GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY
Device Facts
| Record ID | K120199 |
|---|---|
| Device Name | GLYCOSYLATED HEMOGLOBIN ASSAY; CLINICAL CHEMISTRY |
| Applicant | Beckman Coulter, Inc. |
| Product Code | LCP · Hematology |
| Decision Date | Oct 12, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7470 |
| Device Class | Class 2 |
Indications for Use
The HbA1c (Hemoglobin A1c) reagent, when used in conjunction with Beckman Coulter Systems, HbA1c Calibrators, and SYNCHRON and AU Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. For In Vitro Diagnostic Use only. The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio and must not be used individually for diagnostic purposes. The HbA1c Calibrators are an in vitro diagnostic product for the calibration of the hemoglobin A1c (HbA1c) method on the AU clinical chemistry systems. Measurement of hemoglobin A1c is accepted as a method to measure longterm glucose control in patients with diabetes mellitus.
Device Story
The AU Systems HbA1c Test System is an in vitro diagnostic assay for use on Beckman Coulter AU clinical chemistry analyzers. It utilizes human whole blood samples, which are manually pre-treated with a hemolyzing reagent containing tetradecyltrimethylammonium bromide (TTAB) to eliminate leukocyte interference. The system performs two simultaneous measurements: total hemoglobin via a colorimetric method (absorbance at 570/660 nm) and HbA1c via a turbidimetric immunoinhibition method (absorbance at 340/700 nm). In the latter, HbA1c antibodies bind to sample HbA1c, and polyhaptens bind excess antibodies to form agglutinated complexes measured turbidimetrically. The device outputs the HbA1c/Total Hemoglobin ratio in mmol/mol (IFCC) or %HbA1c (NGSP). Used in clinical laboratory settings by trained personnel, the results assist healthcare providers in assessing glycemic control over the preceding 2-3 months, aiding in the management of diabetes mellitus and the prevention of long-term complications.
Clinical Evidence
Bench testing only. Precision evaluated per CLSI EP05-A2 (n=80 for controls, n=15 for patient pools) showing total CVs <2.8%. Linearity confirmed 4-15% range. Interference studies (bilirubin, triglycerides, RF, ascorbic acid, labile A1c, carbamylated Hb, acetylsalicylic acid) showed <10% bias. Hemoglobin variant study (C, D, E, S, F) showed <10% bias. Method comparison (n=130) against predicate showed high correlation (R >0.99).
Technological Characteristics
Turbidimetric inhibition immunoassay; colorimetric total hemoglobin measurement. Reagents: Total Hemoglobin R1, HbA1c R1, HbA1c R2, Hemolyzing Reagent (tetradecylmethyammonium bromide). Calibrators: Lyophilized human/sheep hemolysate. Analyzers: AU480, AU680, AU2700. Connectivity: Integrated into clinical chemistry analyzer workflow. Standards: CLSI EP05-A2, EP06-A, EP07-A2, EP09-A2-IR, EP17-A.
Indications for Use
Indicated for the quantitative determination of hemoglobin A1c in human whole blood to monitor long-term glucose control in patients with diabetes mellitus.
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
- Synchron Systems Hemoglobin A1c reagent (k010748)
Related Devices
- K182651 — HbA1c Advanced · Beckman Coulter Ireland, Inc. · Jan 16, 2019
- 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
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k120199
B. Purpose for Submission:
New Device
C. Measurand:
Glycosylated Hemoglobin A1c (HbA1c)
D. Type of Test:
Quantitative turbidimetric inhibition immunoassay
E. Applicant:
Beckman Coulter, Inc.
F. Proprietary and Established Names:
AU® Systems HbA1c (Hemoglobin A1c) Test System
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LCP | Class II | 864.7470 | Hematology, 81 |
| JIT | Class II | 862.1150 | Chemistry, 75 |
H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) for use:
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The HbA1c (Hemoglobin A1c) reagent, when used in conjunction with Beckman Coulter Systems, HbA1c Calibrators, and SYNCHRON and AU Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. For In Vitro Diagnostic Use only.
