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510(k) Data Aggregation
(280 days)
DiaSys Procalcitonin FS assay is a particle enhanced immunoturbidimetric test intended for the quantitative in vitro determination of procalcitonin (PCT) in human serum and lithium heparin plasma on automated Abbott ARCHITECT c8000 analyzer.
Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock.
The TruCal Procalcitonin Calibrator Set is intended for in vitro use for calibration of the DiaSys Procalcitonin FS assay.
TruLab Procalcitonin Bi-Level Controls are an assayed quality control material for monitoring the performance of quantitative in vitro determination of Procalcitonin (PCT) for the DiaSys Procalcitonin FS assay.
For in vitro diagnostic use only.
The DiaSys Procalcitonin FS assay is a particle enhanced turbidimetric immunoassay (PETIA) test for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and lithium heparin plasma on automated photometric systems.
The test utilizes anti-human PCT polyclonal antibodies (goat) covalently bound to polystyrene particles.
PCT in the sample binds to the anti-PCT antibodies on the particles and causes agglutination. The degree of the turbidity caused by agglutination is optically measured at 660 nm by the automated photometric system and is proportional to the amount of PCT in the sample. DiaSys Procalcitonin FS Reagent specifies settings for an automated photometric analyzer, the Abbott ARCHITECT c8000.
The DiaSys TruCal Procalcitonin Calibrator Set is provided in 6 levels, traceable to a commercial assay for use in the calibration of the DiaSys Procalcitonin FS assay.
The DiaSys TruLab Procalcitonin Bi-Level Controls, Levels 1 (low) and 2 (high) are intended for use as quality control for the DiaSys Procalcitonin FS assay.
DiaSys PCT Calibrators and Bi-Level Controls are ready-to-use, stable, aqueous solutions containing recombinant human full-length PCT and biological additives from bovine origin.
Here's a breakdown of the acceptance criteria and study information for the DiaSys Procalcitonin FS assay, extracted and organized from the provided FDA 510(k) clearance letter:
Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision/Reproducibility | ||
| Total Precision (Serum) | CV ≤ 10% (0.2-1.0 ng/mL)CV ≤ 7% (1.0-3.0 ng/mL)CV ≤ 5% (3.0-20 ng/mL) | Met:0.2-1.0 ng/mL: 5.64%1.0-3.0 ng/mL: 2.34%3.0-20 ng/mL: 1.93% |
| Total Precision (Plasma) | CV ≤ 10% (0.2-1.0 ng/mL)CV ≤ 7% (1.0-3.0 ng/mL)CV ≤ 5% (3.0-20 ng/mL) | Met:0.2-1.0 ng/mL: 8.31%1.0-3.0 ng/mL: 3.24%3.0-20 ng/mL: 2.61% |
| Within-run Precision (Serum) | CV ≤ 10% (0.2 ng/mL range)CV ≤ 7% (1.0-3.0 ng/mL range)CV ≤ 5% (3.0-20 ng/mL range) | Met (except for LoQ proximity):0.252 ng/mL: 16.62% (Determined acceptable given proximity to LoQ)0.555 ng/mL: 3.89%2.02 ng/mL: 2.78%9.68 ng/mL: 2.24%18.8 ng/mL: 2.16% |
| Within-run Precision (Plasma) | CV ≤ 10% (0.2 ng/mL range)CV ≤ 7% (1.0-3.0 ng/mL range)CV ≤ 5% (3.0-20 ng/mL range) | Met:0.314 ng/mL: 8.00%0.475 ng/mL: 6.94%1.910 ng/mL: 2.93%9.851 ng/mL: 1.94%17.953 ng/mL: 1.96% |
| Linearity/Assay Reportable Range | Linearity < 0.5 ng/mL: ± 0.1 ng/mLLinearity 0.5-5 ng/mL: ± 20%Linearity > 5 ng/mL: ± 10% | Met (Human serum and plasma evaluations) |
| Detection Limits | LoB ≤ 0.2 ng/mLLoQ ≤ 0.5 ng/mL | Met:Limit of Blank (LOB): 0.081 ng/mLLimit of Quantitation (LOQ): 0.23 ng/mL (with %CV ≤ 20%) |
| Interference | No significant interference (shift in PCT concentration > ±15%) | Met: (No significant interference observed for substances tested at specified concentrations, including Ascorbic acid, Bilirubin, Lipemia, HAMA, Rheumatoid factor, Hemolysis, and various drugs. N-Terminus interferes.) |
| Stability (Reagent) | ||
| Real-time Stability | 24 months stability | Confirmed: 25 months stability from date of production. |
