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510(k) Data Aggregation
(174 days)
The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.
The Indiko Glucose (HK) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The Indiko is automated random access discrete photometric analyzer, capable of performing up to 30 photometric tests.
The sample disk has an integrated barcode reader which allows cup/tube recognition. The barcode reader can read the following codes: code 128, USS Codabar, interleaved 2 of 5 and code 39 with check digit.
Reaction cells are discrete disposable (single use) multicell cuvettes with 10 reaction measurement cells in a row. On-board capacity of 36 multicell cuvettes (equal to 360 reaction cells), with continuous loading capability, typically 2 hours walk-away time. The quality of the reaction cells is checked at the start of the routine work automatically. The measurements are performed at 37℃.
The analyzer incorporates robotics, computer, and communication technology to render simple and reliable long-term operation. The operating system works with Windows® 7. The user interface software is graphical. The data input can be done online or by touch screen or mouse or keyboard.
Reagents are liquid, the reagent bottles are placed on the reagent/sample disk, which holds maximum 30 positions, the reagent/sample disk is cooled 10℃ below ambient temperature.
Here's a breakdown of the acceptance criteria and study details for the Indiko Glucose (HK) system, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance | Performance Accepted |
|---|---|---|---|
| Method Comparison | y = ax + b, where a = 1.00 ± 0.03, b = 0.00 ± 3.6 mg/dl, r ≥ 0.97, max bias at 90 mg/dl 5% | y = 1.01x + 0.7, r = 1, Range: 6 - 700 mg/dl | Yes |
| Precision (Within run) | Low: CV ≤ 2.0 %Middle: CV ≤ 2.0 %High: CV ≤ 1.8 % | Low: CV 0.7 %Middle: CV 0.6 %High: CV 0.8 % | Yes |
| Precision (Between run) | Not specified | Low: CV 0.8 %Middle: CV 1.2 %High: CV 0.6 % | Yes |
| Precision (Total) | Low: CV ≤ 3.5 %Middle: CV ≤ 3.5 %High: CV ≤ 3.0 % | Low: CV 1.6 %Middle: CV 1.5 %High: CV 1.5 % | Yes |
| Linearity/Measuring Range | Measuring range: 5 - 720 mg/dlMaximum bias from the estimated straight line ± 2.7 mg/dl or ± 5 %. | Measuring range: 5 - 720 mg/dl | Yes |
| Limit of Blank (LoB) | LoB: < 5.4 mg/dl | LoB: 0.18 mg/dl | Yes |
| Limit of Quantitation (LoQ) | LoQ: < 9.0 mg/dl | LoQ: 0.54 mg/dl | Yes |
| Interference (Hemolysate) | No interference found up to 500 mg/dl.Recovery within ± 5 % of initial value. | No interference found up to 1000 mg/dl of hemoglobin. | Yes |
| Interference (Bilirubin unconjugated) | No interference found up to 23 mg/dl.Recovery within ± 5 % of initial value. | No interference found up to 50 mg/dl conjugated bilirubin. | Yes |
| Interference (Bilirubin conjugated) | No interference found up to 23 mg/dl.Recovery within ± 5 % of initial value. | No interference found up to 47 mg/dl conjugated bilirubin. | Yes |
| Interference (Lipemia) | No interference found up to 500 mg/dl.Recovery within ± 5 % of initial value. | No interference found up to 1000 mg/dl of Intralipid®. | Yes |
2. Sample size and Data Provenance for Test Set
- Sample Size for Method Comparison: 117 samples (n = 117).
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is a "method comparison study" comparing the new device to a predicate device, which typically involves running the same samples on both instruments. Given the manufacturer's location (Finland), it's reasonable to infer the study could have been conducted there, but this is not definitively stated.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- This device is a clinical chemistry analyzer with a specific assay for glucose. The "ground truth" for such devices is established by quantitative laboratory measurements, not by expert interpretation of images or clinical cases. Therefore, the concept of "experts establishing ground truth" in the manner of radiologists or pathologists does not directly apply here. Instead, the accuracy of the measurements is compared against a reference (predicate device) and validated against known standards and expected performance.
4. Adjudication Method for Test Set
- Not applicable. As this is a quantitative measurement device, there is no "adjudication" in the sense of resolving disagreements between human readers or interpreters. The comparison is objective, based on numerical results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., imaging studies) and is not applicable to an automated clinical chemistry analyzer.
6. Standalone Performance Study
- Yes, a standalone performance study was done in the sense that the device's performance characteristics (precision, linearity, limits, interference) were evaluated independently against predefined acceptance criteria. The "method comparison" also evaluates the standalone performance of the Indiko against the predicate device.
7. Type of Ground Truth Used
- The ground truth for the performance evaluation of the Indiko Glucose (HK) system is largely established through:
- Comparison to a Predicate Device: The DPC T60i Clinical Chemistry Analyzer (Konelab 60i) was used as a reference for method comparison.
- Internal Validation and Standards: Precision, linearity, limits, and interference studies rely on established laboratory methods, controls, and known concentrations of analytes and interferents.
8. Sample Size for Training Set
- The document does not specify a separate "training set" sample size. For clinical chemistry analyzers, the "training" usually refers to the development and calibration of the assay and instrument, which is typically done by the manufacturer during product development, using various internal samples and standards. Unlike AI/ML models, there isn't a distinct "training set" in the context of this 510(k) summary for a traditional analytical instrument.
9. How the Ground Truth for the Training Set was Established
- Since a distinct "training set" as understood in AI/ML is not explicitly mentioned for this device, the concept of establishing ground truth for it is not detailed. However, the development of such assays and instruments involves rigorous internal testing, calibration using certified reference materials, and validation across various sample types and concentrations to ensure accuracy and reliability. This process establishes the "ground truth" that the instrument is designed to measure.
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