(218 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.
The device is an in-vitro diagnostic reagent and calibrator used for the quantitative measurement of alcohol in human urine, which is for diagnostic purposes, not therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states, "Alcohol measurements are used for the diagnosis and treatment of alcohol intoxication and poisoning." This indicates that the device (EasyRA EtOH reagent used with the EasyRA Chemistry Analyzer) provides information used for diagnostic purposes.
No
The 510(k) summary describes reagents, a calibrator, and quality control material used with a chemistry analyzer, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The intended use statements for the EasyCal Ethanol Calibrator and the EasyQC Ethanol quality control material both explicitly state they are "intended for in-vitro diagnostic use".
- Measurement in Human Samples: The EasyRA EtOH reagent is intended for the quantitative measurement of Alcohol (EtOH) in human urine. This is a key characteristic of IVDs – they are used to examine specimens derived from the human body.
- Clinical Laboratory Use: The intended use specifies use in "clinical laboratories", which is a common setting for IVD testing.
- Diagnosis and Treatment: The intended use of the EasyRA EtOH reagent states that alcohol measurements are used for the "diagnosis and treatment of alcohol intoxication and poisoning". This directly relates the test results to clinical decision-making, a core function of IVDs.
Therefore, based on the provided information, the EasyRA EtOH reagent, EasyCal Ethanol Calibrator, and EasyQC Ethanol quality control material are all components of an In Vitro Diagnostic system.
N/A
Intended Use / Indications for Use
The EasyRA EtOH reagent is intended for the quantitative measurement of Alcohol (EtOH) in human urine, using MEDICA's EasyRA Chemistry Analyzer in clinical laboratories. Alcohol measurements are used for the diagnosis and treatment of alcohol intoxication and poisoning.
The EasyCal Ethanol Calibrator is intended for in-vitro diagnostic use for the calibration of the ethyl alcohol assay on the EasyRA Chemistry Analyzer for the quantitative determination of ethyl alcohol in urine.
The EasyQC Ethanol quality control material is intended for in-vitro diagnostic use for the validation of the ethyl alcohol assay, which is used on the EasyRA Chemistry Analyzer for the quantitative determination of ethyl alcohol in urine.
Product codes
DIC, DLJ, LAS
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
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§ 862.3040 Alcohol test system.
(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Medica Corporation c/o Dr. Photios Makris 5 Oak Park Drive Bedford, MA 01730
NOV 1 5 2011
Re: K111005
Trade Name: Easy RA Ethyl Alcohol Reagent, Calibrator, and QC Material Regulation Number: 21 CFR 862.3040 Regulation Name: Alcohol Test System Regulatory Class: Class II Product Codes: DIC, DLJ, LAS Dated: August 1, 2011 Received: November 7, 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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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).
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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 Viro 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 Par1 803), please go to http://www.fda.goy/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.fdaggov/MedicalDevicesforYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, 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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Attachment 1
Indications for Use
510(k) Number (if known): ≤ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \
| Device Name: | EasyRA Ethyl Alcohol (EtOH) Reagent |
|---|---|
| Indications For Use: | The EasyRA EtOH reagent is intended for the quantitative measurement |
| of Alcohol (EtOH) in human urine, using MEDICA's EasyRA Chemistry | |
| Analyzer in clinical laboratories. Alcohol measurements are used for the | |
| diagnosis and treatment of alcohol intoxication and poisoning. | |
| Device Name: | EasyRA Ethyl Alcohol (EtOH) Calibrator |
| Indications For Use: | The EasyCal Ethanol Calibrator is intended for in-vitro diagnostic use for the |
| calibration of the ethyl alcohol assay on the EasyRA Chemistry Analyzer for the | |
| quantitative determination of ethyl alcohol in urine. | |
| Device Name: | EasyRA Ethyl Alcohol (EtOH) QC Material |
| Indications For Use: | The EasyQC Ethanol quality control material is intended for in-vitro diagnostic |
| use for the validation of the ethyl alcohol assay, which is used on the EasyRA | |
| Chemistry Analyzer for the quantitative determination of ethyl alcohol 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)
lunk 12 ( Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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