The absolute HbA1c and Total Hemoglobin (THb) values generated as part of the HbA1c assay are intended for use in the calculation of the HbA1c/Total Hemoglobin ratio and must not be used individually for diagnostic purposes.
The HbA1c Calibrators are an in vitro diagnostic product for the calibration of the hemoglobin A1c (HbA1c) method on the AU clinical chemistry systems.
Measurement of hemoglobin A1c is accepted as a method to measure long-term glucose control in patients with diabetes mellitus.
3. Special conditions for use statement(s):
- Prescription use only.
- This assay is designed only for the measurement of mmol/mol HbA1c (IFCC) and %HbA1c (NGSP). Individual results for Hb and HbA1c concentration should not be reported.
- Do not use this test for the diagnosis of diabetes mellitus. Performance characteristics for this use have not been determined.
- This assay is not useful in judging day-to-day glucose control and should not be used to replace daily home testing of glucose.
- Shortened red cell survival time will reduce the exposure of red cells to glucose, with a resultant decrease in HbA1c values. Causes of reduced red cell survival time include hemolytic anemia, or other hemolytic diseases, significant blood loss, blood transfusions and pregnancy. Caution should be exercised when interpreting the HbA1c results from patients with these or other conditions affecting red cell survival time, and when the total hemoglobin is <9 g/dL (5.6 mmol/L).
- Caution should be exercised when interpreting the HbA1c results from patients with hemolytic disease or other conditions characterized by shortened erythrocyte survival, acute blood loss, and iron deficiency.
- As with any chemical reaction, users should be aware of the possible effect on results due to unknown interferences from medication or endogenous substances
4. Special instrument requirements:
For use on the Beckman Coulter AU480/AU680/AU2700 Clinical Chemistry Analyzers
I. Device Description:
The AU® Systems HbA1c (Hemoglobin A1c) Test System involves the use of four reagents: Total Hemoglobin R1, HbA1c R1, HbA1c R2, and Hemolyzing Reagent (sold separately). In a pre-treatment step, whole blood is mixed with the Hemolyzing reagent in a 1:100 dilution
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and the resultant hemolysate is used. Tetradecylmethyammonium bromide (TTB) in the hemolyzing reagent eliminated interference from leukocytes.
The concentrations of both HbA1c and Total Hemoglobin are determined. The HbA1c/Total Hemoglobin ratio is expressed either as mmol/mol (IFCC) or %HbA1c (DCCT/NGSP).
The HbA1c Calibrators are provided in 5 lyophilized levels which contain: Hemolystae (human and sheep), 0.9% tetradecyltrimethylammonium bromide
J. Substantial Equivalence Information:
1. Predicate device name(s):
Synchron Systems Hemoglobin A1c reagent
2. Predicate 510(k) number(s):
k010748
3. Comparison with predicate:
| Similarities and Differences:Reagent | | |
| --- | --- | --- |
| Item | Candidate Device HbA1c (Hemoglobin A1c) reagent (k120199) | Predicate Device Synchron Systems Hemoglobin A1c reagent (k010748) |
| Intended Use/Indications for Use | The HbA1c (Hemoglobin A1c) reagent, when used in conjunction with Beckman Coulter Systems, HbA1c Calibrators, and SYNCHRON and AU Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. For In Vitro Diagnostic Use only. | The HbA1c reagent kit, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 600/800 System(s). SYNCHRON® Systems HbA1c Calibrators and SYNCHRON® Systems Hemolyzing Reagent, is intended for the quantitative determination of hemoglobin A1c concentration as a percentage of total hemoglobin in human whole blood |
