AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET

K130762 · Aalto Scientific, Ltd. · JJY · Apr 29, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130762
• Device Name: AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains: Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin. These five levels demonstrate a linear relationship to each other for their respective analytes. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification of reportable range for Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for these analytes. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set should not be used for calibration or standardization of the Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Pheytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valporic Acid and Vancomycin assays. The Audit® MicroCV™ Therapeutic Drug (TDM) Linearity Set is "For In Vitro Diagnostic Use Only".

Device Story

Audit® MicroCV™ TDM Linearity Set is an in-vitro diagnostic quality control material; consists of five levels of lyophilized human-based serum containing 15 therapeutic drug analytes. Used in clinical laboratories to verify linearity and reportable range of quantitative assays. Device does not perform analysis; rather, it serves as a reference material for laboratory instrumentation. Laboratory personnel process the five levels through their existing clinical chemistry analyzers; results are plotted to confirm linear response across the assay range. Benefits include ensuring instrument accuracy and reliability for therapeutic drug monitoring, helping clinicians maintain confidence in patient test results. Materials are tested for HbsAg, HCV, and HIV-1/2.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed 24-month shelf life and 7-day open-vial stability at 2-8°C. Linearity established via 5-point regression analysis on Abbott Axsym and Roche Hitachi 911 instruments, requiring a linear regression value > 0.90.

Technological Characteristics

Lyophilized human-based serum; contains 15 analytes; preserved with sodium azide. 5-level configuration (5 x 5 mL). Storage 2-8°C. Non-sterile. Analyte value assignment performed via quantitative clinical chemistry analyzers (Abbott Axsym, Roche Hitachi 911).

Indications for Use

Indicated for use as an assayed quality control material to simulate human serum for determining linearity, calibration verification, and verification of reportable range for 15 specific therapeutic drugs (Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, Methotrexate, Phenobarbitol, Phenytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valproic Acid, Vancomycin) on quantitative clinical chemistry analyzers. Not for use as a calibrator or standard.

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) #: k130762

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.