ACE Hemoglobin A1c (HbA1c) Reagent
Device Facts
| Record ID | K170623 |
|---|---|
| Device Name | ACE Hemoglobin A1c (HbA1c) Reagent |
| Applicant | Alfa Wassermann Diagnostic Technologies, LLC |
| Product Code | LCP · Hematology |
| Decision Date | Feb 27, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7470 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
ACE Hemoglobin A1c (HbA1c) Reagent is intended for the quantitative determination of percent hemoglobin A1c in venous whole blood collected in K2-EDTA tubes, using the ACE Alera® and ACE Axcel® Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only.
Device Story
The ACE Hemoglobin A1c (HbA1c) Reagent is an in vitro diagnostic assay for use on ACE Alera and ACE Axcel Clinical Chemistry Systems. It requires off-line pretreatment where whole blood samples are lysed and hemoglobin chains hydrolyzed. The assay uses latex agglutination inhibition: HbA1c in the sample competes with a synthetic polymer for antibody-coated microparticle binding sites; agglutination inhibition is inversely proportional to HbA1c concentration, measured monochromatically at 692 nm. Total hemoglobin is measured bichromatically (573/692 nm) after conversion to alkaline hematin. The system calculates the ratio of HbA1c to total hemoglobin to report percent HbA1c. Used in clinical and physician office laboratories by trained personnel to monitor long-term glycemic control in diabetic patients. Results assist clinicians in assessing patient glucose management; however, values cannot be used individually for diagnostic purposes. The device is sensitive to certain hemoglobinopathies (HbF, HbC, HbS), which are noted in labeling.
Clinical Evidence
Bench testing only. Precision studies (internal and external at POL sites) performed per CLSI EP05-A3. Linearity evaluated per CLSI EP06-A (range 2.7-13.0% HbA1c). Interference studies (endogenous substances, hemoglobin variants, labile A1c, carbamylated/acetylated Hb) performed per CLSI EP07-A2. Method comparison study against predicate (N=101-102 internal; N=50-52 per site external) showed high correlation (r > 0.98).
Technological Characteristics
Reagents: Porcine Pepsin, Sodium Hydroxide, HbA1c Hapten Polymer, mouse HbA1c antibody-coupled particles, BSA, surfactants. Principle: Latex agglutination inhibition; monochromatic (692 nm) and bichromatic (573/692 nm) absorbance. Connectivity: Integrated with ACE Alera/Axcel Clinical Chemistry Systems. Standardization: NGSP certified. Software: Delta data acquisition algorithm.
Indications for Use
Indicated for the quantitative determination of percent hemoglobin A1c in venous whole blood (K2-EDTA) to monitor long-term blood glucose control in individuals with diabetes mellitus. For use in clinical and physician office laboratories.
Regulatory Classification
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.
Predicate Devices
- Hemoglobin A1c Reagent on DCA2000+ System (k951361)
Related Devices
- K063306 — ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 · Alfa Wassermann, Inc. · Apr 17, 2007
- K081895 — ADVIA CHEMISTRY HEMOGLOBIN A1C, ADVIA CHEMISTRY A1C CALIBRATORS · Siemens Medical Solutions Diagnostics · Jan 8, 2009
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 27, 2018
Barbara Phillips Vice President, Reagent Technologies Alfa Wassermann Diagnostic Technologies, LLC 4 Henderson Drive West Caldwell, NJ 07006
Re: K170623
Trade/Device Name: ACE Hemoglobin A1c (HbA1c) Reagent Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: January 25, 2018 Received: January 29, 2018
Dear Barbara Phillips:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device 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
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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# 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) K170623
Device Name ACE Hemoglobin A1c (HbA1c) Reagent
#### Indications for Use (Describe)
ACE Hemoglobin A lc (HbA lc) Reagent is intended for the quantitative determination of percent hemoglobin A lc in venous whole blood collected in K2-EDTA tubes using the ACE Axcel® Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only.
