MULTICHEM IA AND IA PLUS

K132091 · Techno-Path Manufacturing , Ltd. · JJY · Sep 20, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132091
• Device Name: MULTICHEM IA AND IA PLUS
• Applicant: Techno-Path Manufacturing , Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 20, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Multichem IA Plus control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Multichem IA Plus is a multi-analyte quality control serum derived from human serum supplemented with purified biochemical materials, chemicals, drugs, preservatives, and stabilizers. It is provided in liquid form in three levels to monitor analytical ranges. Used in clinical laboratories by technicians/scientists to verify the precision of immunoassay testing procedures. The healthcare provider compares the instrument's measured values for the control against the provided assay values to assess system performance and ensure accurate patient testing. It benefits patients by ensuring the reliability and consistency of diagnostic test results.

Clinical Evidence

Bench testing only. Stability studies (real-time and accelerated per CLSI EP25A) confirmed shelf-life of 30 months at -20°C to -80°C and established open-vial stability durations for various analytes. Value assignment was performed using replicate analyses on Abbott ARCHITECT systems.

Technological Characteristics

Human serum-based control; contains purified biochemicals, chemicals, drugs, preservatives, and stabilizers. Liquid form. Storage: -20°C to -80°C. No electronic components, software, or connectivity. Sterilization not applicable (human source material tested negative for HBsAg, HCV, HIV-1/2).

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific analytes (e.g., hormones, tumor markers, therapeutic drugs, cardiac markers) in clinical laboratory settings. No specific patient population is targeted; intended for professional use in monitoring assay performance.

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) #: k132091

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.