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510(k) Data Aggregation
(23 days)
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
Lyphochek® Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.
Lyphochek® Coagulation Control is prepared from human plasma, with added purified biochemicals (tissue extract from animal origin), and preservatives. The control is provided in lyophilized form for increased stability.
Here's a breakdown of the acceptance criteria and the study details for the Lyphochek® Coagulation Control Level 4, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Product Claim) | Reported Device Performance |
|---|---|
| Open Vial Stability: All analytes stable for 24 hours at 2-25°C | Implied to meet this criterion for all analytes (Studies performed, data on file) |
| Shelf Life: Three years when stored at 2-8°C | Three years when stored at 2-8°C |
Note: The document states that stability studies were performed to determine these claims, and all supporting data is retained on file at Bio-Rad Laboratories. It does not explicitly present a table comparing measured values against a predefined acceptable range, but rather asserts that the product meets these stability claims based on the studies.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in the stability studies. It only mentions that "Stability studies have been performed."
Regarding data provenance:
- Country of Origin: Not specified in the provided document.
- Retrospective or Prospective: Not specified, but stability studies are typically prospective, involving monitoring the product over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device (quality control plasma). The "ground truth" for a coagulation control is its inherent stability and performance characteristics, which are determined through laboratory testing using various coagulation systems, not through expert consensus or interpretation of images/data by human experts.
4. Adjudication Method
This information is not applicable to this type of device. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, where multiple reviewers' opinions need to be reconciled (e.g., in medical image analysis).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed and is not applicable to this device. This type of study assesses how human readers' performance changes with AI assistance, which is irrelevant for a laboratory reagent like a coagulation control.
6. Standalone Performance Study
A standalone performance study (algorithm only without human-in-the-loop performance) was not explicitly detailed as such, but the stability studies performed on the Lyphochek® Coagulation Control Level 4 represent its "standalone" performance. The device itself is a control material, and its performance is evaluated directly through laboratory testing using established coagulation methods (PT, APTT, Fibrinogen, AT III, TT), not through an algorithm or human-in-the-loop assessment.
7. Type of Ground Truth Used
The ground truth used for evaluating the device would be the measured values of the coagulation analytes (Prothrombin Time, Activated Partial Thromboplastin Time, Fibrinogen, Antithrombin III, Thrombin Time) over time, compared against expected ranges or reference values for a stable product. This is essentially laboratory test results and established analytical methods.
8. Sample Size for the Training Set
This information is not applicable. This device is a biochemical reagent, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
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(34 days)
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3,
Lyphochek® Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.
Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen and Antithrombin III (AT III) are assayed on the MLA ELECTRA series. Thrombin Time (TT) is assayed on the Dade BBL Fibrometer (Becton Dickinson).
Lyphochek® Coagulation Control is prepared from human plasma, with added purified biochemical and preservatives. The control is provided in lyophilized form for increased stability.
The provided document describes the Bio-Rad Laboratories Lyphochek® Coagulation Control (new device) and its substantial equivalence to a predicate device. The information focuses on the device's characteristics and stability, rather than a clinical study evaluating its performance against specific acceptance criteria for a diagnostic algorithm.
Therefore, the requested information elements related to a study proving the device meets acceptance criteria cannot be fully extracted from this document in the typical sense of an AI/ML device study. However, I can interpret "acceptance criteria" here as the performance specifications the manufacturer claims for the device based on their internal testing (stability studies).
Here's an analysis based on the provided text, addressing the points where information is available and noting when it's not applicable to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Open Vial Stability (Reconstituted state) | All analytes stable for 24 hours when stored tightly capped at 2-8°C |
| Shelf Life (Unopened, Lyophilized state) | Two years when stored at 2-8°C |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "Stability studies" being performed. This implies internal testing of the manufactured control lots.
- Data Provenance: The studies were performed internally by Bio-Rad Laboratories. The data would be considered prospective for the specific lots tested during the stability studies, but not a "test set" in the context of an AI/ML algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This is not applicable to this type of device. The Lyphochek® Coagulation Control is a quality control material, not a diagnostic device that requires expert interpretation or ground truth establishment in a clinical study setting. The performance is determined by instrumental measurements according to known scientific principles in a laboratory setting.
4. Adjudication Method for the Test Set
- This is not applicable to this type of device. Adjudication methods are relevant for subjective interpretations (e.g., image reading) or complex diagnostic outcomes where multiple experts might disagree.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for comparing the effectiveness of human readers (with vs. without AI assistance) in diagnostic tasks, which is not the function of a coagulation control material.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. The device is a quality control material and does not involve an algorithm that performs a diagnostic task independently.
7. Type of Ground Truth Used
- The "ground truth" for the performance of this control material is based on established analytical methods for coagulation assays (Prothrombin Time, aPTT, Fibrinogen, Antithrombin III, Thrombin Time). The expected values and stability are determined through rigorous laboratory testing using calibrated instruments and reference methods, not expert consensus, pathology, or outcomes data in the usual sense for a diagnostic device.
8. Sample Size for the Training Set
- Not applicable. This device does not use an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device does not use an AI/ML algorithm.
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(71 days)
LYPHOCHEK COAGULATION CONTROL
Lyphochek Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.
Lyphochek Coagulation Control is prepared from human plasma with added constituents of non-human origin and purified biochemicals. The control is provided in lyophilized form for increased stability.
The provided text is a 510(k) summary for a medical device called "Lyphochek Coagulation Control." This document describes a quality control product used to monitor the precision of coagulation systems, not a diagnostic or AI-powered device.
Therefore, the information requested in your prompt (such as acceptance criteria, details of a study on device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable to this type of document or device.
The document focuses on demonstrating substantial equivalence to a predicate device based on intended use, form, matrix, storage, open vial stability, and assay claims, which are typical for a quality control product submission.
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