(104 days)
The UniCel DxC Synchron Systems Hemoglobin A1c3 (HbA1c3) Reagent, when used in conjunction with UniCel DxC 600/800 SYNCHRON Systems, UniCel DxC SYNCHRON Systems HbA1c3 Calibrators and HbDIL reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood.
The A1c3 and Hb3 values generated as part of the HbA1c3 assay are intended for use in the calculation of the A1c3/Hb3 ratio and must not be used individually.
Measurement of hemoglobin A1c measures long-term glycemic control in patients with diabetes mellitus.
The UniCel DxC SYNCHRON Systems Hemoglobin A1c3 (HbA1c3) Reagent is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood. The UniCel DxC Systems utilize two unique cartridges, Hb3 and A1c3, to determine hemoglobin A1c concentration as a ratio of total hemoglobin.
Hb3 reagent is used to measure total hemoglobin concentration by a colorimetric method. The system automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 8,6 parts reagent. The system monitors the change in absorbance at 410 nanometers. This change in absorbance is directly proportional to the concentration of total hemoglobin in the sample and is used by the system to calculate and express total hemoglobin concentration.
A1c3 reagent is used to measure the hemoglobin A1c concentration by a turbidimetric immunoinhibition method. In the reaction. hemoglobin A1c antibodies combine with hemoglobin A1c 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. The system automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 28 parts reagent. The system monitors the change in absorbance at 340 nanometers. This change in absorbance is inversely proportional to the concentration of hemoglobin A1c in the sample and is used by the systems to calculate and express hemoglobin A1c concentration as a ratio of total hemoglobin.
Here's an analysis of the acceptance criteria and study detailed in the provided 510(k) summary for the UniCel DxC SYNCHRON Systems Hemoglobin A1c3 (HbA1c3) Reagent:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria and Device Performance for Analytical Studies
| Study Type | Instrument | Units | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|---|
| Method Comparison | DxC 600 | % HbA1c (NGSP) | Slope 1.0 ± 0.05 Intercept ≤ ± 0.50 R ≥ 0.97 | Pass (Slope: 1.031, Intercept: -0.267, R: 0.998) |
| DxC 800 | % HbA1c (NGSP) | Slope 1.0 ± 0.05 Intercept ≤ ± 0.50 R ≥ 0.97 | Pass (Slope: 1.031, Intercept: -0.294, R: 0.999) | |
| Anticoagulant Study (K3-EDTA) | N/A | N/A | Slope 1.0 ± 0.05 Intercept < ± 0.75 R > 0.97 | Y = 1.012X - 0.043; R = 0.999 (Meets criteria for slope, intercept, and R) |
| Anticoagulant Study (Lithium Heparin) | N/A | N/A | R > 0.97 | Y = 1.007X - 0.034; R = 0.999 (Meets criteria for R) |
| Anticoagulant Study (Sodium Heparin) | N/A | N/A | R > 0.97 | Y = 1.007X - 0.034; R = 0.999 (Meets criteria for R) |
| Interferences (Bilirubin) | N/A | N/A | No Significant Interference (NSI, defined as within ± 6% mathematical) | Pass (NSI observed, 30 mg/dL tested) |
| Interferences (Lipemia) | N/A | N/A | No Significant Interference (NSI, defined as within ± 6% mathematical) | Pass (NSI observed, 1000 mg/dL tested) |
| Interferences (Rheumatoid Factor) | N/A | N/A | No Significant Interference (NSI, defined as within ± 6% mathematical) | Pass (NSI observed, 2000 IU/mL tested) |
| Interferences (Ascorbic Acid) | N/A | N/A | No Significant Interference (NSI, defined as within ± 6% mathematical) | Pass (NSI observed, 50 mg/dL tested) |
| Linearity (Hb3) | DxC 600 | g/dL | Slope: 1.0 ± 0.1 Intercept: < ± 1.0 (g/dL) R: > 0.95 | $Y = 0.992x - 0.1051;$ R = 0.9997 (Meets criteria) |
| DxC 800 | g/dL | Slope: 1.0 ± 0.1 Intercept: < ± 1.0 (g/dL) R: > 0.95 | $Y = 0.998x - 0.1899;$ R = 0.9993 (Meets criteria) | |
| Linearity (A1c3) | DxC 600 | g/dL | Slope: 1.0 ± 0.1 Intercept: < ± 0.3 (g/dL) R: > 0.95 | $Y = 1.0007x - 0.0076;$ R = 0.9994 (Meets criteria) |
