GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
Device Facts
| Record ID | K033055 |
|---|---|
| Device Name | GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS |
| Applicant | Diamond Diagnostics, Inc. |
| Product Code | CGA · Clinical Chemistry |
| Decision Date | Jan 30, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Mission Glucose Reagent is intended for the quantitative determination of glucose in serum, plasma, cerebrospinal fluid (CSF), and urine on the Beckman Synchron CX® & CX® Delta Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
Device Story
Reagent for quantitative glucose determination in serum, plasma, CSF, and urine; used on Beckman Synchron CX® and CX® Delta systems. Operates via oxygen rate method; Beckman oxygen electrode measures rate of oxygen consumption, which is directly proportional to glucose concentration in sample. Used in clinical laboratory settings by trained personnel. Output is a numerical glucose value (mg/dL) displayed by the host instrument. Healthcare providers use results to diagnose and manage carbohydrate metabolism disorders. Benefits include accurate glucose monitoring for clinical decision-making.
Clinical Evidence
No clinical studies were performed. Evidence is based on bench testing, including precision/reproducibility (N=18 to 80 per sample type), linearity (0.6–25 mmol/L), and method comparison against the predicate. Method comparison studies (N=50 serum, 57 urine, 36 CSF) showed high correlation (r² ≥ 0.997) and regression slopes near 1.0. Functional sensitivity is 10 mg/dL (CV < 20%).
Technological Characteristics
Quantitative electrochemical assay; oxygen rate method using an oxygen electrode. Reagent composition: 590 U/mL glucose oxidase, 10% denatured alcohol, 0.04 mol/L potassium iodide, buffers, ammonium molybdate, and preservatives. Form factor: 500 mL liquid reagent. Designed for use with Beckman Synchron CX®/CX® Delta Systems. Complies with NCCLS EP5-A and EP9-A2 guidance.
Indications for Use
Indicated for quantitative glucose determination in serum, plasma, CSF, and urine for patients with carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
Regulatory Classification
Identification
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Special Controls
*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Predicate Devices
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE
A. 510(k) Number:
k033055
B. Analyte:
Glucose
C. Type of Test:
Quantitative electrochemical assay
D. Applicant:
Diamond Diagnostics / Mission Diagnostics
E. Proprietary and Established Names:
Mission Diagnostic Glucose Reagent for Beckman Synchron CX® & CX® Delta Systems
F. Regulatory Information:
1. Regulation section:
21 CFR § 862.1345, Glucose Test System
2. Classification:
Class II
3. Product Code:
CGA, glucose oxidase glucose test system
4. Panel:
Clinical Chemistry (75)
G. Intended Use:
1. Indication(s) for use:
Mission Glucose Reagent is intended for the quantitative determination of glucose in serum, plasma, cerebrospinal fluid (CSF), and urine on the Beckman Synchron CX® & CX® Delta Systems.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
2. Special condition for use statement(s):
Intended to serve as a direct replacement to like-named products manufactured by the Original Equipment Manufacturer (OEM).
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3. Special instrument Requirements:
Beckman Synchron CX® & CX® Delta Systems
H. Device Description:
The Mission Diagnostic Glucose Reagent for Beckman Synchron CX® & CX® Delta Systems is a reagent for use with the Beckman Synchron CX® & CX® Delta Systems. The reagent is packaged in 500 mL quantities, and contains 590 U/mL glucose oxidase, 10% denatured alcohol, 0.04 mol/L potassium iodide, buffers, ammonium molybdate, and preservatives.
I. Substantial Equivalence Information:
1. Predicate device name(s):
Beckman PN 443355
2. Predicate K number(s):
K942676, K864236
3. Comparison with predicate:
This reagent is intended to be a secondary reagent. The device and its predicate have the same intended use, composition, packaging quantities and dimensions, storage conditions, and shelf life.
J. Standard/Guidance Document Referenced (if applicable):
NCCLS Guidance document EP5A, Evaluation of Precision Performance of Clinical Chemistry Devices
NCCLS Guidance document EP9A2, Method Comparison and Bias Estimation Using Patient Samples
K. Test Principle:
Glucose concentration is determined by an oxygen rate method employing an oxygen Electrode. Electronic circuits determine the rate of oxygen consumption, which is directly proportional to the concentration of glucose in the sample.
