Beta-CrossLaps CalCheck 5

K170678 · Roche Diagnostics · JJX · Apr 4, 2017 · Clinical Chemistry

Device Facts

• Record ID: K170678
• Device Name: Beta-CrossLaps CalCheck 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Apr 4, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

This CalCheck set is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys ß-CrossLaps/serum reagent on the cobas e immunoassay analyzers.

Device Story

ß-CrossLaps CalCheck 5 is a set of five assayed control levels used for calibration verification and measuring range assessment of Elecsys ß-CrossLaps/serum assays on cobas e immunoassay analyzers. The device consists of synthetic ß-CTx peptide in a human serum matrix, provided in lyophilized form. Users reconstitute the vials with distilled or deionized water and run them on the analyzer. The device is intended for laboratory use to meet certification requirements (e.g., CAP, CLIA). It provides a customer convenience tool for verifying assay performance; it is not required for routine assay operation. Healthcare providers use the output to confirm that the analyzer's measuring range is accurate, ensuring reliable patient test results.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated via value assignment and stability studies (open vial, accelerated, and real-time). Value assignment performed on cobas e 801 modules. Stability studies confirmed 4-hour open-vial stability at 20-25°C and 18-month shelf-life at 2-8°C, with acceptance criteria of 90-110% recovery for levels 2-5 and ≤ 0.05 ng/mL for level 1.

Technological Characteristics

Assayed control material; synthetic ß-CTx peptide in human serum matrix. Five levels of concentration. Lyophilized format requiring reconstitution with 1.0 mL distilled/deionized water. Storage at 2-8°C. Compatible with cobas e immunoassay analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys ß-CrossLaps/serum reagent on 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)

{0}

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

510(k) #: k170678

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.