| DxC 800 | g/dL | Slope: 1.0 ± 0.1 Intercept: < ± 0.3 (g/dL) R: > 0.95 | $Y = 0.9907x + 0.0032;$ R = 0.9999 (Meets criteria) | |
| Linearity (%HbA1c NGSP) | DxC 600 | %HbA1c NGSP | Slope: 1.0 ± 0.1 Intercept: < ± 0.75 (%HbA1c NGSP) R: > 0.95 | $Y = 0.9905x + 0.0387;$ R = 0.994 (Meets criteria) |
| DxC 800 | %HbA1c NGSP | Slope: 1.0 ± 0.1 Intercept: < ± 0.75 (%HbA1c NGSP) R: > 0.95 | $Y = 0.9839x + 0.0521;$ R = 0.9996 (Meets criteria) | |
| Specificity (HbS, HbD, HbE, HbC) | N/A | Recovery within +/- 7% of control sample | Pass (No significant effect reported) | |
| Specificity (HbF, labile glycated hemoglobin) | N/A | Recovery within +/- 10% of control sample | Pass (No significant effect reported for <10% HbF, no significant effect for labile glycated hemoglobin) Note: Samples with >10% HbF may result in lower than expected HbA1c3. |
Precision Data (EP5-A2 and Additional Within-run)
The document primarily reports SD and %CV for various sample types and instruments, derived from experiments following CLSI EP5-A2 guidelines. No explicit "acceptance criteria" (e.g., maximum allowable %CV) are stated for these precision values within the provided text, but the data is presented as a summary of performance. The precision results demonstrate low variability across controls and human whole blood samples for both DxC 600 and DxC 800 instruments, indicating good analytical precision.
2. Sample Sizes and Data Provenance
- Method Comparison:
- DxC 600: N = 119 samples
- DxC 800: N = 118 samples
- Data Provenance: Not explicitly stated, but the context of an FDA submission for a diagnostic kit suggests these would be human blood samples from a clinical laboratory setting. It is not specified if they are retrospective or prospective.
- Anticoagulant Study: The N-value for these studies is not explicitly stated in the summary, but given the Deming Regression analyses, it would involve a sufficient number of samples across the range to establish the stated regressions.
- CLSI EP5-A2 Precision Study:
- DxC 600: 80 data points for each of 5 sample types (2 controls, 3 human whole blood samples) = 400 data points total.
- DxC 800: 80 data points for each of 5 sample types (2 controls, 3 human whole blood samples) = 400 data points total.
- Data Provenance: "Whole Blood Control" and "Human Whole Blood Sample" indicates human samples. Not specified if retrospective or prospective or country of origin.
- Additional Within-run Precision Study:
- DxC 800: 20 data points for one human whole blood sample (@14% HbA1c).
- DxC 600: 20 data points for one human whole blood sample (@14% HbA1c).
- Interference Study: "Whole blood samples spiked with..." various substances. N-values for these individual spiked samples are not specified, but the study was conducted across three HbA1c levels (5%, 7%, & 10% NGSP).
- Linearity Study: N-values for linearity curves are not explicitly stated, but the strong R-values (R > 0.99) indicate a sufficient number of data points were used across the analytical range to establish robust linearity.
- Specificity Study: N-values for samples with HbS, HbC, HbF, etc., are not specified.
3. Number of Experts and Qualifications for Ground Truth
- No human "experts" are referenced for establishing ground truth in this context. The UniCel DxC SYNCHRON Systems Hemoglobin A1c3 (HbA1c3) Reagent is an in vitro diagnostic (IVD) device that quantitatively measures a biomarker (HbA1c).
- For IVD devices, the "ground truth" and comparison methods are typically other established laboratory methods or reference methods. The predicate device (UniCel DxC SYNCHRON Systems Hemoglobin A1c- Reagent, K121492) serves as the primary "ground truth" for method comparison, which itself would have been validated against a gold standard.
