BICARBONATE CALIBRATOR

K141374 · Beckman Coulter Ireland, Inc. · JIT · Jun 30, 2014 · Clinical Chemistry

Device Facts

• Record ID: K141374
• Device Name: BICARBONATE CALIBRATOR
• Applicant: Beckman Coulter Ireland, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jun 30, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Bicarbonate Calibrator is an aqueous preparation of sodium carbonate intended to be used with the Bicarbonate reagent OSR6x37 for the calibration of bicarbonate on Beckman Coulter AU analyzers. For in vitro diagnostic use only.

Device Story

Bicarbonate Calibrator is a two-level aqueous sodium carbonate solution; used to calibrate bicarbonate reagent (OSR6x37) on Beckman Coulter AU clinical chemistry analyzers. Device provides reference values for instrument calibration; ensures accuracy of bicarbonate measurements in patient samples. Used in clinical laboratory settings by trained laboratory personnel. Output is a calibration curve or factor used by the analyzer to calculate bicarbonate concentrations in patient specimens. Benefits include standardized, accurate diagnostic testing for bicarbonate levels, aiding in clinical assessment of acid-base balance.

Clinical Evidence

Bench testing only. Stability studies (shelf life 13 months, open vial 30 days) performed per CLSI EP25A. Value assignment and traceability verified against NIST SRM351 standard. Precision and recovery met acceptance criteria (≤ 3% or SD ≤ 1mEq/L; ±5% deviation from target).

Technological Characteristics

Aqueous solution of sodium carbonate; contains sodium o-phenylphenate tetrahydrate as preservative. Two-level configuration. Traceable to NIST SRM351. Designed for use on Beckman Coulter AU series analyzers. No electronic or software components.

Indications for Use

Indicated for in vitro diagnostic use as a calibrator for bicarbonate assays on Beckman Coulter AU clinical chemistry analyzers.

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) #: k141374

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.