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510(k) Data Aggregation
(124 days)
STA LIATEST D-DI
The STA® - Liatest® D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2% sodium citrate) for use on STA-R®, STA Compact® and STA Satellite® analyzers by professional laboratory personnel. The STA® - Liates® D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and as an aid in the diagnosis of deep venous thrombosis (DVT) in outpatients suspected of PE or DVT.
STA® - Liatest® D-Di kit contains: 6 x 5-ml vials of ready-for-use Tris buffer and 6 x 6-ml vials of a suspension of microlatex particles coated with two different mouse monoclonal anti-human D-dimer antibodies (8D2 and 2.1.16) stabilized with bovine albumin.
The test principle is based on the change in turbidity of a microparticle suspension that is measured by photometry. A suspension of latex microparticles, coated by covalent bonding with monoclonal antibodies specific for D-dimer is mixed with the test plasma for which the D-dimer level is to be assayed. An antigen-antibody reaction takes place, leading to an agglutination of the latex microparticles which causes an increase in turbidity of the reaction medium. This increase in turbidity is reflected by an increase in absorbance, the latter being measured photometrically. The increase in absorbance is a function of the D-dimer level present in the test sample.
Here's a breakdown of the acceptance criteria and the study details for the STA® - Liatest® D-Di device, based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the STA® - Liatest® D-Di device are implicitly tied to its ability to
safely rule out Pulmonary Embolism (PE) in patients with low or moderate pretest probability (PTP).
The key performance metric for exclusion of PE is the Negative Predictive Value (NPV).
| Performance Metric | Acceptance Criteria (Implied by Study) | Reported Device Performance (Overall Study Population) |
|---|---|---|
| Sensitivity for PE | High sensitivity to minimize false negatives | 97.0 % (95% CI: 91.6 % - 99.4 %) |
| NPV for PE Exclusion | High NPV to safely rule out PE | 99.7 % (95% CI: 99.2 % - 100.0 %) |
| Specificity for PE | (No explicit threshold, but reported for completeness) | 75.5 % (95% CI: 72.8 % - 78.1 %) |
| PPV for PE | (No explicit threshold, but reported for completeness) | 25.5 % (95% CI: 23.5 % - 27.7 %) |
| Clinical Cut-off | D-dimer level |
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(213 days)
STA-LIATEST D-DI TEST KIT
The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579) to perform quantitative determinations of D-dimer antigen levels in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with mouse anti-human D-dimer monoclonal antibodies.
The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers to perform quantitative assays of D-dimer antigen in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with specific mouse anti-human D-dimer monoclonal antibodies.
Each STA®-Liatest® D-Di test kit provides: 6 x 5-ml vials of ready-for-use Tris buffer and 6 x 6-ml vials of a suspension of microlatex particles coated with mouse anti-human D-dimer monoclonal antibodies.
Reagents in intact vials remain stable for 18 months after the date of manufacture, when stored at 2°-8°C. After opening of the vials, kit reagents (with STA®-Reducers and perforated caps installed on the vials) are stable for 15 days on board STA® analyzers.
The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. Instead, it describes a 510(k) premarket notification for a medical device, the STA®-Liatest® D-Di Test Kit, which indicates it has been found "substantially equivalent" to a predicate device. This substantial equivalence determination generally means that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval.
Here's a breakdown of the requested information based on the provided text, and where the information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. The document focuses on substantial equivalence, not explicit performance criteria for the new device. | The STA®-Liatest® D-Di test kit "demonstrated substantial equivalence" to the commercially available ASSERACHROM® D-Di kit. This implies performance is comparable to the predicate, but specific metrics are not detailed for the new device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. The substantial equivalence claim is made against a predicate device, not by establishing ground truth based on expert consensus for the new device's performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. The document does not describe a test set or an adjudication process for such a set.
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
- No. This device is an in-vitro diagnostic test kit (an immuno-turbidimetric method), not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is an automated laboratory test kit; its performance is inherently "standalone" in the sense that the analyzer performs the measurement. However, it's not an "algorithm only" in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for chemical assays like D-dimer is typically established through reference methods or validated standards. The document states the new device is "substantially equivalent" to the ASSERACHROM® D-Di kit, which is a "microtiter ELISA-based procedure." This implies the predicate device's established performance serves as the benchmark. The inherent ground truth for D-dimer measurements relates to the actual concentration of D-dimer antigen in the plasma, which would be determined by a highly accurate and precise analytical method. The document does not specify details on how the accuracy of either device was independently validated against a gold standard.
8. The sample size for the training set
- Not applicable/Not specified. This device is a reagent kit and analyzer system, not a machine learning algorithm that requires a "training set" in the conventional sense of AI development.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As mentioned above, there is no "training set" in the context of an AI algorithm for this device.
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