- The calibrator traceability is reported as the IFCC HbA1c reference method, which is a globally recognized, highly accurate, and standardized method for HbA1c measurement, effectively serving as the ultimate "ground truth" for calibration and accuracy.
4. Adjudication Method
- Not applicable for this type of IVD device study. Adjudication methods (like 2+1, 3+1) are typically used in imaging studies or clinical trials where human interpretation or consensus is required to establish a ground truth or resolve discrepancies in observations. This submission is for an analytical instrument's performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for AI/ML-driven diagnostic aids that assist human interpretation, particularly in radiology or pathology. This device is an automated in vitro diagnostic reagent system, not an AI-assisted interpretation tool.
6. Standalone (Algorithm Only) Performance Study
- Yes, this entire submission is a standalone performance study (algorithm only, in the context of an automated analytical instrument). The device (UniCel DxC SYNCHRON Systems HbA1c3 Reagent) on the DxC 600/800 SYNCHRON Systems operates as a quantitative analytical instrument, without human-in-the-loop interpretation impacting the result generation. The performance metrics (method comparison, precision, linearity, interference) directly assess the analytical output of the system.
7. Type of Ground Truth Used
- The ground truth used for validation is primarily comparison to the predicate device (UniCel DxC SYNCHRON Systems Hemoglobin A1c- Reagent, K121492), which itself is established against the IFCC HbA1c reference method (mentioned for calibrator traceability). For linearity and precision studies, the intrinsic property of the samples (e.g., known concentrations for linearity, reproducibility for precision) serves as the ground truth.
8. Sample Size for the Training Set
- Not applicable. This device is an in vitro diagnostic device based on established chemical and immunochemical reactions. It is not an AI/ML device that requires a "training set" in the machine learning sense. The device is developed and optimized through traditional analytical chemistry and immunochemistry principles. Therefore, there is no "training set" as understood in AI/ML.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no "training set" for an AI/ML algorithm, the concept of establishing ground truth for it does not apply here. The analytical performance of the new reagent system is compared against the predicate device and established analytical methods.
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K140f29
JUL 1 4 2014
510(k) SUMMARY
1.0 Submitted By:
Annette Hellie Senior Staff Regulatory Affairs Beckman Coulter, Inc. 250 S. Kraemer Boulevard M/S E1 SE.01 Brea, California 92821 Telephone: (714) 961-4517 Email: athellie@beckman.com
2.0 Date Submitted:
July 2, 2014
3.0 Device Name(s):
- 3.1 Proprietary Names UniCel DxC SYNCHRON Systems Hemoglobin A1c3 (HbA1c3) Reagent
3.2 Classification Name
Glycosylated hemoglobin assay 21 CFR § 864.7470 [LCP]
4.0 Predicate Device:
| Candidate(s) | Predicate | Manufacturer | DocketNumber |
|---|---|---|---|
| UniCel DxCSYNCHRON SystemsHemoglobin A1c(HbA1c3) Reagent | UniCel DxCSYNCHRON SystemsHemoglobin A1c-(HbA1c-) Reagent | BeckmanCoulter, Inc. | K121492 |
5.0 Description:
The UniCel DxC SYNCHRON Systems Hemoglobin A1c3 (HbA1c3) Reagent is intended for the quantitative determination of hemoglobin A1c concentration in human whole The UniCel DxC Systems utilize two unique cartridges, Hb3 and A1c3, to blood. determine hemoglobin A1c concentration as a ratio of total hemoglobin.
Hb3 reagent is used to measure total hemoglobin concentration by a colorimetric method. The system automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 8,6 parts reagent. The system monitors the change in absorbance at 410 nanometers. This change in absorbance is directly proportional to the concentration of total hemoglobin in the sample and is used by the system to calculate and express total hemoglobin concentration.
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A1c3 reagent is used to measure the hemoglobin A1c concentration by a turbidimetric immunoinhibition method. In the reaction. hemoglobin A1c antibodies combine with hemoglobin A1c 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. The system automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 28 parts reagent. The system monitors the change in absorbance at 340 nanometers. This change in absorbance is inversely proportional to the concentration of hemoglobin A1c in the sample and is used by the systems to calculate and express hemoglobin A1c concentration as a ratio of total hemoglobin.