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| <div><span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>□ Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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# 510(K) SUMMARY - K170623
## I. Applicant/Submitter Contact Information
| Applicant: | Alfa Wassermann Diagnostic Technologies, LLC |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Address: | 4 Henderson Drive<br>West Caldwell, NJ 07006 |
| Contact Person:<br>Alternate Contact:<br>Phone Number:<br>Fax Number: | Barbara Phillips, MT (ASCP)<br>Hyman Katz, Ph.D.<br>(973) 852 - 0112<br>(973) 852 - 0237 |
| Date of Preparation: | 02/21/2018 |
## II. Device
| Trade Name: | ACE Hemoglobin A1c (HbA1c) Reagent |
|-------------------------|------------------------------------|
| Regulatory Information: | 21 C.F.R. § 864.7470 |
| Regulation Numbers: | Assay, Glycosylated Hemoglobin |
| Regulation Names: | Class 2 |
| Regulatory Class: | LCP |
| Product Codes: | |
# III. Predicate Devices
K951361 DCA 2000+ System for Hemoglobin A1c
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## IV. Device Description
The ACE Hemoglobin A1c (HbA1c) Reagent assay requires a pretreatment step of denaturation of the whole blood samples, which is performed off-line. The red blood cells in the sample are lysed by the Hemoglobin Denaturant and the hemoglobin chains are hydrolyzed. For determination of HbA1c, a latex agglutination inhibition assay is used. In the absence of HbA1c in the sample, the synthetic polymer containing the immunoreactive portion of HbA 1c Agglutinator Reagent will agglutinate with the antibody-coated microparticles in the HbA1c Antibody Reagent. The presence of HbA1c in the blood sample competes for the antibody binding sites and inhibits agglutination. The increase in absorbance, monochromatically at 692 mm, is inversely proportional to the HbA1c present in the sample. For the determination of total hemoglobin, all hemoglobin derivatives in the sample are converted to alkaline hematin. The reaction produces a green colored solution. which is measured bichromatically at 573 nm/692 nm. The intensity of color produced is directly proportional to the total hemoglobin concentration in the sample. The concentrations of both HbA 1 c and total hemoglobin are measured, the ratio is calculated, and the result reported as percent HbA1c.
#### V. Intended Use
Indication for use:
ACE Hemoglobin Alc (HbA1c) Reagent is intended for the quantitative determination of percent hemoglobin A1c in venous whole blood collected in K2-EDTA tubes, using the ACE Alera® and ACE Axcel® Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only.
#### VI. Comparison of Technological Characteristics with the predicate device
Both candidate and predicate devices are used for the measurement of the same analyte, have the same intended use, utilize whole blood samples, and are read on an automated instrument.
The candidate device utilizes a different reaction type and different reading wavelengths.
The candidate device requires an off-board pretreatment of the whole blood sample prior to analyzing the sample.
