(205 days)
Not Found
No
The device description and performance studies focus on standard HPLC technology and data analysis methods, with no mention of AI or ML algorithms. The "Advisor" feature is described as comparing reports against programmed rules, which is a rule-based system, not necessarily AI/ML.
No.
The device is described as an in vitro diagnostic (IVD) test for measuring HbA1c levels, which is used as an aid in the diagnosis and monitoring of diabetes. It does not directly treat or alleviate a disease, but rather provides diagnostic and monitoring information.
Yes
The indication for use states that "Hemoglobin A1c measurements are used as an aid in diagnosis of diabetes mellitus". This directly points to the device's utility in diagnosing a medical condition.
No
The device description clearly outlines hardware components like a high-pressure pumping system, analytical cartridge, detector, and flow cell, which are integral to the device's function. While software is mentioned for data analysis, it is part of a larger hardware system.
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 D-100™ HbA1c test is intended for the quantitative determination of hemoglobin A1c in human whole blood. This is a biological sample taken from the human body.
- Purpose: The intended use also clearly states that these measurements are used as an aid in diagnosis of diabetes mellitus, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. These are all diagnostic and monitoring purposes related to a disease state.
- Method: The device description details a method (ion-exchange high-performance liquid chromatography - HPLC) used to analyze the components of the human whole blood sample.
- Professional Use Only: The indication for "Professional Use Only" is common for IVD devices used in clinical laboratory settings.
- Calibrators: The mention of calibrators specifically for the quantitative determination of HbA1c in human whole blood further supports its use in a diagnostic context.
Based on these points, the D-100™ HbA1c test fits the definition of an In Vitro Diagnostic device, as it is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The D-100™ HbA1c test is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood using ion-exchange high-performance liquid chromatography (HPLC) on the D-100 Hemoglobin Testing System.
Hemoglobin A1c measurements are used as an aid in diagnosis of diabetes mellitus, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.
The D-100TM HbA1c test is intended for Professional Use Only.
Calibrators:
The D-100™ HbA1c Calibrator Pack is for the calibration of the D-100 Hemoglobin Testing System used for the quantitative determination of hemoglobin A1c(HbA1c) in human whole blood.
Product codes (comma separated list FDA assigned to the subject device)
PDJ, LCP, JIT
Device Description
The Bio-Rad D-100™ HbA1c utilizes principles of ion-exchange high-performance liquid chromatography (HPLC). A high-pressure pumping system delivers a buffer solution to an analytical cartridge and detector. Whole blood samples undergo an automatic hemolysis and dilution process before being introduced into the analytical flow path. Prediluted samples are identified based upon the use of a microvial adapter in the sample rack, and the automatic dilution step is omitted.
A programmed buffer gradient of increasing ionic strength delivers the sample to the analytical cartridge where the hemoglobin species are separated based upon their ionic interactions with the cartridge material and the buffer gradient. The separated hemoglobin species then pass through the flow cell where changes in the absorbance are measured at 415 nm and recorded as a digital chromatogram.
The software performs an analysis of the hemoglobin peaks in the chromatogram, recording information including retention time, peak area, and relative are percent. Any peaks that are identified as the target analyte(s) are calibrated before generating a sample report and chromatogram for each sample. The software includes an optional feature (Advisor) that compares the sample report against a set of rules that are programmed to take user-specified actions.
The D-100™ HbA1c test is designed to be used on the D-100™ Hemoglobin Testing System.
Reagents:
The D-100™ HbA1c reagents contain the following components:
Description
D-100 ™ HbAic Analytical Cartridge/Calibrator Pack. One pack consisting of:
- . Cation exchange cartridge. 10,000 tests each
- . Calibrator Pack: 1 vial of Conditioner, 1 vial of Calibrator Level 1, and 1 vial of Calibrator Level 2. The vials contain Ivophilized human whole blood with glycine and trehalose as preservatives.
D-100 TM Prefilters. 2000 tests each. Package of 5.
D-100 ™ Cleaning Tube. One microvial containing 1.5 mL of a liquid cleaning solution. Single use.
D-100 ™ Sample Diluent. Each bottle contains 1 L of deionized water with
§ 862.1373 Hemoglobin A1c test system.
(a)
Identification. A hemoglobin A1c test system is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA.