| Technology | Colorimetric | Same |
| Analytical | 4-15% HbA1c (NGSP)/20-140 | 2-20% HbA1c |
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| Similarities and Differences:Reagent | | |
| --- | --- | --- |
| Item | Candidate Device HbA1c (Hemoglobin A1c) reagent (k120199) | Predicate Device Synchron Systems Hemoglobin A1c reagent (k010748) |
| Measuring Range | mmol/mol (IFCC) | |
| Methodology | Turbidimetric Inhibition | Same |
| Sample Types | K2-EDTA, K3-EDTA, Li-Heparin or Na-Heparin (freshly drawn blood treated with EDTA is preferred) | Whole blood EDTA or heparin (freshly drawn blood treated with EDTA is preferred) |
| Similarities and Differences: Calibrator | | |
| --- | --- | --- |
| Item | Candidate Device (k120199) | Predicate Device (k010748) |
| Intended Use/Indications for Use | The HbA1c Calibrators are an in vitro diagnostic product for the calibration of the hemoglobin A1c (HbA1c) method on the AU clinical chemistry systems. | For calibration of HbA1c on the Synchron Systems analyzers when used in conjunction with the HbA1c reagent on the UniCel® DxC 600/800 System(s). |
| Calibrator base matrix | Hemolysate (human and sheep) | Same |
| Calibrator Format and Levels | Lyophilized 5 levels THb=two point calibration HbA1c=multi point calibration | Lyophilized 5 levels THb=single point HbA1c=multi point calibration |
# K. Standard/Guidance Document Referenced (if applicable):
CLSI C28-A3, Defining Establishing and Verifying Reference Intervals in the Clinical Laboratory
CLSI EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition
CLSI EP07-A2, Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition
CLSI-EP09-A2-IR, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Second Edition (Interim Revision)
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CLSI-EP17-A, Protocols for Determination of Limits of Detection and Limits of Quantitation
CLSI-EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
Draft Guidance Document for 510(k) Submission of Glycohemoglobin (Glycated or Glycosylated) Hemoglobin for IVDs
## L. Test Principle:
Total Hemoglobin Reagent is used to measure total hemoglobin by a colorimetric method. Change in absorbance is measured at 570/660 nm.
HbA1c reagent is used to measure hemoglobin A1c concentration by a turbidimetric immunoinhibition method. In the reaction, Hemoglobin A1c antibodies combine with HbA1c from the sample to form soluble antigen-antibody complexes. Polyhaptens from the reagent then bind with the excess antibodies and the resulting agglutinated complex is measured turbidimetrically. Change in absorbance is measured at 340/700 nm.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Precision studies were performed according to CLSI EP05-A2. Within-run and Total precision were evaluated by testing a commercial low and high control treated with hemolyzing reagent. A medium control pool was prepared by mixing the low and high pool and treated with hemolyzing reagent. Each sample pool was assayed 2 replicates per run, 2 runs per day, for 20 days (n=80) on the Beckman AU480, AU680 and AU2700 analyzers.
An additional precision study was performed according to CLSI-EP05-A2. Within-run and Total precision were evaluated using three natural patient EDTA blood sample pools. A low sample (4-5% HbA1c) a medium sample (~6.5% HbA1c) a high sample (~8.0% HbA1c) and a very high sample pool (12-14% HbA1c) were analyzed in triplicate, once a day over 5 days (n=15).
