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The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in vitro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in virro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

The ILab 600 Clinical Chemistry System is an automated, random access clinical chemistry analyzer that quantifies analytes in physiological fluids using photometry and potentiometry. The device was found substantially equivalent to the ILab 900/1800 Clinical Chemistry System (K932467, K943595) and IL Test assays (K943366, K952646, K943367, K952647).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ILab 600 are implicit in its claim of substantial equivalence to the predicate device, the ILab 900. This means the performance of the ILab 600 must be "statistically similar" to that of the ILab 900 across various analytes and sample types (serum, urine, cerebrospinal fluid).

The reported device performance is demonstrated through method comparison studies and precision studies.

Method Comparison Studies (ILab 600 vs. ILab 900):

Precision Studies (ILab 600):

• Serum Samples: Two levels of serum samples (three for Cholesterol) were tested in triplicate twice a day for 10 days (n=60 total). The Total %CV for most analytes was generally low, indicating good precision. For example:
  • Albumin: Level 1 (1.79%), Level 2 (1.08%)
  • ALT/GPT: Level 1 (1.26%), Level 2 (0.99%)
  • Cholesterol: Level 1 (2.11%), Level 2 (1.35%), Level 3 (1.37%)
  • ISE Sodium: Level 1 (0.94%), Level 2 (0.67%)
• Urine Samples: Two levels of urine samples were tested in triplicate twice a day for 10 days (n=60 total). Similar to serum, Total %CV remained low:
  • Amylase: Level 1 (2.56%), Level 2 (2.02%)
  • Creatinine: Level 1 (2.11%), Level 2 (1.73%)
  • ISE Sodium: Level 1 (1.13%), Level 2 (0.65%)
• Cerebrospinal Fluid Samples: Two levels of CSF samples were tested using IL Test Glucose Oxidase in triplicate twice a day for 5 days (n=30 total).
  • Glucose Oxidase: Level 1 (1.49%), Level 2 (0.98%)

The studies conclude that the ILab 600 and ILab 900 are "statistically similar" for the tests evaluated. The precision studies demonstrate acceptable levels of reproducibility based on the reported Coefficient of Variation (%CV) values for within-run, among-run, among-day, and total precision. No specific numerical thresholds for acceptance criteria were explicitly stated, but the robust statistical similarity and low %CV values imply the device meets the necessary performance standards for clinical use.

2. Sample Sizes and Data Provenance

• Test Set (Method Comparison):

  • Serum Samples: Sample sizes ranged from a minimum of 64 (Lipase) to a maximum of 137 (Glucose Oxidase).
  • Urine Samples: Sample sizes ranged from 49 (ISE Potassium and Sodium) to 95 (Glucose Hexokinase).
  • Cerebrospinal Fluid Samples: Sample size was 20 (Glucose Oxidase).
  • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

• Test Set (Precision Studies):

  • Serum Samples: n=60 for most analytes (triplicate measurements, twice a day, for 10 days). Cholesterol used n=60 across three levels.
  • Urine Samples: n=60 for all analytes (triplicate measurements, twice a day, for 10 days).
  • Cerebrospinal Fluid Samples: n=30 for Glucose Oxidase (triplicate measurements, twice a day, for 5 days).
  • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document pertains to the performance characteristics of a clinical chemistry analyzer, which measures quantitative values of analytes. The "ground truth" in this context refers to the actual concentration of the analytes in the samples. Clinical chemistry analyzer performance is typically evaluated by comparing results to a reference method (in this case, the predicate device ILab 900) or by using certified reference materials with known concentrations. Therefore, expert interpretation or consensus, as might be used in image-based diagnostic AI, is not applicable here. No mention of human experts defining "ground truth" is provided or expected.

4. Adjudication Method

Not applicable. As described in point 3, this is a quantitative measurement device, not an interpretation task requiring adjudication of expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The device is a clinical chemistry analyzer, not an AI system assisting human readers in diagnostic interpretation. The study evaluates the analyzer's performance directly against a predicate device and for precision, not the human reader's effectiveness with or without AI.

6. Standalone Performance Study

Yes, standalone performance was done.

• Method Comparison Studies: The performance of the ILab 600 was compared directly to that of the ILab 900 (predicate device). This is a standalone comparison of the new device against an established one.
• Precision Studies: The precision of the ILab 600 was evaluated independently, measuring its reproducibility across different runs and days. This is also a standalone performance evaluation of the device itself.

7. Type of Ground Truth Used

The ground truth used for these studies is the quantitative analytical result obtained from the predicate device (ILab 900) for method comparison studies, and the inherent, measured concentration within the biological samples for precision studies. This is a form of reference method comparison or analytical accuracy assessment, rather than pathology, expert consensus, or outcomes data, which are typically associated with qualitative or interpretative diagnostics. For precision, the ground truth is implicitly the true, stable concentration in the control/patient samples being repeatedly measured.

8. Sample Size for the Training Set

Not applicable. The ILab 600 is a clinical chemistry analyzer, which operates based on established chemical and photometric/potentiometric principles and internal calibration curves. It is not an AI/ML device that requires a "training set" in the sense of supervised learning. Its analytical methods are pre-programmed and validated, not learned from data in the way a machine learning algorithm would be.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for this type of device. The device's operational parameters and calibration are established through engineering design and standard laboratory calibration procedures, not through a data-driven training process.

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