The Avie™ Total Hb Test System is for the quantitative measurement of total hemoglobin in whole blood (capillary or venous EDTA,K2). The test system is designed for point-of-care use in primary care settings. The test system is for professional in vitro diagnostic use only.

Device Description

The Avie™ Total Hb Test System is a point of care (POC) IVD system that utilizes general chemistry reactions to quantify total hemoglobin in fresh capillary blood and venous blood. The test system includes a small instrument (Reader) and disposable reagent strips- the strips are packaged in a reusable canister with desiccant, similar to the packaging of routine urine test strips. The concentration of total hemoglobin is calculated photometrically and is based on the optical intensity of the reaction within the quantitative area of the test strip. The calibration of the Avie™ Total Hb Test is traceable to the same high-order reference method as the HemoCue (hemiglobincyanide [HiCN].

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the Avie™ Total Hb Test System based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for each performance metric (e.g., "Slope must be between 0.98 and 1.02"). Instead, it reports the results of the performed studies, implying that these results were considered acceptable for demonstrating substantial equivalence to the predicate device.

However, we can infer performance goals based on the reported values and the comparison to the HiCN method (a high-order reference method). The reported "r" values (correlation coefficients) close to 1.0 indicate a strong correlation, and slopes near 1.0 with y-intercepts near 0 indicate good agreement with the reference method. Precision %CV values in the low single digits ($<3%$) are generally considered good for hemoglobin measurement.

Performance Characteristic	Acceptance Criteria (Inferred / Implied)	Reported Device Performance
Linearity	Device should be linear across its operational range.	Linear range of 5 to 24 g/dL.
Precision (Non-Clinical)	Low %CV values, indicating reproducibility.	Level 1: %CV for Total Hb not explicitly provided (table unreadable). Level 2: %CV for Total Hb not explicitly provided (table unreadable). Level 3: %CV for Total Hb not explicitly provided (table unreadable).
Precision (Clinical - Site 1)	Low %CV values across different Hb levels.	Level 1 (5.6 g/dL): 1.0% CV Level 2 (11.1 g/dL): 2.1% CV Level 3 (14.3 g/dL): 2.0% CV
Precision (Clinical - Site 2)	Low %CV values across different Hb levels.	Level 1 (5.3 g/dL): 0.8% CV Level 2 (10.7 g/dL): 2.8% CV Level 3 (13.7 g/dL): 1.4% CV
Precision (Clinical - Site 3)	Low %CV values across different Hb levels.	Level 1 (5.4 g/dL): 1.2% CV Level 2 (10.8 g/dL): 3.0% CV Level 3 (14.1 g/dL): 2.3% CV
Accuracy (Capillary vs. HiCN)	High correlation (r ≈ 1), Slope ≈ 1, y-intercept ≈ 0.	n=177, Min=9.5 g/dL, Max=18.0 g/dL, Slope=1.02, y-intercept=0.13, "r"=0.97
Accuracy (Venous vs. HiCN)	High correlation (r ≈ 1), Slope ≈ 1, y-intercept ≈ 0.	n=224, Min=5.1 g/dL, Max=23.5 g/dL, Slope=1.04, y-intercept=-0.42, "r"=0.99
Interference	No significant interference from common substances at specified concentrations.	Not affected by listed interferents at specified concentrations (Acetaminophen, etc.).

Note: The precision summary table for the 20-day in-house precision test is largely unreadable in the provided text. Therefore, specific %CV values for that section cannot be extracted.

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

Linearity Study Test Set: 11 samples. Data provenance is implied to be in-house (non-clinical).
20-day In-house Precision Test Set: 80 per level (for 3 levels), totaling 240 measurements. Data provenance is in-house (non-clinical).
Clinical Precision Study Test Set: 30 measurements per level per site, for 3 sites and 3 levels (total of 270 measurements). Data provenance is from "three external POL-type sites" (Physician's Office Laboratory), indicating prospective clinical data from human samples, likely from the US or a similar regulatory jurisdiction given the FDA submission.
Clinical Accuracy Study Test Set:
- Capillary vs. HiCN: 177 patient samples.
- Venous vs. HiCN: 224 patient samples.
  Data provenance is from "three US clinical sites," indicating prospective clinical data from human samples within the United States.

