(104 days)
Not Found
No
The device description and performance studies focus on standard chemical and turbidimetric methods for measuring hemoglobin A1c. There is no mention of AI, ML, or related concepts in the provided text.
No.
The device is for the quantitative determination of hemoglobin A1c concentration, which is used for diagnostic purposes (measuring long-term glycemic control in patients with diabetes mellitus), not for treating a disease or condition.
Yes
The device is described as "intended for the quantitative determination of hemoglobin A1c concentration in human whole blood," and the "Measurement of hemoglobin A1c measures long-term glycemic control in patients with diabetes mellitus." These statements indicate its use in diagnosing or monitoring a medical condition.
No
The device is a reagent kit intended for use with specific hardware systems (UniCel DxC 600/800 SYNCHRON Systems) to perform a chemical assay. It involves physical reagents and their interaction with a sample within a hardware system, not solely software processing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "quantitative determination of hemoglobin A1c concentration in human whole blood." This is a diagnostic measurement performed on a biological sample (whole blood) taken from the human body.
- Device Description: The description details how the device analyzes the whole blood sample using specific reagents (Hb3 and A1c3) and methods (colorimetric and turbidimetric immunoinhibition) to measure the concentration of hemoglobin A1c and total hemoglobin. This process is performed in vitro (outside the body).
- Purpose: The measurement of hemoglobin A1c is used to "measure long-term glycemic control in patients with diabetes mellitus," which is a diagnostic purpose related to a medical condition.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for 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.
Product codes
LCP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
DxC Method Comparison Summary
Instrument: DxC 600
Units: % HbA1c (NGSP)
Sample Range: 4.4 to 16.6% HbA1c (NGSP)
Acceptance Criteria: Slope 1.0 ± 0.05, Intercept ≤ ± 0.50, R ≥ 0.97
N: 119
R: 0.998
Slope: 1.031
Intercept: -0.267
Result: Pass
Instrument: DxC 800
Units: % HbA1c (NGSP)
Sample Range: 4.3 to 15.9% HbA1c (NGSP)
Acceptance Criteria: Slope 1.0 ± 0.05, Intercept ≤ ± 0.50, R ≥ 0.97
N: 118
R: 0.999
Slope: 1.031
Intercept: -0.294
Result: Pass
Anticoagulant Study Summary
Anticoagulant: K3-EDTA
Level of Anticoagulant Tested: 1.74 mg/mL
Test Criteria: Slope 1.0 ± 0.05, Intercept 0.97
Deming Regression Analysis: Y = 1.007X - 0.034; R = 0.999
Anticoagulant: Sodium Heparin
Level of Anticoagulant Tested: 15.8 USP units/mL
Test Criteria: R > 0.97
Deming Regression Analysis: Y = 1.007X - 0.034; R = 0.999
CLSI EP5-A2 Precision Estimate Method Summary
DxC 600:
Within-run:
Whole Blood Control 1: No. Data Points: 80, Mean Value (%HbA1c): 5.5, SD: 0.07, % CV: 1.24
Whole Blood Control 2: No. Data Points: 80, Mean Value (%HbA1c): 10.0, SD: 0.11, % CV: 1.13
Human Whole Blood Sample 1: No. Data Points: 80, Mean Value (%HbA1c): 8.9, SD: 0.09, % CV: 0.96
Human Whole Blood Sample 2: No. Data Points: 80, Mean Value (%HbA1c): 6.3, SD: 0.08, % CV: 1.30
