LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)

K121143 · Bio-Rad Laboratories · DIF · May 18, 2012 · Clinical Toxicology

Device Facts

• Record ID: K121143
• Device Name: LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
• Applicant: Bio-Rad Laboratories
• Product Code: DIF · Clinical Toxicology
• Decision Date: May 18, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Indications for Use

Liquichek Whole Blood Immunosuppressant Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Liquichek Whole Blood Immunosuppressant Control is a liquid, human whole blood-based quality control material containing preservatives and stabilizers. It is designed for use in clinical laboratories to monitor the precision of testing procedures for immunosuppressant drugs (Cyclosporine, Tacrolimus, Sirolimus, Everolimus). The device is provided with mean values for four control levels, derived from replicate analyses. Laboratory personnel use the control to establish their own means and acceptable ranges based on their specific test systems and tolerance limits. By comparing observed results against these established ranges, clinicians and laboratory staff can assess the performance and precision of their analytical methods, ensuring the reliability of patient test results.

Clinical Evidence

Bench testing only. Stability studies were performed to determine open vial stability (10 days for Tacrolimus, 14 days for other analytes at 2-8°C) and shelf life (40 months at -20°C to -70°C).

Technological Characteristics

Human whole blood matrix with added preservatives and stabilizers. Liquid form. Analyte content: Cyclosporine, Tacrolimus, Sirolimus, Everolimus. Storage: -20°C to -70°C. Open vial stability: 10-14 days at 2-8°C.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes Sirolimus, Tacrolimus, Cyclosporine, and Everolimus.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Submission Summary (Full Text)

{0}

# Decision Summary

Statement for the Record, K121143

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.