(394 days)
The Biolis 12i is a discrete photometric chemistry analyzer with ion-selective electrode (ISE), with direct quantitative measurement of sodium, potassium, chloride, and glucose in serum. It is a device intended for the in-vitro, spectrophotometric determination of general chemistry assays for clinical use. The Biolis 12i includes an optional lon Selective Electrode (ISE) module for the measurement of sodium, potassium and chloride in serum. The Biolis 12i is not for Point-Of-Care testing. It is for vitro diagnostic use only.
Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.
Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
The Biolis 12i analyzer with glucose hexokinase assay is intended to measure glucose quantitatively in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic glycemia, and of the pancreatic islet cell carcinoma.
Using photometry, the Biolis 12i instrument measures the glucose concentration in serum by monitoring the change in absorbance at 340 nm. Additionally, the Biolis 12i with lon-Selective Elective module additionally measures the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.
The provided 510(k) summary describes the Biolis 12i, a clinical chemistry analyzer with an optional Ion-Selective Electrode (ISE) module, and its performance for measuring glucose, sodium, potassium, and chloride in serum. The study focuses on demonstrating substantial equivalence to predicate devices (Sirrus for Glucose and Prestige 24i for ISE).
Here's an analysis of the acceptance criteria and study as requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical "acceptance criteria" in the format of a predefined pass/fail threshold. Instead, it presents performance characteristics (correlation, linearity, precision, and interference) and asserts "substantial equivalence" to the predicate devices. The implicit acceptance criterion is that the performance of the Biolis 12i must be comparable or equivalent to the predicate devices.
| Performance Metric | Analyte | Acceptance Criteria (Implicit: Comparable to Predicate) | Reported Device Performance (Biolis 12i) |
|---|---|---|---|
| Correlation | |||
| (vs. Predicate) | Sodium | Comparable to Prestige 24i | 0.9872 (Correlation Coefficient) |
| Potassium | Comparable to Prestige 24i | 0.9992 (Correlation Coefficient) | |
| Chloride | Comparable to Prestige 24i | 0.9922 (Correlation Coefficient) | |
| Glucose | Comparable to Sirrus | 0.9975 (Correlation Coefficient) | |
| Linearity | |||
| Range (Serum) | Sodium | Reportable range | 100 - 200 mmol/L |
| Potassium | Reportable range | 1 - 10 mmol/L | |
| Chloride | Reportable range | 70 - 200 mmol/L | |
| Glucose | Reportable range | 25 - 540 mg/dL | |
| Precision | |||
| Within Run %CV | Sodium | Low variability | 0.85, 0.61, 0.93 |
| Potassium | Low variability | 0.90, 0.91, 0.94 | |
| Chloride | Low variability | 0.79, 0.83, 0.69 | |
| Glucose | Low variability | 1.31, 1.19, 1.04 | |
| Day-by-Day %CV | Sodium | Low variability | 0.4, 0.4, 0.3 |
| Potassium | Low variability | 0.8, 0.9, 0.4 | |
| Chloride | Low variability | 1.0, 0.7, 0.4 | |
| Between-run %CV | Glucose | Low variability | 0.87, 0.78, 0.70 |
| Interferences | All Analytes | No significant interference at specified concentrations | No significant interference observed at specified concentrations (Bilirubin, Hemoglobin, Lipemia, Lithium Chloride, Sodium Bromide, Sodium Salicylate, Sodium Thiocyanate) |
| Sensitivity | |||
| Minimum Detectable Value | Glucose | Quantifiable low limit | 7.83 mg/dL |
| Stability | |||
| Calibration Stability CV (%) | Glucose | Low variability | 2.1, 2.5, 2.1 |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not explicitly state the total number of patient samples (serum) used for the correlation, linearity, and interference studies.
- For precision studies:
- ISE (Sodium, Potassium, Chloride): N=20 for Within Run (repeated measurements of 3 samples), N=15 for Day-by-Day (measurements of 3 samples over 15 days).
- Glucose: N=20 for Within-run (repeated measurements of 3 samples), N=20 for Between-run (measurements of 3 samples over 20 runs, likely implying 20 days if one run/day).
- For precision studies:
- Data Provenance: The document does not specify the country of origin of the data or explicitly state whether the study was retrospective or prospective. Given that the manufacturer is in Japan, it's possible the studies took place there, but this is not confirmed in the text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Experts: Not applicable. For this type of in vitro diagnostic device, "ground truth" is established by reference methods or predicate devices, not human expert consensus on interpretations. The ground truth for the correlation studies was the measurements obtained from the predicate devices (Prestige 24i for ISE and Sirrus for glucose) and for linearity studies, it would be prepared known concentrations. For calibrator verification, the ground truth for glucose was NIST SRM 965b.
- Qualifications: Not applicable in the context of expert interpretation for ground truth.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. This is an IVD device measuring analytes, not making diagnostic interpretations that require human adjudication. The performance is assessed by direct comparison to established methods or known concentrations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- This is not applicable. The Biolis 12i is an automated clinical chemistry analyzer, not an AI-assisted diagnostic tool that involves human readers interpreting images or data outputs and making diagnoses. Therefore, an MRMC study and effects on human reader improvement are not relevant to this device.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Yes, this study essentially represents standalone performance. The Biolis 12i is an automated analyzer. The performance characteristics (correlation, linearity, precision, interference) are measured for the device itself using predefined protocols, without a "human-in-the-loop" interaction for interpretation that would alter its output. The results are quantitative measurements directly from the algorithm/instrument.
7. The Type of Ground Truth Used:
- For Correlation Studies: The ground truth was the measurements obtained from the predicate devices (Sirrus for Glucose, Prestige 24i for Na, K, Cl).
- For Linearity Studies: The ground truth was based on a range of known concentrations (likely serially diluted or prepared samples).
- For Calibrator Verification (Glucose): The ground truth was NIST SRM 965b, Glucose in Frozen Serum, which is a certified reference material.
8. The Sample Size for the Training Set:
- Not applicable / Not disclosed. Automated clinical chemistry analyzers typically do not have a "training set" in the machine learning sense. Their operational parameters are often determined by engineering design, chemical principles, and calibration curves established with known standards. The document clarifies how calibrators were verified but does not mention a distinct "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As a traditional in vitro diagnostic device, it does not involve machine learning "training sets" and associated ground truth establishment in the way AI/ML devices do. Its "calibration" is performed using known concentration calibrator materials and validated against reference standards. For instance, the glucose calibrator was verified against NIST SRM 965b.
§ 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.