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• HemosIL LA Positive Control .
  For use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].

The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.

• . HemosIL LA Negative Control
  For use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].

The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.

• . HemosIL LA Positive Control
  The LA Positive Control is a lyophilized preparation from human donors exhibiting the presence of anti-phospholipid antibodies with added buffer, which has been determined to be positive for LA in accordance with the Guidelines from ISTH1.

The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.

• HemosIL LA Negative Control
  The LA Negative Control is a lyophilized preparation using human citrated platelet-poor plasma to make a Pooled Normal Plasma with added buffer. The guidelines from ISTH', recommends a plateletpoor plasma as a negative control for Lupus Anticoagulant (LA).

The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.

The provided text describes a 510(k) summary for the HemosIL LA Positive Control and HemosIL LA Negative Control devices. These devices are quality controls for Lupus Anticoagulant (LA) assays performed on specific IL Coagulation Systems. The study presented aims to demonstrate the precision of these control devices.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Note: The "Conclusion" section explicitly states: "All results were well within specification for both lots of controls tested." The tables provided show detailed CV% values, all of which are below 6% for both within-run and total precision across various instruments and reagents.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: N=80 (2 replicates per run / 2 runs per day / 20 days) for each of two lots of each control level, with two different LA assays per instrument platform.
• Data Provenance: The document does not specify the country of origin of the data. It is a prospective study as it describes a specific experimental protocol for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This study is evaluating the precision of quality control materials for an in-vitro diagnostic device, not an interpretation of images or clinical data by experts. Therefore, the concept of "ground truth established by experts" as typically understood in AI/medical imaging does not directly apply here. The "ground truth" for these controls is their expected value (positive or negative for LA) and their performance characteristics against established quality standards (precision).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is described as this is a laboratory assay precision study, not a study involving human interpretation with potential discrepancies.

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. This is not an MRMC comparative effectiveness study. It's a precision study for diagnostic controls.

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

Yes, this is a standalone performance study. The devices (quality controls) are tested on automated coagulation systems. There is no human interpretation or "human-in-the-loop" component being evaluated beyond the inherent operation of the lab instruments.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for these controls is their known characteristics:

• HemosIL LA Positive Control: Lyophilized preparation from human donors exhibiting the presence of anti-phospholipid antibodies, confirmed positive for LA according to ISTH Guidelines.
• HemosIL LA Negative Control: Lyophilized preparation using human citrated platelet-poor plasma to make a Pooled Normal Plasma, recommended as a negative control for LA by ISTH Guidelines.

The performance of the controls is then measured against a precision specification (≤ 6% CV).

8. The sample size for the training set

This document does not describe the development of an algorithm or AI. It describes the performance evaluation of quality control materials. Therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

As there is no training set for an algorithm, this question is not applicable. The "ground truth" for the controls themselves (their positive or negative status) is established by their formulation and adherence to established guidelines (ISTH).

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PlasmaCon N is a human lyophilized plasma control intended for use as a normal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.

PlasmaCon L-1 is a human lyophilized plasma control intended for use as a mid-level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.

PlasmaCon L-2 is a human lyophilized plasma control intended for use as a high level abnormal control with citrated plasma to monitor the performance of the Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) tests.

The PlasmaCon Control Plasma devices contain lyophilized citrated human plasma, for use in the verification of system performance for PT and aPTT assays.

Here's a breakdown of the acceptance criteria and study information for the PlasmaCon N, PlasmaCon L-1, and PlasmaCon L-2 devices, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of the tendsma for LA detection carried out with the following tests: STA® -Staclor® dRVV Screen (#00339 & #00333) STA® -Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)

The STA® - Control LA 1+2 kit provides a lupus anticoagulant (LA) negative plasma and a LA positive plasma. These plasmas are intended for the quality control of LA testing using the following kits: STA® - Staclot® dRVV Screen (#00339 & 00333) STA® - Staclot® dRVV Confirm (#00334) Staclot® LA (#00600, 00594)

The provided text is a 510(k) summary for a control plasma device (STA® - Control LA 1+2), not a diagnostic algorithm or AI-powered device. Therefore, much of the requested information (like AI performance metrics, training/test sets, expert adjudication, MRMC studies) is not applicable to this submission.

However, I can extract the relevant information regarding the device's intended use and the general nature of its "performance" as a control product.