6.0 Intended Use:
The UniCel DxC Synchron Systems Hemoglobin A1c3 (HbA1c3) Reagent, when used in conjunction with UniCel DxC 600/800 SYNCHRON Systems, UniCel DxC SYNCHRON Systems HbA1c3 Calibrators and HbDIL reagent, is intended for the quantitative determination of hemoglobin A1c concentration in human whole blood.
The A1c3 and Hb3 values generated as part of the HbA1c3 assay are intended for use in the calculation of the A1c3/Hb3 ratio and must not be used individually.
Measurement of hemoglobin A1c measures long-term glycemic control in patients with diabetes mellitus.
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicate identified in Section 4.0 of this summary. Similarities to the Pres
| DxCHbA1c3Reagent | Intended Use | Similarities to the Predicate |
|---|---|---|
| Predicate:"The Hemoglobin A1c- reagent, when used in conjunction withUniCel DxC 600/800 SYNCHRON Systems, UniCel DxCSYNCHRON Systems HbA1c- Calibrators and SYNCHRON andAU Systems Hemolyzing Reagent, is intended for the quantitativedetermination of hemoglobin A1c concentration in human wholeblood." | ||
| "The UniCel DxC Synchron Systems Hemoglobin A1c3 (HbA1c)Reagent, when used in conjunction with UniCel DxC 600/800SYNCHRON Systems, UniCel DxC SYNCHRON SystemsHbA1c3 Calibrators and HbDIL reagent, is intended for thequantitative determination of hemoglobin A1c concentration inhuman whole blood." | ||
| Note:Hemolyzing Reagent (offline sample preparation) = HbDIL (onlinesample preparation) same formulation | ||
| Reagentformulations | Same | |
| Calibrator | Same: | |
| levels/formulation | 5 levels, Hemolysate (human and sheep) |
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| Calibratortraceability | IFCC HbA1c reference method |
|---|---|
| AcceptableAnticoagulants | EDTA & heparin whole blood. |
| K2-EDTA | |
| K3-EDTA | |
| Lithium Heparin | |
| Sodium Heparin | |
| SpecimenStability | Whole blood samples stable for 8 hours at 15° to 25°C |
| 7 days at 2 - 8°C | |
| 3 months at -15° to -20°C | |
| 18 months at -70°C (literature reference) | |
| Analytical Range | Hb- 6.0 - 24 g/dL |
| A1c- 0.30 - Cal 5 g/dL | |
| %HbA1c 4.0 - 17% % (NGSP) | |
| Technology | Colorimetric |
| Methodology | Turbidimetric immunoinhibition |
Differences From The Predicate
| DxCHbA1c3Reagent | Sample preparation | Differences From The Predicate |
|---|---|---|
| Reagentvolumes/tests perkit | HbA1c3Two A1c3 Cartridges (125 tests/cartridge)Antibody Reagent (50 mL)Polyhapten Reagent (12.7 mL)Two Hb3 Cartridge (125 tests/cartridge)Hemoglobin Reagent (42 mL)HbA1c-Two A1c- Cartridges (200 tests/cartridge)Antibody Reagent (64 mL)Polyhapten Reagent (16.9 mL)One Hb- Cartridge (400 tests/cartridge)Hemoglobin Reagent (103 mL) | |
| New device employs on-line sample dilution utilizing sameformulation of hemolyzing reagent. |
!
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8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, linearity, and imprecision, and sensitivity experiments.
