(498 days)
Not Found
No
The device description and performance studies focus on spectrophotometry and antigen-antibody reactions, with no mention of AI or ML.
No
This device is an in vitro diagnostic device used to measure hemoglobin A1c for monitoring long-term glucose control. It does not provide any therapeutic intervention.
Yes
The 'Intended Use' section states, "The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use..."
No
The device description explicitly states it is comprised of a "fully automated desktop electric spectrophotometer" and a "dedicated cartridge," which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The system is for in vitro diagnostic use".
- Nature of the Test: The device measures the percent of hemoglobin A1c in blood samples. This is a test performed on biological samples outside of the body to provide information about a person's health status. This is the definition of an in vitro diagnostic test.
- Intended Use: The intended use is for "monitoring long-term glucose control of persons with diabetes," which is a clinical purpose.
- Device Description: The description details a "spectrophotometer that measures HbA1c in capillary or venous whole blood samples" using reagents and antigen-antibody reactions, all of which are characteristic of in vitro diagnostic methods.
N/A
Intended Use / Indications for Use
The URight Hemoglobin A1c System is intended to quantitatively measure the percent of hemoglobin A1c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use.
The URight Hemoglobin A1c Control Solution is intended for use as quality control material for the URight Hemoglobin A1c System.
The FORA A1c System is intended to quantitatively measure the percent of hemoglobin A1c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use.
The FORA A1c Control Solution is intended for use as quality control material for the FORA A1c System.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JJE, JJX
Device Description
The hemoglobin A1c system is comprised of a fully automated desktop electric spectrophotometer that measures HbA1c in capillary or venous whole blood samples collected in EDTA (K2 and K3) or sodium heparin using a dedicated cartridge, which is pre-filled with the reagent; latex (reagent 1), antibody and sample dilute solution (reagent 2). The hemoglobin A1c system shines a light through the test material and measures the quantity of hemoglobin A1c in the total hemoglobin (HbA1c %) based on the lot-specific reagent parameters and changes in light absorbency caused by antigen-antibody reactions.
Two levels of hemoglobin A1c control are provided for routine quality checks - level 1 in the normal HbA1c range and level 2 in the elevated HbA1c range. The HbA1c controls are lyophilized hemolysates prepared from packed human erythrocytes.
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
clinical laboratory and point of care use. Professional and Point of Care 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)
Linearity: Varying amounts two fresh EDTA blood samples, 4.3% and 13% HbA1c, were mixed to in different proportions to obtain 11 samples. Two additional samples, 14.3% and 15.5% HbA1c, were created by spiking fresh blood sample. A linear regression was calculated based on the Tosoh G8 vs. measured % HbA1c values.
Results: Slope = 1.0037, Intercept = 0.0355, R2 = 0.9913, Recovery (%) = 95-104.
Precision: Two levels HbA1c control solutions and three levels of blood samples were used for precision evaluation on three different sites. The expected values were determined by Tosoh G8. Within-run precision was perform measurements from each sample with 20 tests. Between day precision were tested from each sample in duplicate twice a day for 20 days.
Results:
Control solution Low level (Expected value 5.7):
- Site 1: Mean 5.9 (Within run), 5.8 (Between run), 5.8 (Between day)
- Site 2: Mean 5.7 (Within run), 5.7 (Between run), 5.7 (Between day)
- Site 3: Mean 5.8 (Within run), 5.7 (Between run), 5.7 (Between day)
- Combined: Mean 5.8 (Within run), 5.7 (Between run), 5.7 (Between day)
Control solution High level (Expected value 11.3): - Site 1: Mean 11.4 (Within run), 11.3 (Between run), 11.3 (Between day)
- Site 2: Mean 11.4 (Within run), 11.2 (Between run), 11.2 (Between day)
- Site 3: Mean 11.2 (Within run), 11.3 (Between run), 11.2 (Between day)
- Combined: Mean 11.3 (Within run), 11.3 (Between run), 11.2 (Between day)
Blood sample Low level (Expected value 5.5): - Site 1: Mean 5.3 (Within run), 5.3 (Between run), 5.3 (Between day)
- Site 2: Mean 5.3 (Within run), 5.3 (Between run), 5.3 (Between day)
- Site 3: Mean 5.3 (Within run), 5.3 (Between run), 5.3 (Between day)
- Combined: Mean 5.3 (Within run), 5.3 (Between run), 5.3 (Between day)
Blood sample Middle level (Expected value 7.7): - Site 1: Mean 7.9 (Within run), 7.8 (Between run), 7.8 (Between day)
- Site 2: Mean 7.7 (Within run), 7.7 (Between run), 7.6 (Between day)
- Site 3: Mean 7.6 (Within run), 7.7 (Between run), 7.7 (Between day)
- Combined: Mean 7.7 (Within run), 7.7 (Between run), 7.7 (Between day)
Blood sample High level (Expected value 10.3): - Site 1: Mean 10.4 (Within run), 10.4 (Between run), 10.4 (Between day)
- Site 2: Mean 10.4 (Within run), 10.5 (Between run), 10.5 (Between day)
- Site 3: Mean 10.4 (Within run), 10.5 (Between run), 10.5 (Between day)
- Combined: Mean 10.4 (Within run), 10.5 (Between run), 10.5 (Between day)
Accuracy: A method comparison study was performed with 149 EDTA venous blood and 146 capillary blood patient samples in three different sites. Samples were analyzed on TD-4601 Hemoglobin A1c Reagent Cartridge and compared with Tosoh G8 analyzer.
