ELECSYS LH CALCHECK 5

K121279 · Roche Diagnostics · JJX · May 10, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121279
• Device Name: ELECSYS LH CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Elecsys LH 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 LH reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys LH CalCheck 5 is a lyophilized, human serum-based control containing luteinizing hormone (LH). It is used by laboratory professionals to verify calibration and assay range for Elecsys LH reagents on Roche immunoassay analyzers (Elecsys 2010, cobas e 411, 601, 602, and MODULAR ANALYTICS E170). The product is reconstituted with distilled or deionized water. It provides five levels of analyte concentration (level 1 is analyte-free) to confirm instrument performance across the analytical measurement range. By comparing measured values against assigned target values, clinicians ensure the accuracy and reliability of patient LH test results, facilitating appropriate clinical management of endocrine conditions.

Clinical Evidence

Bench testing only. Evidence includes value assignment testing performed in duplicate on at least three E170 analyzer measuring cells, with target values defined by the median of at least 6 determinations. Acceptance criteria required assigned values on additional platforms (Elecsys 2010, cobas e 411, 601, 602) to be within 10% of the master platform. Stability testing (real-time and accelerated) supports a 4-hour open-vial stability at 20-25°C and an initial 18-month shelf-life at 2-8°C.

Technological Characteristics

Lyophilized human serum matrix containing luteinizing hormone. Five concentration levels. Reconstitution required with 1.0 mL distilled/deionized water. Standardized against 2nd International Standard (NIBSC) 80/552. 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 LH reagent on 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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# Decision Summary

Statement for the Record, k121279

This 510(k) was reviewed under OIVD’s Pilot Triage 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.