(319 days)
Not Found
No
The description focuses on a chemical reaction-based measurement system with a reader for displaying results. There is no mention of AI/ML in the device description, intended use, or performance studies.
No.
The device is for measuring %A1C (glycated hemoglobin) to monitor glycemic control, not for treatment.
Yes
Explanation: The device quantitatively measures %A1C (glycated hemoglobin) to monitor glycemic control in people with diabetes mellitus, which is a diagnostic function.
No
The device description explicitly states the system consists of a "small instrument ('Reader')", a diluent solution vial, and reagent test cartridges, in addition to software. This indicates the presence of significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device "quantitatively measures %A1C (glycated hemoglobin) in capillary or venous whole blood samples." This is a measurement performed in vitro (outside the body) on a biological sample.
- Device Description: The description details a system that uses a "single-use diluent solution vial" and "single-use reagent test cartridges" to perform a chemical reaction on a blood sample. This is characteristic of an in vitro diagnostic test.
- Sample Type: The device uses "capillary or venous whole blood samples," which are biological specimens collected from the patient for analysis.
- Measurement: The device measures "%A1C," which is a specific analyte in the blood used for diagnostic and monitoring purposes.
The definition of an In Vitro Diagnostic (IVD) device generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that description by measuring a marker (%A1C) used to monitor glycemic control in people with diabetes mellitus.
N/A
Intended Use / Indications for Use
The Avie™ Alc test is a point of care system that quantitatively measures %A1C (glycated hemoglobin) in capillary or venous whole blood samples. The test is for prescription use and physician-directed home use to monitor glycemic control in people with diabetes mellitus. The device cannot be used in patients with hemoglobinopathies of HbF, HbC, and HbD.
Product codes
LCP
Device Description
The Avie A1C test system is for the quantitative measurement of %A1C in fingerstick whole blood at the point-of-care (Professional or Physician Directed Home Use). The system consists of a small instrument ("Reader), a single-use diluent solution vial, single-use reagent test cartridges, and control levels I and II solutions.
To perform one test, the Reader is turned on by the push of a button on its top surface, and a self-check (optics and software) is performed automatically. If a malfunction is detected, the Reader displays an error message on the LCD display. When the LCD display denotes "Ready" a test cartridge is inserted into an unambiguous slot in the reader. About four uL of whole blood is delivered into a vial containing wash solution or diluent, via a transfer pipette, and the vial is inverted five times for mixing. At the instruction of the reader (LCD read-out), three drops of blood mixture are applied to a well in the cartridge: the reactions then proceed automatically. There are no further procedural steps, and results in %A1C are displayed on the reader's LCD screen in approximately three minutes. The concentration of A1C is expressed as a percentage of the total hemoglobin as follows: %HBA1C = (HBA1C ÷ TOTAL HB) ×100
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
Professional and Physician Directed Home 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, and NGSP traceability 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 A1C 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 system is sensitive to high levels of Metformin and glybenclamide (greater than 0.39 mg/dL and 0.02 mg/dL, respectively), as well as high levels of hemoglobinopathies. The Avie A1C Test System may be operated between temperatures of 18°C to 28°C. NGSP issued a certificate of traceability granting manufacturer certification to MEC Dynamics, Corporation.
Clinical studies were conducted across four sites with approximately 150 subjects. Subjects first performed one Avie A1C test on themselves, and this was followed by a second Avie AlC test performed by a health care professional at the site. Venous blood was collected and sent to the NGSP laboratory in Columbia. MO.
Regression statistics:
Professional: Avie = 0.95 (NGSP) + 0.004 r = 0.94
Self: Avie = 0.99 (NGSP) + 0.001 r = 0.94
Clinical sensitivity testing of professional vs. self testing conducted at four sites with 109 subjects within the linearity range combined results were:
Y=0.98S+0.003 r=0.94
The ability of untrained non-laboratory physician office staff was evaluated in an additional clinical sensitivity study conducted at three sites with 42 subjects. Testing comparing at least 2 untrained operators given only documented instructions and one trained operator per site resulted in the following combined values for trained vs. untrained operators:
Y=1.05x -0.1899 r^2 = 0.95
A comparison test of the Avie™ A1C Test System to the A1C Now+ was run at one site with 60 subjects with the following results:
Y=1.000x +0.004 r^2 = 0.981 venous
Y=0.993x +0.020 r^2 = 0.946 capillary
A comparison of venous to capillary samples using the Avie™ A1C Test System on 60 subjects results were:
Y=0.972x +0.191 r^2 = 0.947
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision: Percent coefficient of variation within 5%
Accuracy (estimated bias) Versus NGSP: Y=0.992±0.001 R=0.94 N=155
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).