Results:
- Site 1, Capillary (49 tests): y = 1.002x - 0.016, R2 = 0.9834
- Site 1, K2EDTA venous blood (49 tests): y = 1.018x - 0.101, R2 = 0.9807
- Site 2, Capillary (48 tests): y = 1.015x - 0.044, R2 = 0.9846
- Site 2, K2EDTA venous blood (50 tests): y = 1.022x - 0.076, R2 = 0.9885
- Site 3, Capillary (49 tests): y = 0.958x + 0.280, R2 = 0.9849
- Site 3, K3EDTA venous blood (50 tests): y = 0.968x + 0.160, R2 = 0.9861
Interference: The following interfering substances at the indicated concentrations produce less than 6% deviation when tested at indicated concentration: Acetaminophen 20 mg/dL, Glibenclamide 0.19 mg/dL, Ibuprofen 50 mg/dL, Metformin 4 mg/dL, Triglycerides 3000 mg/dL, Bilirubin (unconjugate) 20 mg/dL, Ascorbic acid 3 mg/dL, Rheumatoid factor 26 IU/mL, Carbamylated Hb 5 mmol/L, and Acetylated Hb 5 mmol/L. The testing results also indicate there is no significant interference for HbC
§ 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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other to create a sense of depth. The profiles are connected to a flowing, ribbon-like shape that resembles a wing or a wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 29, 2016
TAIDOC TECHNOLOGY CORPORATION PAUL LIU REGULATORY AFFAIRS SPECIALIST 6F, NO. 127, WUGONG 2ND RD. WUGU DISTRICT NEW TAIPEI CITY, 24888 TAIWAN
Re: K142664 Trade/Device Name: URight Hemoglobin A1c System. FORA A1c System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP, JJE, JJE, JJX Dated: January 21, 2016 Received: January 27, 2016
Dear Paul Liu:
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142664
Device Name URight Hemoglobin A1c System
Indications for Use (Describe)
The URight Hemoglobin A I c System is intended to quantitatively measure the percent of hemoglobin A le in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A 1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use.
The URight Hemoglobin A1c Control Solution is intended for use as quality control material for the URight Hemoglobin Alc System.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Indications for Use
510(k) Number (if known) K142664
Device Name FORA Alc System
Indications for Use (Describe)
The FORA A ic System is intended to quantitatively measure the percent of hemoglobin A 1 c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use.
The FORA A1c Control Solution is intended for use as quality control material for the FORA A1c System.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Section 9 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The Assigned 510(k) number is:_ K142664
1. Submitter Information
| Company Name: | TaiDoc Technology Corporation |
|---|---|
| Contact Person: | Paul Liu |
| Title: | Regulatory Affairs Specialist |
| Address: | B1-7F, No. 127, Wugong 2nd Rd., Wugu Township, Taipei County |
| 24888, Taiwan | |
| Phone: | +886-2-6625-8188 |
| Fax: | +886-2-6625-0288 |
| E-mail: | paul@taidoc.com.tw |
| Prepared Date: | January 21st, 2016 |
2. Device name
| Proprietary Name: | URight Hemoglobin A1c System |
|---|---|
| URight Hemoglobin A1c Control Solution | |
| FORA A1c System | |
| FORA A1c Control Solution | |
| Common Name: | Glycosylated hemoglobin assay |
| Discrete photometric chemistry analyzer | |
| Analyte controls | |
| Product Code: | LCP |
| JJE | |
| JJX |
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| Classification Panel: | Hematology
Clinical Chemistry
Clinical Chemistry |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification: | Class II
Class I
Class I |
| Regulation Citation: | 21 CFR 864.7470, Hemoglobin A1c test system
21 CFR 862.2160, Discrete photometric chemistry analyzer
for clinical use.
21 CFR862.1660, Quality control material (assayed and
unassayed) |
3. Predicate Device
| Proprietary Name: | DCA VANTAGE (K071466) |
|---|---|
| HEMOGLOBIN A1C REAGENT SET (K031539) | |
| Common Name: | Glycosylated hemoglobin assay |
| Analyte controls |
4. Intended Use
URight Hemoglobin A1c System
The URight Hemoglobin A1c System is intended to quantitatively measure the percent of hemoglobin A 1c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A 1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use.