Device: STA® - Control LA 1+2 (Lupus Control Plasmas)

1. A table of acceptance criteria and the reported device performance

For a control plasma, the "acceptance criteria" generally involve demonstrating that the control material performs as expected (LA positive and LA negative) when tested with the specified diagnostic assays and that it is substantially equivalent to a predicate device. The performance is typically assessed by its reactivity in the target assays.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. For a control material, "test set" would typically refer to the various batches of the control manufactured and tested, or the number of runs/analyses performed to establish its characteristics and lot-to-lot consistency. The summary does not disclose the specifics of these studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. This device is a control material for laboratory tests, not a diagnostic or AI algorithm requiring expert adjudication of ground truth for patient data. Its "ground truth" is defined by its known formulation (LA positive vs. LA negative) and its reactivity with specific diagnostic assays.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. As explained above, this device does not involve human interpretation of medical images or data that would necessitate an adjudication method for a test set.

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

This information is not applicable and not provided. This is not an AI-powered device or a diagnostic tool that involves human readers.

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

This information is not applicable and not provided. This device is a control material, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this control device, the "ground truth" is its known composition as either LA-positive or LA-negative plasma, and its established reactivity when tested with specific Lupus Anticoagulant detection kits. It is a manufactured reagent designed to elicit a specific, known response.

8. The sample size for the training set

This information is not applicable and not provided. This device is a manufactured control plasma, not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided. As above, there is no "training set" for this product in the AI context.

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CryoCheck Weak Lupus Positive Control is prepared from human source plasma and is recommended for use as a positive control in assays for lupus anticoagulant.

CryoCheck Weak Lupus Positive Control contains citrated human plasma collected from donors that have tested positive in accordance with the revised criteria of the SSC Subcommittee for the Standardization of Lupus Anticoagulants. Source plasmas are processed in a manner that yields platelet-poor plasmas. Plasma is then buffered, aliquoted and rapidly frozen.

The provided text describes a 510(k) premarket notification for a medical device called "CryoCheck Weak Lupus Positive Control." The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for the new device. Therefore, many of the requested sections regarding a study cannot be directly extracted as such a study with detailed performance metrics is not included.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document. The document's purpose is to establish substantial equivalence, not to demonstrate performance against specific quantitative acceptance criteria for the new device itself. The "performance" described is in terms of its characteristics being similar to the predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided. The document does not describe a clinical study or a test set in the traditional sense for evaluating the new device's performance. It states that the device "contains citrated human plasma collected from donors that have tested positive in accordance with the revised criteria of the SSC Subcommittee for the Standardization of Lupus Anticoagulants." This indicates the source material, but not a separate "test set" for performance evaluation, nor its provenance details.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. As there's no described "test set" for performance evaluation, there's no mention of experts establishing ground truth for such a set. The "ground truth" for the source plasma is implicitly the results of the tests performed on the donors to determine their lupus anticoagulant status, following the SSC Subcommittee's criteria.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided. There is no described test set or adjudication method.

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

This information is not applicable/not provided. The device is a "Lupus Positive Control" (a biological reagent), not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study or AI assistance is not relevant to this device.

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

This information is not applicable/not provided. The device is a biological control, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the source plasma used in the device is based on "donors that have tested positive in accordance with the revised criteria of the SSC Subcommittee for the Standardization of Lupus Anticoagulants." This implies a set of established laboratory test results and clinical criteria for diagnosing lupus anticoagulant status.

8. The sample size for the training set

This information is not provided. The concept of a "training set" as understood in machine learning/AI is not applicable to this biological control device.

9. How the ground truth for the training set was established

This information is not provided. As above, the concept of a training set is not applicable. The "ground truth" for the source material refers to the diagnostic criteria for lupus anticoagulants used to select the plasma donors.

Summary of Device and Substantial Equivalence Claim:

The "CryoCheck Weak Lupus Positive Control" is a biological control designed for use in assays for lupus anticoagulant. It is composed of citrated human plasma from donors who have tested positive for lupus anticoagulant according to specific scientific guidelines (SSC Subcommittee criteria). The manufacturer, Precision BioLogic Inc., is seeking 510(k) clearance by demonstrating substantial equivalence to their previously cleared device, the "CryoCheck Lupus Positive Control (K952623)."

The claim of substantial equivalence is based on the following similarities:

• Intended Use: Both devices are recommended as positive controls in assays for lupus anticoagulant.
• Matrix: Both consist of citrated human plasma from donors testing positive for lupus anticoagulant based on the same SSC Subcommittee criteria.
• Format: Both are provided in a frozen format.
• Volume: Both are available in 0.5 mL and 1.0 mL vial sizes.

