(88 days)
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
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):
| Acceptance Criterion (Inferred from Substantial Equivalence Basis) | Reported Device Performance (LIGAND PLUS CONTROL) |
|---|---|
| Intended Use Equivalence: Monitor performance of routine chemistry test procedures. | Assayed or unassayed quality control for monitoring performance of routine chemistry test procedures. (Matches Predicate) |
| Matrix Equivalence: Processed Human Serum. | Processed Human Serum. (Matches Predicate) |
| Form Equivalence: Lyophilized. | Lyophilized. (Matches Predicate) |
| Number of Levels Equivalence: Three (3) Levels. | Three (3) Levels. (Matches Predicate) |
| Storage Equivalence: 2 °C to 8 °C. | 2 °C to 8 °C. (Matches Predicate) |
| Stability Equivalence: Until expiration date noted on vial label. | Until expiration date noted on vial label. (Matches Predicate) |
| Analyte Content (Functional Equivalence): Capable of monitoring clinically significant analytes. | Contains 55 analytes of clinical significance. (Comparable to Predicate's 59 analytes, implying similar function) |
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:
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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.
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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.
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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.
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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.
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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.
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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.
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The sample size for the training set:
- Not applicable / Not provided. There is no "training set" as this is not an AI/ML algorithm.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.