(2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity, and interference, including the following:
(i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 percent hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least three lots of the device and three instruments, as applicable.
(ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. Results must demonstrate little or no bias versus the standardized method.
(iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6 percent.
(iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S.
(3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles, suggesting health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BIO-RAD LABORATORIES, INC. JACKIE BUCKLEY REGULATORY AFFAIRS REP IV 4000 ALFRED NOBEL DR. HERCULES CA 94547
December 9, 2015
Re: K151321 Trade/Device Name: D-100™ HbA1c D-100™ HbA1c Calibrator Pack Regulation Number: 21 CFR 862.1373 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: PDJ, LCP, JIT Dated: November 06, 2015 Received: November 09, 2015
Dear Jackie Buckley:
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,
Katherine Serrano -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
2
Indications for Use
510(k) Number (if known) K151321
Device Name D-100™ HbA1c D-100™ HbA1c Calibrator Pack
Indications for Use (Describe)
The D-100™ HbA1c test is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood using ion-exchange high-performance liquid chromatography (HPLC) on the D-100 Hemoglobin Testing System.
Hemoglobin A1c measurements are used as an aid in diagnosis of diabetes mellitus, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.
The D-100TM HbA1c test is intended for Professional Use Only.
Calibrators:
The D-100™ HbA1c Calibrator Pack is for the calibration of the D-100 Hemoglobin Testing System used for the quantitative determination of hemoglobin A1c(HbA1c) in human whole blood.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
510(k) Summary (Summary of Safety and Effectiveness)
This Summary of 510(k) Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K151321
Date Summary prepared: Nov. 4, 2015
1. Applicant Name:
Bio-Rad Laboratories, Inc. Clinical Diagnostics Group 4000 Alfred Nobel Drive Hercules, California 94547
2. Contact Person(s):
Jackie Buckley, Regulatory Affairs Representative IV Telephone Number: (510) 741-5309 FAX: (510) 741-6471 E-Mail: jackie buckley@bio-rad.com
Alfred Evans, RA/QA Director Telephone Number: (510) 741-4579 FAX: (510) 741-6471 E-Mail:al_evans@bio-rad.com
3. Device Name/Trade Name:
Reagents:
Trade Name: D-100™ HbA1c Classification Name: Assay, Glycosylated Hemoglobin Common Name: HbA1c Product Code: PDJ, LCP C.F.R Section: 21 CFR 862.1373 Device classification: Class II Panel Classification: Chemistry
Calibrators:
Trade Name: D-100™ HbA1c Calibrator Pack Classification Name: Calibrator, Secondary Common Name: Calibrator Product Code: JIT C.F.R Section: 21 CFR 862.1150 Device classification: Class II Panel Classification: Clinical Chemistry
4. Predicate Device:
| Predicate Device
Name | Predicate Device
510(k) Number |
|---------------------------------------|-----------------------------------|
| VARIANT II TURBO HbA1c Kit -2.0 | K142448 |
| VARIANT II Hemoglobin A1c Calibrators | K070452 |
4
5. Description of the Device:
The Bio-Rad D-100™ HbA1c utilizes principles of ion-exchange high-performance liquid chromatography (HPLC). A high-pressure pumping system delivers a buffer solution to an analytical cartridge and detector. Whole blood samples undergo an automatic hemolysis and dilution process before being introduced into the analytical flow path. Prediluted samples are identified based upon the use of a microvial adapter in the sample rack, and the automatic dilution step is omitted.
A programmed buffer gradient of increasing ionic strength delivers the sample to the analytical cartridge where the hemoglobin species are separated based upon their ionic interactions with the cartridge material and the buffer gradient. The separated hemoglobin species then pass through the flow cell where changes in the absorbance are measured at 415 nm and recorded as a digital chromatogram.
The software performs an analysis of the hemoglobin peaks in the chromatogram, recording information including retention time, peak area, and relative are percent. Any peaks that are identified as the target analyte(s) are calibrated before generating a sample report and chromatogram for each sample. The software includes an optional feature (Advisor) that compares the sample report against a set of rules that are programmed to take user-specified actions.
The D-100™ HbA1c test is designed to be used on the D-100™ Hemoglobin Testing System.
