ELECSYS ESTRADIOL III CALCHECK 5

K142127 · Roche Diagnostics · JJX · Sep 5, 2014 · Clinical Chemistry

Device Facts

• Record ID: K142127
• Device Name: ELECSYS ESTRADIOL III CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Sep 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Elecsys Estradiol III CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Estradiol III reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys Estradiol III CalCheck 5 is a lyophilized, multi-level (5 levels) quality control material containing synthetic estradiol in a human serum matrix. Used in clinical laboratories to verify calibration and assay range of Elecsys Estradiol III reagent on Elecsys and cobas e immunoassay analyzers. User reconstitutes lyophilized material with distilled/deionized water, mixes by inversion, and runs on the analyzer. Instrument measures estradiol levels; results compared against assigned target values to ensure system accuracy and performance within established ranges. Provides objective verification of analytical measurement range; helps ensure reliable patient test results.

Clinical Evidence

Bench testing only. No clinical data. Stability studies (open-vial and accelerated) confirmed performance claims. Value assignment was validated by running lots in duplicate on at least three cobas e 601/MODULAR ANALYTICS E170 analyzers, with mean values meeting pre-defined acceptance criteria.

Technological Characteristics

Lyophilized human serum matrix containing synthetic estradiol. Five levels provided. Standardized against ID-GC/MS. Reconstitution required with 1.0 mL distilled/deionized water. Storage at 2-8°C. Compatible with Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys Estradiol III reagent on Elecsys and cobas e immunoassay analyzers. No specific patient population is targeted as this is a laboratory quality control material.

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) #: k142127

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.