(51 days)
HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems.
Urea nitrogen results are used in the treatment of numerous renal and metabolic diseases.
This reagent is intended for professional use only.
HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems.
Here's a breakdown of the acceptance criteria and study details for the HiChem® BUN Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are implied by the comparison to the predicate device (Beckman® SYNCHRON® CX® Systems BUN Reagent Kit). The study's goal was to demonstrate similar performance. The quantitative acceptance criteria are not explicitly stated as numerical thresholds (e.g., "within X% difference"), but rather through statistical comparisons like correlation coefficients (r) and differences in regression equations.
| Performance Metric | Acceptance Criteria (Implied - Similar to Predicate) | HiChem® Reagent Performance | Beckman® Reagent Performance (Predicate) | Device Meets Criteria? |
|---|---|---|---|---|
| Precision | Similar %CV and 1SD values to predicate | See detailed tables below | See detailed tables below | Yes |
| Serum 1 (7.1 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 9.1%, 9.4%, 0.65, 0.66 | 9.1%, 8.4%, 0.65, 0.60 | Yes (very similar) |
| Serum 2 (35.4 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 1.8%, 1.9%, 0.62, 0.66 | 1.5%, 1.6%, 0.53, 0.57 | Yes (very similar) |
| Serum 3 (63.8 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.8%, 1.3%, 0.50, 0.80 | 1.1%, 1.2%, 0.72, 0.76 | Yes (very similar) |
| Urine 1 (21.7 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 4.1%, 3.8%, 0.89, 0.82 | 2.9%, 2.9%, 0.62, 0.63 | Yes (similar) |
| Urine 2 (112.2 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.7%, 1.1%, 0.75, 1.25 | 0.7%, 1.2%, 0.82, 1.31 | Yes (very similar) |
| ORDAC Precision | Similar %CV and 1SD values to predicate | See detailed tables below | See detailed tables below | Yes |
| Serum 1 (179-180 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.7%, 1.4%, 1.18, 2.58 | 0.7%, 1.2%, 1.18, 2.17 | Yes (very similar) |
| Serum 2 (258-262.4 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.7%, 1.4%, 1.91, 3.55 | 0.7%, 1.1%, 1.75, 2.78 | Yes (very similar) |
| Method Comparison (Serum/Plasma) | High correlation (r ≥ 0.99) and small intercept/slope deviation from 0/1 | r = 0.999, HiChem® = -0.3 + 0.987 * Beckman® | Not applicable (comparison) | Yes (very strong correlation, small bias) |
| Method Comparison (Urine) | High correlation (r ≥ 0.99) and small intercept/slope deviation from 0/1 | r = 1.000, HiChem® = 0.9 + 0.979 * Beckman® | Not applicable (comparison) | Yes (perfect correlation, small bias) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision Study:
- Serum/Urine Samples (non-ORDAC): For each of the 5 samples (3 serum, 2 urine), n = 60 (This represents 60 individual measurements for each sample type, collected over 10 days, assayed twice per day in triplicate).
- ORDAC Samples: For each of the 2 spiked serum samples, n = 60 (This represents 60 individual measurements for each sample type).
- Data Provenance: Not explicitly stated, but clinical laboratory studies often use control materials and patient samples from the country where the manufacturer is based (USA in this case, based on FDA submission). The study design (assaying twice per day over 30 days) suggests prospective data collection for the precision aspect.
- Patient Comparison (Method Comparison) Study:
- Serum/Plasma: n = 160
- Urine: n = 79
- Data Provenance: "collected from adult patients" - implies prospective collection of patient samples. Likely from the US, given the FDA submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This type of submission for a diagnostic reagent does not typically involve experts establishing a "ground truth" in the way an imaging or diagnostic AI model would. In in-vitro diagnostics, the "ground truth" is typically the quantitative result obtained from a reference method or the predicate device itself, which is assumed to be accurate.
Therefore, this section is not applicable for this device. The "ground truth" for comparison is the performance of the established, legally marketed predicate device (Beckman® SYNCHRON® CX® Systems BUN Reagent Kit).
4. Adjudication Method for the Test Set
Not applicable. There's no subjective interpretation requiring adjudication in a quantitative diagnostic assay comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a study comparing the performance of two quantitative diagnostic reagents, not a study involving human readers interpreting cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, in the sense that the device (reagent) performance itself is being evaluated and compared to a predicate, independent of human interpretation of the results. The "algorithm" here is the chemical reaction and analytical measurement process on the SYNCHRON CX® and CX® DELTA Systems. The reported performance metrics are purely analytical measurements of the reagent's characteristics.
7. The Type of Ground Truth Used
The ground truth or reference standard for comparison is the Beckman® SYNCHRON® CX® Systems BUN Reagent Kit. This is a well-established, legally marketed predicate device, and its performance is assumed to be the "gold standard" against which the new HiChem® BUN Reagent is evaluated for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a diagnostic reagent, not an AI/ML model that requires a "training set." The development of the reagent itself would involve R&D and formulation, but not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of 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.