(393 days)
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No
The document describes quality control materials and calibrators for a chemistry analyzer, with no mention of AI or ML technology in the intended use or any other provided sections.
No
The devices described are quality control materials and calibrators for chemistry analyzers, used to estimate test precision, detect analytical deviations, and establish reference points. They are not used for treating or diagnosing patients.
No
The provided text describes several quality control materials and calibrators for clinical chemistry analyzers. These materials are used to ensure the accuracy and precision of the analytical instruments (MEDICA EasyRA Chemistry Analyzer) and to establish points of reference for measurements. They are not used to diagnose a patient's condition or disease directly, but rather to validate the performance of the diagnostic equipment.
No
The device description is not provided, but the intended use clearly describes quality control materials and a calibrator for a chemistry analyzer, which are physical substances, not software.
Based on the provided information, yes, these devices are IVDs (In Vitro Diagnostics).
Here's why:
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Intended Use: The intended use statements clearly describe the devices as "quality control material for clinical chemistry" and "calibrator" intended for use in a "clinical chemistry analyzer" to "estimate test precision," "detect potential systemic analytical deviations," and "establish points of reference in the measurement of a number of analytes in human serum" and "Creatinine in urine." These are all activities performed in vitro (outside the living body) on biological samples (serum and urine) to provide information for medical purposes.
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Definition of IVD: The definition of an IVD generally includes reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, a congenital abnormality, a mental disorder, injury, or disability, or to monitor therapeutic measures.
The descriptions provided for these MEDICA products fit squarely within this definition. They are materials used in vitro with a clinical chemistry analyzer to provide information about the performance of the analytical system, which is essential for accurate diagnostic testing.
N/A
Intended Use / Indications for Use
MEDICA's EasyQC - Chemistry, Levels A and B, is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.
MEDICA's EasyElectroLytes kit is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.
MEDICA's EasyQC - Chemistry and Electrolytes, Levels A and B is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.
MEDICA's EasyCal - Multiconstituent Calibrator is intended for use in the MEDICA EasyRA Chemistry Analyzer to establish points of reference in the measurement of a number of analytes in human serum.
MEDICA CREA-U Cal is intended for use in the MEDICA EasyRA Chemistry Analyzer to establish points of reference in the measurement of Creatinine in urine.
Product codes
JIT, JIX, JJY, JJR
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
Prescription Use
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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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 its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple, using only black and white, and is designed to be easily recognizable.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 3 2009
Medica Corporation c/o Dr. Photios Makris 5 Oak Park Drive Bedford, MA 01730
K080404 Re:
Trade/Device Name: MEDICA's EasyOC Chemistry, Levels A and B; MEDICA's Easy Electrolytes kit; MEDICA's Easy OC Chemistry and Electrolytes, Levels A and B; MEDICA's Easy Cal; MEDICA CREAT-U Cal Regulation Number: 21CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JIX, JJY, JJR Dated: February 23, 2009 Received: February 25, 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).
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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 (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
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Indications for Use
510(k) Number (if known):
EasyQC - Chemistry Device Name:
Indications For Use: MEDICA's EasyQC - Chemistry, Levels A and B, is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.
Device Name: EasyElectroLytes Kit
Indications For Use: MEDICA's EasyElectroLytes kit is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.
EasyQC - Chemistry & Electrolytes Device Name:
Indications For Use: MEDICA's EasyQC - Chemistry and Electrolytes, Levels A and B is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.
Device Name: EasyCal
Indications For Use: MEDICA's EasyCal - Multiconstituent Calibrator is intended for use in the MEDICA EasyRA Chemistry Analyzer to establish points of reference in the measurement of a number of analytes in human serum.
Device Name: CREA-U Cal
Indications For Use: MEDICA CREA-U Cal is intended for use in the MEDICA EasyRA Chemistry Analyzer to establish points of reference in the measurement of Creatinine in urine.
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)
Carol Benson
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C Sice of In Vitro Diagnostic Device
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