(76 days)
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No
The description details a system using Integrated Multisensor Technology (IMT) and a Severinghaus electrode to measure ion activity and CO2. There is no mention of AI, ML, or any computational learning processes. The performance studies are based on standard statistical comparisons of analytical results.
No
The device performs in vitro diagnostic tests to measure levels of sodium, potassium, chloride, and total carbon dioxide in samples, which is for diagnostic purposes, not therapeutic intervention.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the system "performs four in vitro diagnostic tests."
No
The device description clearly outlines hardware components like a multisensor cartridge and a Severinghaus electrode, indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Dade Indirect IMT system with TCQ2 electrode performs four in vitro diagnostic tests: sodium (Na), potassium (K), chloride (CI) and total carbon dioxide (TCO2)."
This statement directly identifies the device's purpose as performing diagnostic tests on samples taken from the body (in vitro), which is the definition of an IVD.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Dade Indirect IMT system with TCO2 electrode performs four in vitro diagnostic tests: sodium (Na), potassium (K), chloride (CI) and total carbon dioxide (TCO2).
The sodium, potassium and chloride (Na/K/CI) 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 (TCQ2) method uses a Severinghaus electrode designed to measure the liberated CO2 from a diluted, acidified sample.
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
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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)
A spit sample comparison study was conducted versus another indirect electrolyte system, the Beckman SYNCHRON CX63 clinical system. with the following results:
n = 270; 149 serum and 121 plasma
n = Na, 100; K, 95; Cl, 105
| 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 |
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.
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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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§ 862.1600 Potassium test system.
(a)
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.(b)
Classification. Class II.
0
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
APR
1 4 1997
The Dade Indirect IMT system with TCQ2 electrode performs four in vitro diagnostic tests: sodium (Na), potassium (K), chloride (CI) and total carbon dioxide (TCO2).
The sodium, potassium and chloride (Na/K/CI) 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 (TCQ2) 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 cartidge 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, chloride and TCC, in human serum or plasma, and for determination of sodium, potassium and chloride in urine.
| 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 |
A spit sample comparison study was conducted versus another indirect electrolyte system, the Beckman SYNCHRON CX63 clinical system. with the following results:
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
Reauce S. Ayres for C.K. George
Regulatory Affairs and
April 2, 1997
Date