The FDA reviewed these similarities and concluded that the new device is substantially equivalent to the predicate device. This means that the new device does not require new efficacy or performance studies to prove its safety and effectiveness, as its characteristics are considered sufficiently similar to an already approved device. The regulatory approval is for the device itself as a control material, not for a diagnostic test utilizing the control, nor an AI algorithm.

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Control Plasma P is assayed for use as an accuracy control of the following parameters in the pathological range: Prothrombin time (PT); Activated partial thromboplastin time (aPTT); Fibrinogen (Clauss method); Coagulation factors II, V, VII, VIII, VWf, IX, X, XI, XII and XIII*; Inhibitors: Antithrombin III, Protein C, Protein S, a2-antiplasmin, C, inhibitor*; Total complement activity*, Plasminogen. (* Not available in the U.S.)

Control Plasma P is a lyophilized control prepared from pooled human plasma, adjusted to defined factor concentrations, and then stabilized with HEPES buffer solution. It is an assayed control intended to monitor and evaluate the accuracy and precision of coagulation and fibrinolysis tests in the pathological ranqe.

The Dade Behring Inc. Control Plasma P is a lyophilized control prepared from pooled human plasma, intended to monitor and evaluate the accuracy and precision of coagulation and fibrinolysis tests in the pathological range.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: The document states "In duplicate determinations," which indicates that the stability tests were performed at least twice for each condition. However, a specific numerical sample size (e.g., number of vials, number of lots) beyond "duplicate determinations" is not provided.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. It is a submission for a 510(k) modification, implying that the data was generated specifically for this regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable to this type of device and study. The "ground truth" for a control plasma in this context refers to the assigned values or defined factor concentrations of the control and the expected performance within a specified range. These are established through manufacturing processes, analytical methods, and internal quality control, not by expert consensus readings of an outcome.

4. Adjudication method for the test set:

• This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., imaging studies) where there might be disagreement in expert opinions. For a quantitative test like a control plasma, the determination of whether the device "recovers within the assigned values" is an objective, analytical measurement.

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:

• This information is not applicable. The Control Plasma P is an in-vitro diagnostic (IVD) control material, not an AI-powered diagnostic tool, nor does it involve human readers in the context of interpretation. Therefore, an MRMC study or assessment of AI assistance is irrelevant.

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

• This question is not applicable for this device. The Control Plasma P is a reagent (control material), not an algorithm or an automated diagnostic system that performs a standalone analysis. Its "performance" is its stability and its ability to consistently yield specific assay values when tested on laboratory instruments.

7. The type of ground truth used:

• The ground truth used for this device is based on assigned values/defined factor concentrations of the control plasma. The document states it is "adjusted to defined factor concentrations" and the performance criteria involve "recovering within the assigned values." This refers to the pre-established, analytically determined target values for the various coagulation and fibrinolysis parameters. These values are typically derived through extensive characterization during product development and manufacturing.

8. The sample size for the training set:

• This information is not applicable as the Control Plasma P is not an AI/machine learning model that requires a training set. Its "development" involves chemical and biological formulation, stabilization, and analytical characterization rather than algorithmic training.

9. How the ground truth for the training set was established:

• This information is not applicable for the same reasons as #8.

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Lyphochek® Hemostasis Control is intended for use as a quality control plasma to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Lyphochek® Hemostasis Control is prepared from human plasma with added purified biochemicals and preservatives. The control is provided in lyophilized form for increased stability.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document describes stability studies as the performance data. Regulatory filings for this type of product often focus on demonstrating that the control material remains stable and performs as expected over time, showing "precision" in monitoring laboratory tests. The acceptance criteria aren't explicitly stated as numerical targets in a table, but rather implied through the successful completion of these stability studies to support specific product claims.

Study Information

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated. The document mentions "stability studies have been performed," but does not provide details on the number of control units tested, or the frequency/duration of testing within the stated stability periods.
• Data Provenance: Not explicitly stated, though it would be from the manufacturer's (Bio-Rad Laboratories) internal testing as implied by "All supporting data is retained on file at Bio-Rad Laboratories." The country of origin of the data is therefore likely USA. The studies are prospective in nature, as they are establishing future shelf-life and reconstituted stability claims.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This type of study (stability testing of a quality control plasma) does not typically involve human expert adjudication in the same way an image analysis device would. The "ground truth" is established through analytical methods in a laboratory setting, comparing results from the control material to established reference values or predicate device performance. Therefore, no "experts" in the sense of clinicians or radiologists are involved in establishing ground truth for individual data points from the test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert opinion, typically in diagnostic or screening scenarios. For a quality control product's stability study, performance is measured against established analytical methods and specifications, not subjective expert reviews.

