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The Diazyme Fibrinogen Assay is for the quantitative determination of fibrinogen levels in citrated human plasma. For in vitro diagnostic use only.

The Diazyne Fibringen Calibrator Set is intended for use in the Diazyme Fibrinogen Assay. For in vitro diagnostic use only.

The Diazyme Fibringen Control Set is intended for use as quality controls for the Diazyme Fibrinogen Assay. For in vitro diagnostic use only.

The performance of this device has not been established in neonate and pediatric patient populations.

Diazyme Fibrinogen Assay System consists of the following items:

• 1. The Diazyme Fibrinogen Assay: containing reagent R1 and reagent R2. Reagent 1 contains buffer, saline, and sodium azide. Reagent 2 containing anti-human fibrinogen Ig fraction tittered to optimal concentrations dependent on sera lot and sodium azide.
• 2. Diazyme Fibrinogen Calibrator Set: 3 levels, serum based, intended for use in the calibration of the Diazyme Fibrinogen Assay. The calibrators are in lyophilized form containing purified human fibrinogen antigen, defibrinated human serum and sodium azide
• 3. Diazyme Fibrinogen Control Set: 2 levels, serum based, intended for use as quality controls for the Diazyme Fibrinogen Assay. The controls are in lyophilized form containing purified human fibrinogen antigen, defibrinated human serum and sodium azide.

The Diazyme Fibrinogen Assay is run on Roche Modular P analyzer (K953239/005). The Diazyme Fibrinogen Assay never comes into direct contact with patient's venous blood sample is first collected by a phlebotomist and then submitted for determination of fibrinogen concentration using Diazyme Fibrinogen Assay by trained professionals.

The Control Unit of the Roche Modular P analyzer uses a graphical interface to control all instrument functions. The computer, keyboard, and touchscreen monitor allows users to navigate through the software, enter assay, calibrator, and control information, and make test selections. The Diazyme Fibrinogen Modular P application parameters provided are programmed into the Modular P analyzers. The reagents, calibrators and controls are loaded into the analyzer. The Roche Modular P stores the Diazyme Fibrinogen Assay reagents in a refrigerated compartment. Reagent and sample pipettes automatically aspirate and dispense specified amounts of reagent or calibrators, controls, and sample into reaction cells. The change in absorbance is measured at specified wavelengths.

After a 4-point calibration, spline-fitting is used to smoothly fit polynomial functions through mean values of the response for calibrators of known concentrations. The Roche Modular P calculates the fibrinogen concentration of a patient sample by interpolation of the obtained signal to a stored 4-point calibration curve.

This document describes the Diazyme Fibrinogen Assay and compares its performance characteristics to a predicate device, the Kamiya K-Assay Fibrinogen (K993482), to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, pre-defined set of values that the device met. Instead, it presents performance characteristics and then concludes "Performance data and risk analysis indicates that differences should not affect the safety and effectiveness of the Diazyme Fibrinogen Assay and offers users an in vitro diagnostic device system to measure fibrinogen in human plasma," implicitly suggesting these performance levels are acceptable for substantial equivalence.

Here's a comparison of the Diazyme Fibrinogen Assay's performance against the predicate:

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

• Precision (Sample Repeatability): 6 citrated plasma samples. Tested over 10 days, 2 runs/day, 2 replicates/run = 240 measurements per sample type.
• Precision (Calibrator Repeatability): 3 levels of calibrators. Tested over 10 days, 2 runs/day, 2 replicates/run = 360 measurements per calibrator level.
• Precision (Control Repeatability): 2 levels of controls. Tested over 20 days, 2 runs/day, 2 replicates/run = 160 measurements per control level.
• Reproducibility (Multi-site precision): 6 citrated plasma samples, 3 calibrator levels, 2 control levels. Plasma: 60 measurements per sample (implies 3 sites, but not explicitly stated how many measurements per site). Calibrator/Control: 120 measurements per level.
• Linearity: An eleven-level linearity set prepared by mixing a pooled fibrinogen spiked plasma sample and saline at different proportions.
• Method Comparison: A total of 176 human plasma samples.
• Interference: Not specified as a specific "test set" size, but various interferents were tested at specified concentrations.

Data Provenance:
The document does not explicitly state the country of origin of the samples. For precision, linearity, and interference, it implies in-house testing by Diazyme Laboratories. For method comparison, it states "Human plasma samples" from "3 clinical sites," but the location of these sites and whether the data is retrospective or prospective is not specified.

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

This information is not provided in the document. For in vitro diagnostic devices like this, the "ground truth" for method comparison is typically established by results from the predicate device itself, or in some cases, a well-established reference method. There is no mention of experts establishing a ground truth for individual samples.

4. Adjudication Method for the Test Set

This information is not applicable/provided. For analytical performance studies of quantitative IVD assays, an adjudication method (like 2+1 expert consensus) is typically not used in the same way it would be for qualitative image-based diagnostic systems. The reference method (predicate device) provides the comparative "truth."

