CIBA CORNING 348 SYSTEM

K962021 · Ciba Corning Diagnostics Corp. · CHL · Jun 24, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962021
• Device Name: CIBA CORNING 348 SYSTEM
• Applicant: Ciba Corning Diagnostics Corp.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Jun 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Intended Use

The Ciba Corning 348 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

System analyzes whole blood samples (arterial, venous, capillary) for blood gases (pCO2, pO2), electrolytes (Na+, K+, Ca2+), pH, and hematocrit. Used in point-of-care and laboratory settings by clinical staff. Employs electrochemical sensors (potentiometric, amperometric, conductimetric) to convert analyte concentrations into electrical signals. System processes signals to provide quantitative analyte values. Output used by clinicians for diagnostic assessment of patient metabolic and respiratory status.

Clinical Evidence

No clinical data provided; device relies on electrochemical sensor performance characteristics.

Technological Characteristics

Electrochemical sensor system. Potentiometric method for pH, Na+, K+, Ca2+, and pCO2; amperometric method for pO2; conductimetric method for hematocrit. Reference electrode uses silver/silver chloride in potassium chloride. Bench-top analyzer form factor.

Indications for Use

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

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 850 Analyzer (K933373)

Submission Summary (Full Text)

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Company Confidential
K962021
JUN 24 1996

# Summary of Safety and Effectiveness

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: May 22, 1996

## 2. Device Information

| Proprietary Name: | Ciba Corning 348 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 |
| | Hematocrit - 21 CFR 864.6348, 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 850 Analyzer
Manufacturer: Ciba Corning Diagnostics Corp.
510(k) Number: D.C. # K933373

## 2. Device Description

The 348 Series system analyzer is a point of care and laboratory testing analyzer used for the direct measure of whole blood samples for the determination of the following parameters:

- partial pressures of carbon dioxide; $p\mathrm{CO}_{2}$
- partial pressure of oxygen $p\mathrm{O}_{2}$

Ciba Corning 400 System
4/18/96
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Company Confidential

- pH
- sodium; Na⁺
- potassium; K⁺
- ionized calcium; Ca²⁺
- hematocrit; Hct

## 3. Statement of Intended Use

The Ciba Corning 348 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 348 Series System uses measurement technology that is based on electrochemical phenomena. The device uses 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 348 Series sensors (i.e., electrodes) provide direct measurement of the specific analytes or substances in the sample. Each sensor in the 348 system is highly selective for one substance over others.

The sensors use the following measurement technology:

| Sensor | Measurement Technology |
| --- | --- |
| | |
| pH, Na⁺, K⁺, Ca²⁺, | potentiometric method using ion-selective electrode technology |
| reference | silver electrode in potassium chloride and silver chloride |
| pCO₂ | potentiometric method |
| pO₂ | amperometric method |
| hematocrit | conductimetric method |

Ciba Corning 400 System
4/18/96
Page 3