(610 days)
Not Found
No
The device description details a chemical and optical measurement process for A1C and total hemoglobin, with calculations based on these measurements. There is no mention of AI or ML algorithms being used for analysis, interpretation, or decision-making.
No.
Explanation: The device measures % A1C (glycated hemoglobin) to monitor glycemic control in patients with diabetes mellitus. It is a diagnostic device used for measurement rather than a therapeutic device that treats or prevents a disease.
Yes
The device quantitatively measures % A1C (glycated hemoglobin) to monitor glycemic control in patients with diabetes mellitus, which is a diagnostic function.
No
The device description explicitly states that the system consists of a "Reader" and "disposable test cartridges," which are hardware components. The process involves applying blood to a cartridge and inserting it into the reader for optical measurement.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system "quantitatively measures % A1C (glycated hemoglobin) in capillary and venous whole blood." This involves testing a biological sample (blood) in vitro (outside the body) to provide information about a patient's health status (glycemic control in patients with diabetes mellitus).
- Device Description: The description details how the system analyzes the blood sample using chemical reactions and optical measurements to determine the concentration of A1C and total hemoglobin. This process is characteristic of an in vitro diagnostic test.
- Sample Type: The device uses whole blood, which is a biological specimen.
- Purpose: The purpose is to monitor glycemic control, which is a diagnostic and monitoring function performed on a biological sample.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Avie™ A1C System clearly fits this definition.
N/A
Intended Use / Indications for Use
The Avie™ A1C System test is a point of care system that quantitatively measures % A1C (glycated hemoglobin) in capillary and venous whole blood. The Avie™ A1C System consists of the Avie™ A1C System Reader, Avie™ A1C System Test Cartridge and Avie™ A1C System Diluent. The test is for physician directed prescription home use and professional use to monitor glycemic control in patients with diabetes mellitus. Single use, auto-disabling lancing devices are to be used in the professional setting. The device cannot be used in patients with hemoglobinopathies of Hemoglobin C and Hemoglobin D.
Product codes
LCP
Device Description
The Avie A1C Test is a point of care system that utilizes a Reader and disposable test cartridges to measure %A1C in whole blood samples. Whole blood from either capillary of venous is directly applied to the sample port of a test cartridge. Insertion of the test cartridge into the reader automatically prompts the operator to add diluent. Addition of diluent lyses the red bloods cell which allows both the A1C and total hemoglobin analytes to be measured. The test completes in less than three (3) minutes. Both the A1C and Total Hemoglobin (Total Hb) analytes are measured using its own distinct wavelength. Hemoglobin from the lyzed blood is converted to met-hemoglobin and is read at 420 nm. The concentration of hemoglobin is directly proportional to the intensity of met-hemoglobin concentration. For A1C the lysed blood is mixed with anti-hemoglobin antibodies conjugated to colored microparticles. After a predetermined time the microparticle mixture is automatically released onto a reagent strip where the reacted and unreacted microparticle species are separated and read optically. The final displayed result is expressed as; %A1C = (A1C = Total Hb)×100.
MEC Dynamics, Corp. calibrates the Avie™ A1C System using National Glycohemoglobin Standardization Program (NGSP) certified laboratory value assigned blood samples. Lot specific information is transferred to the Avie™ AIC Reader via radio frequency identification (RFID).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician directed prescription home use and professional use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Studies were done that evaluated precision, linearity, interference, operational condition limits, NGSP traceability and venous vs. fingerstick whole blood matrices for the Avie™ A1C Test System. The Avie™ A1C Test System demonstrates precision within 5 %CV at each of two levels- normal and abnormal %A1C. The Avie™ AIC Test System is linear between 5 and 14 %A1C. The Avie A1C Test System is insensitive to high physiological levels of triglyceride and bilirubin, high therapeutic levels of various over-the-counter pharmaceuticals, and hemoglobin levels ranging from approximately 9 g/dL to 20 g/dL. The Avie™ A1C Test System may report unreliable results if there is high levels of, Hemoglobin D, Hemoglobin C or other hemoglobin variants. NGSP issued a certificate of traceability granting manufacturer certification to MEC Dynamics, Corporation.
Clinical studies were conducted across four sites with approximately 350 comparative data. Subjects first performed one Avie™ A1C test on themselves, and this was followed by a second Avie™ A1C test performed by a health care professional at the site. Venous blood was collected and sent to the NGSP laboratory in Columbia, MO.