Human Whole Blood Sample 3: No. Data Points: 80, Mean Value (%HbA1c): 4.8, SD: 0.07, % CV: 1.52
Total (DxC 600):
Whole Blood Control 1: No. Data Points: 80, Mean Value (%HbA1c): 5.5, SD: 0.09, % CV: 1.56
Whole Blood Control 2: No. Data Points: 80, Mean Value (%HbA1c): 10.0, SD: 0.15, % CV: 1.46
Human Whole Blood Sample 1: No. Data Points: 80, Mean Value (%HbA1c): 8.9, SD: 0.14, % CV: 1.56
Human Whole Blood Sample 2: No. Data Points: 80, Mean Value (%HbA1c): 6.3, SD: 0.10, % CV: 1.62
Human Whole Blood Sample 3: No. Data Points: 80, Mean Value (%HbA1c): 4.8, SD: 0.09, % CV: 1.93
DxC 800:
Within-run:
Whole Blood Control 1: No. Data Points: 80, Mean Value (%HbA1c): 5.4, SD: 0.06, % CV: 1.13
Whole Blood Control 2: No. Data Points: 80, Mean Value (%HbA1c): 9.9, SD: 0.08, % CV: 0.80
Human Whole Blood Sample 1: No. Data Points: 80, Mean Value (%HbA1c): 8.9, SD: 0.07, % CV: 0.81
Human Whole Blood Sample 2: No. Data Points: 80, Mean Value (%HbA1c): 6.3, SD: 0.07, % CV: 1.16
Human Whole Blood Sample 3: No. Data Points: 80, Mean Value (%HbA1c): 4.6, SD: 0.06, % CV: 1.34
Total (DxC 800):
Whole Blood Control 1: No. Data Points: 80, Mean Value (%HbA1c): 5.4, SD: 0.09, % CV: 1.61
Whole Blood Control 2: No. Data Points: 80, Mean Value (%HbA1c): 9.9, SD: 0.13, % CV: 1.34
Human Whole Blood Sample 1: No. Data Points: 80, Mean Value (%HbA1c): 8.9, SD: 0.13, % CV: 1.47
Human Whole Blood Sample 2: No. Data Points: 80, Mean Value (%HbA1c): 6.3, SD: 0.11, % CV: 1.72
Human Whole Blood Sample 3: No. Data Points: 80, Mean Value (%HbA1c): 4.6, SD: 0.09, % CV: 1.89
Additional With-run Precision Study Summary
Within-run (DxC 800): Human Whole Blood Sample @14% HbA1c, No. Data Points: 20, Mean Value (%HbA1c): 14.6, SD: 0.15, % CV: 1.03
Within-run (DxC 600): Human Whole Blood Sample @14% HbA1c, No. Data Points: 20, Mean Value (%HbA1c): 14.6, SD: 0.16, % CV: 1.10
DxC Interferences Summary
Bilirubin (unconjugated): Highest Level Tested: 30 mg/dL (0.3 g/L), Observed Effect: NSI*, Result: Pass
Lipemia: Highest Level Tested: 1000 mg/dL (10 g/L), Observed Effect: NSI, Result: Pass
Rheumatoid Factor: Highest Level Tested: 2000 IU/mL (2 x 10^6 IU/L), Observed Effect: NSI, Result: Pass
Ascorbic Acid: Highest Level Tested: 50 mg/dL (0.5 g/L), Observed Effect: NSI, Result: 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.
DxC Linearity Summary
Hb3 (6.0 - 24 g/dL): Linear Regression Slope: 1.0 ± 0.1, Intercept: 0.95
DxC 600: Y = 0.992x - 0.1051; R = 0.9997
DxC 800: Y = 0.998x - 0.1899; R = 0.9993
A1c3 (0.30 - Cal 5* g/dL): Linear Regression Slope: 1.0 ± 0.1, Intercept: 0.95
DxC 600: Y = 1.0007x - 0.0076; R = 0.9994
DxC 800: Y = 0.9907x + 0.0032; R = 0.9999
%HbA1c (NGSP) (4.0 - 17%): Linear Regression Slope: 1.0 ± 0.1, Intercept: 0.95
DxC 600: Y = 0.9905x + 0.0387; R = 0.994
DxC 800: Y = 0.9839x + 0.0521; R = 0.9996
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
0
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 | Docket
Number |
|----------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------|------------------|
| UniCel DxC
SYNCHRON Systems
Hemoglobin A1c
(HbA1c3) Reagent | UniCel DxC
SYNCHRON Systems
Hemoglobin A1c-
(HbA1c-) Reagent | Beckman
Coulter, 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.
