CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE

K033061 · Diamond Diagnostics, Inc. · JIX · Nov 7, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033061
• Device Name: CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The three products encompassed by this request are intended for in-vitro diagnostics use. Mission Electrolyte Reference Reagent provides reference points for Na, K, CI, Ca (on Delta's only) and TCO2. When used in conjunction with CO2 Acid Reagent, CO2 Alkaline Buffer and Electrolyte Buffer, the ISE Electrolyte Reference is used for the calibration of the ISE electrodes; sodium, potassium chloride and calcium (on Delta's only) and CO2. The CO2 Acid reagent is used to release CO2 from samples. The CO2 Alkaline in used to provide a constant CO2 concentration as reference for the CO2 electrode. Mission reagents are intended to serve as direct replacements to the predicate devices manufactured by the OEM. The products encompassed are to be handled using normal laboratory precautions.

Device Story

The device consists of three liquid reagents (CO₂ Alkaline Buffer, CO₂ Acid Reagent, and ISE Electrolyte Reference) used as calibrators for Beckman Synchron CX® and CX® Delta clinical chemistry analyzers. These reagents provide reference points for Na, K, Cl, Ca, and TCO2 measurements. The CO₂ Acid reagent releases CO2 from samples; the Alkaline buffer provides a constant CO2 reference; the ISE Electrolyte Reference provides reference points for electrolytes. The device is used in clinical laboratory settings by trained laboratory personnel. It serves as a direct replacement for OEM reagents. By calibrating the analyzer, the device ensures the accuracy of patient sample measurements, which healthcare providers use to diagnose and monitor electrolyte and acid-base status.

Clinical Evidence

No clinical studies were performed. Evidence consists of analytical bench testing. Precision was evaluated on CX® Delta and CX®3 analyzers; total precision CVs ranged from 0.29% to 8.97% across analytes. Method comparison studies against the predicate device showed high correlation (R² 0.991–0.998) for CO2, Chloride, Potassium, and Sodium. Traceability was established via NIST standards and OEM calibrators.

Technological Characteristics

Multi-analyte liquid calibrator set. CO₂ Alkaline buffer: 6 mmol/L potassium bicarbonate, 10 mmol/L potassium chloride, buffer, dye, surfactant, preservative (pH 8.8). CO₂ Acid reagent: 6 mmol/L sulfuric acid, preservative. ISE Electrolyte Reference: 140 mmol/L sodium, 4 mmol/L potassium, 100 mmol/L chloride, 10 mmol/L total CO₂, 2 mmol/L calcium, buffer, surfactant, preservative. Gravimetric preparation. Traceable to NIST standards and OEM calibrators.

Indications for Use

Indicated for use as a multi-analyte calibrator for the Beckman Synchron CX® and CX® Delta clinical chemistry systems to provide reference points for sodium, potassium, chloride, calcium, and total CO2 measurements.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device 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

• CO2 Alkaline Buffer (443320) (K942676)
• CO2 Acid (443330) (K942676)
• ISE Electrolyte Reference (450214) (K864236)

Submission Summary (Full Text)

{0}

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K033061

B. Analyte:
Sodium, potassium, chloride, calcium, carbon dioxide (CO₂)

C. Type of Test:
Instrument calibrator

D. Applicant:
Diamond Diagnostics / Mission Diagnostics

E. Proprietary and Established Names:
CO₂ Alkaline Buffer for Beckman Synchron CX® & CX® Delta Systems
CO₂ Acid Reagent for Beckman Synchron CX® & CX® Delta Systems
ISE Electrolyte Reference for Beckman Synchron CX® & CX® Delta Systems

F. Regulatory Information:
1. Regulation section:
21 CFR § 862.1150, Calibrator
2. Classification:
Class II
3. Product Code:
JIX, Calibrator, multi-analyte mixture
4. Panel:
Clinical Chemistry (75)

G. Intended Use:
1. Indication(s) for use:
Mission CO₂ Acid Reagent is used to release CO2 from samples on the Beckman Synchron CX® & CX® Delta.

Mission CO₂ Alkaline Buffer provides a constant CO2 concentration as reference for the CO2 electrode on the Beckman Synchron CX® & CX® Delta.

Mission Electrolyte Reference Reagent provides reference points for Na, K, Cl, Ca (on Delta’s only) and TCO2 for Beckman Synchron CX® & CX® Delta.

2. Special condition for use statement(s):

{1}

Page 2 of 5

These reagents are intended to serve as direct replacements to like-named products of the original equipment manufacturer (OEM).

For use with the Synchron CX® & CX® Delta Systems.

For in vitro diagnostic use.

3. Special instrument Requirements:
The Synchron CX® & CX® Delta analyzers.

H. Device Description:
Three reagents make up the calibrating material: the CO₂ Alkaline buffer, the CO₂ Acid reagent, and the ISE Electrolyte Reference. These reagents are used to provide reference points for the listed analytes using the Beckman Synchron CX® & CX® Delta Systems.

The CO₂ Alkaline buffer (pH 8.8) contains 6 mmol/L potassium bicarbonate, 10 mmol/L potassium chloride, buffer, dye, surfactant, and preservative.

The CO₂ Acid reagent contains 6 mmol/L sulfuric acid and preservative.

The ISE Electrolyte Reference contains 140 mmol/L sodium, 4 mmol/L potassium, 100 mmol/L chloride, 10 mmol/L total CO₂, 2 mmol/L calcium, buffer, surfactant, and preservative.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Beckman PN 443320, 443330, 450214
2. Predicate K number(s):
K942676, K864236
3. Comparison with predicate:
These reagents are intended to be able to be used in place of the OEM reagents. 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):

K. Test Principle:
These reagents are for use in the calibration of the Synchron CX® & CX® Delta Systems. Please refer to the predicate submission for test principles.

L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:

{2}

Total precision was measured on the CX® Delta analyzer. Samples were measured in triplicate 4 to 5 days in 2 to 5 runs per day. Results are summarized below (units = mmol/L):

| Analyte | Level | N | Mean | SD | % CV |
| --- | --- | --- | --- | --- | --- |
| Sodium (Na+) | DControl 1 | 43 | 142.0 | 6.4 | 4.5 |
| | DControl 2 | 38 | 155.7 | 6.9 | 4.4 |
| | CSF 1 | 13 | 127.4 | 6 | 3.8 |
| | CSF 2 | 12 | 159.9 | 5 | 4.9 |
| | Urine 1 | 48 | 65.6 | 4.9 | 7.5 |
| | Urine 2 | 44 | 208.2 | 7.9 | 3.8 |
| Potassium (K+) | DControl 1 | 43 | 4.22 | 0.22 | 5.10 |
| | DControl 2 | 45 | 8.10 | 0.37 | 4.59 |
| | Urine 1 | 48 | 33.7 | 2.2 | 6.4 |
| | Urine 2 | 45 | 108.4 | 6.1 | 5.6 |
| Chloride (Cl-) | DControl 1 | 43 | 107 | 5 | 4 |
| | DControl 2 | 38 | 118 | 5 | 4 |
| | CSF 1 | 13 | 89 | 4 | 4 |
| | CSF 2 | 12 | 105 | 3 | 3 |
| | Urine 1 | 47 | 100 | 6 | 6 |
| | Urine 2 | 47 | 256 | 10 | 4 |
| Calcium (Ca++) | DControl 1 | 31 | 2.51 | 0.08 | 3.06 |
| | DControl 2 | 27 | 3.35 | 0.18 | 5.23 |
| | Urine 1 | 29 | 1.57 | 0.14 | 8.97 |
| | Urine 2 | 32 | 3.50 | 0.14 | 3.99 |
| CO2 | DControl 1 | 40 | 14.8 | 0.7 | 4.4 |
| | DControl 2 | 43 | 25.4 | 1.1 | 4.2 |

Within run precision was tested by running serum controls (or samples for calcium) in triplicate six times. Sodium, potassium, chloride, and $\mathrm{CO}_{2}$ were tested on the CX®3 analyzer while calcium was tested on the CX® Delta analyzer. Results are summarized below (units = mmol/L):

| Analyte | Level | N | Mean | SD | % CV |
| --- | --- | --- | --- | --- | --- |
| Sodium (Na+) | DControl 1 | 18 | 139.7 | 0.08 | 0.6 |
| | DControl 2 | 18 | 154.1 | 1.03 | 0.7 |
| Potassium (K+) | DControl 1 | 14 | 4.07 | 0.01 | 0.29 |
| | DControl 2 | 12 | 7.36 | 0.03 | 0.42 |
| Chloride (Cl-) | DControl 1 | 18 | 104 | 0.5 | 0.5 |
| | DControl 2 | 18 | 118 | 0.8 | 0.7 |
| CO2 | DControl 1 | 18 | 14.8 | 0.2 | 1.4 |
| | DControl 2 | 18 | 26.5 | 0.3 | 1.3 |
| Calcium (Ca++) | Normal | 18 | 2.42 | 0.06 | 2.5 |
| | Low | 18 | 1.96 | 0.06 | 3.1 |

{3}

Page 4 of 5

| High | 18 | 3.65 | 0.13 | 3.6 |
| --- | --- | --- | --- | --- |

b. Linearity/assay reportable range:
Not applicable.

c. Traceability (controls, calibrators, or method):

Calibrators and reagents are prepared gravimetrically and traceable to the following standards (using the following methods):

| Analyte | Standard Used for Determination of Analyte Value | Instrument Used |
| --- | --- | --- |
| sodium & potassium | NIST | Flame Photometer |
| Calcium | NIST | Ion selective electrode (ISE) |
| chloride | OEM Calibrator | Ion selective electrode (ISE) |
| Total CO2 | OEM Calibrator | TCO2 module |

Reagents are tested prior to bottling, adjusted if necessary to meet specifications, tested during bottling process, and prior to release to stock for distribution.

Stability studies are summarized for the calibrators. Accelerated studies are being used by the sponsor to estimate the expiration date; however, on-going real time studies are being performed.

d. Detection limit:
Not applicable.

e. Analytical specificity:
Not applicable.

f. Assay cut-off:
Not applicable.

2. Comparison studies:

a. Method comparison with predicate device:

The analyzer was calibrated using the Mission reagents and the predicate reagents, and samples were measured and compared to yield the following correlations:

CO2:
- Range = 8 – 30.7 mmol/L, y = 0.93x – 1.58, R² = 0.991

Chloride:
- Range = 54 – 203 mmol/L, y = 0.97x – 1.49, R² = 0.998

Potassium:
- Range = 1.81 – 8.79 mmol/L, y = 0.99x – 0.03, R² = 0.998

Sodium:
- Range = 95.4 – 203.4 mmol/L, y = 0.95x – 3.59, R² = 0.992

{4}

Page 5 of 5

b. Matrix comparison:
Not applicable.

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):

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Not applicable.

M. Conclusion:
I recommend that the Mission Diagnostic CO₂ Alkaline Buffer for Beckman
Synchron CX® & CX® Delta Systems, CO₂ Acid Reagent for Beckman Synchron
CX® & CX® Delta Systems, ISE Electrolyte Reference for Beckman Synchron CX®
& CX® Delta Systems are substantially equivalent to the legally marketed predicate
device.