(463 days)
ELITech Clinical Systems PHOSPHORUS reagent is for the quantitative in vitro diagnostic determination of inorganic phosphorus in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
ELITech Clinical Systems URIC ACID MONO SL reagent is for the quantitative in vitro diagnostic determination of uric acid in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements obtained by this device 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.
ELITech Clinical Systems UREA UV SL reagent is for the quantitative in vitro diagnostic determination of urea nitrogen in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL I is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELITech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
The device for this submission is available as kit only. It consists of 2 reagents: Reagent 1 contains Tris buffer (pH 7.60), Adenosine diphosphate potassium salt (ADP), alpha-Ketoglutarate, Urease (jack bean), Glutamate dehydrogenase (GIDH) (bovine liver) and sodium azide. Reagent 2 contains NADH and sodium azide
The device for this submission is available as kit only. It consists of 1 reagent R. Reagent R consists of sulfuric acid and ammonium molybdate.
The device for this submission is available as kit only. It consists of 1 reagent R. Reagent R consists of Phosphate buffer (pH 7.0), N-Ethyl-N-(2-Hydroxy-3-Sulfopropyl) m-Toluidine (EHSPT), Ferrocyanide, Amino-4-antipyrine (4-AAP), Uricase (microorganisms), Peroxidase (horseradich) and sodium azide.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
The provided text describes several in vitro diagnostic (IVD) devices: ELITech Clinical Systems ELICAL 2 (calibrator), ELITech Clinical Systems UREA UV SL (reagent), ELITech Clinical Systems PHOSPHORUS (reagent), ELITech Clinical Systems URIC ACID MONO SL (reagent), and ELITech Clinical Systems ELITROL I and ELITROL II (controls).
The studies performed for these devices are primarily method comparison and precision studies, focusing on demonstrating substantial equivalence to predicate devices rather than proving a specific clinical utility through a multi-reader multi-case study or a standalone algorithm performance study.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate devices. The performance metrics presented are directly compared.
For ELITech Clinical Systems UREA UV SL (K100263):
| Performance Metric | Acceptance Criteria (Predicate: ABX PENTRA UREA CP) | Reported Device Performance (ELITech Clinical Systems UREA UV SL) |
|---|---|---|
| Measuring Range | 1.03 to 140.3 mg/dL (Automatic post-dilution: 701.5 mg/dL) | 4.7 to 140.0 mg/dL (Extended measuring range: 140.0 to 670.0 mg/dL) |
| Limit of Detection (LoD) | Not explicitly stated | 0.3 mg/dL |
| Limit of Quantification (LoQ) | 0.9 mg/dL | 2.3 mg/dL |
| Precision | ||
| Within Run (Level 7.3 mg/dL) | 2.27% (for 18.7 mg/dL) | CV=2.1% |
| Within Run (Level 29.2 mg/dL) | 1.66% (for 72.8 mg/dL) | CV=0.8% |
| Within Run (Level 72.4 mg/dL) | 2.76% (for 6.0 mg/dL) etc. | CV=0.7% |
| Total (Level 7.3 mg/dL) | 2.14% (for 18.5 mg/dL) | CV=2.8% |
| Total (Level 29.2 mg/dL) | 1.93% (for 71.7 mg/dL) | CV=1.3% |
| Total (Level 72.4 mg/dL) | 2.14% (for 19.2 mg/dL) etc. | CV=1.6% |
| Method Comparison | y=0.99 x - 0.06 mg/dL, r²=0.996, range: 1.03 to 138.89 mg/dL | y=0.991 x + 0.6 mg/dL, r=0.999, range: 4.4 to 139.8 mg/dL |
| Interference (Hemoglobin) | No significant influence up to 460 mg/dL | No significant interference up to 500 mg/dL |
| Interference (Triglycerides) | No significant influence up to 612.5 mg/dL | No significant interference up to 614 mg/dL triglyceride equivalent |
| Interference (Total Bilirubin) | No significant influence up to 22.23 mg/dL | No significant interference up to 30 mg/dL (unconjugated) / 29.5 mg/dL (conjugated) |
| Calibration Frequency | 8 days | 7 days |
| On-board Stability | 70 days | 14 days |
For ELITech Clinical Systems PHOSPHORUS (K100263):
| Performance Metric | Acceptance Criteria (Predicate: ABX PENTRA PHOSPHORUS CP) | Reported Device Performance (ELITech Clinical Systems PHOSPHORUS) |
|---|---|---|
| Measuring Range | 0.30 to 24.18 mg/dL (Automatic post-dilution: 96.72 mg/dL) | 2.0 to 20.0 mg/dL |
| Limit of Detection (LoD) | 0.28 mg/dL | 0.02 mg/dL |
| Limit of Quantification (LoQ) | Not explicitly stated | 1.00 mg/dL |
| Precision | ||
| Within Run (Level 2.37 mg/dL) | 1.25% (for 4.08 mg/dL) | CV=1.1% |
| Within Run (Level 4.80 mg/dL) | 0.77% (for 6.34 mg/dL) | CV=1.5% |
| Within Run (Level 9.55 mg/dL) | 2.48% (for 2.39 mg/dL) etc. | CV=1.7% |
| Total (Level 2.37 mg/dL) | 2.50% (for 4.01 mg/dL) | CV=1.9% |
| Total (Level 4.80 mg/dL) | 1.82% (for 6.35 mg/dL) | CV=1.7% |
| Total (Level 9.55 mg/dL) | 3.56% (for 2.50 mg/dL) etc. | CV=2.2% |
| Method Comparison | y=1.04x + 0.15 mg/dL, r²=0.998, range: 0.30 to 24.08 mg/dL | y=0.999 - 0.09 mg/dL, r=0.999, range: 2.02 to 20.08 mg/dL |
| Interference (Hemoglobin) | No significant influence up to 125 mg/dL | No significant interference up to 50 mg/dL |