1
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
| DxC
HbA1c3
| Reagent | Intended Use | Similarities to the Predicate |
|---|---|---|
| Predicate: | ||
| "The Hemoglobin A1c- reagent, when used in conjunction with | ||
| UniCel DxC 600/800 SYNCHRON Systems, UniCel DxC | ||
| SYNCHRON Systems HbA1c- Calibrators and SYNCHRON and | ||
| AU Systems Hemolyzing Reagent, is intended for the quantitative | ||
| determination of hemoglobin A1c concentration in human whole | ||
| blood." | ||
| "The UniCel DxC Synchron Systems Hemoglobin A1c3 (HbA1c) | ||
| 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." | ||
| Note: | ||
| Hemolyzing Reagent (offline sample preparation) = HbDIL (online | ||
| sample preparation) same formulation | ||
| Reagent | ||
| formulations | Same | |
| Calibrator | Same: | |
| levels/formulation | 5 levels, Hemolysate (human and sheep) |
2
| Calibrator
| traceability | IFCC HbA1c reference method |
|---|---|
| Acceptable | |
| Anticoagulants | EDTA & heparin whole blood. |
| K2-EDTA | |
| K3-EDTA | |
| Lithium Heparin | |
| Sodium Heparin | |
| Specimen | |
| Stability | 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
| DxC
HbA1c3
| Reagent | Sample preparation | Differences From The Predicate |
|---|---|---|
| Reagent | ||
| volumes/tests per | ||
| kit | HbA1c3 | |
| Two 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 same
formulation of hemolyzing reagent. | |
!
3
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 | Sample
Range | Acceptance
Criteria | N | R | Slope | Intercept | Result |
|------------|-------------------|------------------------------------|-------------------------------------------------------|-----|-------|-------|-----------|--------|
| DxC 600 | % HbA1c
(NGSP) | 4.4 to
16.6%
HbA1c
(NGSP) | Slope 1.0 ± 0.05
Intercept
≤ ± 0.50
R ≥ 0.97 | 119 | 0.998 | 1.031 | -0.267 | Pass |
| DxC 800 | % HbA1c
(NGSP) | 4.3 to
15.9%
HbA1c
(NGSP) | Slope 1.0 ± 0.05
Intercept
≤ ± 0.50
R ≥ 0.97 | 118 | 0.999 | 1.031 | -0.294 | Pass |
DxC Method Comparison Summary
Anticoagulant Study Summary
| Anticoagulant | Level of Anticoagulant
Tested | Test Criteria | Deming Regression Analysis |
|-----------------|----------------------------------|---------------------------------------|----------------------------------|
| K3-EDTA | 1.74 mg/mL | Slope 1.0 ± 0.05
Intercept 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 of
Imprecision | Sample Type | No. Data
Points | Mean Value
(%HbA1c) | EP5-A2 Calculated Point
Estimates | |
|-------------------------|----------------------------|--------------------|------------------------|--------------------------------------|------|
| | | | | 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 |
4
| Type of
Imprecision | Sample Type | No. Data
Points | Mean Value
(%HbA1c) | EP5-A2 Calculated Point
Estimates | |
|-------------------------|----------------------------|--------------------|------------------------|--------------------------------------|------|
| | | | | 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 of
Imprecision | Sample Type | No. Data
Points | 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 Level
Tested | Observed
Effect | Result |
|-----------------------------|-------------------------------------------------------------------------------------|------------------------------|--------------------|--------|
| Bilirubin
(unconjugated) | Whole blood samples spiked with
stock unconjugated bilirubin solution
(Sigma) | 30 mg/dL (0.3 g/L) | NSI* | Pass |
| Lipemia | Whole blood samples spiked with a
fat emulsion
(Intralipid) | 1000 mg/dL (10
g/L) | NSI | Pass |
| Rheumatoid
Factor | Whole blood samples spiked with
high RF positive material (Human) | 2000 IU/mL
(2 x 106 IU/L) | NSI | Pass |
| Ascorbic Acid | Whole blood samples spiked with
stock 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.
5
| Hb3 | A1c3 | %HbA1c (NGSP) |
|---|---|---|
| (6.0 - 24 g/dL) | (0.30 - Cal 5* g/dL) | (4.0 - 17%) |
| Linear Regression | ||
| Slope: 1.0 ± 0.1 | ||
| Intercept: 0.95 | Linear Regression | |
| Slope: 1.0 ± 0.1 | ||
| Intercept: 0.95 | Linear Regression | |
| Slope: 1.0 ± 0.1 | ||
| Intercept: 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.
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
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.
7
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
8
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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