MULTICHEM P

K131992 · Techno-Path Manufacturing , Ltd. · JJY · Sep 25, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131992
• Device Name: MULTICHEM P
• Applicant: Techno-Path Manufacturing , Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 25, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Multichem P is intended for use as a single level assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. The following analytes are listed in the package insert: Alpha-1 Acidglycoprotein, Alpha-1 Antitrypsin, Apolipoprotein A1 (APO A1), Apolipoprotein B (APO B), Beta-2 Microglobulin, Ceruloplasmin, Complement C3, Complement C4, C-Reactive Protein, Haptoglobin, Immunoglobulin A, Immunoglobulin G. Immunoglobulin M, Prealbumin, Rheumatoid Factor (RF), and Transferrin,

Device Story

Multichem P is a liquid, human serum-based quality control material used in clinical laboratories to monitor the precision of testing procedures for various biochemical analytes. It is provided in single-level 3 mL vials. The control is prepared from human serum supplemented with purified biochemical extracts, chemicals, drugs, and stabilizers. It is intended for use by laboratory professionals on clinical chemistry systems (e.g., Abbott ARCHITECT c8000). The healthcare provider uses the control to verify the performance of their analytical methods; if the control results fall within established statistical limits, the provider gains confidence in the accuracy of patient sample testing. The device benefits patients by ensuring the reliability and precision of diagnostic test results, thereby supporting accurate clinical decision-making.

Clinical Evidence

No clinical data. Performance was established via bench testing, including value assignment and stability studies. Stability was validated using accelerated and real-time testing on the Abbott ARCHITECT c8000 system, supporting a 30-month shelf-life at -20°C to -80°C and 14-day open-vial stability at 2-8°C. Value assignment ranges were established with a 20% criterion.

Technological Characteristics

Human serum-based matrix with added biochemical extracts, chemicals, and stabilizers. Liquid form. Storage: -20°C to -80°C. Open-vial stability: 14 days at 2-8°C. Analyte monitoring for proteins and immunoglobulins. No electronic components or software algorithms.

Indications for Use

Indicated for use as a single-level assayed quality control material to monitor the precision of laboratory testing procedures for specific biochemical analytes in human serum. No specific patient population is targeted as this is an in vitro diagnostic control for laboratory use.

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

510(k) #: k131992

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.