| Instrument | Units | SampleRange | AcceptanceCriteria | N | R | Slope | Intercept | Result |
|---|---|---|---|---|---|---|---|---|
| DxC 600 | % HbA1c(NGSP) | 4.4 to16.6%HbA1c(NGSP) | Slope 1.0 ± 0.05Intercept≤ ± 0.50R ≥ 0.97 | 119 | 0.998 | 1.031 | -0.267 | Pass |
| DxC 800 | % HbA1c(NGSP) | 4.3 to15.9%HbA1c(NGSP) | Slope 1.0 ± 0.05Intercept≤ ± 0.50R ≥ 0.97 | 118 | 0.999 | 1.031 | -0.294 | Pass |
DxC Method Comparison Summary
Anticoagulant Study Summary
| Anticoagulant | Level of AnticoagulantTested | Test Criteria | Deming Regression Analysis |
|---|---|---|---|
| K3-EDTA | 1.74 mg/mL | Slope 1.0 ± 0.05Intercept <± 0.75 | Y = 1.012X - 0.043;R = 0.999 |
| Lithium Heparin | 15.8 USP units/mL | R > 0.97 | Y = 1.007X - 0.034;R = 0.999 |
| Sodium Heparin | 15.8 USP units/mL | R > 0.97 | Y = 1.007X - 0.034;R = 0.999 |
CLSI EP5-A2 Precision Estimate Method Summary
| Type ofImprecision | Sample Type | No. DataPoints | Mean Value(%HbA1c) | EP5-A2 Calculated PointEstimates | |
|---|---|---|---|---|---|
| SD | % CV | ||||
| Within-run(DxC 600) | Whole Blood Control 1 | 80 | 5.5 | 0.07 | 1.24 |
| Whole Blood Control 2 | 80 | 10.0 | 0.11 | 1.13 | |
| Human Whole Blood Sample 1 | 80 | 8.9 | 0.09 | 0.96 | |
| Human Whole Blood Sample 2 | 80 | 6.3 | 0.08 | 1.30 | |
| Human Whole Blood Sample 3 | 80 | 4.8 | 0.07 | 1.52 | |
| Total(DxC 600) | Whole Blood Control 1 | 80 | 5.5 | 0.09 | 1.56 |
| Whole Blood Control 2 | 80 | 10.0 | 0.15 | 1.46 | |
| Human Whole Blood Sample 1 | 80 | 8.9 | 0.14 | 1.56 | |
| Human Whole Blood Sample 2 | 80 | 6.3 | 0.10 | 1.62 | |
| Human Whole Blood Sample 3 | 80 | 4.8 | 0.09 | 1.93 |
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| Type ofImprecision | Sample Type | No. DataPoints | Mean Value(%HbA1c) | EP5-A2 Calculated PointEstimates | |
|---|---|---|---|---|---|
| SD | % CV | ||||
| Within-run(DxC 800) | Whole Blood Control 1 | 80 | 5.4 | 0.06 | 1.13 |
| Whole Blood Control 2 | 80 | 9.9 | 0.08 | 0.80 | |
| Human Whole Blood Sample 1 | 80 | 8.9 | 0.07 | 0.81 | |
| Human Whole Blood Sample 2 | 80 | 6.3 | 0.07 | 1.16 | |
| Human Whole Blood Sample 3 | 80 | 4.6 | 0.06 | 1.34 | |
| Total(DxC 800) | Whole Blood Control 1 | 80 | 5.4 | 0.09 | 1.61 |
| Whole Blood Control 2 | 80 | 9.9 | 0.13 | 1.34 | |
| Human Whole Blood Sample 1 | 80 | 8.9 | 0.13 | 1.47 | |
| Human Whole Blood Sample 2 | 80 | 6.3 | 0.11 | 1.72 | |
| Human Whole Blood Sample 3 | 80 | 4.6 | 0.09 | 1.89 |
Additional With-run Precision Study Summary
| Type ofImprecision | Sample Type | No. DataPoints | Mean Value(%HbA1c) | Calculated Point Estimates | |
|---|---|---|---|---|---|
| SD | % CV | ||||
| Within-run(DxC 800) | Human Whole Blood Sample@14% HbA1c | 20 | 14.6 | 0.15 | 1.03 |
| Within-run(DxC 600) | Human Whole Blood Sample@14% HbA1c | 20 | 14.6 | 0.16 | 1.10 |
DxC Interferences Summary
| Substance | Interference Pool Details(5%, 7%, & 10% HbA1c NGSP) | Highest LevelTested | ObservedEffect | Result |
|---|---|---|---|---|
| Bilirubin(unconjugated) | Whole blood samples spiked withstock unconjugated bilirubin solution(Sigma) | 30 mg/dL (0.3 g/L) | NSI* | Pass |
| Lipemia | Whole blood samples spiked with afat emulsion(Intralipid) | 1000 mg/dL (10g/L) | NSI | Pass |
| RheumatoidFactor | Whole blood samples spiked withhigh RF positive material (Human) | 2000 IU/mL(2 x 106 IU/L) | NSI | Pass |
| Ascorbic Acid | Whole blood samples spiked withstock ascorbic acid solution (Sigma) | 50 mg/dL (0.5 g/L) | NSI | Pass |
*NSI = No Significant Interference (within ± 6% mathematical)
Specificity
The antibody used in this assay shows no cross-reactivity with HbA0, HbA1b, acetylated hemoglobin, carbamylated hemoglobin, and glycated albumin.
