(83 days)
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No
The summary describes a reagent kit, calibrator, and quality control materials for a clinical chemistry analyzer, focusing on the quantitative determination of HbA1c. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
Explanation: This device is an in-vitro diagnostic reagent kit used for measuring HbA1c in human blood, which is for monitoring purposes, not for treating any condition.
Yes
The text explicitly states that the "EasyRA HbA1c Reagent kit is intended for use in the quantitative in-vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood". This clearly indicates its purpose as a diagnostic device.
No
The device description is not found, but the intended use clearly describes a reagent kit, calibrator, and quality control materials used with a clinical chemistry analyzer (EasyRA). These are physical components, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The provided text explicitly states the intended use of the EasyRA HbA1c Reagent kit as:
- "intended for use in the quantitative in-vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood"
This phrase directly indicates that the device is used for diagnostic purposes in vitro (outside of the living body) using biological samples (human whole blood).
The descriptions of the calibrator and QC materials also support this, as they are components used in conjunction with the reagent kit for the diagnostic determination of HbA1c.
N/A
Intended Use / Indications for Use
The EasyRA HbA1c Reagent kit is intended for use in the quantitative in-vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood using the EasyRA clinical chemistry analyzer. HbA1c measurements are used for the monitoring of long term blood glucose control in diabetic patients.
The EasyCAL HbA1c calibrator is used for calibrating the HbA1c on the EasyRA clinical chemistry analyzer when used in conjunction with EasyRA HbA1c Reagent. The HbA1c calibrator is used to establish points of reference that are used in the determination of values in the measurement of HbA1c in human whole blood.
The EasyQC HbA1c QC Materials are intended to use as quality control material for the HbA1c immunoturbidimetric assay, using EasyRA HbA1c Reagent and EasyCAL HbA1c calibrator on the EasyRA clinical chemistry analyzer.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JIT, JJX
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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§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Image /page/0/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized image of an eagle's head. The eagle's head is composed of three curved lines, representing the department's mission to protect the health of all Americans and provide essential human services.
10903 New Hampshire Avenue Silver Spring, MD 20993
Medica Corporation c/o Photios Makris, Ph.D. 5 Oak Park Drive, Bedford MA 01730
MAY 1 4 2012
Trade/Device Name: EasyRA HbA1c Reagent Kit, HbA1c Calibrator Kit, HbA1c QC materials Regulation Number: 21CFR 864.7470 Regulation Name: HbA1c test system Regulatory Class: Class II Product Code: LCP, JIT, JJX Dated: Mav 4, 2012 Received: May 7, 2012
Dear Dr. Makris:
Re: K120497
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/Medical
Devices/Safety/ReportalProblem/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/Resourcesfor You/Industry/default.htm
Sincerely yours,
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Attachment J
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
| Device Name: | EasyRA HbA1c Reagent |
|---|---|
| Indications For Use: | The EasyRA HbA1c Reagent kit is intended for use in the quantitative in-vitro |
| diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood using | |
| the EasyRA clinical chemistry analyzer. HbA1c measurements are used for the | |
| monitoring of long term blood glucose control in diabetic patients. | |
| Device Name: | EasyCAL HbA1c Calibrator |
| Indications For Use: | The EasyCAL HbA1c calibrator is used for calibrating the HbA1c on the EasyRA |
| clinical chemistry analyzer when used in conjunction with EasyRA HbA1c Reagent. | |
| The HbA1c calibrator is used to establish points of reference that are used in the | |
| determination of values in the measurement of HbA1c in human whole blood. | |
| Device Name: | EasyQC HbA1c Quality Control Material |
| Indications For Use: | The EasyQC HbA1c QC Materials are intended to use as quality control |
| material for the HbA1c immunoturbidimetric assay, using EasyRA HbA1c | |
| Reagent and EasyCAL HbA1c calibrator on the EasyRA clinical chemistry | |
| analyzer. |
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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120499
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