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

This type of information is not applicable to this device. The Avie™ Total Hb Test System is an in vitro diagnostic (IVD) device that measures a quantitative biomarker (total hemoglobin). The "ground truth" for such devices is established by a reference method (HemoCue® 201+, hemiglobincyanide [HiCN]) rather than through expert consensus or interpretation of images/data by human experts.

4. Adjudication Method for the Test Set

This is not applicable as the ground truth is established by a reference laboratory method (HiCN) and the predicate device (HemoCue® 201+), not by subjective expert assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study typically applies to imaging or diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the AI's impact on human performance.
The Avie™ Total Hb Test System is an automated IVD device that provides a quantitative result. Its performance is compared to a reference method, not to human reader interpretations. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment was done. The entire study, particularly the accuracy and precision sections, evaluates the Avie™ Total Hb Test System (device and strips) as an algorithm/system in measuring hemoglobin. The resulting numerical values (e.g., slope, intercept, 'r' value, %CV) represent the device's standalone performance compared to the reference method. There is no human interpretation component integrated into the device's core measurement process that would make it "human-in-the-loop" in the artificial intelligence sense.

7. The Type of Ground Truth Used

The ground truth used for the accuracy studies was:

Reference Method: Hemiglobincyanide (HiCN) method (CLSI reference method, CLSI Doc H15-A3).

8. The Sample Size for the Training Set

The document does not explicitly describe a training set in the context of machine learning or AI algorithm development. The Avie™ Total Hb Test System is described as utilizing "general chemistry reactions" and "photometric measurement." It is a traditional IVD device, not an AI/ML-driven one. Therefore, the concept of a "training set" for an AI model is not applicable here. The device is factory-calibrated based on the HiCN method.

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

As noted above, the concept of a "training set" in the AI/ML sense is not applicable. The device is factory calibrated against the HiCN method. This calibration process establishes the internal parameters and algorithms of the device to accurately convert photometric measurements into hemoglobin concentrations, using the HiCN method as the standard for correctness.

Summary

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JAN 7 2013

SECTION 8 510(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 K121752.

807.92 (a)(1): Name:	MEC Dynamics Corporation
Address:	90 Rose Orchard WaySan 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

Trade name: Avie™ Total Hb Test System

Common Name: Total Hemoglobin Analyzing System

Classification: Total hemoglobin assay, §21 CFR 864.5620

807.92 (a)(3): Identification of the legally marketed predicate devices

HemoCue® 201+ (HemoCue AB, Sweden)

807.92 (a)(4): Device Description

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MEC

DYNAMICS

807.92 (a)(5): Indications Use

The Avie™ Total Hb Test System is for the quantitative measurement of total hemoglobin in whole blood (capillary or venous EDTA, K2). The test system is designed for point-of-care use in primary care settings. The test system is for professional in vitro diagnostic use only.

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

The following chart describes similarities and differences between the two test systems.

Characteristic	HemoCue® 201+ SystemK041234	Avie™ Total HbK121752
Sample Type	Capillary and venous whole blood	Capillary and venous EDTA, K2 whole blood
Visual Display	LCD readout	LCD readout
Test Principle	General chemistry using a modifiedazidemethohemoglobin reaction.Reaction takes 60 sec	Photometric measurement of totalHemoglobin concentration in sample.Final results in 15 sec
Calibration	Factory calibrated	Factory calibrated reader against HiCNmethod (CLSI reference method, CLSIDoc H15-A3).
RecommendedTestingEnvironment	Doctors' offices	Doctors' offices
ReagentStorage	Room temperature	Room temperature
OperatingConditions	65-90 ° F (18-32°C), less than 85%relative humidity (withoutcondensation).	59-113 ° F (15-45°C), less than 85%relative humidity (without condensation).
ReportableRange	0- 25.6 g/dL	5- 24.0 g/dL
Quality ControlRequirements	Users are directed to perform dailyelectronic quality control testing andliquid control testing: with each newshipment and/or lot of test strips, orwhen test results are suspect	Users are directed to perform daily liquidcontrol testing, testing of each newshipment and/or lot of test strips, or whentest results are suspect

807.92 (b)(1): Brief Description of Nonclinical Data

A series of studies were performed that evaluated the following nonclinical performance characteristics: linearity, 20-day in-house precision, and interference testing,

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Linearity

Eleven samples that spanned a wide range of Hb concentrations were prepared by mixing various proportions of low and high concentration samples. The samples were assayed by Avie™, and observed results were compared to expected results, based on the mathematical calculations of the proportions. The linear range of the Avie™ test system is 5 to 24 g/dL.

