CIBA CORNING 400 SYSTEM

K961657 · Ciba Corning Diagnostics Corp. · CHL · Jun 25, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961657
• Device Name: CIBA CORNING 400 SYSTEM
• Applicant: Ciba Corning Diagnostics Corp.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Jun 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The Ciba Corning 400 System is intended for the point-of-care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.

Device Story

Ciba Corning 400 System is a point-of-care and laboratory analyzer for whole blood samples. It utilizes electrochemical sensors to measure pH, blood gases (pCO2, pO2), electrolytes (Na+, K+, Ca++, Cl-), glucose, and hematocrit. The device employs thick-film hybrid, solid-state planar sensors in a disposable cartridge, replacing traditional internal-fill electrodes. Input is 75 uL of whole blood; sensors convert electrochemical potential (potentiometry, amperometry, conductimetry) into electrical signals. The system processes these signals to output analyte concentrations. Used by clinicians in laboratory or point-of-care settings to provide rapid diagnostic data for clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrochemical sensing system using thick-film hybrid, solid-state planar sensors. Measurement methods: potentiometry (pH, Na+, K+, Ca++, Cl-, pCO2), amperometry (pO2, glucose via glucose oxidase), and conductimetry (hematocrit). Reference electrode uses silver/silver chloride in potassium chloride. Designed for use with compact disposable measurement cartridges. Requires 75 uL sample volume. Maintenance-free sensor design.

Indications for Use

Indicated for point-of-care and laboratory testing of arterial, venous, and capillary whole blood samples to measure pH, pCO2, pO2, sodium, potassium, ionized calcium, chloride, glucose, and hematocrit.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Predicate Devices

• Model 860 Analyzer (K934907)

Submission Summary (Full Text)

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K961657

# Summary of Safety and Effectiveness

JUN 25 1996

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

## 1. Submitters Information

Contact person: William J. Pignato
Director of Regulatory Affairs

Address: Ciba Corning Diagnostics Corp.
63 North Street
Medfield, MA 02052

Phone: [phone]

Date Summary Prepared: April 29, 1996

## 2. Device Information

| Proprietary Name: | Ciba Corning 400 System |
| --- | --- |
| Common Name: | Analyzer for Blood Gas, electrolytes and metabolites |
| Classification Name: | Electrode/Sensor measurement of blood gases, blood pH and blood electrolytes |
| Classification Number: | Calcium - 21 CFR 862.1145, Class II |
| | Chloride - 21 CFR 862.1170, Class II |
| | Glucose - 21 CFR 862.1345, Class II |
| | Hematocrit - 21 CFR 864.6400, Class II |
| | Potassium - 21 CFR 862.1600, Class II |
| | Sodium - 21 CFR 862.1665, Class II |
| | pCO2 - 21 CFR 862.1120, Class II |
| | pO2 - 21 CFR 862.1120, Class II |
| | pH - 21 CFR 862.1120, Class II |

## 1. Predicate Device Information

Name: Model 860 Analyzer
Manufacturer: Ciba Corning Diagnostics Corp.
510(k) Number: D.C. # K934907

## 2. Device Description

The 400 Series system analyzer is a point of care and laboratory testing analyzer used to for the direct measure of whole blood samples for the determination of the following parameters:

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- partial pressures of carbon dioxide; $p\mathrm{CO}_{2}$
- partial pressure of oxygen $pO_{2}$
- pH
- sodium; $\mathrm{Na}^{+}$
- potassium; $\mathrm{K}^{+}$
- ionized calcium; $\mathrm{Ca}^{++}$
- chloride; $\mathrm{Cl}^{-}$
- glucose
- hematocrit; Hct

## 3. Statement of Intended Use

The Ciba Corning 400 System is intended for the point-of-care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.

## 4. Summary of Technological Characteristics

The 400 Series System uses measurement technology that is based on electrochemical phenomena. The device use potentiometry, amperometry and conductimetric methods to convert the potential generated by the sensor to an electrical signal which the system then converts to a value that represents that concentration of a specific analyte in the whole blood sample.

The 400 Series sensors (i.e., electrodes) provide direct measurement of the specific analytes or substances in the sample. Each sensor in the 400 system is highly selective for one substance over others.

The sensors employ the use of thick-film hybrid technology and a solid-state design in place of the traditional electrodes that use internal fill solutions that are used in the traditional blood gas/electrolyte systems.

Features the planar-format sensors include:

- Suitability for use with the compact disposable measurement cartridge used with the 400 Series
- Sensors require a small volume of sample (75 uL)
- Sensors are maintenance free

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The sensors use the following measurement technology:

| Sensor | Measurement Technology |
| --- | --- |
| | |
| pH, Na+, K+, Ca++, Cl- | potentiometric method using ion-selective electrode technology |
| reference | silver electrode in potassium chloride and silver chloride |
| pCO2 | potentiometric method |
| pO2 | amperometric method |
| glucose | amperometric method using an enzyme electrode that uses glucose oxidase |
| hematocrit | conductimetric method |

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