Search Results

HEMOCLOT Quanti VL is an in vitro diagnostic test for the quantitative determination of Factor V Leiden (FVL) activity in human citrated plasma, using automated or manual methods, by its resistance to the action of Activated Protein C ( APC).

Patients with the Factor V-L (mutalion R506Q), are exposed to an increased thrombotic risk.

Biophen V-L CAL (undiluted), at defined Factor V-Leiden (FV-L) concentrations, for the callibration of Factor V-Leiden aclivity on human plasma, using the Hemoclot Quanti V-L kit.

Factor V-L Cafibrator, pre diluted (1:20) human plasmas. at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity on human plasma using Hemoclot Quanti V-L Kit.

Biophen Act PC-r Control Plasma contains human plasma, presenting an Activated Protein C Resistance (APC-R) is used as quality control plasma for the testing of Activated Protein C resistance (APC-R) on human plasma using Hemoclot Quarti V-L Kit.

(Updated) BIOPHEN Normal Control Plasma is a set of 12 vials of normal citrated human plasma for the quality control of some coagulation factors. The following table shows parameters, which are measured using assays from HYPHEN BioMed or from other manufacturers, and according to the package inserts:

DVVtest, DVVconfirm are registered trademarks from American Diagnostica, Inc.

The BIOPHEN Normal Control Plasma is tested for the absence of Lupus Anticoagulant and can be used as a negative control for this investigation. This control plasma is also tested for the absence of Activated Protein C resistance (Act PC-7). When the APTT is performed with or without Activated Protein C (APC) the ratio obtained (APTT + APC/APTT) is ≥2.00.

• 1. HEMOCLOT Quanti V-L is an in vitro diagnostic test kit containing 3 vials of each of the following 2 lyophilized reagents:
     R1: Reagent 1: Clotting mixture containing human Fibrinogen, human prothrombin, Protein S at a constant concentration, optimized for the assay, and human Activated Protein C, lyophilized. It also contains a heparin neutralizing substance. Each vial is to be reconstituted with exactly 2 ml of distilled water.

R2: Reagent 2: Purified Human Factor Xa, containing rabbit brain phospholipds (cephalin), lyophilized. Each vial is to be reconstituted with exactly 1 ml of distilled water.

Calibrators and controls to be used with the test kit are supplied separately. The following calibrators and control are included in this submission:

• 2. Factor V-L Calibrator is a calibrator kit containing 3 vials each of 1.0 ml prediluted human plasma (1:20), freeze dried, at 4 different concentrations of FV-L, to cover the assay range, from 10% to 100%. Each vial is restored with 1.0 ml Owren Koller type buffer.
• 3. BIOPHEN V-L CAL (Undiluted) is a calibrator kit containing 3 vials each of 0.5 ml undiluted human plasma, freeze dried, at 3 different concentrations of FV-L, to cover the assay range, from about 10% to 100%. Each vial is restored with 0.5 ml distilled water.
• BIOPHEN Act PC-r Control Plasma is a controls kit containing 12 vials of 0.5 ml human 4. plasma, presenting an Activated Protein C Resistance (APC-R), citrated and Iyophilized. Each vial is to be reconstituted with exactly 0.5 ml of distilled water.
• BIOPHEN Normal Control Plasma manufactured by Hyphen-Biomed, is also used with the test kit and is currently marketed in the US under 510(k) # K043451, It is a controls kit containing 12 vials of 1.0 ml of normal citrated human plasma, lyophilized. Each vial is to be reconstituted with exactly 1.0 ml of distilled water.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HEMOCLOT Quanti V-L device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in terms of numerical thresholds for sensitivity, specificity, or agreement. Instead, it demonstrates consistency with a predicate device and molecular biology results. The performance is presented as direct agreement percentages.

2. Sample Size Used for the Test Set and Data Provenance

• Comparison with Predicate Device (COATEST APCr):
  • Sample Size: 189 total samples (108 Normal, 70 Abnormal, 10 inconclusive/borderline based on detailed table analysis: 108 Normal + 1 Abnormal + 2 Inconclusive=111 from Predicate Normal; 7 Abnormal + 70 Abnormal + 1 Inconclusive = 78 from Predicate Abnormal). However, the "Sample Size" row explicitly states 189 for the overall comparison.
  • Data Provenance: "combined from 4 studies (2 in US, 2 in Europe)." This indicates a retrospective or prospective collection across multiple sites. The specific nature (retrospective/prospective) is not explicitly stated, but clinical studies often involve a mix.
• Comparison with Molecular Biology:
  • Sample Size: 21 total samples (15 Normal, 6 Abnormal).
  • Data Provenance: Not explicitly stated, but implied to be part of the overall validation studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of "experts" for establishing ground truth in the traditional sense of clinical readings.

• For the comparison with the predicate device, the "ground truth" for the test set was the classification (Normal/Abnormal) provided by the COATEST APCr kit. This is a laboratory diagnostic assay, not an expert human interpretation.
• For the comparison with Molecular Biology, the "ground truth" was the molecular biology result itself (indicating presence or absence of the R506Q mutation). This is an objective genetic test, not subject to expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. As the ground truth was established by another diagnostic assay (COATEST APCr) or molecular biology, there was no human adjudication process involved. The results were compared against these established methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This study is for an in vitro diagnostic (IVD) assay, which measures an analytical marker in human plasma. It does not involve human readers interpreting images or data, so an MRMC study comparing human readers with and without AI assistance is not relevant or applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, this entire study represents the standalone performance of the HEMOCLOT Quanti V-L device. It evaluates the device's ability to classify samples as Normal, Abnormal, or Inconclusive based on its own measurements, compared against a predicate device and a molecular biology reference. There is no human interpretation involved in the direct result generation of the HEMOCLOT Quanti V-L assay itself.

7. The Type of Ground Truth Used

• Comparison with Predicate Device: The ground truth was the result obtained from the COATEST APC Resistance V (K963111) predicate device.
• Comparison with Molecular Biology: The ground truth was the molecular biology result for the Factor V Leiden (mutation R506Q). This is pathology/genetic testing data, considered a highly objective measure for the presence of the mutation.

8. The Sample Size for the Training Set

The document doesn't explicitly mention a separate "training set" for the HEMOCLOT Quanti V-L assay in the context of machine learning or AI. For IVD kits like this, the "training" typically refers to the optimization and validation performed by the manufacturer during product development, using various samples to establish assay parameters, linearity, sensitivity, specificity, and reproducibility. The performance data presented here is the validation or "test" set used to demonstrate substantial equivalence.

9. How the Ground Truth for the Training Set Was Established

As there's no mention of a traditional machine learning "training set" with separate ground truth establishment, this question is not fully applicable in the context of this document. For IVD development, the "ground truth" for calibrators, controls, and method development would have been established through highly characterized reference materials, potentially confirmed by molecular methods or established clinical diagnoses of FVL status.

Ask a specific question about this device