The URight Hemoglobin A1c Control Solution is intended for use as quality control material for the URight Hemoglobin A1c System.
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FORA A1c System
The FORA A1c System is intended to quantitatively measure the percent of hemoglobin A1c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use.
The FORA A1c Control Solution is intended for use as quality control material for the FORA A1c System.
5. Device Description:
The hemoglobin A1c system is comprised of a fully automated desktop electric spectrophotometer that measures HbA1c in capillary or venous whole blood samples collected in EDTA (K2 and K3) or sodium heparin using a dedicated cartridge, which is pre-filled with the reagent; latex (reagent 1), antibody and sample dilute solution (reagent 2). The hemoglobin A1c system shines a light through the test material and measures the quantity of hemoglobin A1c in the total hemoglobin (HbA1c %) based on the lot-specific reagent parameters and changes in light absorbency caused by antigen-antibody reactions.
Two levels of hemoglobin A1c control are provided for routine quality checks - level 1 in the normal HbA1c range and level 2 in the elevated HbA1c range. The HbA1c controls are lyophilized hemolysates prepared from packed human erythrocytes.
6. Test Principle:
The hemoglobin A1c system is an immuno-turbidimetric method enhanced by latex particles using a two-reagent sequence. Hemolysate is mixed with the reagent 1. Addition of the reagent 2 leads to agglutination complexes, formed by the interaction between latex-bound HbA1c and the corresponding antibodies. Turbidity created by these aggregates is proportional to the amount of latex-bound HbA Ic therefore is proportional to the % of HbA1c in the total hemoglobin.
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7. Comparison with Predicate
Hemoglobin A1c test system
| Similarities and Differences | ||||
|---|---|---|---|---|
| Item | New Device | Predicate Device | ||
| Intended Use | Quantitative measurement | Same | ||
| of the percent Hemoglobin | ||||
| A1c in human whole blood. | ||||
| Methodology | Immuno-turbidimetric | Same | ||
| Sample Type | whole blood samples, | Whole blood and finger | ||
| venous whole blood (K2 or | stick samples | |||
| K3 EDTA or sodium | ||||
| heparin) or capillary whole | ||||
| blood from fingertips | ||||
| Recommended Testing | Professional and Point of | Same | ||
| Environment | Care Use | |||
| Analytical Range | 4.0-16.0% | 2.5 - 14.0% | ||
| Reagent storage | 2-8°C | Same |
Hemoglobin A1c control
| Similarities and Differences | ||||
|---|---|---|---|---|
| Item | New Device | Predicate Device | ||
| Intended Use | Intended for use as quality | |||
| control materials | Same | |||
| Format (Material) | Lyophilized hemolysates | Same | ||
| Levels | Level 1, Level 2 | Same | ||
| Storage Conditions | 2-8°C | Same | ||
| Use Lifetime | 3 weeks after reconstitution | 4 weeks after reconstitution |
8. Performance Characteristics:
• Linearity
Varying amounts two fresh EDTA blood samples, 4.3% and 13% HbA1c, were mixed to in different proportions to obtain 11 samples. Two additional samples, 14.3% and 15.5% HbA1c, were created by spiking fresh blood sample. A linear regression was calculated
8
based on the Tosoh G8 vs. measured % HbA1c values.
| Slope | Intercept | R2 | Recovery (%) |
|---|---|---|---|
| 1.0037 | 0.0355 | 0.9913 | 95-104 |
• Precision
Two levels HbA1c control solutions and three levels of blood samples were used for precision evaluation on three different sites. The expected values were determined by Tosoh G8. Within-run precision was perform measurements from each sample with 20 tests. Between day precision were tested from each sample in duplicate twice a day for 20 days.
