(32 days)
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No
The summary describes a standard blood gas and electrolyte analyzer and does not mention any AI or ML capabilities.
No.
The device is used for diagnostic testing and provides measurements of various blood parameters, but it does not describe any therapeutic function or direct treatment of a disease or condition.
Yes
The device measures blood gases, electrolytes, and metabolites, which are parameters used by healthcare professionals to diagnose conditions.
No
The device description clearly states it is an "analyzer" used for direct measurement of whole blood samples, indicating it is a hardware device with integrated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "point-of-care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples." This involves testing biological samples in vitro (outside the body) to provide information about a patient's health status.
- Device Description: The device description details the measurement of various parameters (blood gases, electrolytes, hematocrit) in whole blood samples. These are all tests performed on biological specimens in vitro.
The definition of an IVD is a medical device that is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Ciba Corning 348 System clearly fits this definition.
N/A
Intended Use / Indications for 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.
Product codes
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, p02 - 21 CFR 862.1120, Class II, pH - 21 CFR 862.1120, Class II
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; pCO2 .
- partial pressure of oxygen pO2 .
- pH
- sodium; Na* .
- potassium; K* ●
- ionized calcium; Ca** ●
- . hematocrit: Hct
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
point-of-care and laboratory
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
D.C. # K933373
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
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.(b)
Classification. Class II.
0
JUN 24 1998
Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitters Information
1 177
| Contact person: | William J. Pignato |
|---|---|
| Director of Regulatory Affairs |
- Address: Ciba Corning Diagnostics Corp. 63 North Street Medfield, MA 02052
- Phone: 508 359-3825
- 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 | |
| p02 - 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:
- م partial pressures of carbon dioxide; pCO2 .
- partial pressure of oxygen pO2 .
1
- pH
- sodium; Na* .
- potassium; K* ●
- ionized calcium; Ca** ●
- . 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.
| Sensor | Measurement Technology |
|---|---|
| pH, Na+, K+, Ca++, | potentiometric method using ion-selective electrode technology |
| reference | silver electrode in potassium chloride and silver chloride |
| pCO2 | potentiometric method |
| pO2 | amperometric method |
| hematocrit | conductimetic method |
The sensors use the following measurement technology: