(207 days)
HemoCue® 201+ (HemoCue AB, Sweden)
Not Found
No
The device description and performance studies focus on standard photometric measurement and general chemistry reactions, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is an in vitro diagnostic (IVD) system designed to measure total hemoglobin for diagnostic purposes, not to treat or alleviate a medical condition.
Yes
The device is an "in vitro diagnostic device" (IVD) based on the "Intended Use / Indications for Use" and "Device Description" sections, which states it's for "quantitative measurement of total hemoglobin in whole blood" and "for professional in vitro diagnostic use only."
No
The device description explicitly states that the system includes a "small instrument (Reader)" and "disposable reagent strips," indicating it is a hardware-based system with software components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The test system is for professional in vitro diagnostic use only."
- Device Description: The "Device Description" section also refers to it as a "point of care (POC) IVD system".
- Function: The device measures total hemoglobin in whole blood, which is a biological sample taken from the body and analyzed in vitro (outside the body) to provide diagnostic information.
- Care Setting: It is intended for use in a professional healthcare setting (primary care settings, doctors' offices) for diagnostic purposes.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GKR
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].
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
point-of-care use in primary care settings. The test system is for professional in vitro diagnostic use only.
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)
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.
Nonclinical Data:
- Linearity: Eleven samples spanning a wide range of Hb concentrations were prepared and assayed. The linear range of the Avie™ test system is 5 to 24 g/dL.
- 20-day In-house Precision: Studies followed CLSI EP5-A2, with three levels of samples tested four times a day for 20 days (n=80 per level).
- Interference Testing: Studies followed CLSI EP7-A2. The data demonstrated that the Avie™ Total Hb Test System was not affected by high levels of various substances (Acetaminophen, Acetylsalicylic acid, L-Ascorbic acid, Bilirubin (unconjugated), Creatinine, Ibuprofen, Intralipid, Tetracycline, Urea, Uric acid) at noted concentrations.
Clinical Data:
- Precision: Three controls (low, mid and high Total Hb) were tested over multiple days by multiple operators at multiple sites (three external POL-type sites).
- Site 1: n=30 per level (Level 1 mean 5.6 g/dL, SD 0.1, %CV 1.0; Level 2 mean 11.1 g/dL, SD 0.2, %CV 2.1; Level 3 mean 14.3 g/dL, SD 0.3, %CV 2.0)
- Site 2: n=30 per level (Level 1 mean 5.3 g/dL, SD 0.0, %CV 0.8; Level 2 mean 10.7 g/dL, SD 0.3, %CV 2.8; Level 3 mean 13.7 g/dL, SD 0.2, %CV 1.4)
- Site 3: n=30 per level (Level 1 mean 5.4 g/dL, SD 0.1, %CV 1.2; Level 2 mean 10.8 g/dL, SD 0.3, %CV 3.0; Level 3 mean 14.1 g/dL, SD 0.3, %CV 2.3)
- Accuracy (method comparison): Conducted at three US clinical sites using nine Avie™ Total Hb Readers and four Avie™ Total Hb Test strip lots. Capillary and venous sampling was performed on each patient, with a portion tested using the HiCN method for comparison. Results ranged from 5.1 to 23.5 g/dL total hemoglobin.
- Avie™ Professional Capillary vs. HiCN: n=177, Min g/dL 9.5, Max g/dL 18.0, Slope 1.02, y-intercept 0.13, "r" 0.97
- Avie™ Venous vs. HiCN: n=224, Min g/dL 5.1, Max g/dL 23.5, Slope 1.04, y-intercept -0.42, "r" 0.99
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
HemoCue® 201+ (HemoCue AB, Sweden)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/16 description: The image shows the logo for MEC Dynamics. The word "MEC" is in large, bold letters at the top of the image. Below that, the word "DYNAMICS" is in smaller, bold letters. There is a curved line above the word "MEC" and a dot in the middle of the curved line.
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 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
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
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].
1
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+ System
K041234 | Avie™ Total Hb
K121752 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 modified
azidemethohemoglobin reaction.
Reaction takes 60 sec | Photometric measurement of total
Hemoglobin concentration in sample.
Final results in 15 sec |
| Calibration | Factory calibrated | Factory calibrated reader against HiCN
method (CLSI reference method, CLSI
Doc H15-A3). |
| Recommended
Testing
Environment | Doctors' offices | Doctors' offices |
| Reagent
Storage | Room temperature | Room temperature |
| Operating
Conditions | 65-90 ° F (18-32°C), less than 85%
relative humidity (without
condensation). | 59-113 ° F (15-45°C), less than 85%
relative humidity (without condensation). |
| Reportable
Range | 0- 25.6 g/dL | 5- 24.0 g/dL |
| Quality Control
Requirements | Users are directed to perform daily
electronic quality control testing and
liquid control testing: with each new
shipment and/or lot of test strips, or
when test results are suspect | Users are directed to perform daily liquid
control testing, testing of each new
shipment and/or lot of test strips, or when
test 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,
2
Image /page/2/Picture/0 description: The image shows the logo for MEC Dynamics. The logo is in black and white. The word MEC is on the top line, and the word DYNAMICS is on the bottom line. There are two curved lines above and below the words.
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 | e
446 |
| 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 Comerc
t
40 4 40 |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | evel 3 | An
ﺎ 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 |
3
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.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
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
5
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
6
Indications for Use
510(K) Number (if known): K121752
Device Name: Avie™ Total Hb Test System
Indications for 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.
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