| In-use Stability | 24 months stability | Confirmed: At least 25 months stability after opening. |
| Specimen Stability | Within ± 15% of concentration at time zeroSlope of regression line within ± 10% | Met: for 24 hours at 20-25°C, 5 days at 2-8°C, and 14 days at -20°C (for both serum and plasma, and measurements >10% over specified durations). |
| Freeze-Thaw Cycle (2 cycles) | Within 15% of concentration at time zero | Met: for both serum and plasma samples after one and two freeze-thaw cycles. |
| Hook Effect (Prozone) | No hook/prozone effect | Confirmed: No hook/prozone effect up to 1000 ng/mL. |
| Method Comparison (Study 1, 2021) | Slope: 0.85 – 1.15Intercept: ± 1.0 ng/mLCorrelation coefficient R: ≥ 0.95n ≥ 100 | Met:N = 120Slope = 1.08Intercept = 0.105 ng/mLR = 0.991PCT Cutoff 0.5 ng/mL: NPA 93.9%, PPA 100%PCT Cutoff 2.0 ng/mL: NPA 93.3%, PPA 97.8% |
| Method Comparison (Study 2, 2025) | Slope: 0.85 – 1.15Intercept: ± 1.0 ng/mLCorrelation coefficient R: ≥ 0.95n ≥ 100 | Met:N = 210Slope = 0.940Intercept = 0.017 ng/mLR = 0.965PCT Cutoff 0.5 ng/mL: NPA 98%, PPA 100%PCT Cutoff 2.0 ng/mL: NPA 100%, PPA 94% |
| Matrix Comparison | Slope: 0.85 – 1.15Intercept: ± 1.0 ng/mLCorrelation coefficient R ≥ 0.98n ≥ 20 | Met: (Human serum vs. lithium heparin plasma, for at least 20 native patient samples) |
Study Details:
-
Sample Size used for the test set and the data provenance:
- Precision/Reproducibility (Total Precision): 3 human serum samples, 3 human plasma samples.
- Precision/Reproducibility (Within-run Precision): 5 human serum samples, 5 human plasma samples.
- Linearity/Assay Reportable Range: Stock solutions assayed in quadruplicate.
- Detection Limits (LOB, LOD, LOQ): Evaluated in human serum and plasma.
- Interference: Human samples at approximate PCT concentrations of 0.5 and 2.0 ng/mL.
- Specimen Stability: 15 human samples (serum and lithium heparin plasma).
- Freeze-Thaw Cycle Stability: 15 human samples (serum and plasma).
- Method Comparison (Study 1): 120 native patient samples.
- Method Comparison (Study 2): 210 native patient samples.
- Matrix Comparison: At least 20 native patient samples (serum and lithium heparin plasma).
- Data Provenance: Not explicitly stated as retrospective or prospective, nor country of origin for patient/human samples. The nature of "native patient samples" generally implies retrospective analysis of collected clinical samples, but this is not definitively stated.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of in vitro diagnostic device (analyte measurement). The "ground truth" for the test set samples is typically established by reference methods or established values/concentrations for controls/calibrators, rather than expert clinical consensus.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is an assay for quantitative measurement of an analyte. "Adjudication" typically refers to the process of multiple readers/experts reviewing images or clinical cases.
-
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:
- No. This is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or clinical decision support system. The comparison studies are against a predicate device (another PCT assay), not human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance listed in the table effectively represents the standalone performance of the DiaSys Procalcitonin FS assay when run on the automated Abbott ARCHITECT c8000 analyzer, without human intervention in the result generation itself. The results are quantitative measurements of the Procalcitonin analyte.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Analytical Performance: Ground truth is based on known concentrations of analytes in controls and calibrators, and comparative measurements against a legally marketed predicate device (VIDAS B.R.A.H.M.S. PCT ASSAY, K071146).
- Clinical Efficacy/Impact: The device aids in risk assessment of critically ill patients for progression to severe sepsis and septic shock, "in conjunction with other laboratory findings and clinical assessments." This implies that the actual clinical "ground truth" (e.g., diagnosis of severe sepsis or septic shock, patient outcome) relies on a broader clinical picture, not solely on the PCT measurement. The study primarily focuses on analytical equivalence, not a direct measure of clinical outcomeprediction compared to a gold standard outcome.
-
The sample size for the training set:
- The document primarily describes validation and verification studies for the device's analytical performance and equivalence to a predicate. It does not mention a "training set" in the context of machine learning or AI algorithm development, as this device appears to be a traditional IVD assay.
-
How the ground truth for the training set was established:
- Not applicable, as there is no apparent "training set" in the machine learning sense. The device is a chemical reagent-based assay.
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(210 days)
The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock.
The Access PCT assay is a paramaqnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of Intensive Care Unit (ICU) admission for progression to severe sepsis and septic shock. A description of the reagent pack is provided below.
- R1a: Dynabeads* paramagnetic particles coated with mouse anti-. human Procalcitonin monoclonal antibody in a TRIS buffer with surfactant, protein (bovine), ≤ 0.1% sodium azide, and 0.1% ProClin**300
- R1b: 0.10 N Sodium Hydroxide ●
- R1c: MOPS Buffer with surfactant and protein (bovine, murine), ≤ ● 0.1 % sodium azide, and 0.1% ProClin 300
- R1d: Rat anti-Procalcitonin recombinant alkaline phosphatase . coniugate in a MOPS buffer with surfactant and protein (bovine, murine, recombinant).
≤ 0.1% sodium azide, and 0.1% ProClin 300
The device in question is the Access PCT Assay for the Dxl 9000 Access Immunoassay Analyzer, used for the in vitro quantitative determination of procalcitonin (PCT) levels. The study presented aims to demonstrate its substantial equivalence to the previously cleared Access PCT Assay on the Access 2 Immunoassay System (K192271).
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (New Device) | Reported Device Performance (New Device - Access PCT on Dxl 9000) |
|---|---|---|
| Method Comparison(vs. Predicate Access PCT on Access 2) | R² ≥ 0.95 | R² ≥ 0.95 (Met) |
| Slope | 1.00 ± 0.10 | 1.00 ± 0.10 (Met) |
| Method Concordance (at 0.5 ng/mL cutoff) | Not explicitly stated | 100.0% |
| Method Concordance (at 2.0 ng/mL cutoff) | Not explicitly stated | 98.3% |
| Imprecision (Within Laboratory) | SD ≤ 0.012 ng/mL for PCT < 0.150 ng/mL | SD between 0.006 - 0.008 ng/mL for PCT < 0.150 ng/mL (Met) |
| % CV ≤ 8.0% for PCT ≥ 0.150 ng/mL | % CV between 2.2% - 6.1% for PCT ≥ 0.150 ng/mL (Met) | |
| Imprecision (Within Run) | SD ≤ 0.009 ng/mL for PCT < 0.150 ng/mL | SD between 0.004 - 0.007 ng/mL for PCT < 0.150 ng/mL (Met) |
| % CV ≤ 6.0% for PCT ≥ 0.150 ng/mL | % CV between 1.9% - 4.7% for PCT ≥ 0.150 ng/mL (Met) | |
| Linearity | Detectable nonlinearity within ± 0.012 ng/mL for PCT ≤ 0.150 ng/mL | Met |
| Detectable nonlinearity within ± 10% for PCT > 0.150 ng/mL | Met | |
| Limit of Blank (LoB) | ≤ 0.005 ng/mL | 0.002 ng/mL (Met) |
| Limit of Detection (LoD) | ≤ 0.01 ng/mL | 0.003 ng/mL (Met) |
| Limit of Quantitation (LoQ) | ≤ 0.02 ng/mL (20% CV) | 0.002 ng/mL (reported as 0.003 ng/mL to align with LoD per CLSI EP17-A2 recommendation, Met) |
2. Sample Size and Data Provenance
The document does not explicitly state the specific sample sizes used for each test (e.g., method comparison, imprecision, linearity). It also does not specify the country of origin of the data or whether the data was retrospective or prospective. It states "The study" for imprecision and linearity, suggesting a single study per characteristic. The "Method Comparison" and "Method Concordance" imply patient samples were used to compare results between the new device and the predicate.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is an in vitro diagnostic immunoassay measuring procalcitonin levels. Ground truth is established through analytical validation and comparison to an established predicate device, not through expert review of interpretations.
