SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1

K963533 · Sigma Diagnostics, Inc. · JIX · Oct 29, 1996 · Clinical Chemistry

Device Facts

• Record ID: K963533
• Device Name: SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1
• Applicant: Sigma Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Oct 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Sigma Diagnostics CX®3 Calibration Standard Level 1 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, plasma, urine, or cerebrospinal fluid. Calibration Standard Level 1 should be used with CX®3 Calibration Standard Level 2.

Device Story

Calibration reagent for Beckman SYNCHRON CX®3 clinical chemistry analyzer; contains defined concentrations of BUN/urea, calcium, total CO2, creatinine, potassium, sodium, chloride, and glucose; used in clinical laboratory settings by trained personnel; ensures system accuracy for quantitative diagnostic testing; functions as reference standard for instrument calibration; supports clinical decision-making by maintaining analytical precision of patient sample measurements.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Liquid reagent containing specified concentrations of analytes (Calcium, Chloride, Creatinine, Glucose, Potassium, Sodium, Urea, BUN); intended for use with Beckman SYNCHRON CX®3 System; non-reactive components included; no specific materials or software algorithms described.

Indications for Use

Indicated for calibration of the Beckman SYNCHRON CX®3 System for quantitative determination of BUN/urea, calcium, total CO2, creatinine, potassium, sodium, chloride, and glucose in 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 1 (Part No. 443360)

Submission Summary (Full Text)

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K963533
OCT 29 1996

510(K) NOTIFICATION

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

CX®3 Calibration Standard, Level 1
Procedure Number C7308
August 31, 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

Sigma Diagnostics CX®3 Calibration Standard Level 1 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, plasma, urine, or cerebrospinal fluid. Calibration Standard Level 1 should be used with CX®3 Calibration Standard Level 2.

CX®3 Calibration Standard Level 1 contains the following analytes and other non-reactive components:

| ANALYTE | CONVENTIONAL UNITS | SI UNITS |
| --- | --- | --- |
| Calcium | 10.0 mg/dL | 2.495 mmol/L |
| Chloride | 109 mmol/L | 109 mmol/L |
| Creatinine | 5.0 mg/dL | 442 umol/L |
| Glucose | 150 mg/dL | 8.34 mmol/L |
| Potassium | 4.0 mmol/L | 4.0 mmol/L |
| Sodium | 150 mmol/L | 150 mmol/L |
| Urea | 107 mg/dL | 17.8 mmol/L |
| BUN (Urea Nitrogen) | 50 mg/dL | 17.8 mmol/L |

The safety and effectiveness of Sigma Diagnostics CX®3 Calibration Standard, Level 1, Procedure Number C7308, are demonstrated by its substantial equivalency to Beckman Calibration Standard 1, Part No. 443360.