The results of both precision studies are shown below:
AU480 analyzer
| Sample | N | Mean (%A1c) | Within Run | | Total Imprecision | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV |
| Low Control Pool | 80 | 5.38 | 0.05 | 1.02 | 0.11 | 2.07 |
| Medium Control Pool | 80 | 7.44 | 0.05 | 0.70 | 0.10 | 1.36 |
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AU680 Analyzer
| Sample | N | Mean (%A1c) | Within Run | | Total Imprecision | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV |
| Low Control Pool | 80 | 5.35 | 0.06 | 1.09 | 0.07 | 1.34 |
| Medium Control Pool | 80 | 7.43 | 0.06 | 0.87 | 0.10 | 1.33 |
| High Control Pool | 80 | 9.66 | 0.07 | 0.75 | 0.09 | 0.93 |
| Low Blood Pool (4-5%) | 15 | 4.94 | 0.09 | 1.7 | 0.09 | 1.7 |
| Medium Blood Pool (6.5%) | 15 | 6.87 | 0.05 | 0.7 | 0.06 | 0.9 |
| High Blood Pool (~8%) | 15 | 8.47 | 0.05 | 0.6 | 0.07 | 0.8 |
| High Blood Pool (12-14%) | 15 | 12.92 | 0.05 | 0.4 | 0.13 | 1.0 |
AU2700 Analyzer
| Sample | N | Mean (%A1c) | Within Run | | Total Imprecision | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | %CV | SD | %CV |
| Low Control Pool | 80 | 5.30 | 0.08 | 1.44 | 0.11 | 2.07 |
| Medium Control Pool | 80 | 7.39 | 0.08 | 1.03 | 0.14 | 1.84 |
| High Control Pool | 80 | 9.39 | 0.10 | 1.03 | 0.16 | 1.68 |
| Low Blood Pool (4-5%) | 15 | 4.86 | 0.12 | 2.4 | 0.14 | 2.8 |
| Medium Blood Pool (6.5%) | 15 | 6.81 | 0.12 | 1.8 | 0.16 | 2.4 |
| High Blood Pool (~8%) | 15 | 8.40 | 0.09 | 1.1 | 0.09 | 1.1 |
| High Blood Pool (12-14%) | 15 | 12.47 | 0.21 | 1.7 | 0.24 | 1.9 |
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b. Linearity/assay reportable range:
The claimed linearity range is 4-15% for HbA1c
Linearity was evaluated according to CLSI EP-06A. A series of eleven analyte concentrations, covering the measuring range of the assay, were prepared by interdilution of a high (19.6) and low (3.6) %HbA1c. Each dilution was assayed in quadruplicate and the mean analytical results were plotted versus the relative analyte concentration. Data was analyzed using 1st, 2nd, and 3rd order least square regressions according to CLSI Protocol EP6-A. Sponsor chose the 3rd order because it was the best fit. The percent bias between the 1st order and the 2nd order was <10%.
1st order y=0.22x-2.09
2nd order y=0.00x²+0.20x-2.32
3rd order y=9.61x³-0.00x²+0.16x+2.67
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The Beckman Coulter HbA1c Test System assay standardization is traceable to the IFCC reference calibrators. The Beckman Coulter HbA1c Test System assay is certified with the National Glycohemoglobin Standardization Program (NGSP), with an expiration date of September 1, 2013. The NGSP certification expires one year from the certification date and needs to be renewed annually. See NGSP website for current certification at http://www.ngsp.org
Two different units of measure are provided to the customers: NGSP equivalent units (%) and IFCC equivalent units (mmol/mol).
The HbA1c Calibrators are stable when unopened and stored at 2-8°C up to the stated expiration date printed on the bottle. Reconstituted calibrators are stable for 8 hours when stored at 15-25°C or 30 hours when stored at 2-8°C until the expiration date is reached. Calibrators are stable for 30 days when reconstituted and stored at -20°C. Protocols and acceptance criteria were reviewed and found acceptable to support the claimed conditions.
Calibrator values are assigned using multiple analyzers and multiple runs over several days. The data generated provides set points for use on the AU480, AU680, and AU2700 platforms. Once the calibration set points are established on the analyzers; principal samples (IFCC calibrators, IFCC controls, freshly prepared test calibrators, NGSP traceable samples to cover the NGSP range, and HbA1c/Thb linearity sets) are run in triplicate and must meet the sponsor's pre-determined acceptance criteria.
Controls- The sponsor recommends any commercially available control for HbA1c. Alternatively, the user may use controls previously cleared in k043070
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# d. Detection limit:
The Limit of Blank (LoB) and Limit of Detection (LoD) were determined by assaying an analyte free sample (blank) and five low level HbA1c samples according to CLSI guideline EP17A. Each sample was assayed once a day for 12 days on the Beckman AU480, AU680 and AU2700 analyzers. The detection limits are summarized in the table below:
HbA1c
| Platform/Method | LoB (% A1c) | LoD (% A1c) |
| --- | --- | --- |
| Beckman AU480, AU680 and AU2700 analyzer | 2.2 | 2.2 |
The assay has a reportable range of $4.0 - 15.0\%$ for HbA1c on the Beckman AU480, AU680 and AU2700 analyzer.