A comparison NGSP vs. Avie™ A1C capillary results by non-professional users testing 174 subjects showed regression statistics: Non-Professional Users (Capillary) = 0.976 (NGSP) + 0.151 r = 0.987.
A comparison NGSP vs. Avie™ A1C capillary results by trained professional users testing 174 subjects showed regression statistics: Professional Users (Capillary) = 0.973 (NGSP) + 0.172 r = 0.988.
A comparison between capillary Professional vs. capillary non-professional people gave a regression statistic. Results were gathered from 169 capillary sample pairs run on the Avie system: Non-Professional Users = 0.998(Professional Users) +0.019 r=0.984.
A comparison of NGSP vs. Avie™ A1C venous results by trained professional users testing 279 whole blood samples: Professional Users (Venous) = 0.972(NGSP) +0.210 r = 0.993.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
JUL 2 0 2011
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K093548
MEC Dynamics Corporation 807.92 (a)(1): Name:
| Address: | 90 Rose Orchard Way | |
|---|---|---|
| San Jose, CA 95134 | ||
| Phone: | 408-428-9427 | |
| FAX: | 408-456-0279 | |
| Contact: | Mr. Emmanuel Mpock |
807.92 (a)(2): Device name- trade name and common name, and classification
Avie™ AIC System Trade name:
Glycosylated hemoglobin assay Common Name:
Classification: CFR §21.864.7470
807.92 (a)(3): Identification of the legally marketed predicate device
The Avie™ A1C Test System is substantially equivalent to other AIC test systems, and specifically, the Avie A1C System, cleared under premarket notification K091400 on 6/11/09. " ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰ ۱۰
807.92 (a)(4): Device Description
.....
The Avie A1C Test is a point of care system that utilizes a Reader and disposable test cartridges to measure %A1C in whole blood samples. Whole blood from either capillary of venous is directly applied to the sample port of a test cartridge. Insertion of the test cartridge into the reader automatically prompts the operator to add diluent. Addition of diluent lyses the red bloods cell which allows both the A1C and total hemoglobin analytes to be measured. The test completes in less than three (3) minutes. Both the A1C and Total Hemoglobin (Total Hb) analytes are measured using its own distinct wavelength. Hemoglobin from the lyzed blood is converted to met-hemoglobin and is read at 420 nm. The concentration of hemoglobin is directly proportional to the intensity of met-hemoglobin concentration. For A1C the lysed blood is mixed with anti-hemoglobin antibodies conjugated to colored microparticles. After a predetermined time the microparticle mixture is automatically released onto a reagent strip where the
K093548 Section 5 pg 1
1
reacted and unreacted microparticle species are separated and read optically. The final displayed result is expressed as;
%A1C = (A1C = Total Hb)×100
MEC Dynamics, Corp. calibrates the Avie™ A1C System using National Glycohemoglobin Standardization Program (NGSP) certified laboratory value assigned blood samples. Lot specific information is transferred to the Avie™ AIC Reader via radio frequency identification (RFID).
807.92 (a)(5): Intended Use
. -
The Avie™ A1C System test is a point of care system that quantitatively measures % A1C (glycated hemoglobin) in capillary and venous whole blood. The Avie™ A1C System consists of the Avie™ A1C System Reader, Avie™ A1C System Test Cartridge and Avie™ A1C System Diluent. The test is for physician directed prescription home use and professional use to monitor glycemic control in patients with diabetes mellitus. Single use, auto-disabling lancing devices are to be used in the professional setting. The device cannot be used in patients with hemoglobinopathies of Hemoglobin C and Hemoglobin D.
