(308 days)
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No
The summary describes a standard clinical chemistry analyzer using indirect potentiometry, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is a clinical chemistry analyzer used for measurement of electrolytes, not for therapeutic intervention or treatment.
Yes
The device is a clinical chemistry analyzer used to measure specific analytes (sodium, potassium, chloride) in serum, which provides information to monitor electrolyte balance. This measurement provides diagnostic information, fitting the definition of a diagnostic device.
No
The device description explicitly states it is a "clinical chemistry analyzer" and uses "indirect potentiometry" with an "Ion Selective Electrode (ISE) module," indicating it is a hardware device that performs physical measurements.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is a "clinical chemistry analyzer intended to be used for the measurement of sodium, potassium and chloride in serum to monitor electrolyte balance." This describes a test performed on a biological sample (serum) outside of the body to provide information for medical purposes (monitoring electrolyte balance).
- Device Description: The device description further clarifies that it "measures the concentration of the electrolytes, sodium, potassium and chloride in samples, using indirect potentiometry." This confirms it's performing a measurement on a sample.
- Performance Studies: The performance studies describe tests performed on samples (correlation with another device, linearity, precision) which are typical evaluations for IVD devices.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
This device with an optional Ion Selective Electrode (ISE) module is a clinical chemistry analyzer intended to be used for the measurement of sodium, potassium and chloride in samples.
This device with an optional Ion Selective Electrode (ISE) module is a clinical chemistry analyzer intended to be used for the measurement of sodium, potassium and chloride in serum to monitor electrolyte balance.
Product codes (comma separated list FDA assigned to the subject device)
CEM, CGZ, JGS, JIX, JJE
Device Description
The Prestige 24i with Ion Selective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in samples, using indirect potentiometry.
Prestige 24i; Sirrus; MGC 240 (three identical models varying in name only)
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 correlation analysis between Roche Cobas Mira Plus and the Prestige 24i yielded the following results :
1 Sodium - Correlation Coefficient: 0.97, Slope (Least-Squares): 0.95, Y-axis intercept: +6.8625 mmol/L
2 Potassium - Correlation Coefficient: 0.99, Slope (Least-Squares): 0.98, Y-axis intercept: - 0.0135 mmol/L
3 Chloride - Correlation Coefficient: 0.98, Slope (Least-Squares): 0.97, Y-axis intercept: +3.2579 mmol/L
The linearity test yielded the following results:
Sodium: 70 - 200 mmol/L (Serum)
Potassium: 1 - 50 mmol/L (Serum)
Chloride: 70 - 200 mmol/L (Serum)
The precision test results:
Within Run N=20:
Sodium - Sample 1 %CV: 1.0, Sample 2 %CV: 0.6
Potassium - Sample 1 %CV: 1.7, Sample 2 %CV: 1.0
Chloride - Sample 1 %CV: 0.5, Sample 2 %CV: 0.8
Day by Day-Run N=20:
Sodium - Sample 1 %CV: 1.4, Sample 2 %CV: 1.3
Potassium - Sample 1 %CV: 1.5, Sample 2 %CV: 1.3
Chloride - Sample 1 %CV: 2.5, Sample 2 %CV: 2.3
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.
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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§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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