# e. Analytical specificity:
i.) Interference studies were performed to assess common or known substances that could interfere with the AU® Systems HbA1c (Hemoglobin A1c) Test System. The interfering substances were evaluated using $\mathrm{K}^2$ EDTA whole blood samples. Sample pools were tested at two HbA1c concentrations ( $\sim 5\%$ and $\sim 10\%$ ). Each sample was tested in quadruplicate to give a total of four replicates per sample on the Beckman AU460, AU680 and the AU2700 Clinical Systems using the AU CLINICAL SYSTEMS HbA1c assay. The percent difference of the samples with and without the potential interfering substance was calculated. The sponsor's acceptance criteria is analyte recovery should not vary from the base recovery by more than $6\%$ . No significant interference was defined as the $\%$ recovery of $\leq \pm 6\%$ for Unconjugated Bilirubin, Rheumatoid Factor and Ascorbic Acid. No significant interference was defined as the $\%$ recovery of $\leq \pm 7\%$ for Triglycerides.
The sponsor claimed that there was no significant interference by the following interfering substances:
Unconjugated bilirubin up to $30\mathrm{mg / dL}$
Triglycerides (Intralipid) up to $400\mathrm{mg / dL}$
Rheumatoid Factor up to 1000 IU/mL
Ascorbic Acid $50\mathrm{mg / dL}$
- Labile glycated hemoglobin up to $2000\mathrm{mg / dL}$
ii.) An interference study was performed to assess the affect of labile A1c with the AU® Systems HbA1c (Hemoglobin A1c) Test System. Two levels of EDTA whole blood samples ( $\sim 5\%$ and $\sim 10\%$ A1c) were used and each pool was split into two aliquots. One aliquot was used as the control sample while the other
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aliquot was supplemented with glucose to a glucose concentration of 2000 mg/dL. The aliquots were incubated for 1 hour at 37 degrees Celsius and then tested on the Beckman AU480, AU680 and AU2700 Clinical Systems using the AU® Systems HbA1c (Hemoglobin A1c) Test System. The percent difference of the samples with and without the potential interfering substance was calculated. The sponsor’s acceptance criteria is analyte recovery should not vary from the base recovery by more than 10%. No significant interference was defined as % recovery of ≤ ± 10%.
The sponsor claimed that there was no significant interference with labile A1c concentrations up to 2000 mg/dL
iii.) To study the effect of carbamylated hemoglobin, two EDTA whole blood patient samples with A1c concentration of ~5% and ~10% were split into two aliquots. Sodium cyanate (10.5 mg/ml in stock solution) was added to one aliquot of each concentration. Samples were incubated at 37 degrees Celsius for >1 hour. Samples were tested using the AU® Systems HbA1c (Hemoglobin A1c) Test System. The sponsor’s acceptance criterion is ≤10% bias between the tested and the control samples.
The sponsor concludes that carbamylated A1c does not interfere with the AU® Systems HbA1c (Hemoglobin A1c) Test System.
iv.) An interference study was performed to assess the effect of acetylsalicylic acid on the AU® Systems HbA1c (Hemoglobin A1c) Test System. Two EDTA whole blood patient samples with A1c concentration of ~5% and ~10% were split into two aliquots. One aliquot of each concentration was supplemented by adding acetylsalicylic acid (10.1 mg/ml in stock solution). The samples were tested using the AU CLINICAL SYSTEMS HbA1c assay. The sponsor’s acceptance criterion is ≤10% bias between the tested and the control samples.