Reagents:
The D-100™ HbA1c reagents contain the following components:
Description
D-100 ™ HbAic Analytical Cartridge/Calibrator Pack. One pack consisting of:
- . Cation exchange cartridge. 10,000 tests each
- . Calibrator Pack: 1 vial of Conditioner, 1 vial of Calibrator Level 1, and 1 vial of Calibrator Level 2. The vials contain Ivophilized human whole blood with glycine and trehalose as preservatives.
D-100 TM Prefilters. 2000 tests each. Package of 5.
D-100 ™ Cleaning Tube. One microvial containing 1.5 mL of a liquid cleaning solution. Single use.
D-100 ™ Sample Diluent. Each bottle contains 1 L of deionized water with 9% | 11 | 8.5 |
| Total samples | 129 | 100 |
Table 13: Distribution of samples
Deming (weighted) and Passing-Bablok regression analyses were performed for the D-100™ HbA1c versus the NGSP SRL reference method. Deming (weighted), Passing
12
Bablok and Linear regression analyses were performed for the D-100™ HbA1c on the D-100 Hemoglobin Testing System versus the reference G8 HPLC method are summarized in Table 14.
Table 14: Summary of Method Comparison Results
| y-Intercept | 95% CI | Slope | 95% CI | |
|---|---|---|---|---|
| Deming | 0.0223 | -0.0684 – 0.1131 | 0.9867 | 0.9736 – 0.9999 |
| Passing- | ||||
| Bablok | -0.0091 | -0.0803 – 0.0763 | 0.9909 | 0.9789 – 1.0026 |
Image /page/12/Figure/3 description: This image is a scatter plot with a Deming fit. The x-axis is labeled "% HbA1c, NGSP SRL" and the y-axis is labeled "% HbA1c, D100 HbA1C". The data points are clustered tightly around the Deming fit line, and the R-squared value is 0.9996.
Figure 1: Scatter Plot using Deming Fit, %HbA1c, NGSP SRL vs. D-100 HbA1c.
- (1) The following biases between D-100 HbA1c versus NGSP SRL Method (Reference method) were observed in Table 15.
| % HbA1c - Decision
| Level | Bias | % Bias |
|---|---|---|
| 5.0 | -0.047 | -0.85 |
13
| 6.5 | -0.066 | -0.98 |
|---|---|---|
| 8.0 | -0.090 | -1.11 |
| 12.0 | -0.190 | -1.57 |
Total Error Decision Levels
Using the results of bias estimation (%Bias) in the method comparison study and precision estimates in the reproducibility study, Total Error (TE) at four concentrations: (5.0 %, 6.5%, 8.0% and 12.0%) were calculated as follows: %TE=|%Bias| + 1.96 CV (1 + %Bias). The results are presented in Table 16.
Table 16: Total Error Estimation
| % A1c – Decision Level | % Bias | % CV | % TE |
|---|---|---|---|
| 5.0 | -0.85 | 1.7 | 4.2 |
| 6.5 | -0.98 | 1.5 | 3.9 |
| 8.0 | -1.11 | 1.3 | 3.6 |
| 12.0 | -1.57 | 1.2 | 3.9 |
- d. Traceability, Stability, Expected Values (calibrators)
The D-100 HbA1c test standardization is traceable to the International Federation of Clinical Chemistry (IFCC) reference calibrators. The D-100 HbA1c assay is NGSP certified. The NGSP certification expires in one year. See NGSP website for current certification at http://www.ngsp.org. The derived results of (%) from the NGSP correlation are calculated from the individual quantitative results for Hemogloblin A1c (HbA1c). The International Federation of Clinical Chemistry (IFCC) units of mmol/mol are calculated using the Master Equation NGSP (%) = 0.09148 x IFCC (mmol/mol) + 2.152. HbA1c results are provided to the customers using two different units: NGSP equivalent units (%) and IFCC equivalent units (mmol/mol).
Calibrator Materials:
Value assignment for D-100™ HbA1c Calibrators are traceable to IFCC reference method and can be transferred to DCCT/NGSP by calculation.
Stability:
Shelf life claims: Un-opened calibrators can be stored at 2-8°C until the expiration date or for 24 months.
Open-vial claims: The recommended storage condition for in-use calibrators is one day. On-board stability for the D-100 HbA1c calibrator pack and reagents demonstrated 90 days stability on the D-100 Hemoglobin Testing System.
e. Analytical specificity:
- Endogenous Interference i.)