L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility
Within run precision was measured by assaying serum and urine controls in triplicate 6 times to lead to N = 18 (CSF, N = 15). Total precision included samples run in triplicate 2 to 5 runs per day for 4 days (N = 51 serum, 35 urine, 32 CSF). Results are summarized below:
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| Sample | Mean mg/dL | Mean within run SD N=3 | Total Run SD | Total Mean mg/dL | Total SD - all runs | % CV | N |
| --- | --- | --- | --- | --- | --- | --- | --- |
| DControl 1 | 90 | 0.6 | 1.7 | 93 | 4.2 | 4.5 | 51 |
| DControl 2 | 305 | 1.5 | 0.3 | 319 | 13.1 | 4.1 | 51 |
| Urine 1 Cntrl | 43 | 0.6 | 0.3 | 43 | 2.0 | 4.6 | 35 |
| Urine 2 Cntrl | 286 | 2.2 | 2.5 | 295 | 10.8 | 3.7 | 57 |
| CSF1 Cntrl | 53 | 1.4 | 2.9 | 52 | 2.6 | 5.0 | 32 |
| CSF2 Cntrl | 92 | 1.1 | 4.9 | 90 | 3.9 | 4.4 | 32 |
Additional data were submitted as follows. Data was collected per NCCLS EP5-A. Samples were assayed in duplicates twice a day for 20 days.
| | N | Mean mg/dL | Within-run SD | W/in run %CV | Total SD | Total %CV |
| --- | --- | --- | --- | --- | --- | --- |
| CSF Control 1 | 80 | 59 | 0.8 | 1.3 | 3.8 | 6.3 |
| CSF Control 2 | 80 | 30 | 1.5 | 5.0 | 3.0 | 10.1 |
| Serum Control 1 | 80 | 89 | 2.1 | 2.3 | 6.0 | 6.7 |
| Serum Control 2 | 80 | 308 | 2.2 | 0.1 | 21.7 | 7.0 |
| Urine Control 1 | 80 | 45 | 1.0 | 2.3 | 2.3 | 5.1 |
| Urine Control 2 | 80 | 287 | 2.4 | 0.8 | 14.4 | 5.0 |
# b. Linearity/assay reportable range:
The following useable range was specified by the sponsor:
0.6 - 25 mmol/L (or 10 - 450 mg/dL) for serum, plasma, urine, or CSF.
The CX® Systems Over Range Detection and Correction (ORDAC) function will accommodate samples with glucose concentrations between 25 - 50 mmol/L (450 - 900 mg/dL). Users are instructed to dilute these samples that exceed the high end of the analytic range with saline and reanalyze. (an integrated function of the instrument, K942676, K864236)
Percent recovery was evaluated on linearly diluted samples. Pooled serum, urine, or CSF samples were spiked to achieve glucose concentrations in the upper end of the measurement range of the assay. These samples were then diluted, expected concentrations were calculated and each pool was measured using both Mission reagents and the predicate reagents. Results are summarized below.
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| | Reagents | Range of % Recovery | Mean Recovery |
| --- | --- | --- | --- |
| Serum | Mission | 83.3 – 115.4 | 103 % |
| 30 – 835 mg/dL | Predicate | 83.3 – 117.5 | 103 % |
| Urine | Mission | 88 – 120 | 101 % |
| 10 – 300 mg/dL | Predicate | 87 – 110 | 97 % |
| CSF | Mission | 88 – 98 | 94 % |
| 25 – 100 mg/dL | Predicate | 88 - 100 | 95 % |
# c. Traceability (controls, calibrators, or method):
Not applicable in this submission. The use of appropriate commercially available control materials is recommended.
# d. Detection limit:
Serum samples with low glucose concentrations were tested in triplicate over 13 runs. Results are summarized below.
| Mean (mg/dL) | SD | %CV |
| --- | --- | --- |
| 41.9 | 1.52 | 3.6 |
| 14.7 | 0.75 | 5.1 |
| 9.8 | 0.95 | 9.7 |
| 3.6 | 1.35 | 37.6 |
| 2.0 | 0.65 | 32.4 |
The sponsor claims a functional sensitivity of $10\mathrm{mg / dL}$ glucose (the lowest level tested with a CV less than $20\%$ ).
# e. Analytical specificity:
Whole blood samples are not recommended. Lipemic samples $> + 3$ should be ultracentrifuged and the analysis performed on the supernatant fraction. The sponsor refers the user to literature references for other interferences caused by drugs and diseases.
$5.0\mathrm{mg / dL}$ Hydroxyethyl starch may cause a result increase of $3\mathrm{mg / dL}$ .
