical chemistry analyzer when used in conjunction with Medica's dLDL reagent. The dLDL calibrator is used to establish a point of reference that is used in the determination of values in the measurement of LDL Cholesterol in human serum. Device Name: EasyRA EasyQC Quality Control material The EasyRA EasyQC material validates measurements of LDL Cholesterol on the EasyRA Indications For Use: clinical chemistry analyzer when used in conjunction with Medica's dLDL reagent and calibrator. The EasyQC is used to estimate test precision and to detect systemic analytical deviations that may arise from reagent or analytical instrument variation.
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)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Division Sign-Off
Office of In Vitro Diagnos Device Evalu
510(k) K090734