CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3

K090283 · Genchem, Inc. · JIX · Jun 5, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090283
• Device Name: CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
• Applicant: Genchem, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jun 5, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

SYNCHRON® CX Multi-Analyte Mixture Calibrators 1, 2, and 3 are intended to calibrate the Beckman® SYNCHRON CX® Systems for quantitative determination of sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO2

Device Story

SYNCHRON CX Multi-Analyte Mixture consists of three levels of ready-to-use aqueous calibrators containing synthetic inorganic chemicals. Used with Beckman SYNCHRON CX Systems to establish reference points for quantitative in vitro diagnostic testing of sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO2. Calibrators are non-blood based. Healthcare providers use the system output to ensure accurate calibration of clinical chemistry analyzers, facilitating reliable patient test results for metabolic and electrolyte monitoring.

Clinical Evidence

No clinical data. Bench testing only. Stability testing confirmed shelf life and 30-day open-vial stability at 2-8°C. Value assignment performed via gravimetric addition and verified using two analyzers with 3 runs and 3 replicates per level, ensuring results remain within ±2SD of assigned values and Beckman Coulter specifications.

Technological Characteristics

Liquid multi-analyte mixture containing sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO2. Designed for use with Beckman SYNCHRON CX systems. No software or electronic components.

Indications for Use

Indicated for use as a calibration tool for Beckman SYNCHRON CX systems to enable quantitative measurement of sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO2 in clinical laboratory settings.

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.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k090283

B. Purpose for Submission:
New device

C. Measurand:
Calibration material for Sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO₂.

D. Type of Test:
Calibrator

E. Applicant:
Genchem, Inc.

F. Proprietary and Established Names:
SYNCHRON CX Multi-Analyte Mixture

G. Regulatory Information:
1. Regulation section: 21 CFR 862.1150
2. Classification: Class II
3. Product code: JIX, Calibrator, Multi-Analyte Mixture
4. Panel: Chemistry (75)

H. Intended Use:
1. Intended use(s):
See indications for use statement below.

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2. Indication(s) for use:

SYNCHRON CX Multi-Analyte Mixture Calibrators 1, 2, and 3 are intended to calibrate the Beckman SYNCHRON CX Systems for quantitative determination of sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total $\mathrm{CO}_{2}$ .

3. Special conditions for use statement(s):

For in vitro diagnostic use only

4. Special instrument requirements:

Beckman® SYNCHRON CX® Systems.

# I. Device Description:

SYNCHRON CX Multi-Analyte Mixture Calibrators 1, 2, and 3 are intended for use with the Beckman SYNCHRON CX Systems to establish reference points for In Vitro Diagnostic testing applications for multiple analytes. Each of the 3 calibrator mixtures (Level 1, 2, and 3) is supplied in ready to use $25~\mathrm{mL}$ bottles.

The calibrators are mixtures of synthetic inorganic chemicals in an aqueous based matrix and contain no blood based components.

# J. Substantial Equivalence Information:

1. Predicate device name(s):

HICHEM Calibrators 1, 2, and 3

2. Predicate $510(\mathrm{k})$ number(s):

k992845

3. Comparison with predicate:

| Similarities and Differences | | |
| --- | --- | --- |
| Item | Device | Predicate (k992845) |
| Intended Use | SYNCHRON CX Multi-Analyte Mixture Calibrators 1, 2, and 3 are intended to calibrate the Beckman SYNCHRON CX Systems for quantitative determination of sodium, potassium, chloride, urea, glucose, creatinine, calcium, | HiChem Calibrators 1, 2, and 3 are intended to calibrate the Beckman SYNCHRON CX DELTA and CX CE Systems for the quantitative determination of sodium, potassium, chloride, urea, glucose, creatinine, calcium, |
| | to calibrate the Beckman SYNCHRON CX Systems for quantitative determination of sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total $\mathrm{CO}_{2}$ . | calibrators 1, 2, and 3 are intended to calibrate the Beckman SYNCHRON CX DELTA and CX CE Systems for the quantitative determination of sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total $\mathrm{CO}_{2}$ . |

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| Similarities and Differences | | |
| --- | --- | --- |
| Item | Device | Predicate (k992845) |
| | glucose, creatinine, calcium, and total CO_{2}. | and total CO_{2}. |
| Matrix | Aqueous | Aqueous |
| Analytes | Sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO_{2}. | Sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO_{2}. |
| Preparation | Liquid, ready-for-use | Liquid, ready-for-use |
| Number of Levels | 3 | 3 |
| Packaging | 25 mL/level | 25 mL/level |
| Stability | Unopened, until expiration
Opened, 30 days | Unopened, until expiration
Opened, 30 days |
| Storage | 2-8 °C | 2-8 °C |

K. Standard/Guidance Document Referenced (if applicable):

Guidance for Industry – Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators.

L. Test Principle:

Not Applicable.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not Applicable

b. Linearity/assay reportable range:

Not Applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability:

Sponsor claims traceability to NIST and other analytical standards.

Stability: Stability testing protocols and acceptance criteria were reviewed and found to be acceptable. Test sets are stable unopened until the expiration date printed on the bottle and for 30 days after opening when stored at 2° to 8°C and handled according to instructions. It is recommended that they are not frozen.

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Value assignment: The set point values were established based on the gravimetric addition of each of the chemicals to achieve specific concentration of each of the analytes. For value assignment two analyzers were used, with 3 runs, and 3 replicates run for each level. The mean and standard deviation were calculated and the results for each analyte must be within the specifications set by the instrument manufacturer (Beckman Coulter). The analysis for each calibrator constituent must be within $\pm 2\mathrm{SD}$ of the assigned value. Quality controls are included in each run of the value assignment process.

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:
Not Applicable
b. Matrix comparison:

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:

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Not Applicable

**N. Proposed Labeling:**

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

**O. Conclusion:**

The submitted information in this premarket notification is complete and supports substantial equivalence decision.

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