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KOD269
MAR 2 0 2009
MEC 2 oynamics. MEC Dynamics, Corp. 2225 Martin Ave., Suite I Santa Clara, Ca 95050
SECTION 9 510(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 K081269.
MEC Dynamics Corporation 807.92 (a)(1): Name:
| Address: | 2225 Martin Avenue, Suite I
Santa Clara, CA 95050 |
|----------|------------------------------------------------------|
| Phone: | 408-844-9279 |
| FAX: | 408 844-9285 |
| Contact: | Mr. Emmanuel Mpock |
807.92 (a)(2): Device name- trade name and common name, and classification
Trade name: Avie™ A1C Test System
Common Name: Glycosylated hemoglobin assay
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 A1C test systems, and specifically, the G5 I/II HbA1C Test System (Provalis Diagnostics, Ltd.), most recently cleared under premarket notification K041635 on August 16, 2004.
807.92 (a)(4): Device Description
The Avie A1C test system is for the quantitative measurement of %A1C in fingerstick whole blood at the point-of-care (Professional or Physician Directed Home Use). The system consists of a small instrument ("Reader), a single-use diluent solution vial, single-use reagent test cartridges, and control levels I and II solutions.
To perform one test, the Reader is turned on by the push of a button on its top surface, and a self-check (optics and software) is performed automatically. If a
1
S MEC DYNAMICS MEC Dynamics, Corp. 2225 Martin Ave., Suite I Santa Clara, Ca 95050
malfunction is detected, the Reader displays an error message on the LCD display. When the LCD display denotes "Ready" a test cartridge is inserted into an unambiguous slot in the reader. About four uL of whole blood is delivered into a vial containing wash solution or diluent, via a transfer pipette, and the vial is inverted five times for mixing. At the instruction of the reader (LCD read-out), three drops of blood mixture are applied to a well in the cartridge: the reactions then proceed automatically. There are no further procedural steps, and results in %A1C are displayed on the reader's LCD screen in approximately three minutes. The concentration of A1C is expressed as a percentage of the total hemoglobin as follows: %HBA1C = (HBA1C ÷ TOTAL HB) ×100
807.92 (a)(5): Intended Use
The Avie™ Alc test is a point of care system that quantitatively measures %A1C (glycated hemoglobin) in capillary whole blood samples. The test is for Professional and Physician Directed home use to monitor glycemic control in people with diabetes.
2
807.92 (a)(6): Technological Similarities and Differences to the Predicate
Comparison between the Bayer A1C Now+™ the MEC Dynamics Avie™ A1C Systems
| Characteristic | Bayer A1CNow+ K051321 | MEC Dynamics Avie™ AIC K081269 |
|---|---|---|
| Intended Use | Quantitative measurement of the percent of | |
| glycated hemoglobin | 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 | Used in the management and treatment of | |
| diabetes, for monitoring long-term glycemic | ||
| control | ||
| Risk to patient | Not a critical analyte - reflects glucose level | |
| over time | Not a critical analyte - reflects glucose level | |
| over time | ||
| Sample | Whole blood | Whole blood |
| Visual display | LCD readout | LCD readout |
| Hemolysate preparation | Manual via sample dilution kit | Manual, pipette and diluent supplied |
| Methodology | Immunoassay | Immunoassay |
| Detection method | Four-channel reflectance photometer | Transmission |
| Calibration | Factory calibrated | Factory calibrated |
| Recommended testing | ||
| environment | Professional use | Prescription and Physician directed home use |
| Throughput | 5 minutes per sample | 3 minutes per sample |
| Reagent storage | Room temperature up to 120 days then | |
| refrigerate | Room temperature | |
| Quality control requirements | External controls testing recommended: |
- With each new shipment
- With each new lot
- With each new operator
- Whenever problems (storage, operator,
instrument, or other) are identified - To ensure the storage conditions have not
affected the product, run a control sample
before running a patient sample if the test
kit has been stored for more than a month
and it has been a least a month since the
last control testing. | External controls testing recommended:
-Prior to home testing or at the start of each
testing day.
