SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2

K963543 · Sigma Diagnostics, Inc. · JIX · Oct 30, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963543
• Device Name: SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2
• Applicant: Sigma Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Oct 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Sigma Diagnostics CX®3 Calibration Standard Level 2 is used to calibrate the Beckman SYNCHRON CX®3 System. This reagent is used for the quantitative determination of BUN/urea, calcium, and total carbon dioxide in serum or plasma; of creatinine, potassium, and sodium in serum, plasma, or urine; and of chloride and glucose in serum, plasm, urine, or cerebrospinal fluid. Calibration Standard Level 2 should be used with CX®3 Calibration Standard Level 2.

Device Story

Calibration standard for Beckman SYNCHRON CX®3 clinical chemistry analyzer; contains specific concentrations of chloride, potassium, sodium, and total CO2; used in conjunction with Level 1 standard to establish calibration curves for quantitative analyte measurement; utilized in clinical laboratory settings by trained technicians; output enables accurate patient sample quantification; supports clinical decision-making regarding metabolic and electrolyte status.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid reagent calibration standard; contains chloride (65 mmol/L), potassium (10.0 mmol/L), sodium (100 mmol/L), and total CO2 (30 mmol/L); non-reactive components included; designed for use with Beckman SYNCHRON CX®3 system.

Indications for Use

Indicated for use as a calibration standard for the Beckman SYNCHRON CX®3 System to facilitate quantitative determination of BUN/urea, calcium, total CO2, creatinine, potassium, sodium, chloride, and glucose in human serum, plasma, urine, or cerebrospinal fluid.

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

• Beckman Calibration Standard 2 (Part No. 443365)

Submission Summary (Full Text)

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k963543

510(k) NOTIFICATION

Sigma Diagnostics
545 South Ewing Avenue
St. Louis, MO 63103

CX®-3 Calibration Standard, Level 2
Procedure No. C7433
August 30, 1996

OCT 30 1996

# ATTACHMENT 1

## Summary of Safety and Effectiveness

{1}

k963543

510(K) NOTIFICATION

Sigma Diagnostics
545 South Ewing Avenue
St. Louis, MO 63103

CX®3 Calibration Standard, Level 2
Procedure Number C7433
August 31, 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

Sigma Diagnostics CX®3 Calibration Standard Level 2 is used to calibrate the Beckman SYNCHRON CX®3 System. This reagent is used for the quantitative determination of BUN/urea, calcium, and total carbon dioxide in serum or plasma; of creatinine, potassium, and sodium in serum, plasma, or urine; and of chloride and glucose in serum, plasm, urine, or cerebrospinal fluid. Calibration Standard Level 2 should be used with CX®3 Calibration Standard Level 1.

CX®3 Calibration Standard Level 2 contains the following analytes and other non-reactive components:

| ANALYTE | SI UNITS |
| --- | --- |
| Chloride | 65 mmol/L |
| Potassium | 10.0 mmol/L |
| Sodium | 100 mmol/L |
| Total CO₂ | 30 mmol/L |

The safety and effectiveness of Sigma Diagnostics CX®3 Calibration Standard, Level 2, Procedure Number C7433, are demonstrated by its substantial equivalency to Beckman Calibration Standard 2, Part No. 443365.