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LIGAND PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and therapeutic drugs as listed in this package insert.

LIGAND PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert. Human origin components are added to a human serum based matrix. The product contains <0.1% sodium azide. This product will be offered as an assayed or unassayed three level control.

The provided text describes a 510(k) premarket notification for a medical device called "LIGAND PLUS CONTROL." This document aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, "IMMUNOASSAY PLUS CONTROL."

However, it's important to note that the document does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the way that would typically be presented for image-based diagnostic AI, for example. Instead, it focuses on demonstrating substantial equivalence by comparing technical characteristics, intended use, and manufacturing processes to a predicate device.

Therefore, many of the requested sections (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission for a quality control material.

I will fill in the table and address the other points based on the available information.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for a medical device in a 510(k) submission, especially for a quality control material, primarily revolves around demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as the predicate. The performance is assessed by comparing its characteristics and intended use.

Table of Acceptance Criteria and Reported Device Performance (as inferred from substantial equivalence claims):

Note on "Acceptance Criteria" for this device: For a quality control material in a 510(k) submission focused on substantial equivalence to a predicate, the "acceptance criteria" are implicitly met if the device demonstrates comparable characteristics and performance to the predicate device. The submission does not provide explicit numerical performance targets (e.g., specific accuracy, precision, or bias limits) for the LIGAND PLUS CONTROL itself in the context of demonstrating its own effectiveness, but rather demonstrates its equivalence to a device already deemed safe and effective. The customer/end-user would then establish their own analyte assay criteria using this control.

Study Details

The provided text describes a 510(k) submission for substantial equivalence. This type of submission relies on comparisons to a predicate device rather than a comprehensive de novo performance study with the characteristics typically seen for diagnostic algorithms.

Here's an assessment based on the available information:

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

   • Test Set Sample Size: Not explicitly stated. The submission focuses on comparing the "Device Characteristic" features (Intended use, Matrix, Form, Analytes, Levels, Storage, Stability) of the proposed device against the predicate. This isn't a "test set" in the sense of a dataset to evaluate an algorithm's classification performance. Instead, it's a comparison of product specifications.
   • Data Provenance: Not specified. The data provided are product specifications and manufacturing targets, not clinical study results from specific countries.

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

   • Not applicable / Not provided. "Ground truth" in the context of expert consensus for a test set (like for an imaging algorithm) is not relevant for this type of device (quality control material) or submission type (substantial equivalence via characteristic comparison). The "truth" here is the established specifications and performance of the predicate device.

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

   • Not applicable / None. There's no "adjudication" in the sense of reconciling expert opinions on diagnoses. The comparison is based on objective product characteristics and intended use.

4. 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 a quality control material, not an AI diagnostic algorithm or an assist tool for human readers. Therefore, an MRMC study is not relevant and was not performed.

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

   • Not applicable. This device is a biochemical control, not an algorithm.

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

   • Product Specifications and Regulatory Precedent: The "ground truth" for this submission is effectively the established and accepted characteristics and performance of the predicate device, IMMUNOASSAY PLUS CONTROL, which has already received FDA clearance (K020237). The goal is to demonstrate the new device's equivalence to this established "truth." For the LIGAND PLUS CONTROL itself, "expected values" are manufacturing targets, and actual values are determined by the customer for assayed products.

7. The sample size for the training set:

   • Not applicable / Not provided. There is no "training set" as this is not an AI/ML algorithm.

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

   • Not applicable. See point 7.

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QUICKCHECK LIQUID CHEMISTRY CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze routine chemistry analytes as listed in this package insert.

QUICKCHECK LIQUID CHEMISTRY CONTROL is designed to monitor the performance of test procedures that analyze a number of routine chemistry analytes as listed in the package insert. This product will be offered as an assayed and unassayed control. In addition, the control is being expanded to three levels.

This document is a 510(k) Summary for a Quality Control Material (QCM), not a diagnostic or therapeutic medical device. Therefore, the typical acceptance criteria and study designs associated with clinical performance (like sensitivity, specificity, reader studies, etc.) do not directly apply.

Instead, the "acceptance criteria" for a QCM like QuickCheck Liquid Chemistry Control are primarily related to demonstrating substantial equivalence to an existing predicate device based on its intended use, technological characteristics, and safety and effectiveness for its purpose. The study involves a comparative analysis of these characteristics.

Let's break down the information based on your request, adapting it to the context of a QCM 510(k) submission:

Description of Acceptance Criteria and Study

The acceptance criteria for the QuickCheck Liquid Chemistry Control device are based on demonstrating its substantial equivalence to the predicate device, "QUICKCHECK UNASSAYED CHEMISTRY CONTROL, Levels 1 and 2." This equivalence is established by comparing key technological characteristics and intended use. The study demonstrates that the new device is as safe and effective as the predicate for its intended purpose of monitoring the performance of routine chemistry analytes.

1. Table of Acceptance Criteria and Reported Device Performance

Interpretation of "Performance" for a QCM: For a QCM, "performance" here refers to its suitability to serve its purpose (monitoring test procedures) and its inherent characteristics being comparable or improved in a way that doesn't raise new safety or effectiveness concerns. The key "performance" demonstrated is that the device is a quality control material with appropriate characteristics, and the differences (e.g., more analytes, more levels, assayed option) are not considered to diminish safety or effectiveness.