20 mmol/L Glutathione may cause a result increase of $31\mathrm{mg / dL}$
The following anticoagulants or chemical additives are compatible with this method:
| Anticoagulants | Acceptable level |
| --- | --- |
| Sodium Citrate® | 3.5 mg/mL |
| EDTA | 4.0 mg/mL |
| Ammonium Heparin | 45 U/mL |
| Lithium Heparin | 45 U/mL |
| Sodium Heparin | 45 U/mL |
| Lithium Iodoacetate | 1.5 mg/mL |
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* specimens collected with liquid sodium citrate will exhibit a decrease in value due to dilution.
f. Assay cut-off:
Not applicable.
2. Comparison studies:
a. Method comparison with predicate device:
Serum and Urine controls were assayed six times in triplicate using both the Mission and predicate reagents (N = 18).
| | Mission Reagent | | | | Predicate Reagent | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Mean (mg/dL) | Within run SD | Total SD | % CV | Mean (mg/dL) | Within run SD | Total SD | % CV |
| DControl1 | 90 | 0.6 | 1.7 | 0.6 | 90 | 0.6 | 2.3 | 0.8 |
| DControl2 | 305 | 1.5 | 0.3 | 0.4 | 293 | 1.5 | 0.3 | 0.4 |
| Urine 1 | 43 | 0.6 | 0.3 | 0.8 | 44 | 1.0 | 0.5 | 1.1 |
| Urine 2 | 286 | 2.2 | 2.5 | 0.9 | 279 | 2.4 | 1.2 | 0.4 |
Comparisons of spiked serum, CSF, or urine samples or controls using the Mission reagent and the predicate reagent yielded the following correlations:
Serum:
- Range 0 – 400 mg/dL: $y = 1.09x - 2.52$, $R^2 > 0.999$
- Range 0 – 500 mg/dL: $y = 1.08x - 1.78$, $R^2 = 0.999$
- Range 0 – 780 mg/dL: $y = 1.08x - 2.37$, $R^2 = 0.999$
CSF:
- Range 23 – 90 mg/dL: $y = 0.96x + 1.50$, $R^2 = 0.997$
Urine:
- Range 20 – 294 mg/dL: $y = 1.05x - 4.80$, $R^2 = 0.999$
Additional data were submitted. Tests were performed per NCCLS EP9-A2 and analyzed by least squares regression.
Fifty (50) serum samples were spiked or diluted and tested in triplicate with the Mission reagents and the predicate reagents.
Range = 0 to 900 mg/dL
Mission = 1.038 (Predicate) – 2.31
$r^2 = 0.998$
95% CI at 70 mg/dL - 66.4 to 74.3 mg/dL
95% CI at 105 mg/dL – 102.3 to 111.0 mg/dL
Fifty-seven (57) urine samples were spiked or diluted and tested in triplicate with the Mission reagents and the predicate reagents.
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Range = 1 to 293 mg/dL
Mission = 1.022 (Predicate) + 1.067
r² = 0.998
95% CI at 1 mg/dL – 1.18 to 2.99 mg/dL
95% CI at 15 mg/dL – 15.3 to 17.4 mg/dL
Thirty-six (36) CSF samples were spiked or diluted and tested in triplicate with the Mission reagents and the predicate reagents.
Range = 8 to 118 mg/dL
Mission = 1.014 (Predicate) – 0.920
r² = 0.997
95% CI at 40 mg/dL – 37.7 to 41.5 mg/dL
95% CI at 70 mg/dL – 67.6 to 72.5 mg/dL
b. Matrix comparison:
Not applicable. Performance data was submitted for all matrices.
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:
| Sample Type | Units (mmol/L) | SI Units (mg/dL) |
| --- | --- | --- |
| Serum or Plasma | 3.9 – 5.8 | 70 - 105 |
| CSF | 2.2 – 3.9 | 40 - 70 |
| Urine | 0.06 – 0.8 | 1- 15 |
The sponsor states that normal fasting glucose is between 70 and 110 mg/dL. Diabetes (hyperglycemia) is diagnosed when patient glucose levels are: fasting glucose > 126 mg/dL, serum glucose of > 200 mg/dL, or other symptoms. Hypoglycemia is diagnosed when patient glucose levels are < 60 mg/dL.
The sponsor states that these values are intended as a reference, and that no adjustments have been made for age, sex, or dietary differences. Each laboratory should establish a reference range based on their patient population.
M. Conclusion:
I recommend that the Mission Diagnostic Glucose Reagent for Beckman Synchron CX® & CX® Delta Systems is substantially equivalent to the legally marketed predicate device.
