ACETAMINOPHEN FLEX REAGENT CARTRIDGE

K963244 · Dade Intl., Inc. · LDP · Sep 23, 1996 · Clinical Toxicology

Device Facts

• Record ID: K963244
• Device Name: ACETAMINOPHEN FLEX REAGENT CARTRIDGE
• Applicant: Dade Intl., Inc.
• Product Code: LDP · Clinical Toxicology
• Decision Date: Sep 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3030
• Device Class: Class 2

Intended Use

The ACTM FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure the drug acetaminophen in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

Device Story

ACTM FLEX™ reagent cartridge; used on Dimension® clinical chemistry system. Input: human serum or plasma samples. Principle: enzymatic hydrolysis of acetaminophen to acetate and p-aminophenol; colorimetric measurement of p-aminophenol proportional to acetaminophen concentration. Output: quantitative acetaminophen concentration (µg/mL). Used in clinical laboratory settings by trained laboratory personnel. Results assist clinicians in diagnosing and managing acetaminophen overdose.

Clinical Evidence

Bench testing comparing ACTM FLEX™ on Dimension® system vs. aca® ACTMN test pack. Sample size: 154 serum/plasma samples. Range: 10.2–295.0 µg/mL. Results: slope 1.04, intercept -3.27, correlation coefficient 0.998.

Technological Characteristics

In vitro diagnostic reagent cartridge. Enzymatic hydrolysis chemistry. Colorimetric detection. Designed for use on Dimension® clinical chemistry analyzer platform.

Indications for Use

Indicated for the quantitative measurement of acetaminophen in human serum and plasma to aid in the diagnosis and treatment of acetaminophen overdose.

Regulatory Classification

Identification

An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

Predicate Devices

• aca® acetaminophen test pack

Submission Summary (Full Text)

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DADE
K 963244
SEP 23 1996
DADE INTERNATIONAL
Chemistry Systems
P.O. Box 6101
Newark, DE 19714

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

# Acetaminophen FLEX™ Reagent Cartridge

## Summary of Safety and Effectiveness

The ACTM FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an *in vitro* diagnostic test intended to measure the drug acetaminophen in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

The ACTM method is based on the enzymatic hydrolysis of acetaminophen producing acetate and p-aminophenol. The amount of p-aminophenol is measured colorimetrically and is proportional to the acetaminophen concentration.

The ACTM FLEX™ reagent cartridge is substantially equivalent to the aca® acetaminophen test pack, which was cleared by the FDA via the 510(k) process. Both tests use prepackaged reagents for the determination of acetaminophen in human serum and plasma.

One hundred fifty-four serum or plasma samples were tested with the ACTM FLEX™ reagent cartridge on the Dimension® system and the aca® ACTMN analytical test pack on the aca® discrete clinical analyzer, with the following results:

slope = 1.04
intercept = -3.27
correlation coefficient = 0.998
range of samples = 10.2 - 295.0 µg/mL

Carolyn K. George
Regulatory Affairs and
Compliance Manager

September 4, 1996
Date

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