ELECSYS PRECICONTROL TS

K140534 · Roche Diagnostics · JJX · Mar 27, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140534
• Device Name: ELECSYS PRECICONTROL TS
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 27, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Elecsys PreciControl TS is used for quality control of the Elecsys TSH immunoassay on the Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys PreciControl TS is a lyophilized quality control material consisting of recombinant human TSH in an equine serum matrix. It is used by laboratory professionals to monitor the performance of the Elecsys TSH immunoassay on Elecsys and cobas e immunoassay analyzers. The user reconstitutes the lyophilized material with distilled or deionized water, then runs the control on the analyzer. The analyzer measures the TSH concentration, and the result is compared against assigned target ranges to verify assay accuracy and precision. This process helps ensure the reliability of patient TSH test results, aiding clinicians in the diagnosis and management of thyroid disorders.

Clinical Evidence

Bench testing only. Studies included value assignment on MODULAR ANALYTICS E170 analyzers, real-time stability testing (up to 37 months), and reconstitution stability studies on the cobas e 411 analyzer. Acceptance criteria (90-110% recovery) were met for all stability and reconstitution parameters.

Technological Characteristics

Lyophilized quality control material; equine serum matrix; recombinant human TSH analyte. Reconstituted with 2.0 mL distilled/deionized water. Analyte-specific values assigned via immunoassay. Stability: 31 days at -20°C, 72 hours at 2-8°C, 5 hours on-analyzer. Traceable to 2nd IRP WHO Reference Standard 80/558.

Indications for Use

Indicated for use as a quality control material for the Elecsys TSH immunoassay on Elecsys and cobas e immunoassay analyzers. Intended for professional use in clinical laboratory settings.

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) #: k140534

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.