Elecsys Estradiol III CalSet

K142021 · Roche Diagnostics · JIT · Aug 12, 2014 · Clinical Chemistry

Device Facts

• Record ID: K142021
• Device Name: Elecsys Estradiol III CalSet
• Applicant: Roche Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Estradiol III CalSet is used for calibrating the quantitative Elecsys Estradiol III assay on the Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys Estradiol III CalSet is a lyophilized, synthetic estradiol product in a human serum matrix; used to calibrate Elecsys Estradiol III assays on Elecsys and cobas e immunoassay analyzers. The device is operated by laboratory technicians in clinical settings. Users reconstitute the lyophilized material with distilled or deionized water, then load it onto the analyzer. The analyzer uses the calibrator to establish a calibration curve, which is then applied to patient samples to determine quantitative estradiol levels. This calibration process ensures the accuracy and precision of the immunoassay, aiding clinicians in diagnosing and monitoring conditions related to estradiol levels. The device is standardized against ID-GC/MS.

Clinical Evidence

Bench testing only. Evaluations included value assignment, reconstitution, and stability. Value assignment was validated by running calibrators in duplicate on multiple Elecsys 2010/cobas e 411 and cobas e 601/MODULAR ANALYTICS E170 analyzers. Stability studies verified performance at 2-8°C, -20°C, and after freeze/thaw cycles, with acceptance criteria defined as 95-105% signal recovery of reference material. Accelerated stability at 35°C for 3 weeks and ongoing real-time stability studies support the shelf-life claims.

Technological Characteristics

Lyophilized synthetic estradiol in human serum matrix. Two-level calibrator set. Standardized against ID-GC/MS. Designed for use on Elecsys and cobas e immunoassay analyzers. Stability: 24 hours at 2-8°C (opened), 5 hours at 20-25°C (opened), 31 days at -20°C (opened).

Indications for Use

Indicated for use as a calibrator for the quantitative Elecsys Estradiol III assay on Elecsys and cobas e immunoassay analyzers in a clinical laboratory setting.

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) #: k142021

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.