EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL

K120497 · Medica Corp. · LCP · May 14, 2012 · Hematology

Device Facts

• Record ID: K120497
• Device Name: EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
• Applicant: Medica Corp.
• Product Code: LCP · Hematology
• Decision Date: May 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended 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.

Device Story

EasyRA HbA1c system performs quantitative immunoturbidimetric analysis of human whole blood samples. System utilizes three reagents (R1: latex particles; R2: mouse anti-human HbA1c monoclonal antibody; R3: goat anti-mouse IgG polyclonal antibody) to induce agglutination proportional to HbA1c concentration. Samples are hemolyzed prior to analysis. Turbidity measured at 600nm on EasyRA clinical chemistry analyzer. Calibration curve established via Logit/Log4 routine. Results reported as %HbA1c. Used in clinical laboratory settings by trained personnel. Output provides HbA1c percentage for monitoring long-term glycemic control in diabetic patients. System includes calibrators and quality control materials to ensure analytical accuracy and precision.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (Total CV 2.89-3.94%). Linearity confirmed 4-14% range per CLSI EP6-A. Method comparison (n=148) against predicate yielded Y=1.0186X-0.1104, r²=0.986. Interference testing performed for common substances, labile A1c, and Hb variants (S, C, D, E, F). Positive interference noted for HbC/HbS; negative for HbF.

Technological Characteristics

Immunoturbidimetric assay; latex-enhanced agglutination. Reagents: R1 (buffer, latex), R2 (mouse anti-human HbA1c mAb), R3 (goat anti-mouse IgG pAb). Measurement: 600nm absorbance. Traceable to DCCT/NGSP. Stability: 12 months at 2-8°C. Software: Logit/Log4 curve fitting. Requires EasyRA Chemistry Analyzer.

Indications for Use

Indicated for quantitative in-vitro diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood to monitor long-term blood glucose control in diabetic patients.

Regulatory Classification

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.

Submission Summary (Full Text)

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## 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 [phone]. 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 [phone]. 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 [phone] or [phone] 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<br>diagnostic determination of hemoglobin A1c (HbA1c) in human whole blood using<br>the EasyRA clinical chemistry analyzer. HbA1c measurements are used for the<br>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<br>clinical chemistry analyzer when used in conjunction with EasyRA HbA1c Reagent.<br>The HbA1c calibrator is used to establish points of reference that are used in the<br>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<br>material for the HbA1c immunoturbidimetric assay, using EasyRA HbA1c<br>Reagent and EasyCAL HbA1c calibrator on the EasyRA clinical chemistry<br>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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