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# Technological Similarities and Differences
| | Candidate Device | Predicate Device |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)# | K170623 | K951361 |
| Name | ACE Hemoglobin A1c (HbA1c) Reagent | Siemens Healthcare Diagnostics |
| | (Off-board pretreatment) | Hemoglobin A1c Reagent Kit |
| Intended<br>Use/Indications<br>for Use | ACE Hemoglobin A1c (HbA1c) Reagent is<br>intended for the quantitative determination<br>of percent hemoglobin A1c in venous whole<br>blood collected in K2-EDTA tubes, using<br>the ACE Alera® and ACE Axcel® Clinical<br>Chemistry Systems. This test is intended for<br>use in clinical laboratories and physician<br>office laboratories to monitor long term<br>blood glucose control in individuals with<br>diabetes mellitus. For <i>in vitro</i> diagnostic use<br>only. | This assay provides a convenient,<br>quantitative method for measuring the<br>percent concentration of hemoglobin A1c in<br>blood. The measurement of hemoglobin A1c<br>concentration is recommended for<br>monitoring the long-term care of persons<br>with diabetes. The Diabetes Control and<br>Complications Trial (DCCT) showed the<br>importance of improved glycemic control in<br>reducing the risk and progression of the<br>complications of diabetes. Glycemic control<br>was determined by the measurement of<br>hemoglobin A1c. The American Diabetes<br>Association (ADA) recommends<br>measurement of hemoglobin A1c levels two<br>to four times per year, less frequently in<br>patients with stable control. This assay is<br>based on a latex immunoagglutination<br>inhibition methodology. After loading the<br>reagent test cartridge into the DCATM<br>Analyzer, the test result is displayed in six<br>minutes. The DCA Hemoglobin A1c assay is<br>for use in laboratories such as physician<br>office laboratories, clinics, and hospitals. |
| Conditions for<br>Use | The g/dL HbA1c and total hemoglobin<br>values generated are intended for use in the<br>calculation of the HbA1c/THb ratio and<br>cannot be used individually for diagnostic<br>purposes. | No contraindications |
| Instrument<br>Platforms | ACE Alera and ACE Axcel Clinical<br>Chemistry Systems | DCA 2000+ Analyzer |
| Analytes<br>Measured | Same | %HbA1c (ratio of HbA1c to total<br>hemoglobin) |
| | Candidate Device | Predicate Device |
| 510(k)# | K170623 | K951361 |
| Name | ACE Hemoglobin A1c (HbA1c) Reagent | Siemens Healthcare Diagnostics |
| | (Off-board pretreatment) | Hemoglobin A1c Reagent Kit |
| Calibration | 6 point calibration for HbA1c,<br>1 point calibration for Total Hemoglobin | Calibrated by the manufacturer. Before reagent cartridges are released by the manufacturer, each lot of reagent cartridges undergoes a thorough analysis and characterization. Values of calibration parameters based on a DCCT reference method are determined that provide for optimal reagent performance. The DCA HbA1c test method is National Glycohemoglobin Standardization Program (NGSP) Certified and is traceable to International Federation of Clinical Chemistry (IFCC) reference materials and test methods. The values for the calibration parameters are encoded onto the calibration card provided with each lot of reagent cartridges. |
| Method<br>Traceability or<br>Standardization | Same | NGSP Standardization |
| Basic Principle | Same | Photometric |
| Methodology | Same | Antibody-coated latex agglutination<br>inhibition |
| Reactive<br>Ingredients | Porcine pepsin<br>Sodium hydroxide<br>HbA1c hapten polymer<br>Bovine serum albumin<br>HbA1c antibody (mouse) coupled particles<br>Buffer | HbA1c-specific mouse monoclonal<br>antibody<br>adsorbed onto latex particles<br>Glycine Buffer<br>HbA1c hapten polymer<br>Sodium Citrate Buffer<br>Bovine serum albumin<br>Buffer |
| Non-reactive<br>Ingredients | Surfactants, preservatives | Surfactants, preservatives |
| Dimensions | Bottles with total volumes of 12 and 30 mL<br>containing the reagents | Single test cartridges |
| Analysis<br>Temperature | Same | 37°C |
| Reaction Type | HbA1c: Delta<br>Total Hb: Final Point | Endpoint |
| Measurement<br>Type | Same | Quantitative ratio of HbA1c to total<br>hemoglobin, expressed as percent |
| | Candidate Device | Predicate Device |
| 510(k)# | K170623 | K951361 |
| Name | ACE Hemoglobin A1c (HbA1c) Reagent<br>(Off-board pretreatment) | Siemens Healthcare Diagnostics<br>Hemoglobin A1c Reagent Kit |
| Sample Type | K2-EDTA Whole Blood | Capillary whole blood<br>Venous whole blood collected in EDTA,<br>heparin, fluoride/oxalate, citrate<br>anticoagulants |
| Measuring<br>Range | 2.7 – 13.0% HbA1c | 2.5 – 14.0% HbA1c |
| Expected<br>Values | Glycemic recommendation for many non-<br>pregnant adults with diabetes:<br>A1c < 7.0% | 4.2% HbA1c to 6.5% HbA1c<br>95% CI (4.3% to 5.7%)<br>Risk classifications:<br>3% – 6% in non-diabetics<br>6% – 8% in controlled diabetics |
| Testing<br>Environment | Clinical laboratories or physician office<br>laboratories | Laboratories such as physician office<br>laboratories, clinics, and hospitals. |
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# VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
#### Performance Data Detection Limit and Limit of Quantitation:
Because HbA1c is present to some extent in all samples (without homozygous hemoglobin variants), there is no need to determine the detection limit (LoD) of this assay.
