(29 days)
IL Test™ Urea Nitrogen is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of urea and urea nitrogen in human serum, plasma or urine by enzyme-coupled urease/GLDH methodology. Increases in serum urea nitrogen (urea) can be a result of kidney dysfunction or urinary tract obstruction.
IL Test™ Urea Nitrogen is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of urea and urea nitrogen in human serum, plasma or urine by enzyme-coupled urease/GLDH methodology.
This is a 510(k) summary for the IL Test™ Urea Nitrogen device, an in vitro diagnostic test for the quantitative determination of urea and urea nitrogen in human serum, plasma, or urine. The device primarily relies on a "substantial equivalence" claim to a predicate device (IL Test™ Urea Nitrogen K932467 K943595). Therefore, the acceptance criteria and study design are centered around demonstrating this equivalence.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Method Comparison (Correlation to Predicate Device) | |
| Serum samples: High correlation (r) to predicate | r = 0.997 (for 49 serum samples) |
| Urine samples: High correlation (r) to predicate | r = 1.000 (for 25 urine samples) |
| Precision (Within Run CV) | |
| Serum sample: Low CV at 17 mg/dL | CV = 2.1 % |
| Serum sample: Low CV at 50 mg/dL | CV = 2.2 % |
| Urine sample: Low CV at 912 mg/dL | CV = 2.2 % |
Note: The document implies "high correlation" and "low CV" as the implicit acceptance criteria by presenting specific good performance values relative to a predicate device. Specific numerical thresholds for acceptance were not explicitly stated beyond these reported results.
2. Sample sizes used for the test set and the data provenance
- Test Set for Method Comparison:
- Serum samples: 49
- Urine samples: 25
- Test Set for Precision: The number of runs or individual measurements for precision is not explicitly stated, but it was "accessed over multiple runs." For each precision test, only one sample (a serum sample or a urine sample) was used, and its CV was determined.
- Data Provenance: The document does not specify the country of origin of the data. It does not explicitly state if the data was retrospective or prospective. However, given it's a performance summary for an in vitro diagnostic device, it typically refers to prospectively collected samples in a controlled laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an in vitro diagnostic test measuring a quantitative analyte (urea nitrogen). The "ground truth" for the test set is established by the measurements from the predicate device (for method comparison) and the device itself (for precision, against its own mean). It does not involve expert interpretation of images or clinical judgments that would require multiple experts for ground truth establishment.
4. Adjudication method for the test set
Not applicable, as this is a quantitative analytical device. "Adjudication" typically refers to resolving discrepancies in expert interpretations in qualitative or subjective diagnostic tasks. For method comparison, the "truth" is the result obtained by the predicate device; for precision, it is the statistical deviation from the mean of repeated measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an in vitro diagnostic test for measuring an analyte, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The performance data presented (method comparison and precision) are "standalone" in that they characterize the analytical performance of the device itself (the "algorithm" in a broader sense of the test methodology) without explicit human intervention in the result determination process beyond standard laboratory procedures for running the test. The device provides quantitative results directly.
7. The type of ground truth used
- For Method Comparison: The "ground truth" for comparison was the results obtained from the predicate device (IL Test™ Urea Nitrogen K932467 K943595).
- For Precision: The "ground truth" is the mean concentration of the control sample, established by repeated measurements of the investigated device itself, with acceptance based on the variability (CV) around that mean.
8. The sample size for the training set
Not applicable. This device is a chemical reagent kit used with clinical chemistry systems. It is not an AI/ML device that requires a "training set" in the computational sense. The "training" of the device is inherent in its chemical formulation and calibration, which would be validated during its development.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this type of in vitro diagnostic device.
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.