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Quantex D-DIMER is a latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on automated clinical chemistry analyzers.

Device Description

Quantex D-DIMER is a latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on automated clinical chemistry analyzers. The quantex D-DIMER Latex Reagent is a suspension of polystyrene latex particles of uniform size coated with a monoclonal antibody highly specific for the D-Dimer domain included in fibrin soluble derivatives. When a plasma containing D-Dimer is mixed with the Latex Reagent and the Reaction Buffer included in the quantex D-DIMER 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 light caused by the aggregates (turbidimetric immunoassay).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the quantex D-DIMER device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K032419 for quantex D-DIMER) does not explicitly state pre-defined acceptance criteria values in the way one might see for diagnostic accuracy metrics (e.g., "sensitivity must be >90%"). Instead, the performance is demonstrated through a method comparison with a predicate device and precision studies, indicating that the new device's performance should be substantially equivalent to the predicate.

Given the information provided, we can infer the performance metrics reported:

Performance Metric	Acceptance Criteria (Implied/Compared to Predicate)	Reported Device Performance (quantex D-DIMER)
Method Comparison (Correlation)	Substantially equivalent to predicate device performance (ideally high correlation).	Correlation (r) = 0.987 (compared to IL Test D-Dimer on ACL Futura)
Within-run Precision (CV)	Acceptable precision for a diagnostic assay (typically <10% for clinical chemistry, often lower for high-use assays).	4.0% (at mean of 302 ng/mL) 2.2% (at mean of 637 ng/mL)

Important Note: The acceptance criteria are implicitly met if the reported performance demonstrates "substantial equivalence" to the predicate device, as determined by the FDA. The high correlation coefficient (0.987) and acceptable CVs suggest this was the case.

General Study Information for quantex D-DIMER

Feature	Details
2. Sample Size & Data Provenance (Test Set)	Sample Size: 137 citrated plasma samples were used for the method comparison study. Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The study appears to be retrospective as it involved "evaluating 137 citrated plasma samples" which implies pre-collected samples.
3. Number of Experts & Qualifications (Ground Truth)	Not applicable. This device is a quantitative immunoassay. The "ground truth" for the test set is established by the measurement on the predicate device, which itself is a quantitative assay. It does not rely on expert interpretation for individual sample results.
4. Adjudication Method (Test Set)	Not applicable. As a quantitative immunoassay, there is no manual interpretation or adjudication of results in the traditional sense. The "gold standard" for comparison is the predicate device's measurement.
5. MRMC Comparative Effectiveness Study	No. This is a submission for a standalone in vitro diagnostic device, not an AI-assisted interpretation tool for human readers. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant or reported.
6. Standalone Performance	Yes. The method comparison study and precision studies describe the standalone performance of the quantex D-DIMER device operating on an ILab 600 analyzer. It assesses the device's output against the output of a predicate device, without human intervention in the result generation.
7. Type of Ground Truth Used	The "ground truth" in this context is the quantitative measurement of D-Dimer using the predicate device (IL Test D-Dimer on an ACL Futura). This is a form of comparative ground truth, where the new device's performance is validated against an already legally marketed and accepted method.
8. Sample Size for Training Set	The document does not provide information on a "training set" in the context of machine learning or AI models. This is a traditional immunoassay, and its development would involve reagent optimization and assay development, rather than machine learning training. Therefore, a specific sample size for a training set (as understood in AI/ML) is not applicable or provided.
9. How Ground Truth for Training Set was Established	Not applicable, as there is no specific "training set" in the AI/ML sense. The development of an immunoassay involves rigorous biochemical validation, reagent selection, antibody characterization, and analytical performance testing (linearity, limit of detection, interference, etc.) to establish the assay's performance and ensure it accurately measures D-Dimer. The "ground truth" for these developmental stages would be established through known D-Dimer concentrations often prepared from purified D-Dimer antigen or characterized plasma samples.

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