(28 days)
HemosIL D-Dimer HS is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE)
For in vitro diagnostic use.
The D-Dimer HS Latex Reagent is a suspension of polystyrene latex particles of uniform size coated with the F(ab')2 fragment of a monoclonal antibody highly specific for the D-Dimer domain included in fibrin soluble derivatives. The use of the F(ab')2 fragment allows a more specific D-Dimer detection avoiding the interference of some endogenous factors like the Rheumatoid Factor. When a plasma containing D-D-Dimer is mixed with the Latex Reagent and the Reaction Buffer included in the D-Dimer HS kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of D-Dimer in the sample and is determined by measuring the decrease of the transmitted
This document, K151534, is a 510(k) premarket notification for the HemosIL D-Dimer HS device. The submission is a "Special 510(k)" to add information about the association of patient age with D-Dimer levels to the device's insert sheet. This means there are no changes to the device's performance, indications for use, or operating principles. Therefore, there is no new study conducted to demonstrate that the device meets new acceptance criteria. Instead, the focus is on the substantial equivalence to the predicate device (K070927) based on the absence of changes to performance claims.
Given that this is a Special 510(k) submission for minor labeling changes and explicitly states "No change to labeled performance claims", there isn't a new study presented in this document proving the device meets new acceptance criteria. The existing performance acceptance criteria and their proof are derived from the original clearance of the predicate device (K070927).
However, I can extract the reported performance of the device (which remains unchanged from the predicate) and details relevant to a typical device submission, even though a new study isn't detailed here for new acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a Special 510(k) for labeling changes, the acceptance criteria and reported performance are implicitly those established during the original clearance of the predicate device (K070927). The document explicitly states "No change to labeled performance claims."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Indications for Use | Automated latex enhanced immunoassay for quantitative determination of D-Dimer in human citrated plasma on ACL TOP, for use with clinical pretest probability (PTP) assessment model to exclude VTE in outpatients suspected of DVT and PE. |
| Analyte | D-Dimer |
| Methodology | Latex-enhanced immunoturbidimetric assay |
| Analyzers | ACL TOP Family |
| Sample Type | Citrated Plasma |
| Cut-off | 230 ng/mL |
| Linearity | 150 – 69000 ng/mL |
| Detection Limit | 21 ng/mL |
| Performance Claims | No change to labeled performance claims from predicate (K070927) |
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test 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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established
The provided document (K151534) is a Special 510(k) submission that does not include a new study to establish performance for the device. It states, "No change to labeled performance claims, including no change to the assay cut-off." This submission is solely to add general information to the device's insert sheet regarding the association of patient age with D-Dimer levels, citing "peer-reviewed published literature."
Therefore, the information requested in points 2-9 about test sets, experts, adjudication, MRMC studies, standalone performance, ground truth, and training sets is not available in this document. Such details would have been part of the original 510(k) submission (K070927) for the predicate device, which established its performance characteristics. This current submission does not involve new clinical or performance studies for the device itself.
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).