20-day In-house Precision

The studies followed CLSI EP5-A2, where three levels of samples were each tested fourtimes a day for 20 days. The results were as follows:

Precision Summary:

FREE LABOR CLASS CLE	Canada C. Call	Mean (g/dL	Within-Dav	Total %CV
Total Hb	10-14-4-6-8-10-Level	t reg+------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	6000	e446
n= 80 per level	Level Z	ﺎ.	t	But All of All and Collection Collection Collection Collection Comercial Concession Comercial Concession Comercial Concession Comercial Concession Comercial Concession Comerct40 4 40
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	evel 3	Anﺎ ﻓﻲ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ	-------------------------------------------------------------------------------------------------.	.

Interference Testing

The studies followed CLSI EP7-A2. The data demonstrated that the Avie™ Total Hb Test System was not affected by high levels of the following substances at the levels noted:

Interferent	Interferent Concentration (mg/dL)
Acetaminophen	20.0
Acetylsalicylic acid	65.2
L-Ascorbic acid	3.0
Bilirubin (unconjugated)	10.0
Creatinine	5.0
Ibuprofen	50.0
Intralipid	400
Tetracycline	1.51
Urea	257
Uric acid	23.5

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Image /page/3/Picture/0 description: The image shows the logo for MEC Dynamics. The logo features the letters "MEC" in bold, sans-serif font, positioned above the word "DYNAMICS", which is also in a bold, sans-serif font. A curved line runs above the letters "MEC" and below the word "DYNAMICS", creating a visual frame for the text.

807.92 (b)(2): Brief Description of Clinical Data

Studies for precision and method comparison (accuracy) were performed at three external POL-type sites to evaluate the Avie™ Total Hb Test System in one of its targeted intended use environments, the physician's office laboratory.

Precision:

Three controls (low, mid and high Total Hb) were tested over multiple days, by multiple operators at multiple sites.

			Level 1			Level 2			Level 3
Site #	Operators	Days	n	Mean	SD	%CV	n	Mean	SD	%CV	n	Mean	SD	%CV
Site 1	5	3	30	5.6	0.1	1.0	30	11.1	0.2	2.1	30	14.3	0.3	2.0
Site 2	6	2	30	5.3	0.0	0.8	30	10.7	0.3	2.8	30	13.7	0.2	1.4
Site 3	8	2	30	5.4	0.1	1.2	30	10.8	0.3	3.0	30	14.1	0.3	2.3

Accuracy:

Accuracy studies were conducted at three US clinical sites. A total of nine (9) Avie™ Total Hb Readers and four (4) Avie™ Total Hb Test strip lots were used for this study. Capillary and venous sampling was performed on each patient for testing on the Avie™ Total Hb System. A portion of the sampled capillary and venous blood was tested for total hemoglobin using the HiCN method for comparison. The results ranged from 5.1 to 23.5 g/dL total hemoglobin. Comparative results are shown below.

	n	Min g/dL	Max g/dL	Slope	y-intercept	"r"
Avie TM Professional Capillary vs. HiCN	177	9.5	18.0	1.02	0.13	0.97
AvieTM Venous vs. HiCN	224	5.1	23.5	1.04	-0.42	0.99

807.92 (b)(3): Conclusions from Nonclinical and Clinical Testing t

Nonclinical and clinical testing was performed for the Avie Total Hb 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

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Public Health Service

JAN

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

7 2013

MEC Dynamics Corporation (MEC) c/o Mr. Emmanuel Mpock President and CEO 90 Rose Orchard Way San Jose. California 95134

Re: K121752

Trade/Device Name: Avie™ Total Hb Test System

Regulation Number: 21 CFR §864.5620 Regulation Name: Automated hemoglobin system Regulatory Class: II Product Code: GKR Dated: December 26, 2012 Received: December 28, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Emmanuel Mpock

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Maria M. Chan -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(K) Number (if known): K121752

Device Name: Avie™ Total Hb Test System

Indications for Use:

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 (OVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Regulation Number and Section

§ 864.5620 Automated hemoglobin system.

(a)
Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.(b)
Classification. Class II (performance standards).