(56 days)
The Roche Diagnostics, Boehringer Mannheim Inorganic Phosphorus reagent is intended for use for the quantitative in vitro determination of phosphorus in human serum, plasma and urine with automated clinical chemistry analyzers.
According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.1580, a Phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
Endpoint method with sample blanking.
Inorganic phosphate forms an ammonium phosphomolybdate complex with ammonium molybdate in the presence of sulfuric acid. The complex is determined photometrically in the ultraviolet region (340 nm).
The provided text describes the 510(k) summary for the Roche Diagnostics, Boehringer Mannheim Inorganic Phosphorus Reagent. This submission seeks substantial equivalence to an existing device, focusing on extended claims for specimen collection, reportable range (urine), imprecision, and method comparison (urine).
Here's an analysis of the provided information concerning acceptance criteria and the study:
1. A table of acceptance criteria and the reported device performance:
The document describes the changes and similarities to the predicate device but does not explicitly state specific acceptance criteria (e.g., performance targets, accuracy thresholds) or provide a table directly comparing acceptance criteria with reported device performance for the extended claims.
However, it implicitly refers to performance characteristics for the extended claims. The "Limitations - Interferences" section provides some performance details related to interference, which could be considered partial performance data, though not directly tied to explicit acceptance criteria:
| Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Icterus Interference | No significant interference up to an I index of 60 | No significant interference from bilirubin (conjugated or unconjugated) up to an I index of 60 |
| Hemolysis Interference | (Not explicitly stated by the current document) | RBC contamination elevates results. |
| Lipemia Interference | No significant interference up to an L index of 1000 | No significant interference from lipemia up to an L index of 1000 |
| Specimen Collection | (Extended claims - details not provided in this excerpt) | Data described in Section VI (not provided in this excerpt) |
| Reportable Range (Urine) | (Extended claims - details not provided in this excerpt) | Data described in Section VI (not provided in this excerpt) |
| Imprecision | (Extended claims - details not provided in this excerpt) | Data described in Section VI (not provided in this excerpt) |
| Method Comparison (Urine) | (Extended claims - details not provided in this excerpt) | Data described in Section VI (not provided in this excerpt) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The provided text does not specify the sample size used for the test set for any of the performance characteristics or the data provenance (country of origin, retrospective/prospective nature). It only states that specific data on the performance of the system has been incorporated into the draft labeling in Section V and that data related to extended claims is described in Section VI. These sections are not included in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable to this type of in vitro diagnostic device (reagent for chemical analysis). Ground truth for chemical assays is typically established through reference methods and calibrated instruments, not expert human interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable to this type of in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., medical imaging, pathology).
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:
This information is not applicable to this type of in vitro diagnostic device. MRMC studies and concepts of human reader improvement with AI assistance are relevant to AI-based diagnostic tools that assist human interpreters (e.g., radiologists, pathologists). This device is a chemical reagent.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable in the context of an AI algorithm. For this chemical reagent, "standalone performance" refers to the performance of the reagent on an automated clinical chemistry analyzer without manual human intervention in the measurement process, which is inherent to its intended use with "automated clinical chemistry analyzers." However, the document does not explicitly detail the standalone performance study protocol or results beyond general statements about "performance characteristics."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this type of chemical reagent, the ground truth for performance evaluation (e.g., accuracy, precision) would typically be established using:
- Reference materials/calibrators: Samples with known, validated concentrations of inorganic phosphorus.
- Reference methods: Established, highly accurate analytical methods considered the gold standard for measuring inorganic phosphorus.
The document does not explicitly state the type of ground truth used, but these are the standard practices for verifying the performance of such devices.
8. The sample size for the training set:
This information is not applicable because the device is a chemical reagent, not an AI or machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established:
This information is not applicable as there is no "training set" for this chemical reagent.
§ 862.1580 Phosphorus (inorganic) test system.
(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.