| | ACE Alera Clinical<br>Chemistry System | ACE Axcel Clinical<br>Chemistry System |
|---------|----------------------------------------|----------------------------------------|
| LoQ (%) | 2.5 | 2.5 |
## Linearity:
| %HbA1c | ACE Alera | ACE Axcel |
|-----------------------------------|--------------------|--------------------|
| No. of Samples | 11 | 11 |
| No. of Reps/Sample | 4 | 4 |
| Range Tested | 2.7% – 13.0% HbA1c | 2.4% - 13.1% HbA1c |
| Regression Equation | y=0.987x + 0.3 | y=0.954x + 0.3 |
| Coefficient of Determination (r²) | 0.9948 | 0.9936 |
| Total Hemoglobin | ACE Alera | ACE Axcel |
|-----------------------------------|-----------------|-----------------|
| No. of Samples | 11 | 11 |
| No. of Reps/Sample | 4 | 4 |
| Range Tested | 1.4 – 22.2 g/dL | 1.2 – 21.8 g/dL |
| Regression Equation | y=1.006x + 0.10 | y=0.997x + 0.20 |
| Coefficient of Determination (r²) | 0.9978 | 0.9964 |
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# Precision: In-house
| ACE Alera | | Within run | | Total | |
|-----------|------|------------|-----|-------|-----|
| Sample | Mean | SD | %CV | SD | %CV |
| A | 5.1 | 0.07 | 1.4 | 0.13 | 2.5 |
| B | 6.8 | 0.14 | 2.1 | 0.18 | 2.6 |
| C | 8.2 | 0.10 | 1.3 | 0.20 | 2.4 |
| D | 11.2 | 0.32 | 2.8 | 0.34 | 3.1 |
| ACE Axcel | | Within run | | Total | |
|-----------|------|------------|-----|-------|-----|
| Sample | Mean | SD | %CV | SD | %CV |
| A | 5.0 | 0.08 | 1.6 | 0.12 | 2.4 |
| B | 6.8 | 0.14 | 2.0 | 0.17 | 2.6 |
| C | 8.2 | 0.13 | 1.6 | 0.21 | 2.6 |
| D | 11.1 | 0.27 | 2.4 | 0.32 | 2.9 |
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# Precision: Physician office labs
| ACE Alera | | Within-Run | | | Total | |
|-----------|--------|------------|------|-----|-------|-----|
| Lab | Sample | Mean | SD | %CV | SD | %CV |
| POL 1 | 1 | 5.3 | 0.09 | 1.6 | 0.09 | 1.6 |
| POL 2 | | 5.2 | 0.11 | 2.1 | 0.12 | 2.4 |
| POL 3 | | 4.6 | 0.08 | 1.8 | 0.13 | 2.9 |
| POL 1 | 2 | 6.8 | 0.12 | 1.7 | 0.12 | 1.7 |
| POL 2 | | 6.7 | 0.08 | 1.2 | 0.14 | 2.1 |
| POL 3 | | 6.0 | 0.07 | 1.1 | 0.14 | 2.3 |
| POL 1 | 3 | 8.8 | 0.24 | 2.7 | 0.27 | 3.1 |
| POL 2 | | 8.5 | 0.11 | 1.3 | 0.18 | 2.1 |
| POL 3 | | 7.9 | 0.07 | 0.9 | 0.25 | 3.1 |
| POL 1 | 4 | 12.5 | 0.29 | 2.4 | 0.32 | 2.5 |
| POL 2 | | 12.5 | 0.36 | 2.9 | 0.36 | 2.9 |
| POL 3 | | 11.5 | 0.13 | 1.1 | 0.27 | 2.3 |
| ACE Axcel | | | Within-Run | | Total | |
|-----------|--------|------|------------|-----|-------|-----|
| Lab | Sample | Mean | SD | %CV | SD | %CV |
| POL 1 | 1 | 5.4 | 0.12 | 2.2 | 0.24 | 4.3 |
| POL 2 | | 4.6 | 0.09 | 2.0 | 0.11 | 2.3 |
| POL 3 | | 4.8 | 0.10 | 2.1 | 0.10 | 2.2 |
| POL 1 | 2 | 6.8 | 0.08 | 1.1 | 0.13 | 1.9 |
| POL 2 | | 6.1 | 0.13 | 2.2 | 0.16 | 2.7 |
| POL 3 | | 6.3 | 0.11 | 1.7 | 0.12 | 1.8 |
| POL 1 | 3 | 8.8 | 0.12 | 1.3 | 0.20 | 2.2 |
| POL 2 | | 8.8 | 0.16 | 1.8 | 0.24 | 2.8 |
| POL 3 | | 9.1 | 0.15 | 1.7 | 0.27 | 2.9 |
| POL 1 | 4 | 11.9 | 0.19 | 1.6 | 0.29 | 2.5 |
| POL 2 | | 11.8 | 0.34 | 2.9 | 0.42 | 3.5 |
| POL 3 | | 12.2 | 0.15 | 1.2 | 0.35 | 2.9 |
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| | ACE Alera | ACE Axcel |
|---------------------------------|-----------------------|-----------------------|
| n | 101 | 102 |
| Range (x-method) | 3.2% - 12.8%<br>HbA1c | 2.5% - 12.8%<br>HbA1c |
| Regression Equation | y=0.979x + 0.05 | y=0.983x - 0.03 |
| Correlation Coefficient | 0.9839 | 0.9832 |
| Standard Error | 0.32 | 0.34 |
| Confidence Interval – slope | 0.944 to 1.015 | 0.948 to 1.019 |
| Confidence Interval - intercept | -0.21 to 0.31 | -0.29 to 0.24 |
# Comparative Analysis Regression Evaluation: In-house vs. DCA 2000+
# Comparative Analysis Regression Evaluation: Physician office labs vs. DCA 2000+
## ACE Alera
| Lab | n | Range<br>(x-method)<br>% HbA1c | Regression<br>Equation | Correlation<br>Coefficient | Standard<br>Error | Confidence<br>Interval Slope | Confidence<br>Interval<br>Intercept |
|-------|----|--------------------------------|------------------------|----------------------------|-------------------|------------------------------|-------------------------------------|
| POL 1 | 50 | 3.2 - 13.4 | y=0.967x+0.34 | 0.9892 | 0.35 | 0.925 to 1.008 | 0.04 to 0.65 |
| POL 2 | 50 | 3.1 - 12.9 | y=0.984x-0.02 | 0.9945 | 0.21 | 0.955 to 1.014 | -0.23 to 0.18 |
| POL 3 | 50 | 3.2 - 12.4 | y=0.981x-0.09 | 0.9939 | 0.21 | 0.950 to 1.013 | -0.30 to 0.12 |
#### ACE Axcel
| Lab | n | Range<br>(x-method)<br>% HbA1c | Regression<br>Equation | Correlation<br>Coefficient | Standard<br>Error | Confidence<br>Interval Slope | Confidence<br>Interval<br>Intercept |
|-------|----|--------------------------------|------------------------|----------------------------|-------------------|------------------------------|-------------------------------------|
| POL 1 | 52 | 3.2 - 12.9 | y=1.000x-0.28 | 0.9885 | 0.33 | 0.957 to 1.043 | -0.59 to 0.03 |
| POL 2 | 50 | 3.4 - 12.8 | y=0.993x-0.12 | 0.9932 | 0.25 | 0.960 to 1.027 | -0.37 to 0.13 |
| POL 3 | 50 | 3.5 - 12.9 | y=0.980x+0.02 | 0.9960 | 0.22 | 0.955 to 1.006 | -0.16 to 0.20 |
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#### Expected Values:
| Glycemic recommendation for many non-<br>pregnant adults with diabetes: | |
|-------------------------------------------------------------------------|---------|
| A1c | <7.0%/* |
*More or less stringent glycemic goals may be appropriate for individual patients. Goals should be individualized based on duration of diabetes, age/life expectancy, comorbid conditions, known CVD or advanced microvascular complications, hypoglycemia unawareness, and individual patient considerations.
