(56 days)
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No
The document describes a standard blood gas and electrolyte analyzer and does not mention any AI or ML terms or functionalities.
No.
The device is an analyzer used for diagnostic testing of blood samples to measure various parameters, not to treat a medical condition.
Yes
The device is described as an "analyzer" used for "testing of blood gases, electrolytes and metabolites" and directly measures parameters like pCO2, pO2, pH, sodium, potassium, glucose, and hematocrit from whole blood samples. These measurements provide information about a patient's physiological state, which is used for diagnosis and monitoring.
No
The device description clearly states it is an "analyzer" and measures parameters directly from whole blood samples, indicating it is a physical hardware device.
Based on the provided information, 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 clearly indicates the device is used to examine specimens derived from the human body (blood) to provide information for diagnostic purposes.
- Device Description: The device measures parameters like pCO2, pO2, pH, electrolytes, glucose, and hematocrit directly from whole blood samples. These are all common in vitro diagnostic tests.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Ciba Corning 400 System fits this definition perfectly.
N/A
Intended Use / Indications for 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.
Product codes
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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:
- وء partial pressures of carbon dioxide; pCO2 ●
- partial pressure of oxygen pO2 ●
- . pH
- sodium; Na* .
- potassium: K* .
- ionized calcium; Ca** .
- chloride: Cli .
- alucose .
- 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 testing
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
D.C. # K934907
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, which appear to be 'K961657'. The characters are written in a bold, somewhat stylized font, with thick strokes. The overall impression is that of a handwritten code or identifier.
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
508 359-3825 Phone:
April 29, 1996 Date Summary Prepared:
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 | |
| p02 - 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:
1
-
وء partial pressures of carbon dioxide; pCO2 ●
-
partial pressure of oxygen pO2 ●
-
. pH
-
sodium; Na* .
-
potassium: K* .
-
ionized calcium; Ca** .
-
chloride: Cli .
-
alucose .
-
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 substances 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 .
2
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 |
| p02 | amperometric method |
| glucose | amperometric method using an enzyme electrode that uses glucose oxidase |
| hematocrit | conductimetic method |