Elecsys Estradiol III Calcheck

K143284 · Roche Diagnostics · JJX · Dec 16, 2014 · Clinical Chemistry

Device Facts

• Record ID: K143284
• Device Name: Elecsys Estradiol III Calcheck
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

For use in the verification of the calibration established by the Elecsys Estradiol III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys Estradiol III CalCheck is a lyophilized, synthetic estradiol product in a human serum matrix; used to verify calibration of Elecsys Estradiol III reagent on Elecsys and cobas e immunoassay analyzers. Device is reconstituted with distilled/deionized water by laboratory personnel. Analyzers perform automated measurements; output is compared against assigned target values to ensure system calibration accuracy. Benefits include ensuring reliable estradiol measurement performance for clinical diagnostic testing.

Clinical Evidence

Bench testing only. Stability studies (open-vial and accelerated) were conducted on the cobas e 411 to verify shelf-life and usage claims. Value assignment was performed using duplicate runs on at least three cobas e 601/MODULAR ANALYTICS E170 analyzers, with acceptance criteria met for recovery (85-115% for Level 1; 90-110% for Levels 2-3).

Technological Characteristics

Lyophilized synthetic estradiol in human serum matrix. Standardized against CRM6004a via ID-GC/MS. Reconstituted with distilled/deionized water. Storage 2-8°C. Compatible with Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for use as a quality control material to verify the calibration of the Elecsys Estradiol III reagent on specified Elecsys and cobas e immunoassay analyzers.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k143284

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.