807.92 (a)(6): Technological Similarities and Differences to the Predicate
| Parameter | Avie™ A1C Test System
Modified K093548 | Avie™ A1C Test System
K091400 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Intended Use | SAME | Quantitative measurement of the
percent of glycated hemoglobin |
| Indications for Use | Used in the management and
treatment of diabetes, for
monitoring long-term glycemic
control. Device can not be used
patients with elevated levels of
HbC and HbD
hemoglobinopathies. | Used in the management and
treatment of diabetes, for
monitoring long-term glycemic
control. |
| Sample Type | SAME | Whole blood |
| Sample Preparation | Direct application, touch test
cartridge to blood drop | Pipette 5µL into diluent vial,
invert 5 times |
| Calibration | SAME | Cartridge calibration is automatic
via RFID |
| Methodology | SAME | Immunoassay and general
chemistry |
| Reagent Packaging | SAME | 15 Cartridges in a desiccant
lined, tamper evident canister |
| Testing Environment | SAME | Professional use and physician
directed home use |
| Throughput | SAME | 3 minutes/sample |
| Reagent Storage | Room Temperature 64-77°F (18- | Room Temperature 59-82°F (15- |
Comparisons Between Avie A1C- modified and Avie A1C-cleared
2
| 25° C) | 28° C) | |
|---|---|---|
| Display | SAME | % A1C |
| Diluent | 15ml LDPE dropper multi-use | |
| bottle | 1.0 ml single use Vial |
807.92 (b)(1): Brief Description of Nonclinical Data
Studies were done that evaluated precision, linearity, interference, operational condition limits, NGSP traceability and venous vs. fingerstick whole blood matrices for the Avie™ A1C Test System. The Avie™ A1C Test System demonstrates precision within 5 %CV at each of two levels- normal and abnormal %A1C. The Avie™ AIC Test System is linear between 5 and 14 %A1C. The Avie A1C Test System is insensitive to high physiological levels of triglyceride and bilirubin, high therapeutic levels of various over-the-counter pharmaceuticals, and hemoglobin levels ranging from approximately 9 g/dL to 20 g/dL. The Avie™ A1C Test System may report unreliable results if there is high levels of, Hemoglobin D, Hemoglobin C or other hemoglobin variants. NGSP issued a certificate of traceability granting manufacturer certification to MEC Dynamics, Corporation.
807.92 (b)(2): Brief Description of Clinical Data
..
Clinical studies were conducted across four sites with approximately 350 comparative data. Subjects first performed one Avie™ A1C test on themselves, and this was followed by a second Avie™ A1C test performed by a health care professional at the site. Venous blood was collected and sent to the NGSP laboratory in Columbia, MO. The regression statistics from this testing are described below.
A comparison NGSP vs. Avie™ A1C capillary results by non-professional users testing 174 subjects showed regression statistics below:
Non-Professional Users (Capillary) = 0.976 (NGSP) + 0.151 r = 0.987
A comparison NGSP vs. Avie™ A1C capillary results by trained professional users testing 174 subjects showed regression statistics below:
Professional Users (Capillary) = 0.973 (NGSP) + 0.172 r = 0.988
A comparison between capillary Professional vs. capillary non-professional people gave a regression statistic below. Results were gathered from 169 capillary sample pairs run on the Avie system.
Non-Professional Users = 0.998(Professional Users) +0.019 r=0.984
3
A comparison of NGSP vs. Avie™ A1C venous results by trained professional users testing 279 whole blood samples is shown below:
Professional Users (Venous) = 0.972(NGSP) +0.210 r = 0.993
807.92 (b)(3): Conclusions from Nonclinical and Clinical Testing
Nonclinical and clinical testing was performed for the Avie™ A1C Test System. The test system was shown to be safe and effective for its intended use.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of two main elements: a circular text element and an abstract symbol. The text element encircles the symbol and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The abstract symbol is a stylized representation of an eagle or bird-like figure, with flowing lines suggesting movement or flight.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MEC Dynamics, Corp. c/o Emmanuel Mpock 90 Rose Orchard Way San Jose, CA 95134
JUL 2 0 2011
Re: K093548
Trade/Device Name: Avie A1C System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP Dated: July 1, 2011 Received: July 6, 2011
Dear: Mr. Mr. Mpock.
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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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 CFK Patfornial (101) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 the Accificantes (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K093548
Device Name: Avie™ AIC System
Indications for Use:
The Avie™ A1C System test is a point of care system that quantitatively measures % A1C (glycated hemoglobin) in capillary and venous whole blood. The Avie™ A1C System consists of the Avie™ A1C System Reader, Avie™ A1C System Test Cartridge and Avie™ A1C System Diluent. The test is for physician directed prescription home use and professional use to monitor glycemic control in patients with diabetes mellitus. Single use, auto-disabling lancing devices are to be used in the professional setting. The device cannot be used in patients with hemoglobinopathies of Hemoglobin C and Hemoglobin D.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093548
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