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510(k) Data Aggregation
(258 days)
QNext and DG-PT
The QNext is a fully-automated, random-access instrument, intended for in vitro diagnostic use in clinical laboratories to perform hemostasis testing by detecting the changes in optical density.
DG-PT is a thromboplastin reagent for the quantitative determination of Prothrombin Time on human plasma samples collected in 3.2% sodium citrate.
The product is used for the evaluation of the extrinsic and common coagulation pathways in seconds and for the monitoring Oral Anticoagulant Therapy with warfarin in International Normalized Ratio (INR).
For use with ONext.
For clinical professional laboratory and prescription use only.
For in vitro diagnostic use.
The performance of this device has not been established in neonate and pediatric patient populations.
QNext is designed to automatically perform all stages of the procedures associated to hemostasis tests allowing the operator to:
- Absorb the workload involved in running hemostasis laboratory tests profiles, optimizing the execution of these profiles in the shortest time possible, and ensuring the maximum possible precision and accuracy in the results.
- Increase the reliability of the analytical process, eliminating any possible errors in the identification ● and treatment of samples and products and in the revision and transcription of the results.
- Reduce the risk of Operator contamination by minimizing interaction between the Operator and ● samples and products during the analytical process.
To perform the operations for which it has been designed, QNext automatically follows the steps listed below:
- Sample management: loading, positive identification, dilution (if required) and dispensation into cuvettes.
- Reagent management: loading, positive identification, cooling, stirring, aspiration and dispensation into cuvettes.
- Cuvette management: loading, transport, incubation during the reactions and management of used cuvettes.
- Management of test requests. ●
- Execution of test procedures.
- Result management: optical measurement of the reactions, algorithm calculation of analytical parameters from reaction curves, validation of results, traceability, bi-directional transmission of requests and results to the LIS.
- Management of disposable components. ●
The data analyzed can be stored, displayed and printed. Additionally, the analyzer allows conducting integrated functions, such as the analysis of urgent samples or the Quality Control module.
DG-PT consists of a glass vial containing lyophilized thromboplastin (tissue factor and phospholipids) from rabbit brain tissue, buffer, calcium ions and preservative. The closure system includes a stopper and a screw сар.
DG-PT reagent is used to perform PT tests for:
- the evaluation of the extrinsic and common coagulation pathways.
- The monitoring Oral Anticoagulant Therapy with warfarin.
The assay is based on the activation of the extrinsic coagulation pathway by the addition of the reagent to the plasma sample. The thromboplastin interacts with FVII and calcium ions activating a series of specific enzymes that comprise the extrinsic and common pathways of the coagulation cascade ultimately leading to the formation of a fibrin clot. The QNext reader measures the light change produced during the reaction.
The provided text describes the performance testing of the ONext instrument and DG-PT reagent for Prothrombin Time (PT) determination, but it does not contain information related to an AI/ML powered device. Therefore, many of the requested criteria regarding AI/ML device performance (e.g., multi-reader multi-case studies, human-in-the-loop performance, training set details, expert ground truth adjudication) are not applicable to this document.
However, I can extract and present the acceptance criteria and performance data for the described in-vitro diagnostic device:
Device: ONext (fully-automated hemostasis instrument) and DG-PT (thromboplastin reagent for PT determination).
Study Proving Device Meets Acceptance Criteria:
The submission details several performance studies conducted according to CLSI guidelines to demonstrate the substantial equivalence of the ONext and DG-PT to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined quantitative acceptance criteria thresholds for each study (e.g., "Precision CV must be less than X%"). Instead, it presents the results of various performance studies (Precision, Reference Interval, Sensitivity, Specificity, Method Comparison) which are implicitly understood to meet the necessary performance characteristics for substantial equivalence. The "performance" column therefore reflects the observed results from these studies.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (ONext and DG-PT) |
|---|---|---|
| Precision | Repeatability and Within-laboratory precision should demonstrate acceptable variability. | Repeatability (PT seconds / INR): Varies by sample level. For PT (seconds), 1.4-2.1% CV; for INR, 1.6-2.4% CV. Upper One-sided 95% Limits slightly higher. |
| Within-laboratory Precision (PT seconds / INR): Varies by sample level. For PT (seconds), 2.4-5.7% CV; for INR, 2.2-8.2% CV. Upper One-sided 95% Limits higher. | ||
| Reproducibility (PT seconds / INR): Varies by sample level. For PT (seconds), Repeatability 1.6-3.1% CV, Reproducibility 3.1-6.0% CV; for INR, Repeatability 1.9-3.7% CV, Reproducibility 5.5-9.2% CV. Upper One-sided 95% Limits higher. (See Tables 1 & 2 in source for full details) | ||
| Reference Interval | Establish a clear reference interval for healthy individuals. | PT (seconds): 12.1 to 16.1 seconds |
| PT (INR): 0.83 to 1.17 INR | ||
| Sensitivity (Factor) | Demonstrate ability to detect deficiencies in key coagulation factors. | FII: 29 IU/dL |
| FV: 45 IU/dL | ||
| FVII: 44 IU/dL | ||
| FX: 43 IU/dL | ||
| Specificity (Interference) | Demonstrate resistance to interference from common endogenous and exogenous substances. | Maximum Concentration without Significant Interference (Normal/Abnormal samples): |
| Hemoglobin: 10.0 g/L | ||
| Conjugated bilirubin: 43.3 mg/dL | ||
| Triglycerides: 3000 mg/dL | ||
| Citrate: 0.6% | ||
| UFH: 1.1 IU/mL (Normal), 0.7 IU/mL (Abnormal) | ||
| LMWH: 2.3 IU/mL (Normal), 1.8 IU/mL (Abnormal) | ||
| Observed Interference at All Concentrations Tested for: | ||
| Rivaroxaban (e.g., 313, 625, 938, 1250 ng/mL for normal sample) | ||
| Argatroban (e.g., 375, 750, 1125, 1500 ng/mL for normal sample) | ||
| Dabigatran (e.g., 150, 300, 450, 600 ng/mL for normal sample) | ||
| Method Comparison | Results should correlate well with a legally marketed predicate device. | Results from two US sites (n=360): |
| PT (s): Slope 0.913 (95% CI: 0.893-0.938), Intercept 1.118 (95% CI: 0.706-1.477), r=0.983 | ||
| PT (INR): Slope 1.034 (95% CI: 1.010-1.060), Intercept -0.024 (95% CI: -0.054-0.009), r=0.980 | ||
| Results from ex-US site (n=271): | ||
| PT (s): Slope 0.985 (95% CI: 0.962-1.003), Intercept 0.272 (95% CI: -0.078-0.716), r=0.988 | ||
| PT (INR): Slope 1.000 (95% CI: 0.978-1.022), Intercept -0.070 (95% CI: -0.099--0.042), r=0.990 |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision Studies:
- Repeatability and Within-laboratory: 7 patient-derived samples. Data provenance not explicitly stated (e.g., country of origin), assumed to be clinical samples. Retrospective/prospective not specified, but typically for precision studies, these would be collected prospectively or obtained from a biobank.
- Reproducibility: 7 patient-derived samples. Data provenance not explicitly stated (e.g., country of origin), assumed to be clinical samples. Retrospective/prospective not specified.
- Reference Interval Study: 243 reference samples. Data provenance not explicitly stated.
- Sensitivity Study: Not specified, but involved a set of samples spanning from 100% to
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