4. Adjudication Method
Not applicable. As this is an analytical performance study for an immunoassay, adjudication methods typically used for qualitative or imaging-based diagnostics by human readers are not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic tools where human interpretation is involved. The Access PCT assay is an automated immunoassay.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
Yes, the studies described represent the standalone performance of the Access PCT assay on the Dxl 9000 Analyzer. The tests (method comparison, imprecision, linearity, LoB, LoD, LoQ) evaluate the analytical performance of the device itself, independent of human interpretation or interaction beyond standard laboratory procedures.
7. Type of Ground Truth Used
The ground truth or reference for comparison in this submission is the measurements obtained from the previously cleared Access PCT assay on the Access 2 Immunoassay System (K192271). For analytical precision, linearity, and limits of detection/quantitation, the "ground truth" is defined by established analytical methods and statistical calculations following guidelines like CLSI EP17-A2.
8. Sample Size for the Training Set
Not applicable. This device is an immunoassay, not an AI/Machine Learning algorithm that undergoes a "training" phase with a specific dataset. Its performance is based on the chemical and biological reactions designed within the assay.
9. How Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the context of this immunoassay. The development of the assay involves optimization of reagents and protocols, but not in the sense of supervised learning from a labeled dataset. The reference for comparison is the predicate device's performance.
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(96 days)
The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission to severe sepsis and septic shock.
The Access PCT Calibrators are intended to calibrate the Access PCT assay for the quantitative determination of procalcitonin levels in human serum and plasma (lithium heparin and EDTA) using the Access Immunoassay Systems.
The Access PCT assay is a paramagnetic, chemiluminescent immunoassay for in vitro quantitative determination of procalcitonin (PCT) levels in human serum and plasma using the Access Immunoassay Systems. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission for progressive to severe sepsis and septic shock.
A description of the reagent pack is provided below.
- R1a: Dynabeads* paramagnetic particles coated with mouse anti-human ● Procalcitonin monoclonal antibody in a TRIS buffer with surfactant, protein (bovine), ≤ 0.1% sodium azide, and 0.1% ProClin**300
- R1b: 0.10 N Sodium Hvdroxide ●
- R1c: MOPS Buffer with surfactant and protein (bovine, murine). ≤ 0.1% . sodium azide, and 0.1% ProClin 300
- R1d: Rat anti-Procalcitonin recombinant alkaline phosphatase conjugate in a ● MOPS buffer with surfactant and protein (bovine, murine, recombinant), ≤ 0.1% sodium azide, and 0.1% ProClin 300
This document describes the acceptance criteria and study results for the Beckman Coulter Access PCT assay, which measures procalcitonin (PCT) levels in human serum and plasma to aid in the risk assessment of critically ill patients for severe sepsis and septic shock.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Comparison | Slope = 0.90 ± 0.10 relative to predicate (VIDAS® B·R·A·H·M·S PCT®) | Slope = 0.96 (95% CI: 0.94 to 0.99) |
| Correlation Coefficient (r) ≥ 0.95 | r = 0.99 | |
| Imprecision | Total imprecision ≤ 8.0% CV at concentrations ≥ 0.150 ng/mL; SD ≤ 0.012 ng/mL at concentrations < 0.150 ng/mL | Met or exceeded criteria (Exact reported values not specified for all points, but stated to meet criteria). |