| Interference (Triglycerides) | No significant influence up to 262.5 mg/dL | No significant interference up to 732 mg/dL |
| Interference (Total Bilirubin) | No significant influence up to 6 mg/dL | No significant interference up to 15 mg/dL (unconjugated) / 1.5 mg/dL (conjugated) |
| Calibration Frequency | 34 days | 28 days |
| On-board Stability | 70 days | 28 days |
For ELITech Clinical Systems URIC ACID MONO SL (K100263):
| Performance Metric | Acceptance Criteria (Predicate: ABX PENTRA URIC ACID CP) | Reported Device Performance (ELITech Clinical Systems URIC ACID MONO SL) |
|---|---|---|
| Measuring Range | 0.18 to 25.00 mg/dL (Automatic post-dilution: 75.00 mg/dL) | 1.5 to 25.0 mg/dL (Extended measuring range: 25 to 78 mg/dL) |
| Limit of Detection (LoD) | 0.19 mg/dL | 0.02 mg/dL |
| Limit of Quantification (LoQ) | Not explicitly stated | 0.50 mg/dL |
| Precision | ||
| Within Run (Level 2.49 mg/dL) | 0.45% (for 4.62 mg/dL) | CV=0.8% |
| Within Run (Level 5.19 mg/dL) | 0.34% (for 11.63 mg/dL) | CV=1.3% |
| Within Run (Level 7.63 mg/dL) | 1.24% (for 2.53 mg/dL) etc. | CV=1.1% |
| Total (Level 2.49 mg/dL) | 2.81% (for 4.64 mg/dL) | CV=2.6% |
| Total (Level 5.19 mg/dL) | 1.39% (for 11.73 mg/dL) | CV=2.0% |
| Total (Level 7.63 mg/dL) | 2.64% (for 4.67 mg/dL) etc. | CV=2.1% |
| Method Comparison | y=0.95 x + 0.09 mg/dL, r²=0.996, range: 0.18 to 23.59 mg/dL | y=1.015 x + 0.03 mg/dL, r=0.999, range: 1.49 to 24.40 mg/dL |
| Interference (Hemoglobin) | No significant influence up to 500 mg/dL | No significant interference up to 50 mg/dL |
| Interference (Triglycerides) | No significant influence up to 612.5 mg/dL | No significant interference up to 1070 mg/dL |
| Interference (Total Bilirubin) | No significant influence up to 36 mg/dL | No significant interference up to 30 mg/dL (unconjugated) / 14.8 mg/dL (conjugated) |
| Calibration Frequency | 15 days | 28 days |
| On-board Stability | 41 days | 28 days |
2. Sample size used for the test set and the data provenance
- UREA UV SL: The method comparison study gives a range of 4.4 to 139.8 mg/dL for the device. The R-value of 0.999 implies a good correlation across the study range. While a specific number of samples isn't explicitly stated, the R-value is usually calculated from a sufficiently large set of patient samples spanning the analytical range. The data provenance is not stated (e.g., country of origin, retrospective/prospective), but it is implied to be clinical samples used for method comparison.
- PHOSPHORUS: The method comparison study gives a range of 2.02 to 20.08 mg/dL for the device. The R-value of 0.999 implies a good correlation. Similar to UREA UV SL, the number of samples is not explicitly stated, and data provenance is not provided but implied to be clinical samples.
- URIC ACID MONO SL: The method comparison study gives a range of 1.49 to 24.40 mg/dL for the device. The R-value of 0.999 implies a good correlation. The number of samples is not explicitly stated, and data provenance is not provided but implied to be clinical samples.
For ELICAL 2, ELITROL I, ELITROL II: These are calibrators and controls; their performance is validated through stability studies and their intended use in calibrating and controlling assays. No "test set" in the sense of patient samples for diagnostic performance is applicable here. The device description for ELICAL 2, ELITROL I, and ELITROL II mentions they are "prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A." This suggests human-derived materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are in vitro diagnostic devices for quantitative measurements, not imaging or subjective diagnostic interpretations requiring expert consensus for ground truth. "Ground truth" in this context refers to the measured values obtained by the predicate device or a reference method for the method comparison studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or 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
Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is an IVD reagent and calibrator kit, not an algorithm. The performance data presented (e.g., precision, method comparison, LoD, LoQ) represents the "standalone" analytical performance of the device on the specified analyzer (Selectra Junior/Flexor Junior).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the method comparison studies is the quantitative result obtained from the predicate device (ABX PENTRA UREA CP, ABX PENTRA PHOSPHORUS CP, ABX PENTRA URIC ACID CP) or a reference method assumed to be the "truth" for those studies. For precision studies, there isn't an external "ground truth" but rather a measure of the device's own reproducibility.
8. The sample size for the training set
Not applicable. These are traditional IVD reagents and calibrators, not machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, no training set for a machine learning algorithm is involved.
§ 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.