An Endogenous Interference study was performed per CLSI EP07-A2, Interference Testing in Clinical Chemistry. Two EDTA whole blood sample pools were evaluated using a low level whole blood sample with a concentration ~6.5%HbA1c and a high level whole blood sample with a concentration of HbA1c of ~8.0%.
Conjugated bilirubin, unconjugated bilirubin and glucose, available in pure
14
form, were obtained and stock solutions prepared at 10x the intended test concentration. The 10x stock solution of the test substance was pipetted into a low whole blood sample pool (at ~6.5% HbA1c) and a high whole blood sample pool (~8.0% HbA1c), making the test pool. Ten replicates of each pool prepared with the test and control samples were analyzed using the D-100™ HbA1c on the D-100™Hemoglobin Testing System.
Rheumatoid factor, lipemia and total protein were not available as pure standards therefore serum samples with known concentration of these compounds were used. The test pool was prepared by mixing the serum sample known to have a high test substance concentration with a whole blood non-variant sample such that the concentration of test substance in the final mixture would be at the desired level. Ten replicates of each pool prepared with the test and control samples were analyzed using the D-100™ HbA1c on the D-100™ Hemoglobin Testing System.
Significant interference was defined as a ± 7% change in %HbA1c value from the control. Results in Table 17 showed no significant interference up to the stated concentrations.
| Concentration | ||
|---|---|---|
| Endogenous substance | Conventional (US) | |
| units | SI Units | |
| Lipemia (Intralipid) | 6000 mg/dL | 60 g/L |
| Conjugated bilirubin | 60 mg/dL | 712 $\mu$ mol/L |
| Unconjugated bilirubin | 60 mg/dL | 1026 $\mu$ mol/L |
| Glucose | 2000 mg/dL | 111 mmol/L |
| Rheumatoid factor | 750 IU/mL | 750 kIU/mL |
| Total protein | 21 g/dL | 210 g/L |
Table 17: Endogenous Interference Study Results
- ii.) Drug Interference:
A Drug Interference study was performed based per CLSI EP07-A2, Interference Testing in Clinical Chemistry. Two EDTA whole blood sample pools were evaluated using a low level whole blood sample with a concentration ~6.5%HbA1c and a high level whole blood sample with a concentration of ~8.0%HbA1c. Test samples were prepared by spiking each drug at the interferent concentration shown in Table 18. Ten replicates of each drug prepared with the test and control samples were analyzed using the D-100™ HbA1c on the D-100™ Hemoglobin Testing System.
Significant interference was defined as a more than ± 7% change in %HbA1c value from the control. No significant interference was observed at therapeutic levels up to the stated concentrations in Table 18 on the following page.
15
| Potential Drug
Interferent | Highest Level Tested showing no Significant
Interference | |
|-------------------------------|-------------------------------------------------------------|--------------|
| | Conventional (US)
units | SI units |
| Acetylcysteine | 166 mg/dL | 10.2 mmol/L |
| Ampicillin-Na | 1000 mg/dL | 28.65 mmol/L |
| Ascorbic acid | 300 mg/dL | 17.05 mmol/L |
| Cefoxitin | 2500 mg/dL | 58.55 mmol/L |
| Heparin | 5000 U/L | 5000 U/L |
| Levodopa | 20 mg/dL | 1015 µmol/L |
| Methyldopa | 20 mg/dL | 948 µmol/L |
| Metronidazole | 200 mg/dL | 11.7 mmol/L |
| Doxycyclin | 50 mg/dL | 1124 µmol/L |
| Acetylsalicylic acid | 1000 mg/dL | 55.51 mmol/L |
| Rifampicin | 64 mg/L | 78 µmol/L |
| Cyclosporine | 5 mg/L | 4 µmol/L |
| Acetaminophen | 200 mg/L | 1323 µmol/L |
| Ibuprofen | 500 mg/L | 2427 µmol/L |
| Theophylline | 100 mg/L | 556 µmol/L |
| Phenylbutazone | 400 mg/L | 1299 µmol/L |
Table 18: Drug Interference Study Results
iii.) Cross Reactivity with Hemoglobin Derivatives:
A Hemoglobin Derivatives Interference study was performed based on CLSI EP07-A2, Interference Testing in Clinical Chemistry. Potential interference from Acetylated hemogloblin (Hb), Carbamylated hemoglobin (Hb) and Labile HbA1c were evaluated using a low level whole blood EDTA sample with a concentration ~6.5%HbA1c and a high level whole blood EDTA sample with a concentration of
16
~8.0% HbA1c. The potentially interfering hemoglobin derivatives were spiked into the low and high level blood samples and each sample was analyzed using ten replicates each in the same analytical run on the D-100™ Hemoglobin Testing System with the D-100™HbA1c.
