MULTICHEM WBT

K132174 · Techno-Path Manufacturing , Ltd. · DIF · Sep 20, 2013 · Clinical Toxicology

Device Facts

• Record ID: K132174
• Device Name: MULTICHEM WBT
• Applicant: Techno-Path Manufacturing , Ltd.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Sep 20, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Indications for Use

The Multichem WBT 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. The Multichem WBT control consists of 3 different levels of control solutions prepared from human whole blood.

Device Story

Multichem WBT is a liquid, frozen, assayed quality control material derived from human whole blood, supplemented with biochemical extracts, chemicals, drugs, preservatives, and stabilizers. It is provided in three levels to monitor analytical performance. Used in clinical laboratories by technicians to verify the precision of testing procedures for immunosuppressant drugs (Cyclosporine, Sirolimus, Tacrolimus). The control is processed alongside patient samples on clinical chemistry systems (e.g., Abbott ARCHITECT i2000). Healthcare providers compare the measured control values against established ranges to ensure the accuracy and reliability of patient test results. The device aids in identifying potential analytical errors, thereby supporting clinical decision-making by ensuring the validity of immunosuppressant drug monitoring.

Clinical Evidence

Bench testing only. No clinical data. Performance was validated through value assignment testing on the Abbott ARCHITECT i2000 system using 32 data points per analyte across 16 runs. Stability was evaluated using CLSI EP25A protocols, including accelerated and real-time testing to support a 30-month shelf-life at -20°C to -80°C and open-vial stability claims (10 days for Tacrolimus/Cyclosporine, 7 days for Sirolimus) with a 10% drift limit.

Technological Characteristics

Matrix: Processed human whole blood and hemolysate. Form: Liquid, frozen. Storage: -20°C to -80°C. Analytes: Cyclosporine, Sirolimus, Tacrolimus. Stability testing per CLSI EP25A. No traceability to higher-order reference materials claimed.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for Cyclosporine, Sirolimus, and Tacrolimus. For professional use in clinical laboratory settings.

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)

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

510(k) #: k132174

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.