| Sample | Site | n | Expected
value | Within run | | | Between run | | | n | Between day | | |
|----------|----------|----|-------------------|------------|------|-------|-------------|------|-------|-----|-------------|------|-------|
| | | | | Mean | SD | %CV | Mean | SD | %CV | | Mean | SD | %CV |
| Control | 1 | 20 | 5.7 | 5.9 | 0.22 | 3.75% | 5.8 | 0.10 | 1.79% | 80 | 5.8 | 0.20 | 3.48% |
| solution | 2 | 20 | | 5.7 | 0.24 | 4.24% | 5.7 | 0.13 | 2.19% | 80 | 5.7 | 0.20 | 3.47% |
| Low | 3 | 20 | | 5.8 | 0.25 | 4.32% | 5.7 | 0.11 | 1.99% | 80 | 5.7 | 0.22 | 3.82% |
| level | Combined | 60 | | 5.8 | 0.25 | 4.35% | 5.7 | 0.12 | 2.02% | 240 | 5.7 | 0.21 | 3.61% |
| Control | 1 | 20 | 11.3 | 11.4 | 0.44 | 3.88% | 11.3 | 0.24 | 2.11% | 80 | 11.3 | 0.43 | 3.78% |
| solution | 2 | 20 | | 11.4 | 0.44 | 3.85% | 11.2 | 0.25 | 2.22% | 80 | 11.2 | 0.44 | 3.89% |
| High | 3 | 20 | | 11.2 | 0.40 | 3.55% | 11.3 | 0.25 | 2.24% | 80 | 11.2 | 0.46 | 4.12% |
| level | Combined | 60 | | 11.3 | 0.43 | 3.77% | 11.3 | 0.24 | 2.16% | 240 | 11.2 | 0.44 | 3.92% |
| Blood | 1 | 20 | 5.5 | 5.3 | 0.15 | 2.87% | 5.3 | 0.10 | 1.88% | 80 | 5.3 | 0.20 | 3.79% |
| sample | 2 | 20 | | 5.3 | 0.22 | 4.14% | 5.3 | 0.11 | 2.01% | 80 | 5.3 | 0.21 | 4.04% |
| Low | 3 | 20 | | 5.3 | 0.17 | 3.18% | 5.3 | 0.13 | 2.54% | 80 | 5.3 | 0.20 | 3.70% |
| level | Combined | 60 | | 5.3 | 0.18 | 3.46% | 5.3 | 0.12 | 2.18% | 240 | 5.3 | 0.20 | 3.87% |
| Blood | 1 | 20 | 7.7 | 7.9 | 0.33 | 4.18% | 7.8 | 0.13 | 1.62% | 80 | 7.8 | 0.30 | 3.91% |
| sample | 2 | 20 | | 7.7 | 0.38 | 4.95% | 7.7 | 0.10 | 1.36% | 80 | 7.6 | 0.29 | 3.85% |
| Middle | 3 | 20 | | 7.6 | 0.27 | 3.58% | 7.7 | 0.16 | 2.08% | 80 | 7.7 | 0.30 | 3.90% |
| level | Combined | 60 | | 7.7 | 0.35 | 4.50% | 7.7 | 0.14 | 1.79% | 240 | 7.7 | 0.30 | 3.92% |
| Blood | 1 | 20 | 10.3 | 10.4 | 0.34 | 3.26% | 10.4 | 0.17 | 1.66% | 80 | 10.4 | 0.36 | 3.43% |
| sample | 2 | 20 | | 10.4 | 0.37 | 3.60% | 10.5 | 0.18 | 1.67% | 80 | 10.5 | 0.36 | 3.39% |
| High | 3 | 20 | | 10.4 | 0.35 | 3.43% | 10.5 | 0.17 | 1.63% | 80 | 10.5 | 0.37 | 3.49% |
| level | Combined | 60 | | 10.4 | 0.35 | 3.38% | 10.5 | 0.18 | 1.70% | 240 | 10.5 | 0.36 | 3.46% |
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· Accuracy
| TD-4601 Hemoglobin A1c Reagent Cartridge and compared with Tosoh G8 analyzer. | ||||
|---|---|---|---|---|
| Site No. | Sample type | No. of tests | regression line | R2 |
| 1 | Capillary | 49 | $y = 1.002x - 0.016$ | 0.9834 |
| 1 | K2EDTA venous blood | 49 | $y = 1.018x - 0.101$ | 0.9807 |
| 2 | Capillary | 48 | $y = 1.015x - 0.044$ | 0.9846 |
| 2 | K2EDTA venous blood | 50 | $y = 1.022x - 0.076$ | 0.9885 |
| 3 | Capillary | 49 | $y = 0.958x + 0.280$ | 0.9849 |
| 3 | K3EDTA venous blood | 50 | $y = 0.968x + 0.160$ | 0.9861 |
A method comparison study was performed with 149 EDTA venous blood and 146 capillary blood patient samples in three different sites. Samples were analyzed on TD-4601 Hemoglobin A1c Reagent Cartridge and compared with Tosoh G8 an
• Interference
The following interfering substances at the indicated concentrations produce less than 6% deviation when tested at indicated concentration: Acetaminophen 20 mg/dL, Glibenclamide 0.19 mg/dL, Ibuprofen 50 mg/dL, Metformin 4 mg/dL, Triglycerides 3000 mg/dL, Bilirubin (unconjugate) 20 mg/dL, Ascorbic acid 3 mg/dL, Rheumatoid factor 26 IU/mL, Carbamylated Hb 5 mmol/L, and Acetylated Hb 5 mmol/L. The testing results also indicate there is no significant interference for HbC ≤37.4%, HbD ≤48.5%, HbE ≤21.4% and HbA2