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510(k) Data Aggregation
(327 days)
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
The S-Test Inorganic Phosphorous Reagent is intended for the quantitative determination of inorganic phosphorous concentration in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum or heparin plasma using the S40 Clinical Analyzer. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test inorganic phosphorus (IP) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of IP in serum or heparin plasma based on a photometric test measuring the formation of molybdenum blue from IP and ammonium molybdate.
The S-Test uric acid (UA) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of UA in serum or heparin plasma based on a photometric test measuring the formation of a reddish-purple pigment.
Here's a breakdown of the acceptance criteria and study information for the Alfa Wassermann S-Test IP and S-Test UA reagent cartridges, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in a separate section. Instead, the "Performance Data" section describes the results of various tests, and the "Conclusions" section states that the device is "safe and effective" and demonstrates "substantial equivalence to the predicate devices" based on this data. I will present the reported performance data, which implicitly serves as the criteria met for acceptance.
S-Test Inorganic Phosphorus (IP) Reagent Cartridge
| Performance Metric | Acceptance Criteria (Implicit from Results) | Reported Device Performance |
|---|---|---|
| Precision | ||
| 22-day testing (within-run CV) | Low variability (e.g., CV 0.95), low error, slope near 1, intercept near 0 | |
| Main Study (Correlation Coefficient) | r > 0.95 | 0.976 |
| Main Study (Std. Error Estimate) | Low error | 0.3 |
| Main Study (Confidence Interval Slope) | Encompassing 1 | 1.026 to 1.150 |
| Main Study (Confidence Interval Intercept) | Encompassing 0 | -0.03 to 0.34 |
| POL Studies (Correlation Coefficient) | r > 0.95 | 0.992 to 0.998 |
| POL Studies (Std. Error Estimate) | Low error | 0.10 to 0.21 |
| POL Studies (Confidence Interval Slope) | Encompassing 1 | 1.002 to 1.173 |
| POL Studies (Confidence Interval Intercept) | Encompassing 0 | -0.075 to 0.395 |
| Sensitivity | Detect low concentrations (e.g., clinically relevant levels) | Detection limit: 1.2 mg/dL |
S-Test Uric Acid (UA) Reagent Cartridge
| Performance Metric | Acceptance Criteria (Implicit from Results) | Reported Device Performance |
|---|---|---|
| Precision | ||
| 22-day testing (within-run CV) | Low variability (e.g., CV 0.95), low error, slope near 1, intercept near 0 | |
| Main Study (Correlation Coefficient) | r > 0.95 | 0.974 |
| Main Study (Std. Error Estimate) | Low error | 0.7 |
| Main Study (Confidence Interval Slope) | Encompassing 1 | 1.003 to 1.087 |
| Main Study (Confidence Interval Intercept) | Encompassing 0 | -1.03 to -0.49 |
| POL Studies (Correlation Coefficient) | r > 0.95 | 0.967 to 0.995 |
| POL Studies (Std. Error Estimate) | Low error | 0.32 to 0.69 |
| POL Studies (Confidence Interval Slope) | Encompassing 1 | 0.968 to 1.202 |
| POL Studies (Confidence Interval Intercept) | Encompassing 0 | -1.400 to 0.469 |
| Sensitivity | Detect low concentrations (e.g., clinically relevant levels) | Detection limit: 1.4 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
- S-Test IP:
- Sample Size: 95 samples for the main correlation study. "Patient correlation studies at three separate POL sites" are also mentioned, implying additional samples, but the total number for these POL studies is not explicitly stated.
- Data Provenance: Not explicitly stated, but "patient correlation studies at three separate POL sites" and "in-house" studies suggest data collected from different clinical settings and the manufacturer's laboratory, likely within the US given the context of a US FDA submission. It is reasonable to assume these were prospective or a mix of retrospective and prospective, as "patient samples" would either be freshly collected or archived. The summary does not specify.
- S-Test UA:
- Sample Size: 183 samples for the main correlation study. Similar to IP, "patient correlation studies at three separate POL sites" were also conducted, with the total sample size for these not specified individually.
- Data Provenance: Similar to IP, likely from various clinical sites (POLs) and in-house, presuming US origin. The summary does not explicitly state if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for these types of diagnostic tests is typically established by comparison to a recognized predicate or reference method run on a different, established analyzer (as indicated by "comparison method" in the accuracy studies) rather than human expert interpretation of raw data.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as the ground truth is established through a quantitative comparison method, not expert consensus requiring adjudication.
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. This is not an AI/imaging device that involves human readers or an MRMC study. It is an in vitro diagnostic device for chemical analysis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This describes the performance of a reagent cartridge on a clinical analyzer, which is inherently a "standalone" measurement system for the biochemical assay it performs. There is no "algorithm" in the AI sense, nor a human-in-the-loop component for interpretation of the primary measurement.
7. The Type of Ground Truth Used
The ground truth was established by a "comparison method" using predicate or reference devices/methods. This means the results from the S-Test cartridges on the S40 Clinical Analyzer were compared against measurements from other commercially available, legally marketed diagnostic systems (e.g., ACE plus ISE/Clinical Chemistry System, Olympus AU640 Clinical Chemistry Analyzer, Piccolo® xpress Chemistry Analyzer reagents or similar) that measure inorganic phosphorus and uric acid.
8. The Sample Size for the Training Set
This information is not provided. Given that this is a traditional in vitro diagnostic device measuring chemical concentrations, there isn't a "training set" in the machine learning sense. The device's performance characteristics (precision, accuracy, sensitivity) are inherently part of its design and manufacturing process, and validated through the performance studies described, rather than "trained" on data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of this device. The reagents and analyzer are developed and manufactured to perform the specified chemical reactions, with their analytical performance validated through studies against established methods.
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