Source: American Diabetes Association. Glycemic Targets: Standards of Medical Care in Diabetes - 2018. Diabetes Care 2018 Jan; 41 (Supplement 1): S55-S64.
#### Analytical Specificity
| Interferent | No significant<br>interference ≤ |
|-----------------|----------------------------------|
| Bilirubin | 53 mg/dL |
| Triglycerides | 1100 mg/dL |
| Ascorbic Acid | 6 mg/dL |
| Sodium Fluoride | 1200 mg/dL |
| Acetaldehyde | 100 mg/dL |
#### Cross Reactivity:
Acetylated Hb showed no significant interference at 2000 mg/dL. Carbamylated Hb showed no significant interference at 2000 mg/dL. Labile A1c showed no significant interference at 1440 mg/dL. Non-glycated Hb (HbA0) showed no significant interference at 1725 mg/dL. HbA1a+b fraction showed no significant interference at 100 mg/dL.
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| Instrument Used: | Axcel | | | Instrument Used: | Alera | | |
|------------------|-------|-------|-------|------------------|-------|-------|-------|
| Variant: | HbD | | | Variant: | HbD | | |
| % Variant | 36.3% | 34.0% | 17.3% | % Variant | 36.3% | 34.0% | 17.3% |
| Reference Value | 5.2% | 9.4% | 12.0% | Reference Value | 5.2% | 9.4% | 12.0% |
| Mean | 5.1% | 8.9% | 12.0% | Mean | 5.1% | 9.0% | 12.7% |
| % Recovery | 98.6 | 94.4 | 99.8 | % Recovery | 98.1 | 95.2 | 105.6 |
| Instrument Used: | Axcel | | | Instrument Used: | Alera | | |
| Variant: | HbE | | | Variant: | HbE | | |
| % Variant | 22.5% | 14.3% | 20.7% | % Variant | 22.5% | 14.3% | 20.7% |
| Reference Value | 4.7% | 7.8% | 10.8% | Reference Value | 4.7% | 7.8% | 10.8% |
| Mean | 5.1% | 7.7% | 10.8% | Mean | 5.1% | 7.9% | 10.9% |
| % Recovery | 108.0 | 98.4 | 99.5 | % Recovery | 108.5 | 101.6 | 100.9 |
| Instrument Used: | Axcel | | | Instrument Used: | Alera | | |
| Variant: | HbF | | | Variant: | HbF | | |
| % Variant | 10.1% | 16.8% | 29.5% | % Variant | 10.1% | 16.8% | 29.5% |
| Reference Value | 5.1% | 7.6% | 9.3% | Reference Value | 5.1% | 7.6% | 9.3% |
| Mean | 5.2% | 6.6% | 6.7% | Mean | 5.2% | 6.4% | 6.7% |
| % Variant | 0.0% | 7.0% | 14.0% | 21.0% | 28.0% |
|----------------------------|-------|-------|-------|-------|-------|
| Reference Value (Abnormal) | 7.9% | 7.9% | 7.9% | 7.9% | 7.9% |
| Mean | 7.9% | 8.0% | 8.6% | 9.4% | 10.8% |
| % Recovery | 100.0 | 101.9 | 109.6 | 119.1 | 137.3 |
| Instrument Used: | Alera | | | | | | |
|--------------------------|-------|-------|-------|-------|-------|--|--|
| Variant: | HbC | | | | | | |
| % Variant | 0.0% | 8.8% | 17.5% | 26.3% | 35.0% | | |
| Reference Value (Normal) | 4.7% | 4.7% | 4.7% | 4.7% | 4.7% | | |