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging interpretation where human readers are involved. The Diazyme Fibrinogen Assay is an in vitro diagnostic assay run on an automated analyzer (Roche Modular P), not a system designed for human interpretation.

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

Yes, the performance studies described (Precision, Linearity, Method Comparison, Interference) are all standalone performance evaluations of the Diazyme Fibrinogen Assay device itself, without human-in-the-loop performance measurement. The device runs on an automated analyzer (Roche Modular P), and its performance is assessed against established analytical performance metrics and comparison to a predicate device.

7. The Type of Ground Truth Used

For the method comparison study, the predicate device's results (Kamiya K-Assay Fibrinogen) served as the comparative "ground truth" or reference method. For linearity, it was prepared standards. For precision, the "truth" is the statistical mean of repeated measurements.

8. The Sample Size for the Training Set

This information is not applicable/provided. The Diazyme Fibrinogen Assay is an immunoturbidimetric assay based on chemical reactions and optical measurements, not a machine learning or AI-based device that would typically involve a "training set" in the computational sense. The "training" of the assay involves establishing calibration curves using known calibrator concentrations.

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

This information is not applicable/provided. As above, the device is not an AI/ML system requiring a training set with "ground truth" labels. Calibration curves are established using the "Diazyme Fibrinogen Calibrator Set," which contains purified human fibrinogen antigen at known concentrations. These known concentrations serve as the basis for the instrument to interpret sample results.

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The FibroTek FIB fibrinogen kit contains a lyophilized thrombin reagent, lyophilized calibrator plasma, and Imidazole Buffered Saline (IBS) for use in the quantitative determination of fibrinogen in citrated plasma. The fibrinogen test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The fibrinogen test is used to detect disorders of fibrinogen. The FibroTek FIB Fibrinogen Assay Kit should only be used in an appropriate clinical laboratory by qualified laboratory professionals.

FibroTek FIB fibrinogen kit contains Human Thrombin 200, Fibrinogen Calibrator Plasma, and Imidazole Buffered Saline (IBS) and is intended for use in the quantitative determination of fibrinogen in citrated human plasma.

Here's an analysis of the provided text regarding the FibroTek FIB device, including the requested information:

Acceptance Criteria and Device Performance for FibroTek FIB

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo clinical performance criteria. Therefore, the "acceptance criteria" are implied by the performance of the predicate device and the requirement for the new device to demonstrate comparable performance. The study described is a comparison study against the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the exact number of samples used. It mentions "normal and abnormal patient plasma, as well as plasma samples from patients undergoing heparin therapy" were tested.
• Data Provenance: The document does not specify the country of origin of the data. The study involved testing at "two sites and on two different instrument types," which suggests a multi-site evaluation. The data is presented as a prospective comparison study against the predicate device.

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

This type of device (fibrinogen test kit) does not typically rely on "expert ground truth" in the same way an imaging or diagnostic AI model would. The "ground truth" for the test set is established by the measurement obtained from the predicate device. The performance of the FibroTek FIB is then compared to these measurements.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" for comparison is the measurement from the predicate device itself, not a consensus interpretation by experts.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists, pathologists) and would assess the impact of AI assistance on their performance. The FibroTek FIB is an in-vitro diagnostic (IVD) test kit, where the result is generated by the instrument/reagent, not human interpretation of complex data.

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

Yes, the performance evaluation of the FibroTek FIB represents a standalone (algorithm/device-only) performance. The results (fibrinogen levels) are generated directly by the kit and associated laboratory instruments, without human interpretive input as part of the core measurement. The "human-in-the-loop" here refers to qualified laboratory professionals performing the test and interpreting the numerical output, not subjectively assessing raw data to reach a diagnosis.

7. The Type of Ground Truth Used

The ground truth used for this study was the measurements obtained from the predicate device (Fibrinogen Assay Set). The new device's performance was evaluated by its correlation and precision relative to an already legally marketed and established method.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable in the context of this traditional IVD kit submission. The FibroTek FIB is a chemical reagent kit, not an AI/ML algorithm that undergoes a training phase.

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

Not applicable, as there is no "training set" for a chemical reagent kit. The development of such kits involves chemical formulation, optimization, and rigorous manufacturing controls, rather than data-driven machine learning training.

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The K-ASSAY Fibrinogen Assay is intended to be used to determine the fibrinogen levels in disseminated intravascular coagulation (non-localized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrinogen in a blood clot.) FOR IN VITRO DIAGNOSTIC USE.

Not Found

The provided text details an FDA 510(k) clearance for the K-ASSAY Fibrinogen device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The document is a clearance letter from the FDA to Kamiya Biomedical Company, stating that their K-ASSAY Fibrinogen device is substantially equivalent to a legally marketed predicate device. It outlines the regulatory class, product code, and marketing permissions. The "Indications for Use Statement" simply describes what the device is intended for (determining fibrinogen levels in disseminated intravascular coagulation and primary fibrinolysis for in vitro diagnostic use).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

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Ask a specific question about this device