(498 days)
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.
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.
The provided document is a 510(k) Summary for the URight Hemoglobin A1c System and FORA A1c System. It describes the device, its intended use, and performance characteristics in comparison to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the performance characteristics. Instead, it presents the results of various validation studies (linearity, precision, accuracy, interference, matrix comparison) which demonstrate the device's performance against a reference method (Tosoh G8 analyzer) or established expectations for diagnostic devices of this type.
Interpretation for Acceptance Criteria and Performance:
For this type of device, "acceptance criteria" are typically implied requirements for analytical performance that are considered acceptable for clinical use and demonstrate substantial equivalence to a predicate device. These criteria often relate to quantitative measures like R-squared values for correlation, percent recovery for linearity, and Coefficients of Variation (CV%) for precision.
Given the context, I will infer the acceptance criteria based on generally accepted standards for HbA1c assays and what is presented as demonstrating acceptable performance for regulatory approval.
| Performance Characteristic | Inferred Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|---|
| Linearity | R² ≥ 0.98 or similar high correlation; Recovery within a tight range (e.g., 90-110%) | R² = 0.9913; Recovery = 95-104% |
| Precision (Within-run %CV) | Should be low, typically < 5% for clinical assays, especially for control solutions and patient samples. | Control solution (Low): 3.75% - 4.32% (across sites) Control solution (High): 3.55% - 3.88% (across sites) Blood sample (Low): 2.87% - 4.14% (across sites) Blood sample (Middle): 3.58% - 4.95% (across sites) Blood sample (High): 3.26% - 3.60% (across sites) |
| Precision (Between day %CV) | Should be low, typically < 5-10% for clinical assays. | Control solution (Low): 3.47% - 3.82% (across sites) Control solution (High): 3.78% - 4.12% (across sites) Blood sample (Low): 3.70% - 4.04% (across sites) Blood sample (Middle): 3.85% - 3.92% (across sites) Blood sample (High): 3.39% - 3.49% (across sites) |
| Accuracy (Regression R²) | R² ≥ 0.95 (strong correlation to reference method) | Capillary blood: 0.9834, 0.9846, 0.9849 (across sites) Venous blood (K2/K3 EDTA): 0.9807, 0.9885, 0.9861 (across sites) |
| Accuracy (Slope & Intercept) | Slope close to 1, intercept close to 0 (indicating good agreement with reference) | Capillary blood: Slopes 0.958-1.015, Intercepts -0.044 to 0.280 Venous blood: Slopes 0.968-1.022, Intercepts -0.101 to 0.160 |
| Interference | < 6% deviation from target | Achieved for listed substances: Acetaminophen, Glibenclamide, Ibuprofen, Metformin, Triglycerides, Bilirubin, Ascorbic acid, Rheumatoid factor, Carbamylated Hb, Acetylated Hb. No significant interference for: HbC ≤37.4%, HbD ≤48.5%, HbE ≤21.4% and HbA2 < 7.0%. Interference noted for: HbF at 21.2% and HbS at 20.3% (lower than expected HbA1c result). |
| Matrix Comparison (R²) | R² ≥ 0.98 (strong correlation between different sample types) | EDTA vs. Capillary: 0.9896 Sodium heparin vs. Capillary: 0.9885 Sodium heparin vs. EDTA: 0.9879 |
2. Sample sizes used for the test set and the data provenance
- Linearity Test Set: 11 samples (varying proportions of 4.3% and 13% HbA1c fresh EDTA blood samples) + 2 spiked samples (14.3% and 15.5% HbA1c).
- Data Provenance: Not explicitly stated, but likely from a laboratory setting as fresh EDTA blood samples are mentioned. No country of origin is specified. Retrospective/Prospective not specified, but the description implies a prospective creation of samples for the study.
- Precision Test Set:
- Control Solutions: 2 levels of HbA1c control solutions.
- Within-run: 20 tests per control level per site.
- Between-run/Between-day: 80 tests (duplicate twice a day for 20 days) per control level per site. Total n=240 combined across 3 sites for combined between-day.
- Blood Samples: 3 levels of blood samples.
- Within-run: 20 tests per blood level per site.
- Between-run/Between-day: 80 tests (duplicate twice a day for 20 days) per blood level per site. Total n=240 combined across 3 sites for combined between-day.
- Data Provenance: Not explicitly stated for samples but tested at "three different sites." No country of origin is specified. Implies prospective testing.
- Control Solutions: 2 levels of HbA1c control solutions.
- Accuracy Test Set:
- Capillary: 49 (site 1), 48 (site 2), 49 (site 3) = Total 146 samples.
- Venous (K2EDTA/K3EDTA): 49 (site 1), 50 (site 2), 50 (site 3) = Total 149 samples.
- Data Provenance: "patient samples in three different sites." No country of origin is specified. Appears to be prospective.
- Interference Test Set:
- Not specified, but tested with a list of "interfering substances at indicated concentrations." Likely controlled laboratory samples rather than patient samples.
- Matrix Comparison Test Set: 135 samples (HbA1c range 4.5-13%).
- Data Provenance: "collected from 3 POC sites." No country of origin is specified. Implies prospective collection and testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for all performance studies (Linearity, Precision, Accuracy) was established by comparison to the Tosoh G8 analyzer. The Tosoh G8 is a widely accepted and certified reference method for HbA1c measurement.
- No human "experts" (like radiologists) were used to establish ground truth in the traditional sense of medical imaging.
- The comparison is against another established, automated analytical device. Therefore, no information on the number or qualifications of human experts is provided or relevant in this context.
4. Adjudication method for the test set
Not applicable. The ground truth is an analytical measurement from a reference instrument (Tosoh G8), rather than expert consensus requiring an adjudication method.
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
Not applicable. This device is an automated in vitro diagnostic (IVD) system for measuring HbA1c. It does not involve human readers evaluating images or assisting in diagnostic interpretation in the way an AI-powered diagnostic imaging tool would. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the studies presented (Linearity, Precision, Accuracy, Interference, Matrix Comparison) are all standalone performance studies for the URight/FORA A1c System. The device directly measures HbA1c levels, and its performance is assessed independently against a reference method and defined criteria, without human intervention in the measurement process itself.
7. The type of ground truth used
The ground truth used for performance evaluation (linearity, precision, accuracy) was established by measurements obtained from the Tosoh G8 analyzer, which serves as a reference method or known comparative standard for HbA1c testing. For interference and matrix comparison, presumed "true" values or the behavior of various matrices were also assessed against this or similar established analytical standards.
8. The sample size for the training set
The document does not provide information about a "training set" in the context of an algorithm. This device is a spectrophotometer-based immunoassay system, not an AI/machine learning algorithm requiring a specific training dataset in the typical sense. The device's operational parameters (e.g., reagent lot-specific parameters) are predetermined and not "trained" on a large dataset of patient results.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a "training set" for an algorithm for this type of device.
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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.
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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
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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.
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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: | HematologyClinical ChemistryClinical Chemistry |
|---|---|
| Classification: | Class IIClass IClass I |
| Regulation Citation: | 21 CFR 864.7470, Hemoglobin A1c test system21 CFR 862.2160, Discrete photometric chemistry analyzerfor clinical use.21 CFR862.1660, Quality control material (assayed andunassayed) |
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 qualitycontrol 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
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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 | Expectedvalue | 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 < 7.0%. HbF shows interference at 21.2% and HbS shows interference at 20.3%. HbF and HbS levels tested with this assay show interference and samples containing HbF or HbS will show a lower than expected HbA1c result.
• Matrix comparison
The study was performed using 135 samples, with a HbA1c range from 4.5-13%, collected from 3 POC sites in the matrix of capillary blood, K2EDTA venous blood, K3EDTA venous blood and sodium heparin venous blood.
| Matrix comparison | Regression line | R2 |
|---|---|---|
| EDTA vs. Capillary | y = 0.978x + 0.301 | 0.9896 |
| Sodium heparin vs. Capillary | y = 0.982x + 0.227 | 0.9885 |
| Sodium heparin vs. EDTA | y = 0.999x - 0.033 | 0.9879 |
9. Limitations
This test is not for screening or diagnosis of diabetes or neonatal use
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- For clinical laboratory and point-of care use .
- For prescription use only
- . This test should not be used in monitoring daily glucose control
- This test should not be used to replace daily home testing of urine and blood glucose levels •
- . This test should not be used for analyzing samples from patients with conditions causing shortened red blood cell survival, such as hemolytic diseases, pregnancy and significant acute or chronic blood loss
- HbF and HbS levels tested with this assay show interference and samples containing HbF or HbS will . show a lower than expected HbA1c result
10. Reference range
The American Diabetes Association (ADA) expected value range is 4.0-6.0% HbA1c for people without diabetes. The American Diabetes Association's (ADA) most recent Clinical Practice Recommendation for diabetes specified a treatment goal of less than 7% and suggests additional action when HbA1c level is above 8%.
| HA1c Value | Glycemic Goal |
|---|---|
| <8% HbA1c | Less stringent |
| <7% HbA1c | General (Non-Pregnant Adult) |
| <6.5% HbA1c | More stringent |
As recommended by the ADA, patients in the range of 5.7-6.4% HbA1c would be in the category of increased risk for diabetes.
Source: American Diabetes Association. Diabetes Care 38 (2015): Suppl. 1. S8-S40
11. Conclusion
Based on the information provided in this submission, the URight Hemoglobin A1c System / FORA A1c System and URight Hemoglobin A1c Control Solution / FORA A1c Control Solution are substantially equivalent to the predicate device.
§ 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).