| Mean | 4.7% | 4.7% | 4.8% | 5.5% | 6.5% | | |
| % Recovery | 100.0 | 100.4 | 103.1 | 117.0 | 139.4 | | |
| Instrument Used: | Alera | | | | |
|----------------------------|-------|------|-------|-------|-------|
| Variant: | HbC | | | | |
| % Variant | 0.0% | 7.0% | 14.0% | 21.0% | 28.0% |
| Reference Value (Abnormal) | 7.4% | 7.4% | 7.4% | 7.4% | 7.4% |
| Mean | 7.4% | 7.4% | 7.8% | 9.0% | 10.3% |
| % Recovery | 100.0 | 98.9 | 105.0 | 120.5 | 138.0 |
{14}------------------------------------------------
| Instrument Used: | Axcel | | | | |
|----------------------------|-------|-------|-------|-------|-------|
| Variant: | HbS | | | | |
| % Variant | 0.0% | 9.0% | 17.9% | 26.9% | 35.8% |
| Reference Value (Normal) | 4.8% | 4.8% | 4.8% | 4.8% | 4.8% |
| Mean | 4.8% | 5.1% | 5.3% | 5.7% | 5.9% |
| % Recovery | 100.0 | 104.6 | 109.7 | 118.0 | 122.7 |
| Instrument Used: | Axcel | | | | |
| Variant: | HbS | | | | |
| % Variant | 0.0% | 8.6% | 17.1% | 25.7% | 34.2% |
| Reference Value (Abnormal) | 8.0% | 8.0% | 8.0% | 8.0% | 8.0% |
| Mean | 8.0% | 8.3% | 8.5% | 9.5% | 10.0% |
| % Recovery | 100.0 | 103.8 | 106.9 | 119.8 | 125.5 |
| Instrument Used: | Alera | | | | |
|----------------------------|-------|-------|-------|-------|-------|
| Variant: | HbS | | | | |
| % Variant | 0.0% | 9.0% | 17.9% | 26.9% | 35.8% |
| Reference Value (Normal) | 5.0% | 5.0% | 5.0% | 5.0% | 5.0% |
| Mean | 5.0% | 5.3% | 5.4% | 5.8% | 5.9% |
| % Recovery | 100.0 | 106.1 | 108.6 | 117.7 | 119.2 |
| Instrument Used: | Alera | | | | |
| Variant: | HbS | | | | |
| % Variant | 0.0% | 8.6% | 17.1% | 25.7% | 34.2% |
| Reference Value (Abnormal) | 7.8% | 7.8% | 7.8% | 7.8% | 7.8% |
| Mean | 7.8% | 8.1% | 8.5% | 9.2% | 9.7% |
| % Recovery | 100.0 | 103.9 | 109.7 | 118.7 | 125.5 |
High Hemoglobin F (> 10.1%), Hemoglobin C (> 14.0%) and Hemoglobin S (> 17.1%) will result in inaccurate HbA1c results. Therefore, a statement will be included in the labeling as follows:
Hemoglobinopathies may interfere with glycated hemoglobin analysis. The results from both ACE Alera and ACE Axcel Clinical Chemistry Systems show that there is no significant interference for Hemoglobin D (≤ 36.3%) and Hemoglobin E (≤ 22.5%). High Hemoglobin F (> 10.1%) will result in lower than expected HbA1c values. High Hemoglobin C (> 14.0%) and high Hemoglobin S (> 17.1%) will result in higher than expected HbA1c values.
#### VIII. Conclusions
Based on the foregoing data, the device is safe and effective. These data also establish substantial equivalence to the predicate device.