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

• Sample Size: Not applicable in the traditional sense of a clinical test set. The study involves a comparative analysis of the product's specifications and characteristics against a predicate device. It's about comparing the design and composition, not analyzing a sample of clinical cases.
• Data Provenance: The data comes from the specifications and characteristics of the proposed device (QuickCheck Liquid Chemistry Control) as manufactured by Consolidated Technologies, Inc. This is a prospective submission of a new product with its defined characteristics. The predicate device's characteristics are also documented specifications. The country of origin for the data is implicitly the USA, where Consolidated Technologies is located.

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

• Number of Experts: Not applicable. Ground truth as typically defined for diagnostic device performance (e.g., disease presence/absence) is not established for a QCM.
• Qualifications of Experts: Not applicable. The "ground truth" for a QCM's characteristics typically comes from internal manufacturing and quality control processes to establish its composition, stability, and target values.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no "test set" in the clinical sense requiring expert adjudication. The comparison is between documented specifications.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation devices where human reader performance is being evaluated with and without AI assistance. A Quality Control Material does not involve human interpretation or AI assistance in this manner.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This device is a physical material (control serum), not an algorithm or AI.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context refers to the defined specifications and characteristics of the Quality Control Material itself, as determined by the manufacturer through their development, manufacturing, and quality control processes. This includes the matrix, analytes present, stability, and target values or ranges (as provided to customers who request assayed product). For the purpose of substantial equivalence, the "ground truth" is that the device performs as a QCM consistent with its stated specifications and is comparable to the predicate.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. QCMs are not "trained" in the way AI algorithms are. Their "training" is analogous to the rigorous product development, formulation, and quality control that ensures consistent manufacturing and performance Lot-to-Lot.

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

• How Ground Truth for Training Set Was Established: Not applicable. As noted above, there isn't a "training set" in the AI sense. The establishment of "ground truth" (i.e., the reliable characteristics and performance of the QCM) is achieved through:
  • Manufacturing processes: Controlled formulation and production to ensure specific concentrations of analytes.
  • Analytical testing: In-house testing using validated methods to determine the actual values for analytes present (especially for assayed controls), stability studies, and assessment of physical properties.
  • Compliance with quality systems: Adherence to Good Manufacturing Practices (GMP) and ISO standards that govern the production and testing of in vitro diagnostic products to ensure consistency and reliability.

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IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and theraputic drugs as listed in this package insert.

IMMUNOASSAY PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert. Human origin components are added to a human serum based matrix. The product contains 0.1% sodium azide. IMMUNOASSAY PLUS CONTROL will be offered in three levels of 5.0 mL filled vials.

The provided text describes a 510(k) submission for a medical device called "IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3". This is a quality control material used to monitor the performance of immunoassay and therapeutic drug test procedures.

This document describes a substantial equivalence determination for a quality control material, not an AI/ML powered device. Therefore, many of the requested categories (such as human-in-the-loop performance, expert ground truth, adjudication methods, multi-reader multi-case studies, and training/test set details typically associated with AI/ML device studies) are not applicable or described in this type of submission.

The study described here is focused on demonstrating that the new control material (IMMUNOASSAY PLUS CONTROL) is substantially equivalent to a previously cleared predicate device (QUALITROL IMMUNOASSAY PLUS CONTROL) based on its intended use and physical properties.

Here's an attempt to fill in the table and answer the questions based on the provided text, noting where information is not applicable or not provided for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For this quality control material, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to the predicate device. The performance is assessed by comparing key characteristics.

Detailed Study Information (Based on availability in the text):

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: Not explicitly stated as a "test set" in the context of an algorithm's performance. For a quality control material, performance is demonstrated by characterizing the material itself against predicate characteristics and potentially through internal validation testing (stability, homogeneity, assigned values), but specific "sample sizes" for a clinical test set are not typically relevant or provided in this type of submission for a control.
• Data Provenance: Not specified. As a control material, the performance data would typically be generated by the manufacturer during product development and validation.

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)

• Not Applicable. For a quality control material, "ground truth" relates to the assigned values for the analytes within the control. These are established through rigorous testing and assay calibration, not expert consensus in the way an AI diagnostic device would. No experts are mentioned as establishing "ground truth" in the provided text.

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

• Not Applicable. Adjudication methods are relevant for ambiguous cases in diagnostic image interpretation or similar tasks; they do not apply to the characterization of a quality control material.

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 type of study (MRMC for human readers with/without AI assistance) is not applicable to a quality control material.

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

• Not Applicable. This is not an algorithmic device. Performance is inherent to the control material's composition and manufacturing.

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

• For quality control materials, the "ground truth" for the analytes within the control is established by assaying the material against highly calibrated reference methods or against established methods using qualified instruments and reagents. This generally involves internal lab testing and statistical methods to assign target values and ranges, rather than clinical outcomes, pathology, or expert consensus on a diagnostic finding.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device.

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