| Within-run imprecision ≤ 6.0% CV at concentrations ≥ 0.150 ng/mL; SD ≤ 0.009 ng/mL at concentrations < 0.150 ng/mL | Met or exceeded criteria (Exact reported values not specified for all points, but stated to meet criteria). | |
| High-dose Hook Effect | No hook effect up to a specified high concentration. | No hook effect up to 5,000 ng/mL. |
| Linearity | Linear across the assay range. | Demonstrated to be linear (0.05 ng/mL to approximately 100 ng/mL). |
| Dilution Recovery | Overall average recovery of 100 ± 10%; individual sample dose recovery within ± 15% when diluted 10-fold. | Demonstrated to dilute recover across the range (0.05 ng/mL to approximately 100 ng/mL) in serum, lithium heparin plasma, and EDTA plasma samples, for concentrations up to 1,000 ng/mL. Overall average recovery 100 ± 10%, individual sample dose recovery within ± 15%. |
| Limit of Blank (LoB) | ≤ 0.005 ng/mL | ≤ 0.005 ng/mL |
| Limit of Detection (LoD) | ≤ 0.01 ng/mL | ≤ 0.01 ng/mL |
| Limit of Quantitation (LoQ) | ≤ 0.02 ng/mL (based on 20% within-laboratory imprecision) | ≤ 0.02 ng/mL |
| Total Error (at clinical cutoffs) | ≤ 9.4% at 0.5 ng/mL and 2.0 ng/mL (Weighted Deming) / ≤ 11.3% at 0.5 ng/mL and 2.0 ng/mL (Passing Bablok) | At 0.5 ng/mL: Bias (%) 0.6%, CV (%) 4.5%, Total Error (%) 9.4% (Weighted Deming) / Bias (%) -0.6%, CV (%) 4.5%, Total Error (%) 9.4% (Passing Bablok) At 2.0 ng/mL: Bias (%) 0.7%, CV (%) 4.2%, Total Error (%) 8.9% (Weighted Deming) / Bias (%) -3.1%, CV (%) 4.2%, Total Error (%) 11.3% (Passing Bablok) |
| Analytical Specificity | Change in concentration between diluent control and test samples within ± 10% for potential cross-reactants. | No significant cross-reactivity for human calcitonin, human katacalcin, human alpha CGRP, and human beta CGRP (within ± 10% change). |
| Interfering Substances | Change in concentration between diluent control and test sample within ± 10% for potential interferents. | None of the tested substances were found to cause significant interference (within ± 10% change). |
| Expected Reference Intervals | Consistent with commonly used reference intervals (e.g., PCT ≤ 0.1 ng/mL for healthy individuals). | 95th percentile of 0.065 ng/mL with a 95% Confidence Interval (CI) of 0.054 - 0.085 ng/mL. |
| Matrix Comparison | Slopes and confidence intervals within acceptable ranges for comparison between serum (gel), serum (no gel), lithium heparin plasma, and EDTA plasma. | Serum (gel) vs. serum (no gel): Slope = 0.99 (95% CI: 0.98 to 1.00). Lithium heparin plasma vs. serum (no gel): Slope = 0.96 (95% CI: 0.95 to 0.97). EDTA plasma vs. serum (no gel): Slope = 1.03 (95% CI: 1.01 to 1.04). Lithium heparin plasma vs. serum gel: Slope = 0.97 (95% CI: 0.96 to 0.99). EDTA plasma vs. serum gel: Slope = 1.04 (95% CI: 1.03 to 1.05). EDTA plasma vs. lithium heparin plasma: Slope = 1.06 (95% CI: 1.05 to 1.08). |
| Carryover Study | Shift of ≤ 10% for assay carryover. | Individual estimates of carryover ranged from -6% to +8%, indicating no clear trend of positive or negative shifts, thus meeting criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison: Approximately 207 serum samples. The provenance of these samples (country of origin, retrospective/prospective) is not explicitly stated in the provided text.
- Expected Reference Intervals: 202 apparently healthy individuals. These samples were "prospectively procured." The country of origin is not explicitly stated.
- Matrix Comparison: Forty-three (43) matched sets of serum gel, serum no gel, plasma lithium heparin, and plasma EDTA samples. The provenance of these samples is not explicitly stated.