-Upon receipt of each new shipment or use of
a new lot of cartridges
-Whenever storage room conditions have been
above 28°C (82°F).
-To become familiar with the process or to
perform training or retraining of testing
personnel.
-Whenever Avie™ Alc results do not match
other clinical findings or symptoms. |
| Precision | Percent coefficient of variation within 5% | Percent coefficient of variation within 5% |
| Accuracy (estimated bias) | Versus NGSP
Y= 1.02x- 0.23
R=0.95 N=189 | Versus NGSP
Y=0.992±0.001
R=0.94 N=155 |
| NGSP certification status | Certified | Certified |
3
MEC / DYNAMICS . MEC Dynamics, Corp. 2225 Martin Ave., Suite I Santa Clara, Ca 95050
807.92 (b)(1): Brief Description of Nonclinical Data
Studies were done that evaluated precision, linearity, interference, operational condition limits, and NGSP traceability for the Avie A1C Test System. The Avie A1C Test System demonstrates precision within 5 %CV at each of two levelsnormal and abnormal %A1C. The Avie A1C 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 system is sensitive to high levels of Metformin and glybenclamide (greater than 0.39 mg/dL and 0.02 mg/dL, respectively), as well as high levels of hemoglobinopathies. The Avie A1C Test System may be operated between temperatures of 18°C to 28°C. 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 150 subjects. Subjects first performed one Avie A1C test on themselves, and this was followed by a second Avie AlC 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.
Professional: Avie = 0.95 (NGSP) + 0.004 r = 0.94 Self: Avie = 0.99 (NGSP) + 0.001 r = 0.94
Clinical sensitivity testing of professional vs. self testing conducted at four sites with 109 subjects within the linearity range combined results were:
$$\text{Y=0.98S+0.003 r=0.94}$$
The ability of untrained non-laboratory physician office staff was evaluated in an additional clinical sensitivity study conducted at three sites with 42 subjects. Testing comparing at least 2 untrained operators given only documented instructions and one trained operator per site resulted in the following combined values for trained vs. untrained operators:
$$\text{Y=1.05x -0.1899 } \text{r}^{2\text{\textquotedblleft 0.95}}$$
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.
4
MEC Dynamics, Corp. 2225 Martin Ave., Suite I Santa Clara, Ca 95050
A comparison test of the Avie™ A1C Test System to the A1C Now+ was run at one site with 60 subjects with the following results:
Y=1.000x +0.004 $r^{2}$=0.981 venous Y=0.993x +0.020 $r^{2}$=0.946 capillary
A comparison of venous to capillary samples using the Avie™ A1C Test System on 60 subjects results were:
$$\text{Y=0.972x +0.191 r}^{2=} \text{0.947}$$
807.92 (b)(3): Conclusions from Nonclinical and Clinical Testing
Nonclinical and clinical testing was performed for the AvieTM A1C Test System. The test system was shown to be safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and features an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 0 2009
MEC Dynamics Corporation c/o Mr. Emmanuel Mpock 2225 Martin Ave, Suite 1 Santa Clara, CA 95050
Re: K081269
Trade/Device Name: Avie A1C Test System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: February 24, 2009 Received: February 25, 2009
Dear 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 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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Page - 2
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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MEC Dynamics Corporation Avie™ AIC Test System Premarket Notification
Indications for Use
510(K) Number (if known): K081269
Device Name: Avie™ A1C Test System
Indications for Use:
The AvieTM A1c test is a point of care system that quantitatively measures %A1C (glycated hemoglobin) in capillary or venous whole blood samples. The test is for prescription use and physician-directed home use to monitor glycemic control in people with diabetes mellitus. The device cannot be used in patients with hemoglobinopathies of HbF, HbC, and HbD.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Ruta club
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety