(379 days)
Tosoh HLC-723 G8
No
The summary describes a standard in vitro diagnostic test for measuring glycohemoglobin A1c. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis focuses on traditional analytical performance metrics and comparisons to predicate devices.
No
The device is an in vitro diagnostic test used to measure glycohemoglobin A1c, which is used for monitoring long-term glycemic control in individuals with diabetes. It is a diagnostic/monitoring device, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is "an in vitro diagnostic test" and is used to "quantitatively measure the percent glycohemoglobin Alc or glycohemoglobin A1c fraction mmol/mol in venous whole blood samples." This explicitly identifies it as a diagnostic device.
No
The device description and performance studies clearly indicate this is an in vitro diagnostic test system that measures glycohemoglobin in blood samples, implying the use of physical components (reagents, analyzer) to perform the measurement, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the A1C EZ Glycohemoglobin Analysis System is an in vitro diagnostic test.
- Measurement of Analytes in Biological Samples: The device is used to quantitatively measure glycohemoglobin A1c in venous whole blood samples. This is a classic characteristic of an IVD, which analyzes biological samples outside of the body to provide information about a person's health.
- Clinical Purpose: The test is intended to monitor long-term glycemic control in individuals previously diagnosed with diabetes, which is a clinical purpose.
- Professional Use in Clinical Laboratories: The intended user and setting are clinical laboratories, which is where IVD tests are typically performed.
N/A
Intended Use / Indications for Use
A1C EZ Glycohemoglobin Analysis System is an in vitro diagnostic test used to quantitatively measure the percent glycohemoglobin A1c or glycohemoglobin A1c fraction mmol/mol in venous whole blood samples. This system is intended for multiple patient use to monitor long term glycemic control in individuals previously diagnosed with diabetes. This test is not to be used for screening or diagnosis of diabetes or for neonatal use. The A1C EZ Glycohemoglobin Analysis System is intended for professional use in clinical laboratories only.
Product codes
LCP, JJE
Device Description
This product is used to quantitatively measure the percent glycohemoglobin A1c or glycohemoglobin A1c fraction mmol/mol in human whole blood sample.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Professional use in clinical laboratories only.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Internal precision studies were performed according to CLSI EP5-A2 on 1 instrument over 20 consecutive days using 3 lots of test kits. Sample from normal patient (Level 1, HbA1c% = 5.8%) and diabetic patient (Level 2, HbA1c% = 12.2%) were used. All labeled values of blood samples used were determined by Tosoh G8. Total CV for all lots combined was 3.3% at Level 1 and 2.8% at Level 2 for HbA1c % NGSP.
External precision studies evaluated repeatability and reproducibility at 3 external clinical sites. 10 sets of A1C EZ 2.0 analyzers, 3 lots of test strips, and 3 levels of K2-EDTA anticoagulated venous blood samples (level 1- 5.1%, level 2- 7.3%, level 3- 11.7%) were used. For each sample, every operator performed tests in 2 runs per day, with tests at each site finished in two days, using 10 sets of A1C EZ 2.0 analyzers with 3 different lots of test strips. A total of 120 tests were performed at each site for each sample. Total CV for all sites, operators, meters, and test strip lots was 3.1% (Level 1), 2.7% (Level 2), and 2.3% (Level 3) for % NGSP.
Linearity was evaluated according to CLSI EP06-A. Linear regression analysis showed a slope of 1.0334, intercept of -0.1628, and R-square of 0.9989 for A1C EZ 2.0 (HbA1c % NGSP).
Analytical specificity tests showed no significant interference from K2-EDTA, Heparin Sodium fluoride, Acetaminophen, Acetylcysteine, Acetylsalicylic acid, Ampicillin, Ascorbic acid, Bilirubin (conjugated and unconjugated), Cholesterol, Cyclosporine A, Doxycycline, Glucose, Glyburide, Hemoglobin, Hemolysis, Ibuprofen, Levodopa, Metformin, Metronidazole, Phenylbutazone, Rifampicin, Salicylic acid, Theophylline, Triglyceride, and Rheumatoid factor at specified concentrations. There was also no significant interference for Hemoglobin variants C (≤ 44.7%), D (≤ 41.7%), E (≤ 32.6%), S (≤ 37.8%), and F (≤ 14.7%).
Accuracy was evaluated by internal comparison study according to CLSI EP09-A2, comparing A1c EZ 2.0 with the reference HPLC device Tosoh HLC-723 G8 and the predicate device A1CNow+. Linear regression analysis results show for VS Tosoh HLC-723 G8 (HbA1c % NGSP): Lot 1 (Slope 0.973, Intercept 0.188, R-square 0.985), Lot 2 (Slope 0.979, Intercept 0.162, R-square 0.984), Lot 3 (Slope 0.989, Intercept 0.111, R-square 0.985). For VS A1CNow+ (HbA1c % NGSP): Lot 1 (Slope 0.966, Intercept 0.203, R-square 0.963), Lot 2 (Slope 0.976, Intercept 0.152, R-square 0.967), Lot 3 (Slope 0.989, Intercept 0.079, R-square 0.971).
Key Metrics
Internal precision (Total CV): For HbA1c % NGSP, Level 1: 3.3%, Level 2: 2.8%. For HbA1c mmol/mol IFCC, Level 1: 5.8%, Level 2: 4.4%.
External precision (Total CV all sites, operators, meters and test strip lots): % NGSP: Level 1: 3.1%, Level 2: 2.7%, Level 3: 2.3%. mmol/mol IFCC: Level 1: 5.3%, Level 2: 3.8%, Level 3: 2.8%.
Linear regression analysis of linearity test (HbA1c % NGSP): Slope 1.0334, Intercept -0.1628, R 0.9995, R2 0.9989.
Linear regression analysis of linearity test (HbA1c mmol/mol IFCC): Slope 1.0377, Intercept -1.4795, R 0.9995, R2 0.9990.
Accuracy compared to Tosoh HLC-723 G8 for %NGSP (R-Squared): Lot 1: 0.985, Lot 2: 0.984, Lot 3: 0.985.
Accuracy compared to A1CNow+ for %NGSP (R-Squared): Lot 1: 0.963, Lot 2: 0.967, Lot 3: 0.971.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June16, 2017
BIOHERMES CO., LTD C/O FIELD FU, SHENZHEN JOY ANTECH CONSULTING CO., LTD. ROOM 2032, INTERNATIONAL MAYORS COMMUNICATION CENTRE, NO. 55 SHIZHOU MIDDLE ROAD, NANSHAN DISTRICT SHENZHEN, GD755 CHINA
Re: K161533
Trade/Device Name: A1C EZ Glycohemoglobin Analysis System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP. JJE Dated: May 3, 2017 Received: May 8, 2017
Dear Field Fu:
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 (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.
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/Resourcesfor You/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,
Kellie B. Kelm -S
for 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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Indications for Use
510(k) Number (if known) K161533
Device Name
A1C EZ Glycohemoglobin Analysis System
Indications for Use (Describe)
A1C EZ Glycohemoglobin Analysis System is an in vitro diagnostic test used to quantitatively measure the percent glycohemoglobin Alc or glycohemoglobin A1c fraction mmol/mol in venous whole blood samples. This system is intended for multiple patient use to monitor long term glycemic control in individuals previously diagnosed with diabetes. This test is not to be used for screening or diagnosis of diabetes or for neonatal use. The A1C EZ Glycohemoglobin Analysis System is intended for professional use in clinical laboratories only.
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) |
|---|---|
| ------------------------------------------------ | ----------------------------------------------- |
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Contact Details
Product: A1C EZ Glycohemoglobin Analysis System
Version: A/4
K161533
1.1 Applicant information Applicant Name BioHermes Co., Ltd 2F, 3F, No. 136 Mashan Meiliang Road, Binhu District, Wuxi, China Address Phone No. +86-510-85991708 +86-510-85995258 Fax No. Contact person Rao Qiangying Contact person's e-mail raoqiangying@biohermes.com.cn Date Prepared March 28, 2016 Website www.biohermes.com
510(k) Summary
1.2 Submission Correspondent
| | Shenzhen Joyantech Consulting Co., Ltd
Room 2032, International Mayors Communication Centre, NO. 55
Shizhou middle road, Nanshan District, Shenzhen |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 卓远天成 |
| Phone No. | +86-755-86069197 |
| Contact person | Christy Young; Field Fu; |
| Contact person's e-mail | christy@cefda.com; cefda13485@163.com; |
| Website | http://www.cefda.com |
Device information 2.
| Trade name | A1C EZ Glycohemoglobin Analysis System |
|---|---|
| Common name | Percent Hemoglobin A1c (percent glycosylated hemoglobin) |
| Model | / |
| Classification | II; I |
| Classification name | Assay, Glycosylated Hemoglobin; Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Product code | LCP; JJE |
| Regulation No. | 864.7470;862.2160 |
3. Legally Marketed Predicate Device
| Trade Name | A1CNow+ (Professional Use) |
|---|---|
| 510(k) Number | K090413 |
| Product Code | LCP |
| Manufacturer | Bayer HealthCare Diabetes Care |
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4. Device Description
This product is used to quantitatively measure the percent glycohemoglobin A1c or glycohemoglobin A1c fraction mmol/mol in human whole blood sample.
5. Intended Use/Indication for Use
Product: A1C EZ Glycohemoglobin Analysis System
A1C EZ Glycohemoglobin Analysis System is an in vitro diagnostic test used to quantitatively measure the percent glycohemoglobin A1c or glycohemoglobin A1c fraction mmol/mol in venous whole blood samples. This system is intended for multiple patient use to monitor long term glycemic control in individuals previously diagnosed with diabetes. This test is not, to be used for screening or diagnosis of diabetes or for neonatal use. The A1C EZ Glycohemoglobin Analysis System is intended for professional use in clinical laboratories only.
| Proposed Device: | Predicate Device: | |
|---|---|---|
| Item | A1C EZ Glycohemoglobin Analysis System | A1CNow+ (Professional Use) |
| (K090413) | ||
| Product Code | LCP,JJE | LCP |
| Intended Use | A1C EZ Glycohemoglobin Analysis System | |
| is an in vitro diagnostic test used to | ||
| quantitatively measure the percent | ||
| glycohemoglobin A1c or glycohemoglobin | ||
| A1c fraction mmol/mol in venous whole blood | ||
| samples. This system is intended for multiple | ||
| patient use to monitor long term glycemic | ||
| control in individuals previously diagnosed | ||
| with diabetes. This test is not to be used for | ||
| screening or diagnosis of diabetes or for | ||
| neonatal use. The A1C EZ Glycohemoglobin | ||
| Analysis System is intended for professional | ||
| use in clinical laboratories only. | The A1CNow multi-use test provides | |
| quantitative measurement of the percent of | ||
| glycated hemoglobin (%HbAlc, %A1C) | ||
| levels in whole blood samples. The test is | ||
| for professional use for monitoring glycemic | ||
| control in people with diabetes. | ||
| Sample Types | Whole blood sample | Whole blood samples |
| Calibration | Automatic, not required by end-user | Not required by end-user; each unit is |
| factory calibrated | ||
| Testing | ||
| Environment | Professional Use | Professional Use |
| Room | ||
| Temperature | ||
| Stability | 18 months room temperature | 15 months room temperature |
| Methodology | Boronate Affinity | Immunoassay |
| Measuring | ||
| Range | 4%-14% HbA1c | 4%-13% HbA1c |
6. Substantial Equivalence Comparison
5
BioHermes Co., Ltd
SEC 005:001 510K Summary
Version: A/4
Product: A1C EZ Glycohemoglobin Analysis System
| Precision | The overall imprecision (including within-run, between-run, and between-day) was 3.3% CV at the low level and 2.8% CV at the high level. | The overall imprecision (including within-day and between day) was 3.00% CV at the low level and 4.02% CV at the high level. | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accuracy | Linear regression analysis of comparison study between A1c EZ 2.0 and Tosoh G8 Slop Intercept Lot1 0.973 0.188 Lot2 0.979 0.162 Lot3 0.989 0.111 | Linear regression analysis of comparison study between A1CNow+ and Tosoh A1c 2.2 Plus Slop Intercept 1.02 -0.23 | |||||||||||||||
| Analytical | |||||||||||||||||
| Specificity | INTERFERENT | ||||||||||||||||
| Bilirubin | TEST | ||||||||||||||||
| CONCENTRATION | |||||||||||||||||
| 60mg/dl | |||||||||||||||||
| Triglyceride | 900mg/dl | ||||||||||||||||
| Hemoglobin | 500 mg/dL | ||||||||||||||||
| Acetaminophen | 200 µg/mL | ||||||||||||||||
| Ascorbic acid | 30mg/dl | ||||||||||||||||
| INTERFERENT | |||||||||||||||||
| Bilirubin | TEST | ||||||||||||||||
| CONCENTRATION | |||||||||||||||||
| 20 mg/dL | |||||||||||||||||
| Triglyceride | 3000 mg/dL | ||||||||||||||||
| Hemoglobin | 500 mg/dL | ||||||||||||||||
| Acetaminophen | 80 µg/mL | ||||||||||||||||
| Ascorbic acid | 5 mg/dL |
lssue 1: Even though the Room Temperature Stability is different, but the performances between the proposed device within the stable period and the predicate device within the stable period are the same.
Issue 2: The A1c EZ 2.0 glycohemoglobin analysis system utilizes the boronate affinity lateral chromatography method to quantitatively measure the percentage of glycohemoglobinA1c (HbA1c) in total hemoglobin. A solid phase separation matrix in membrane contains both negatively charged groups and boronate groups. When buffer A which is acidic flows through the matrix membrane, positively charged hemoglobin (including glycohemoglobin and non-glycohemoglobin) bind to the negatively charged groups. When buffer B flows through and the pH turns basic, hemoglobin loses its positive charge and is released from the matrix. However, cis-diols of glycohemoglobin can bind with the boronate group and stays in the matrix. The device uses a photometer to measure the reflectance and calculate the ratio of the glycohemoglobin to the total hemoglobin.
A1cNow+'s work mechanism is immunoassay, which utilizes the specific recognition of antibodies to glycohemoglobin and non-glycohemoglobin respectively. Detection and quantification of HbA1c and normal hemoglobin are also achieved by measurement of reflectance by photometer. Although the test method of A1c Ez 2.0 and A1cNow+ differs, both of the devices use photochemistry and reflectance measure to quantify the percentage of glycohemoglobin. According to the comparison study, their accuracy is similar to each other.
7. Non-clinical Testing
- 7.1 Test strip stability test
The test strip's stability was tested and the test results showed that A1c Ez 2.0 HbA1c test kit can keep stable in room temperature for at least eighteen months.
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7.2 Traceability
The A1C EZ Glycohemoglobin Analysis System is certified with the National Glycohemoglobin Standardization Program (NGSP) and International Federation of Clinical Chemistry and laboratory medicine (IFCC).
7.3 Performance test-bench (Analysis Performance)
a) Precision and reproducibility
Internal precision
Precision studies in internal laboratory were performed according to CLSI EP5-A2. Sample from normal patient (Level 1, HbA1c% = 5.8%, all labeled value of blood sample used in this performance test were determined by Tosoh G8) and diabetic patient (Level 2, HbA1c% = 12.2%) were run in the precision study. The precision study was performed on 1 instrument over 20 consecutive days by using 3 lots of the test kits.
| CV % | Lot 1 | Lot 2 | Lot 3 | All lots combined | ||||
|---|---|---|---|---|---|---|---|---|
| Level 1 | Level 2 | Level 1 | Level 2 | Level 1 | Level 2 | Level 1 | Level 2 | |
| Within-run | 3.0% | 2.7% | 3.4% | 2.9% | 3.3% | 2.9% | 3.2% | 2.8% |
| Between-run | 0.8% | 0.5% | 0.0% | 0.0% | 1.3% | 0.0% | 0.9% | 0.0% |
| Between-day | 2.1% | 1.6% | 1.1% | 0.9% | 0.0% | 1.0% | 0.0% | 0.3% |
| Total | 3.8% | 3.1% | 3.5% | 3.0% | 3.5% | 3.1% | 3.3% | 2.8% |
Results of internal precision tests (HbA1c % NGSP)
| Results of internal precision tests (HbA1c mmol/mol IFCC) | |
|---|---|
| ----------------------------------------------------------- | -- |
| CV % | Lot 1 | Lot 2 | Lot 3 | All lots combined | ||||
|---|---|---|---|---|---|---|---|---|
| Level 1 | Level 2 | Level 1 | Level 2 | Level 1 | Level 2 | Level 1 | Level 2 | |
| Within-run | 4.8% | 3.2% | 5.4% | 3.5% | 5.2% | 3.6% | 5.3% | 3.4% |
| Between-run | 1.3% | 0.7% | 0.0% | 0.0% | 2.1% | 0.0% | 1.4% | 0.0% |
| Between-day | 3.4% | 1.9% | 1.7% | 1.1% | 0.0% | 1.2% | 0.0% | 0.5% |
| Total | 6.0% | 3.8% | 5.6% | 3.6% | 5.6% | 3.8% | 5.8% | 4.4% |
External precision
In this study, repeatability and reproducibility of A1C EZ 2.0 test strips have been evaluated at 3 external clinical sites. 10 sets of A1C EZ 2.0 analyzers, 3 lots of test strips and 3 levels of K2-EDTA anticoagulated venous blood samples (level 1- 5.1%, level 2- 7.3%, level 3- 11.7%) were used. For each sample, every operator performed the tests in 2 run per day, tests at each site were finished in two days) by 10 sets of A1C EZ 2.0 analyzers with 3 different lots of test strips. Totally 120 tests were performed at each site for each sample. The precision represented as CV and mean value by percentage are given as below:
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Version: A/4
| Level | 1 | 2 | 3 | |
|---|---|---|---|---|
| N | 360 | 360 | 360 | |
| % NGSP | MEAN | 5.09 | 7.37 | 11.54 |
| CV | 3.1% | 2.7% | 2.3% | |
| mmol/mol | ||||
| IFCC | MEAN | 32.2 | 57.1 | 102.6 |
| CV | 5.3% | 3.8% | 2.8% |
Table: Total CV includes all sites, operators, meters and test strip lots
Table: CV calculated for test strip lots
| Strip Lot | 1 | 2 | 3 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Level | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | |
| N | 120 | 120 | 120 | 120 | 120 | 120 | 120 | 120 | 120 | |
| % NGSP | MEAN | 5.09 | 7.37 | 11.57 | 5.10 | 7.35 | 11.47 | 5.09 | 7.41 | 11.58 |
| CV | 3.2% | 2.8% | 2.1% | 3.1% | 2.6% | 2.3% | 3.0% | 2.6% | 2.4% | |
| mmol/mol | ||||||||||
| IFCC | MEAN | 32.1 | 57.0 | 102.9 | 32.3 | 56.8 | 101.9 | 32.2 | 57.5 | 103.0 |
| CV | 5.5% | 4.0% | 2.5% | 5.3% | 3.7% | 2.9% | 5.2% | 3.6% | 2.9% |
Table: CV calculated for sites
| Site 1 | Site 2 | Site 3 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Level | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | |
| N | 120 | 120 | 120 | 120 | 120 | 120 | 120 | 120 | 120 | |
| % NGSP | MEAN | 5.04 | 7.29 | 11.49 | 5.06 | 7.43 | 11.57 | 5.11 | 7.40 | 11.56 |
| CV | 3.0% | 2.7% | 2.5% | 2.7% | 2.5% | 2.1% | 2.9% | 2.5% | 2.2% | |
| mmol/mol IFCC | MEAN | 31.6 | 56.2 | 102.0 | 32.9 | 57.7 | 103.0 | 32.0 | 57.3 | 102.8 |
| CV | 5.2% | 3.8% | 3.0% | 5.0% | 3.6% | 2.6% | 4.9% | 3.5% | 2.7% |
Table: CV calculated for operators
| Operator | 1 | 2 | 3 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Level | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | |||
| N | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | |||
| % NGSP | MEAN | 5.04 | 7.28 | 11.45 | 5.05 | 7.30 | 11.52 | 5.18 | 7.47 | 11.56 | ||
| CV | 3.0% | 3.0% | 2.4% | 3.0% | 2.3% | 2.5% | 2.8% | 2.5% | 2.1% | |||
| mmol/mol IFCC | MEAN | 31.5 | 56.1 | 101.6 | 31.6 | 56.2 | 102.4 | 33.0 | 58.1 | 102.8 | ||
| CV | 5.2% | 4.2% | 3.0% | 5.2% | 3.3% | 3.1% | 4.9% | 3.5% | 2.6% | |||
| Operator | 4 | 5 | 6 | |||||||||
| Level | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | |||
| N | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 | 60 |
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BioHermes Co., Ltd
SEC_005:001_510K Summary
| % NGSP | MEAN | 5.15 | 7.40 | 11.59 | 5.10 | 7.44 | 11.55 | 5.09 | 7.35 | 11.57 |
|---|---|---|---|---|---|---|---|---|---|---|
| CV | 3.0% | 2.5% | 2.2% | 3.1% | 2.7% | 2.2% | 3.0% | 2.1% | 2.4% | |
| mmol/mol | MEAN | 32.8 | 57.4 | 103.2 | 31.7 | 57.8 | 102.7 | 32.3 | 56.8 | 102.9 |
| IFCC | CV | 5.2% | 3.6% | 2.7% | 4.8% | 3.8% | 2.5% | 5.0% | 3.0% | 2.9% |
Product: A1C EZ Glycohemoglobin Analysis System
Version: A/4
b) Linearity and reportable range/detection limit
Linearity was evaluated according to CLSI EP06-A. The test results and linear regression analysis are given in Table 5.
Table 5: Linear regression analysis of linearity test
| Slope | Intercept | R | R2 | |
|---|---|---|---|---|
| A1C EZ 2.0 | ||||
| (HbA1c % NGSP) | 1.0334 | -0.1628 | 0.9995 | 0.9989 |
| A1C EZ 2.0 | ||||
| (HbA1c mmol/mol IFCC) | 1.0377 | -1.4795 | 0.9995 | 0.9990 |
The reportable range / detection limit of A1C EZ 2.0 is 4%~14% NGSP or 20-130 mmol/mol IFCC
c) Analytical specificity
Anticoagulants:
The results show that K2-EDTA, Heparin Sodium fluoride have no significant interference on HbA1c determination by A1c EZ 2.0 HbA1c Test System. Lithium Heparin,Sodium Fluoride or K2-EDTA venous whole blood are suitable to be used with the device.
General interference substance:
The following substances do not interfere with test result:
| Interfering Substance Study | Test Concentration |
|---|---|
| Acetaminophen | 200 mg/L |
| Acetylcysteine | 1,663 mg/L |
| Acetylsalicylic acid | 1,000 mg/L |
| Ampicillin | 1,000 mg/L |
| Ascorbic acid | 300 mg/L |
| Bilirubin, conjugated | 600 mg/L |
| Bilirubin, unconjugated | 600 mg/L |
| Cholesterol | 10,000 mg/L |
| Cyclosporine A | 5 mg/L |
| Doxycycline | 50 mg/L |
| Glucose | 10,000 mg/L |
| Glyburide | 2 mg/L |
| Hemoglobin | 500 mg/dL |
| Hemolysis (Hemolysate) | 5,000 mg/dL |
| lbuprofen | 500 mg/L |
| Levodopa | 20 mg/L |
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| Metformin | 40 mg/L |
|---|---|
| Metronidazole | 200 mg/L |
| Phenylbutazone | 400 mg/L |
| Rifampicin | 64 mg/L |
| Salicylic acid | 599 mg/L |
| Theophylline | 100 mg/L |
| Triglyceride | 9,000 mg/L |
| Rheumatoid factor | 491 IU/mL |
Hemoglobin variant interference
The results from the A1C EZ 2.0 Glycohemoglobin Analysis System show that there is no significant interference for Hemoglobin C (≤ 44.7%), Hemoglobin D (≤ 41.7%), Hemoglobin E (≤ 32.6%), Hemoglobin S (≤ 37.8%), and Hemoglobin F (≤ 14.7%)
-
- Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
- 8.1 Sample volume study:
The sponsor performed a study to verify the test strip minimum sample volume requirement and the test strip fill error requirement established for the HbA1c analyzer. Blood samples were tested at five sample volumes (0.5, 1.5, 3, 4 and 5.5μL). Results support the claimed sample volume of 2.5-4.5ul.
-
8.2 Test System operating conditions:
Operating conditions were evaluated for temperatures ranging from 50 ~104°F (10°C-40°C) and relative humidity from 10% to 90%. The following temperature and relative humidity (RH) conditions were tested: 22°C and 40% RH, 11°C and 11% RH, 10°C and 90% RH, 38°C and 10% RH, 40°C and 90% RH. Protocol and acceptance criteria were provided and found to be acceptable. The results supported the Sponsor's claimed operating temperature from 50 ~104°F and relative humidity range from 30% to 75%. -
8.3 Infection Control Studies:
Disinfection efficacy studies were performed on the materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Clorox Healthcare Bleach Germecidal Wipes (EPA Registraiton# 67619-12). Robustness studies were also performed to demonstrate that there was no change in performance or in external materials of the meter after 18250 cleaning and disinfection cycles with Clorox Healthcare Bleach Germecidal Wipes. The robustness studies were designed to simulate 5 years of multiple-patient use.
9. Accuracy
Internal comparison study was performed according to CLSI EP09-A2 to evaluate accuracy of A1c EZ 2.0. The A1c EZ 2.0 was compared with the reference HPLC device Tosoh HLC-723 G8 and the predicate device A1CNow+ in this study. Linear regression analysis results of the accuracy study are
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given as below:
Linear regression analysis of internal method comparison study (Unit: %NGSP)
| VS Tosoh HLC-723 G8 | VS A1CNow+ | |||||
|---|---|---|---|---|---|---|
| Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | |
| Slop | 0.973 | 0.979 | 0.989 | 0.966 | 0.976 | 0.989 |
| Intercept | 0.188 | 0.162 | 0.111 | 0.203 | 0.152 | 0.079 |
| R-square | 0.985 | 0.984 | 0.985 | 0.963 | 0.967 | 0.971 |
Linear regression analysis of internal method comparison study (Unit: mmol/IFCC)
| VS Tosoh HLC-723 G8 | VS A1CNow+ | |||||
|---|---|---|---|---|---|---|
| Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | |
| Slop | 0.975 | 0.979 | 0.989 | 0.966 | 0.975 | 0.988 |
| Intercept | 1.326 | 1.266 | 0.957 | 1.431 | 1.127 | 0.652 |
| R-square | 0.985 | 0.984 | 0.985 | 0.963 | 0.967 | 0.971 |
10. Conclusions
Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to legally marketed predicate devices (K090413).