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510(k) Data Aggregation
(34 days)
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
The ISE module of the COBAS INTEGRA systems is intended for use for the quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes. This Chloride electrode is recommended to be used if a significant amount of the samples are plasma samples. Serum and urine samples may also be analyzed with this electrode. Chloride measurements are used in diagnosis and treatment of electrolyte and metabolic disorders.
The ISE module of the COBAS INTEGRA systems is intended for use for the quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes. The ion-selective electrode is using undiluted (ISE Direct) or automatically diluted (ISE Indirect, ISE Urine) specimens. This Chloride electrode is recommended to be used if a significant amount of the samples are plasma samples. Serum and urine samples may also be analyzed with this electrode.
Here's a breakdown of the acceptance criteria and study information for the Chloride Electrode Gen. 2, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the "Modified Chloride Electrode Gen. 2" to a "Predicate Device – Chloride Electrode (approved via K963627)". While explicit "acceptance criteria" for the modified device are not stated as separate numerical targets, the study's goal is to demonstrate "substantial equivalence" to the predicate. Therefore, the "acceptance criteria" implicitly are that the modified device's performance should be comparable to or better than the predicate device for all relevant characteristics, and within acceptable clinical ranges.
The table below summarizes the key performance characteristics that were compared:
| Feature | Predicate Device Performance (K963627) | Modified Chloride Electrode Gen. 2 Performance |
|---|---|---|
| Stability (Onboard) | 2 months or 6000 samples (reduced when majority of plasma samples are used) | 3 months (serum samples only, reduced when plasma samples are used) |
| Precision (ISE Direct mode, Serum) | Within run CV% (n=20): 0.19% @ 92.9 mmol/L, 0.19% @ 127.2 mmol/L | |
| Between run CV% (n=20): 0.9% @ 94.3 mmol/L, 1.1% @ 126.5 mmol/L | Within run CV% (n=21): 0.69% @ 86 mmol/L, 0.46% @ 99 mmol/L | |
| Between day CV% (n=21): 1.3% @ 86 mmol/L, 0.92% @ 99 mmol/L | ||
| Total CV% (n/a): 0.9% @ 94.4 mmol/L, 1.1% @ 126.4 mmol/L | ||
| Precision (ISE Direct mode, Plasma) | Within run CV% (n/a): N/A | |
| Between run CV% (n/a): N/A | Within run CV% (low n=20, high n=21): 0.36% @ 89.2 mmol/L, 0.15% @ 125 mmol/L | |
| Between day CV% (n=21): 1.0% @ 91.6 mmol/L, 1.2% @ 126.0 mmol/L | ||
| Total CV% (n/a): 1.0% @ 91.8 mmol/L, 1.4% @ 125.8 mmol/L | ||
| Precision (ISE Indirect mode, Serum) | Within run CV% (n/a): N/A | |
| Between run CV% (n/a): N/A | Within run CV% (n=21): 0.65% @ 90.3 mmol/L, 0.25% @ 124.1 mmol/L | |
| Between day CV% (n=21): 1.0% @ 92.0 mmol/L, 0.9% @ 122.8 mmol/L | ||
| Total CV%: 1.0%@ 92.1mmol/L, 1.0% @ 122.8 mmol/L | ||
| Precision (ISE Indirect mode, Plasma) | Within run CV% (n/a): N/A | |
| Between run CV% (n/a): N/A | Within run CV% (n=21): 0.29% @ 86.4 mmol/L, 0.23% @ 121.9 mmol/L | |
| Between day CV% (n=21): 1.1% @ 88.7 mmol/L, 1.0% @ 121.6 mmol/L | ||
| Total CV%: 1.1% @ 88.8 mmol/L, 1.0% @ 121.6 mmol/L | ||
| Precision (ISE Indirect mode) | Within run CV% (n=20): 0.77% @ 87 mmol/L, 0.72% @ 101 mmol/L | |
| Between run CV% (n=20): 1.5% @ 87 mmol/L, 1.2% @ 101 mmol/L | (Specific to serum/plasma concentrations as above) | |
| Precision (ISE Urine mode) | Within run CV% (n=20): 0.97% @ 53 mmol/L, 1.2% @ 267 mmol/L | |
| Between run CV% (n=20): 2.8% @ 53 mmol/L, 2.2% @ 267 mmol/L | Within run CV% (low n=21, high n=20): 0.5% @ 61.4 mmol/L, 0.5% @ 194.4 mmol/L | |
