DRUG CALIBRATOR II

K962817 · Dade Intl., Inc. · DKB · Sep 16, 1996 · Clinical Toxicology

Device Facts

• Record ID: K962817
• Device Name: DRUG CALIBRATOR II
• Applicant: Dade Intl., Inc.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Sep 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

Drug Calibrator II is an in vitro diagnostic product intended for the calibration of test methods packaged in FLEX™ reagent cartridges.

Device Story

Liquid bovine serum-based calibrator; contains weighed-in quantities of purified drugs. Used in clinical laboratory settings to calibrate drug test methods within FLEX™ reagent cartridges. Provides reference points for assay quantification. Supports healthcare providers in ensuring accurate drug concentration measurements for patient diagnostic testing.

Technological Characteristics

Liquid bovine serum base; contains purified drugs; packaged in 10 vials (five levels, two vials each, 5.0 mL per vial).

Indications for Use

Indicated for the calibration of drug test methods packaged in FLEX™ reagent cartridges for in vitro diagnostic use.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Dimension® Drug Calibrator

Submission Summary (Full Text)

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DADE
SEP 16 1996
K962817
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

## Drug Calibrator II

## Summary of Safety and Effectiveness

Drug Calibrator II is an *in vitro* diagnostic product intended for the calibration of test methods packaged in FLEX™ reagent cartridges.

Drug Calibrator II is a liquid bovine serum base product containing weighed-in quantities of purified drugs. It is packaged as 10 vials, two vials each of five levels. Each vial contains 5.0 mL.

Drug Calibrator II is substantially equivalent to the Dimension® Drug Calibrator as they are both intended to be used as calibrators for drug methods and are spiked with purified drugs.

Carolyn K. George
Regulatory Affairs and
Compliance Manager

July 18, 1996
Date

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