SYSTEM CALIBRATER

K141388 · Beckman Coulter Ireland, Inc. · JIX · Jul 11, 2014 · Clinical Chemistry

Device Facts

• Record ID: K141388
• Device Name: SYSTEM CALIBRATER
• Applicant: Beckman Coulter Ireland, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jul 11, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The System Calibrator is a calibration serum intended to be used for the calibration of ALP, ALT, AST, Amylase, CK-NAC, GGT and LDH enzymes on Beckman Coulter AU480, AU680 and AU5800 analysers. For In Vitro Diagnostic use only.

Device Story

System Calibrator is a lyophilized human serum-based product containing chemical additives, preservatives, and enzymes of human, animal, and plant origin. It serves as a calibration reference for specific enzyme assays (ALP, ALT, AST, Amylase, CK-NAC, GGT, LDH) on Beckman Coulter AU480, AU680, and AU5800 clinical chemistry analyzers. The device is used in clinical laboratory settings by trained laboratory personnel. The calibrator is reconstituted and loaded onto the analyzer; the system uses the assigned calibrator values to adjust the instrument's response to reagent-analyte reactions, ensuring accurate quantitative determination of patient sample enzyme levels. This calibration process is essential for the clinical utility of the enzyme assays, enabling healthcare providers to make informed diagnostic and monitoring decisions based on reliable patient test results.

Clinical Evidence

Bench testing only. Stability studies (shelf life and open-vial) were conducted per CLSI EP25A on representative AU analyzer platforms. Value assignment was performed using 80 data points per reagent (10 replicates across 8 runs) to determine set points. No clinical data was required or provided.

Technological Characteristics

Lyophilized human serum matrix; contains chemical additives, preservatives, and enzymes. Designed for use on Beckman Coulter AU480, AU680, and AU5800 analyzers. Traceability to theoretical extinction coefficients. Stability: 36 months at 2-8°C (shelf life); 8 hours at 2-8°C (open vial).

Indications for Use

Indicated for the calibration of ALP, ALT, AST, Amylase, CK-NAC, GGT, and LDH enzyme assays on Beckman Coulter AU480, AU680, and AU5800 clinical chemistry analyzers. For professional in vitro diagnostic use.

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
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k141388

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.