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Acceptance Criteria (Implied)	Reported Device Performance (COATEST APC™ RESISTANCE V or V S)
Improved sensitivity for Factor V mutation (FV:Q506) compared to original device.	"considerably increased sensitivity for the mutation in factor V." "greater than 99 % sensitivity for FV:Q506."
High discrimination for FV:Q506.	"high discrimination for FV:Q506." "clear and complete discrimination is obtained for FV:Q506 by both instruments."
Correlation with the original COATEST® APC™ RESISTANCE method (K945940).	Good correlation (R=0.74 in one study) between the new and original methods.
Applicability on different clot detection instruments.	Successfully utilized on Thrombolyzer, MLA/Electra 900C, ACL 300, and ST-4 instruments.
Appropriate results for patients on: - Oral anticoagulants (OAC) - Normal or low molecular weight (LMW) heparin - Phospholipid antibody syndrome	"appropriate results are obtained on analysis of plasmas from patients receiving oral anticoagulants, normal or low molecular weight (LMW) heparin or patients with the phospholipid antibody syndrome." Specific data show correct classification for genotyped patients on heparin and those with phospholipid antibody syndrome.
Ability to provide normal APT times on heparin up to 1 IU/mL.	"provides normal APT times to at least 1 IU/mL of normal heparin."
Similar repeatability and reproducibility to the original device.	"provides a similar repeatability and reproducibility as Coatest APC Resistance."
Determination of a narrower APC Ratio range for normal Factor V genotype individuals compared to the original kit.	"significantly narrower range is obtained with COATEST APC® RESISTANCE V or V S compared to the original Coatest APC Resistance kit."
Stability of V-DEF Plasma and other reconstituted reagents.	Data supports assigned stabilities in the package insert for reconstituted V-DEF plasma. Similar stability for 3mL and 4mL vials. Whole blood and plasma can be stored for at least 7 hours at room temperature.

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

The provided text describes several studies that collectively form the basis of the test set.

Study 1 (Correlation and Discrimination):
- Sample Size: 218 acutely ill patients with suspected venous thrombosis or pulmonary emboli and family members.
- Data Provenance: Retrospective (implied, as patients are "acutely ill" suggesting existing conditions) and likely from clinical settings where these patients were managed. No specific country of origin is mentioned.
Study 2 (Correlation and Discrimination):
- Sample Size: 399 plasmapheresis donors.
- Data Provenance: Retrospective (implied, as donors would have already provided samples). No specific country of origin is mentioned.
Instrument Studies:
- Thrombolyzer: 97 patients with myocardial infarction and 132 healthy controls.
- MLA/Electra 900C: 50 thrombotic patients or family members.
- ACL 300 & ST-4 (OAC patients): 147 patients on OAC therapy (ACL 300) and 129 patients on OAC therapy (ST-4).
- ACL 300 & ST-4 (Healthy Controls): 61 healthy controls (ACL 300) and 62 healthy controls (ST-4).
- Heparin Patients: Implied within the OAC/healthy control groups, all genotyped for Factor V.
- Phospholipid Antibody Syndrome Patients: Samples from these patients were also tested, but no specific number is provided.
- Data Provenance for Instrument Studies: Retrospective, as these are existing patient samples and controls. No specific country of origin is mentioned.

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

The text does not explicitly state the number or qualifications of experts used to establish the ground truth for the test sets.

4. Adjudication Method for the Test Set

The text does not describe any adjudication method like 2+1 or 3+1. The ground truth appears to be solely based on Factor V gene nucleotide determination (FV:Q506 mutation).

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a diagnostic assay, not an AI-assisted interpretation tool for human readers.

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

Yes, the studies described are standalone performance evaluations of the COATEST APC™ RESISTANCE V or V S assay. The device itself performs the measurement and provides a result (APC ratio), which is then interpreted against established cut-off values. There is no human-in-the-loop performance described in the context of improving the device's output.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The primary ground truth used for the test sets was Factor V gene nucleotide determination specifically for the FV:Q506 mutation at position 1691. This is a genetic-level diagnostic certainty.

8. The Sample Size for the Training Set

The document does not separately describe a distinct "training set." The studies appear to be validation or test sets. It's possible that the initial development and optimization of the assay (which would involve some form of "training") utilized samples, but those are not clearly delineated as a separate training set with specific numbers in this summary.

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

As no distinct training set is identified, the method for establishing its ground truth is not specified. However, by extension, if any samples were used for initial assay development, their ground truth would likely also be based on Factor V gene nucleotide determination, similar to the test sets.

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K Number

K952515

Device Name

COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY

Manufacturer

CHROMOGENIX AB

Date Cleared

1996-01-23

(237 days)

Product Code