Significant interference was defined as more than a ±7% change in HbA1c value from the control. The test result conclusions are as follows:
- . Acetylated Hb- up to 50 mg/dL does not interfere with this assay.
- Carbamylated Hb - up to 5% does not interfere with this assay.
- Labile A1c- up to 1200 mg/dL of glucose does not interfere with this . assay.
Results showed there was no cross reactivity with these substances at physiological levels.
iv.) Hemoqlobin Variant Study:
A Hemoglobin Variant study was performed using specific variant samples known to contain hemoglobin variants S. C. E. D. A2 and F. Two whole blood EDTA patient samples containing an HbA1c ~6.5% and ~ 8% and the appropriate hemoglobin variant were tested. Testing of the samples containing hemoglobin variants S. C. E. D. A2 and F were performed in duplicate. Testing of the samples was performed using the D-100™ HbA1c on the D-100™ Hemoglobin Testing System and compared to results obtained by a NGSP reference method that has been demonstrated to be free from the hemoglobin interferent. Table 19 contains the number of samples, range of samples and concentration of samples used in the Hemoglobin Variant Study. Table 20 contains the results for the Hemoglobin Variant study bias.
| Hemoglobin
Variant | n | Range in % Abnormal
Variant | Range in %HbA1c
Concentration |
|-----------------------|----|--------------------------------|----------------------------------|
| HbS | 20 | 28.7 - 40.2 | 5.6 - 9.6 |
| HbC | 20 | 34.4 - 44.1 | 5.0 - 10.7 |
| HbD | 20 | 36.6 - 43.4 | 5.8 - 8.6 |
| HbE | 20 | 25.5 - 32.5 | 5.9 - 8.3 |
| HbA2 | 25 | 5.0 - 13.3 | 5.0 - 14.5 |
| HbF | 30 | 4.1 - 30.2 | 4.4 - 14.4 |
Table 19: Variant samples used in Hemoglobin Variant Study
Table 20: Hemoglobin Variant Study Bias Results
| Hemoglobin
| Relative % Bias to Comparative Method | ||
|---|---|---|
| Variant | Relative %Bias (Range of %Bias) for | |
| HbA1c | ||
| ~6.5% | Relative %Bias (Range of %Bias) | |
| for HbA1c | ||
| ~9.0% | ||
| HbS | -0.6 (-5.8 to 5.5) | -1.5 (-3.3 to -0.1) |
| HbC | -1.3 (-4.0 to 1.3) | -3.9 (-5.5 to -2.4) |
| HbD | -4.7 (-6.7 to -1.1) | -4.4 (-6.3 to -2.4) |
| HbE | -2.7 (-6.7 to 1.6) | -1.3 (-2.0 to -0.6) |
| HbA2 | -1.3 (-5.1 to 0.5) | 3.4 (2.8 to 4.1) |
| HbF | -2.3 (-4.1 to -0.7) | -3.5 (-4.2 to -2.8) |
17
2. Matrix comparison
The data supports the use of the following blood collection tubes with the D-100™ HbA1c test in Table 21.
| Table 21: Anticoagulant |
|---|
| K2-EDTA |
| K3-EDTA |
| Potassium Oxalate/Sodium Fluoride |
| Sodium Citrate |
| Sodium Heparin |
| Lithium Heparin |
3. Expected Values/Reference Range
Hemoglobin A1c expected values range was cited from American Diabetes Association Standards of Medical Care in Diabetes 2010, 33 (Supplement 1), S62-S69 for Diagnosis of Diabetes are presented in Table 22.
Table 22: Hemoglobin A1c Expected Values
| Hemoglobin A1c | Suggested Diagnosis | |
|---|---|---|
| NGSP % | IFCC mmol/mol | |
| >6.5 | >47 | Diabetic |
| 5.7 - 6.4 | 39-46 | Pre-Diabetic |