MULTICHEM U

K131993 · Techno-Path Manufacturing , Ltd. · JJY · Oct 15, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131993
• Device Name: MULTICHEM U
• Applicant: Techno-Path Manufacturing , Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Oct 15, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Multichem U is intended for use as an assayed urine quality control to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. Two levels of Controls (Level 1 and Level 2) are supplied in liquid form. The following analytes are listed in the package insert: Amylase, Calcium, Chloride, Creatinine Enzymatic, Creatinine Picrate, Glucose, Magnesium, Microalbumin, Phosphorous, Potassium, Sodium, Urea Nitrogen, Uric Acid, and Urinary Protein.

Device Story

Multichem U is a liquid, human urine-based quality control material; contains purified biochemical extracts, chemicals, drugs, preservatives, and stabilizers. Used in clinical laboratories to monitor precision of urine chemistry testing procedures. Supplied in two levels (Level 1 and Level 2) to cover analytical ranges. Healthcare providers use the control by running it through clinical chemistry systems (e.g., Abbott ARCHITECT c8000) alongside patient samples; results are compared against established value assignment ranges to verify system performance and ensure accuracy of patient test results. Benefits include improved reliability of diagnostic testing and early detection of analytical drift.

Clinical Evidence

Bench testing only. Value assignment performed on Abbott ARCHITECT c8000 systems using 32 data points (16 runs, 2 replicates). Stability validated per CLSI EP25A; open vial stability established at 30 days at 2-8°C; accelerated shelf-life testing supports 24-month stability at 2-8°C. Drift limits set at 10% for most analytes, with 20% for others.

Technological Characteristics

Human urine-based matrix; liquid form. Contains purified biochemical material, chemicals, drugs, preservatives, and stabilizers. Storage: 2° to 8°C. Open vial stability: 30 days at 2° to 8°C. Analyte concentration adjusted using commercially available sources. No traceability to higher-order reference materials claimed.

Indications for Use

Indicated for use as an assayed urine quality control to monitor the precision of laboratory testing procedures for specific analytes (Amylase, Calcium, Chloride, Creatinine, Glucose, Magnesium, Microalbumin, Phosphorous, Potassium, Sodium, Urea Nitrogen, Uric Acid, Urinary Protein). Intended for professional 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) #: k131993

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.