Search Results
Found 2 results
510(k) Data Aggregation
(210 days)
Access PCT
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 | 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.
Ask a specific question about this device
(96 days)
Access PCT, Access PCT Calibrators
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 |
Ask a specific question about this device
Page 1 of 1