No significant effect of HbS, HbC, and up to 10% HbF was observed with this assay. Glycated HbF is not detected by the A1c3 assay as it does not contain the glycated β-chain. However, HbF is measured in the Hb3 assay.
Samples containing >10% HbF may result in lower than expected HbA1c3 results.
No significant effect of labile glycated hemoglobin (up to 2000 mg/dL, 5 hours at +37°C) was observed with this assay.
Criteria: Recovery within +/- 7% of control sample for HbS, HbD, HbE and HbC. Recovery within +/- 10% of control sample for HbF and labile glycated hemoglobin.
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| Hb3 | A1c3 | %HbA1c (NGSP) |
|---|---|---|
| (6.0 - 24 g/dL) | (0.30 - Cal 5* g/dL) | (4.0 - 17%) |
| Linear RegressionSlope: 1.0 ± 0.1Intercept: < ± 1.0 (g/dL)R: > 0.95 | Linear RegressionSlope: 1.0 ± 0.1Intercept: < ± 0.3 (g/dL)R: > 0.95 | Linear RegressionSlope: 1.0 ± 0.1Intercept: < ± 0.75 (%HbA1cNGSP)R: > 0.95 |
| DxC 600$Y = 0.992x - 0.1051;$R = 0.9997 | DxC 600$Y = 1.0007x - 0.0076;$R = 0.9994 | DxC 600$Y = 0.9905x + 0.0387;$R = 0.994 |
| DxC 800$Y = 0.998x - 0.1899;$R = 0.9993 | DxC 800$Y = 0.9907x + 0.0032;$R = 0.9999 | DxC 800$Y = 0.9839x + 0.0521;$R = 0.9996 |
DxC Linearity Summary
Cal 5 Value is printed on the HbA1c3 calibrator value assignment sheet included in the kit.
Reference Interval Summary
Each laboratory should establish its own reference intervals based upon its patient population. The reference intervals listed below were taken from literature and confirmed by internal testing.
| Interval | Sample Type | Conventional Units |
|---|---|---|
| Literature | Whole Blood | NGSP 4.0 - 6.0%IFCC 20 - 42 mmol/mol |
M. Panteghini, et al., "Implementation of hemoglobin A1c results traceable to the IFCC reference system: the way forward," Clinical Chemistry and Laboratory Medicine 45(8) (2007): 942-944.
Conclusion:
As summarized, the HbA1c3 Reagent is substantially equivalent to the HbA1c- Reagent (K121492). Substantial equivalence has been demonstrated through performance to verify that the device functions as intended and that design specifications have been satisfied.
This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BECKMAN COULTER, INC. ANNETTE HELLIE 250 S. KRAEMER ST BREA CA 92821
July 14, 2014
Re: K140829
Trade/Device Name: UniCel DxC Synchron Systems Hemoglobin (HbA1c3) Reagent Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP Dated: May 29, 2014 Received: June 2, 2014
Dear Ms. Hellie:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Ms. Lloyd
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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" (21CFR 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/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance 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. IDirector Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140829
Device Name
UniCel DxC Synchron Systems Hemoglobin Alc3 (HbA Ic3) Reagent
Indications for Use (Describe)
The UniCel DxC Synchron Systems Hemoglobin A1c3 (HbA1c3) Reagent, when used in conjunction with UniCel DxC 600/800 SYNCHRON Systems, UniCel DxC SYNCHRON Systems HbA1c3 Calibrators and HbDIL reagent, is intended for the quantitative determination of hemoglobin A Ic concentration in human whole blood.
The Alc3 and Hb3 values generated as part of the HbA1c3 assay are in the calculation of the A1c3/Hb3 ratio and must not be used individually.
Measurement of hemoglobin Alc is accepted as a method to measure long-term glucose control in patients with diabetes mellitus.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Stayce Beck -S
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§ 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).