| Between day (n=21): 2.3% @ 64.9 mmol/L, 4.3% @ 186.4 mmol/L | ||
| Total: 2.8% @ 65.1mmol/L, 4.4% @ 186.5 mmol/L | ||
| Linearity (Serum/Plasma) | ISE Direct: 20-250 mmol/L; ISE Indirect: 20-250 mmol/L | ISE Direct: 60-140 mmol/L; ISE Indirect: 60-140 mmol/L |
| Linearity (Urine) | 20-350 mmol/L | 20-250 mmol/L |
| Sensitivity for electrode: slope | -42 to -56 mV/dec | ISE Direct: -35 to -56 mV/dec; ISE Indirect: -38 to -56 mV/dec |
2. Sample Sizes and Data Provenance for the Test Set
- Sample Size for Precision Studies:
- ISE Direct mode (Modified Device):
- Within run CV%: n=21 for serum (86 mmol/L and 99 mmol/L), n=20 (low) and n=21 (high) for plasma (89.2 mmol/L and 125 mmol/L).
- Between day CV%: n=21 for serum (86 mmol/L and 99 mmol/L), n=21 for plasma (91.6 mmol/L and 126.0 mmol/L).
- ISE Indirect mode (Modified Device):
- Within run CV%: n=21 for serum (90.3 mmol/L and 124.1 mmol/L), n=21 for plasma (86.4 mmol/L and 121.9 mmol/L).
- Between day CV%: n=21 for serum (92.0 mmol/L and 122.8 mmol/L), n=21 for plasma (88.7 mmol/L and 121.6 mmol/L).
- ISE Urine mode (Modified Device):
- Within run CV%: n=21 (low) and n=20 (high) for urine (61.4 mmol/L and 194.4 mmol/L).
- Between day CV%: n=21 for urine (64.9 mmol/L and 186.4 mmol/L).
- (Predicate Device Precision): Sample sizes for the predicate device's precision studies (n=20 for within-run and between-run CV%) are also mentioned for comparison.
- ISE Direct mode (Modified Device):
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a laboratory performance study rather than a clinical study with patient samples for diagnosis. The samples would typically be control materials or spiked samples.
3. Number of Experts and Qualifications for Ground Truth
- N/A. This device is an in vitro diagnostic (IVD) for quantitative determination of analytes using an ion-selective electrode. The "ground truth" for performance studies like precision and linearity is established through reference methods, certified reference materials, or gravimetric preparations, not expert clinical consensus.
4. Adjudication Method
- N/A. As this is an IVD device performance study, there is no expert adjudication of results. The performance is assessed against established analytical standards and the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not a diagnostic imaging device or an AI-assisted diagnostic tool that involves human readers. It's an automated laboratory assay.
6. Standalone Performance (Algorithm Only)
- Yes, effectively. The performance data presented (precision, linearity, sensitivity, interference) are all measures of the device's inherent analytical performance without human intervention in the measurement process (beyond operating the instrument). This is a standalone performance study of the device itself.
7. Type of Ground Truth Used
- The ground truth for these types of studies is based on:
- Reference materials/known concentrations: For precision, linearity, and sensitivity, samples with known or target concentrations of chloride are used.
- Comparative methods: The performance is also implicitly compared to the predicate device, which itself would have been validated against established reference methods.
- Clinical ranges: Expected values for adults are given, implying the device measures within clinically relevant ranges.
8. Sample Size for the Training Set
- N/A. This is not a machine learning or AI device that requires a "training set." It's an ion-selective electrode system.
9. How Ground Truth for the Training Set Was Established
- N/A. See point 8.
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