The sponsor concludes that acetylsalicylic acid does not interfere with the AU® Systems HbA1c (Hemoglobin A1c) Test System.
v.) A hemoglobin variant study was performed using commercial samples known to contain Hemoglobin variants C, D, E, S, F. These variant samples were tested on the AU 680 Clinical System using the AU® Systems HbA1c (Hemoglobin A1c) Test System. All variants tested showed <10% bias at ~5% and ~7% for HbC, ~5%, ~7% and ~9% for HbD, ~6% and ~9 HbE, ~5%, ~7% and ~10% for HbS and ~5 and ~7% for HbF.
The labeling states “Samples containing >10% HbF may result in lower than expected HbA1c results.”
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f. Assay cut-off:
Not applicable
# 2. Comparison studies:
# a. Method comparison with predicate device:
A method comparison study was performed using the AU®Systems HbA1c (Hemoglobin) Test system on the AU480, AU680 and the AU2700 analyzers versus the Synchron Systems Hemoglobin A1c (HbA1c) Reagent on the Beckman DXC800 analyzer. The study was completed using 130 whole blood donor samples. Each sample was analyzed in singlicate using the candidate device and the predicate device. Sample range tested was $4.9 - 14.2\%$ HbA1c. The linear regression correlation is summarized below:
| Analyzer | Sample Range | n | R | Slope | Intercept |
| --- | --- | --- | --- | --- | --- |
| AU480 | 4.9-14.2% HbA1c | 130 | 0.9930 | 0.913 | 0.322 |
| AU680 | 4.9-14.2% HbA1c | 130 | 0.9941 | 0.901 | 0.3140 |
| AU2700 | 4.9-14.2% HbA1c | 130 | 0.9927 | 0.905 | 0.3276 |
Another method comparison study was performed using the AU®Systems HbA1c (Hemoglobin) Test system on the AU480, AU680 and the AU2700 analyzers versus the Olympus Hemoglobin A1c (HbA1c) Reagent (k031380) on the same analyzers. The study was completed using 116 whole blood donor samples. Each sample was analyzed in singlicate using the candidate device and the predicate device. Sample range tested was $4.6 - 12.0\%$ HbA1c. The linear regression correlation is summarized below:
| Analyzer | Sample Range | n | R | Slope | Intercept |
| --- | --- | --- | --- | --- | --- |
| AU480 | 4.6-12.0% HbA1c | 116 | 0.9962 | 1.028 | -0.2211 |
| AU680 | 4.6-12.0% HbA1c | 116 | 0.9968 | 1.036 | -0.3821 |
| AU2700 | 4.6-12.0% HbA1c | 116 | 0.9957 | 1.024 | -0.4150 |
# b. Matrix comparison:
A matrix comparison study was performed using $\mathrm{K}_3$ EDTA, Lithium Heparin, and Na-Heparin. $\mathrm{K}_2\mathrm{EDTA}$ was used as the reference anticoagulant. 52 total samples were analyzed for HbA1c. Each single set of samples were analyzed on the Beckman AU680 Clinical Chemistry analyzer. Samples ranged from $4.8\%$ -14.6% HbA1c. The results using Deming regression analysis are as follows:
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| Anticoagulant | n | Deming Regression Analysis |
| --- | --- | --- |
| K_{3} EDTA | 52 | Y=0.993x+0.029; r=0.999 |
| Lithium Heparin | 52 | Y=0.986x + 0.055; r=0.999 |
| Sodium Heparin | 52 | Y=0.993x+0.031; r=0.999 |
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
The expected normal HbA1c range in adults is 4.0-6.0% (NGSP); 20-42 mmol/mol (IFCC units) $^{1,2,3}$
$^{1}$Panteghini M, John WG. Implementation of Hemoglobin A1c results traceable to the IFCC reference system: the way forward. Clin Chem Lab Med 2007; 45(8):942-944.
$^{2}$Wu, A., ed., Tietz clinical guide to Laboratory Tests, 4$^{\text{th}}$ edition
$^{3}$McPherson, R.A, Pincus, M.R., Henry’s Clinical Diagnosis and Management by Laboratory Methods, 22$^{\text{nd}}$ Edition
The sponsor recommends in the labeling that each clinical laboratory should establish its own reference range/expected values as dictated by good laboratory practices.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