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:

• Not applicable. This device is a quality control plasma, not an AI diagnostic or assistance tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

• Not applicable. This device is a laboratory reagent (control plasma) and does not involve an algorithm. Its "performance" is its ability to provide consistent and accurate results when used in laboratory instruments to monitor the precision of other assays.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for evaluating the stability and performance of the Lyphochek® Hemostasis Control would be analytical reference values and established performance characteristics of the analytes within the plasma. This means that at specified time points, the levels of PT, APTT, Fibrinogen, etc., are measured using validated laboratory methods, and these measurements are compared against the expected values and acceptable ranges determined during product development and characterization, often with reference to predicate devices.

8. The sample size for the training set:

• Not applicable. This device is a physical control material, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithm development. Product development and characterization would involve extensive testing, but this is distinct from training a model.

9. How the ground truth for the training set was established:

• Not applicable, as there is no training set for this type of device.

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Sigma Diagnostics ACCUCLOT™ LA Control is a human plasma control that is suitable for use as a positive control for lupus anticoagulant testing such as activated partial prothrombin time (APTT) and dilute Russell's viper venom time (dRVVT). Plasma controls are routinely used in the coagulation laboratory as a means of quality control.

Sigma Diagnostics ACCUTROL™ LA Control is a lyophilized human plasma based product. After reconstitution with water, ACCUTROL™ LA Control is stable for 48 hours when stored at 2-8°C and 4 weeks when stored at -20°C.

This submission focuses on a control material used for in-vitro diagnostic tests, rather than an AI/ML device that would typically generate performance metrics like sensitivity, specificity, or AUC. Therefore, many of the requested categories (e.g., sample size for test sets, number of experts, MRMC studies) are not applicable in this context.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for specific test sets. The submission relies on demonstrating substantial equivalence to a predicate device, which implies that the performance characteristics were compared against established parameters of the predicate, rather than an independent "test set" in the context of an AI/ML diagnostic.
• Data Provenance: Not specified. As a human plasma control, the source of the plasma itself (e.g., country of origin) is not detailed in the provided summary. The data presented is for the characterization of the control material (stability, intended use) to demonstrate equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable as this is a control material for in-vitro diagnostic tests, not a device requiring expert interpretation for ground truth establishment. The effectiveness is determined by its behavior as a control in laboratory assays, which have their own established validation procedures.

4. Adjudication method for the test set

• Not applicable for the reasons stated above.

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

• Not applicable. This is an in-vitro diagnostic control material, not an AI/ML diagnostic tool.

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

• Not applicable. This is an in-vitro diagnostic control material.

7. The type of ground truth used

• The "ground truth" for this device is its performance characteristics as a control material, primarily its ability to mimic a positive sample for lupus anticoagulant testing and its stability. This is established through laboratory experiments and comparison to a legally marketed predicate device with established performance. The "ground truth" here refers to the expected behavior and stability of the control plasma itself, not a diagnosis for a patient.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, and therefore does not have a "training set" in that conventional sense. The product development would involve manufacturing and quality control batches, but these are not analogous to training data for an algorithm.

9. How the ground truth for the training set was established

• Not applicable for the reasons stated above.

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As a consistent test sample of known concentration for monitoring the performance of D-Dimer immunoturbidimetric assays.

Not Found

This is an FDA K-number document. The information provided does not include the details to fill out the table of acceptance criteria and the study that proves the device meets the acceptance criteria. This document primarily focuses on the FDA's decision regarding the substantial equivalence of the K-ASSAY D-Dimer Controls to a legally marketed predicate device, allowing it to proceed to market.

Here's why the requested information cannot be extracted from this document:

• Acceptance Criteria and Reported Device Performance: This document states the device is being cleared for marketing based on substantial equivalence. It does not contain details about specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) or the acceptance criteria established for those metrics. These would typically be found in the actual 510(k) submission, which is not fully provided here.
• Study Details (Sample size, data provenance, expert ground truth, adjudication, MRMC, Standalone, Ground Truth type, Training set info): The document summarizes the regulatory decision. It doesn't present the detailed study design, results, or methodologies (like sample sizes, experts, adjudication, or training data) that would be part of the technical data submitted by the manufacturer to the FDA. The "K012422" is the submission number, not a report of the study details itself.

In summary, this document is a regulatory approval letter, not a scientific study report describing the performance evaluation of the device.

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