- Analytical Specificity and Interfering Substances: Serum patient samples. The number of samples is not explicitly stated, nor is their provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This device is an in vitro diagnostic (IVD) assay for measuring a biomarker (procalcitonin). The "ground truth" for such assays is typically established by reference methods or validated comparative assays, not by expert human graders. The studies compare the device's performance against either a legally marketed predicate device (VIDAS® B·R·A·H·M·S PCT®) or accepted analytical standards (e.g., CLSI guidelines). Therefore, no human experts were used to establish ground truth in the traditional sense of image or clinical interpretation.
4. Adjudication Method for the Test Set
Not applicable. As an IVD assay, the performance is assessed by comparing quantitative measurements against a predicate device or pre-defined analytical acceptance criteria, not through an adjudication process involving human experts.
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 IVD assay, not an AI-assisted diagnostic tool that relies on human readers or interpretation of complex medical images/cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are all standalone performance assessments of the Access PCT assay. The device quantitatively determines PCT levels, and its performance characteristics (accuracy, precision, limits, specificity, interference) are evaluated intrinsically or by comparison to another diagnostic test, without a human-in-the-loop component for result generation.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in these studies is based on:
- Reference Method/Comparative Device: For method comparison, the predicate device (VIDAS® B·R·A·H·M·S PCT®) serves as the comparator.
- Analytical Standards: For characteristics like linearity, imprecision, LoB, LoD, LoQ, analytical specificity, and interference, the "ground truth" is established by predefined analytical criteria, often guided by CLSI guidelines (e.g., EP17-A2 for LoQ, EP07 for interference).
- Clinically Relevant Concentrations: For some studies (e.g., analytical specificity, interference), specific PCT concentrations (e.g., 0.25 ng/mL, 0.5 ng/mL, 2.0 ng/mL) are used as reference points for evaluation.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. This device is an immunoassay, not an AI algorithm that requires training data. The studies presented are primarily analytical performance verification and validation studies.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this is an immunoassay and does not involve an AI training set in the conventional sense.
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(245 days)
Diazyme PCT Assay is a latex particle enhanced immunoturbidimetric method for the quantitative determination of PCT in human serum, EDTA or lithium heparin plasma. Measurement of PCT in conjunction with other laboratory findings and clinical assessments aids in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock. For in vitro diagnostic use only.
The Diazyme PCT Calibrator Set is intended for use in the Diazyme PCT Assay. For in vitro diagnostic use only.
The Diazyme PCT Control Set is intended for use as quality control for the Diazyme PCT Assay. For in vitro diagnostic use only.
Diazyme PCT Assay is a latex particle enhanced immunoturbidimetric method for the quantitative determination of PCT in human serum, EDTA or lithium heparin plasma.
This document is a 510(k) premarket notification acceptance letter from the FDA for a Diazyme Procalcitonin (PCT) Assay system. It confirms that the device is substantially equivalent to a predicate device for aiding in the risk assessment of critically ill patients for progression to severe sepsis and septic shock.
The provided document DOES NOT CONTAIN the detailed information requested regarding acceptance criteria and the study that proves the device meets those criteria. Such information would typically be found in the 510(k) submission itself, which includes performance data, analytical and clinical studies, and the establishment of ground truth. The letter only acknowledges the acceptance of the submission and states the device is substantially equivalent.
Therefore, I cannot provide the specific details for the following points based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not in the acceptance letter.
- Sample sizes used for the test set and the data provenance: Not in the acceptance letter.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not in the acceptance letter.
- Adjudication method for the test set: Not in the acceptance letter.
- 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 device is a diagnostic assay (in-vitro diagnostic), not an AI image analysis tool. Therefore, an MRMC study is not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As this is an in-vitro diagnostic assay, "standalone performance" refers to the assay's performance characteristics (e.g., analytical sensitivity, specificity, precision, accuracy), which are not detailed here. It's not an "algorithm" in the sense of AI.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While the indication for use mentions "other laboratory findings and clinical assessments," the specific ground truth methodology for the study is not stated. For a PCT assay, ground truth would typically involve clinical diagnosis of sepsis/septic shock based on established criteria (e.g., Sepsis-3 definitions), potentially including microbiology, inflammatory markers, and patient outcomes.
- The sample size for the training set: Not in the acceptance letter.
- How the ground truth for the training set was established: Not in the acceptance letter.
To fully answer your request, you would need access to the actual 510(k) submission document for K162297, which contains the detailed study reports.
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