DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE

K970330 · Dade Intl., Inc. · CEM · Apr 14, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970330
• Device Name: DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE
• Applicant: Dade Intl., Inc.
• Product Code: CEM · Clinical Chemistry
• Decision Date: Apr 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1600
• Device Class: Class 2

Intended Use

The Dade Indirect IMT system with TCO₂ electrode performs four in vitro diagnostic tests: sodium (Na), potassium (K), chloride (Cl) and total carbon dioxide (TCO₂).

Device Story

System performs in vitro diagnostic testing for Na, K, Cl, and TCO₂; utilizes Dimension XL or RxL clinical chemistry system. Sample diluted automatically on-board; processed in multisensor cartridge using Integrated Multisensor Technology (IMT) to measure electrical potential proportional to ion activity. TCO₂ measured via Severinghaus electrode following sample acidification and CO₂ liberation. Used in clinical laboratory settings by trained personnel. Output provides quantitative electrolyte concentrations to healthcare providers for diagnostic assessment of patient metabolic and electrolyte status.

Clinical Evidence

Bench testing via split-sample comparison against Beckman SYNCHRON CX®3. Serum/plasma study (n=270) showed correlation coefficients: Na 0.983, K 0.996, Cl 0.968, TCO₂ 0.945. Urine study (n=95-105) showed correlation coefficients: Na 0.997, K 0.998, Cl 0.979. Slopes and intercepts provided for all analytes.

Technological Characteristics

Integrated Multisensor Technology (IMT) for ion-selective potentiometry; Severinghaus electrode for TCO₂. Automated dilution system. Operates on Dimension XL or RxL clinical chemistry platforms. Analyte range: Na (serum 98-160, urine 20-178), K (serum 2.3-9.5, urine 9-98), Cl (serum 71-119, urine 38-323), TCO₂ (serum 10.6-41.5).

Indications for Use

Indicated for the determination of sodium, potassium, chloride, and TCO₂ in human serum or plasma, and for the determination of sodium, potassium, and chloride in urine.

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Predicate Devices

• Dade direct IMT system (ISE sensor cartridge with revised TCO₂ electrode) (K970330)

Reference Devices

• Beckman SYNCHRON CX®3 clinical system

Submission Summary (Full Text)

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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

# Dade Indirect IMT System with TCO₂ Electrode

## Summary of Safety and Effectiveness

K970330
APR 14 1997

The Dade Indirect IMT system with TCO₂ electrode performs four *in vitro* diagnostic tests: sodium (Na), potassium (K), chloride (Cl) and total carbon dioxide (TCO₂).

The sodium, potassium and chloride (Na/K/Cl) methods use a sample which is diluted automatically on-board the Dimension® XL or RxL clinical chemistry system. The diluted sample is then processed in a multisensor cartridge which uses Integrated Multisensor Technology (IMT) to develop an electrical potential proportional to the activity of each specific ion in the sample. The total carbon dioxide (TCO₂) method uses a Severinghaus electrode designed to measure the liberated CO₂ from a diluted, acidified sample.

The Dade Indirect IMT system with TCO₂ electrode is substantially equivalent to the Dade direct IMT system (ISE sensor cartridge with revised TCO₂ electrode), which was cleared by the FDA through the 510(k) process. Both systems use integrated multisensor technology on an automated system for the determination of sodium, potassium, chloride and TCO₂ in human serum or plasma, and for determination of sodium, potassium and chloride in urine.

A split sample comparison study was conducted versus another indirect electrolyte system, the Beckman SYNCHRON CX®3 clinical system, with the following results:

| Serum/Plasma* | Slope | Intercept | Correlation Coefficient | Range of Samples |
| --- | --- | --- | --- | --- |
| Na | 1.03 | -4.8 | 0.983 | 98-160 |
| K | 1.00 | 0.06 | 0.996 | 2.3-9.5 |
| Cl | 1.05 | -0.3 | 0.968 | 71-119 |
| TCO₂ | 1.00 | 0.3 | 0.945 | 10.6-41.5 |
| Urine ** | | | | |
| Na | 0.91 | 5 | 0.997 | 20-178 |
| K | 0.93 | 0.2 | 0.998 | 9-98 |
| Cl | 1.03 | 2.0 | 0.979 | 38-323 |

* n = 270; 149 serum and 121 plasma
** n = Na, 100; K, 95; Cl, 105

SYNCHRON CX® is a registered trademark of Beckman Instruments, Brea, CA 92621

Rebecca S. Cayson for C.K. George
Carolyn K. George
Regulatory Affairs and
Compliance Manager

April 2, 1997
Date