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.

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).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Avie™ A1C System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state formal "acceptance criteria" in a numerical or target performance format (e.g., "accuracy must be > 95%"). However, it does report on performance metrics that would typically be used to assess the device's suitability. Based on the "Brief Description of Nonclinical Data" and "Brief Description of Clinical Data" sections, here's an interpretation of relevant performance characteristics:

Performance Metric	Acceptance Criteria (Implied/Derived)	Reported Device Performance
Precision	%CV within 5% at normal and abnormal levels	Within 5% CV at each of two levels (normal and abnormal %A1C)
Linearity	Linear over the intended measurement range	Linear between 5 and 14 %A1C
Interference	Insensitive to high physiological levels of common interferents and therapeutic drug levels; sensitive to certain hemoglobin variants	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. May report unreliable results if high levels of Hemoglobin D, Hemoglobin C, or other hemoglobin variants are present.
NGSP Traceability	Certified traceability to NGSP standards	NGSP issued a certificate of traceability granting manufacturer certification to MEC Dynamics, Corporation.
User Capillary Blood Regression (Non-Professional vs. NGSP)	Strong correlation and close agreement to NGSP reference method	y = 0.976 (NGSP) + 0.151, r = 0.987 (174 subjects)
User Capillary Blood Regression (Professional vs. NGSP)	Strong correlation and close agreement to NGSP reference method	y = 0.973 (NGSP) + 0.172, r = 0.988 (174 subjects)
User Capillary Blood Regression (Non-Professional vs. Professional)	Strong correlation and close agreement between user types	y = 0.998 (Professional Users) + 0.019, r = 0.984 (169 sample pairs)
Professional Venous Blood Regression (Professional vs. NGSP)	Strong correlation and close agreement to NGSP reference method	y = 0.972 (NGSP) + 0.210, r = 0.993 (279 whole blood samples)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- For non-professional user capillary results: 174 subjects
- For professional user capillary results: 174 subjects
- For comparison between professional and non-professional capillary users: 169 capillary sample pairs
- For professional user venous results: 279 whole blood samples
Data Provenance: The document does not explicitly state the country of origin for the data. It mentions "Clinical studies were conducted across four sites" and "Venous blood was collected and sent to the NGSP laboratory in Columbia, MO," indicating the clinical data was likely collected in the United States and sent to a US-based reference lab. The data is prospective as it describes studies being conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth for the clinical studies (determination of %A1C values) was established by the National Glycohemoglobin Standardization Program (NGSP) laboratory in Columbia, MO.
The number and specific qualifications of individual experts at the NGSP laboratory are not detailed in the provided text, but the NGSP provides "certified laboratory value assigned blood samples" and "a certificate of traceability," implying a high level of expertise and standardized methodology.

4. Adjudication Method for the Test Set

The document implies that the NGSP laboratory results serve as the definitive ground truth for comparison. There is no mention of an adjudication method for the test set data between multiple readers or methods other than the direct comparison of the Avie™ A1C system's results against the NGSP reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not explicitly described in the provided text. The study compares the device's performance against a reference method (NGSP) and also compares professional vs. non-professional users of the device itself. It does not assess the improvement of human readers with AI vs. without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance assessment was done. The Avie™ A1C System is a point-of-care device that directly measures %A1C. The clinical studies compare the device's output (whether operated by a professional or non-professional) directly against the NGSP reference standard. This is a standalone assessment of the device's measurement capabilities. The "algorithm" in this context refers to the internal workings of the device to produce the %A1C result.

7. The Type of Ground Truth Used

The primary ground truth used was NGSP certified laboratory values, which represent a standardized and highly accurate reference method for glycated hemoglobin (A1C) measurement. This is a form of expert consensus on a standardized analytical method.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. The described studies are performance evaluations (clinical and non-clinical) of the device. The device itself is calibrated using "NGSP certified laboratory value assigned blood samples," and lot-specific information is transferred via RFID. This suggests that the device's internal algorithms and calibrations are established via a robust process, but specific "training set" details are not provided for a machine learning context.

9. How the Ground Truth for the Training Set Was Established

As mentioned above, the document states: "MEC Dynamics, Corp. calibrates the Avie™ A1C System using National Glycohemoglobin Standardization Program (NGSP) certified laboratory value assigned blood samples." This indicates the ground truth for calibration (which can be considered analogous to "training" in a broad sense for a medical device) is established by using NGSP-certified reference materials with known, highly accurate %A1C values.

Summary

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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

.....

K093548 Section 5 pg 1

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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

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807.92 (a)(6): Technological Similarities and Differences to the Predicate

Parameter	Avie™ A1C Test SystemModified K093548	Avie™ A1C Test SystemK091400
Intended Use	SAME	Quantitative measurement of thepercent of glycated hemoglobin
Indications for Use	Used in the management andtreatment of diabetes, formonitoring long-term glycemiccontrol. Device can not be usedpatients with elevated levels ofHbC and HbDhemoglobinopathies.	Used in the management andtreatment of diabetes, formonitoring long-term glycemiccontrol.
Sample Type	SAME	Whole blood
Sample Preparation	Direct application, touch testcartridge to blood drop	Pipette 5µL into diluent vial,invert 5 times
Calibration	SAME	Cartridge calibration is automaticvia RFID
Methodology	SAME	Immunoassay and generalchemistry
Reagent Packaging	SAME	15 Cartridges in a desiccantlined, tamper evident canister
Testing Environment	SAME	Professional use and physiciandirected 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

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	25° C)	28° C)
Display	SAME	% A1C
Diluent	15ml LDPE dropper multi-usebottle	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

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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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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

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Indications for Use

510(k) Number (if known): K093548

Device Name: Avie™ AIC System

Indications for Use:

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

Page 1 of /

Regulation Number and Section

§ 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).