(13 days)
Lyphochek Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Lyphochek Immunoassay Plus Control is prepared from human serum, with added constituents of human origin, pure chemicals and therapeutic drugs. The control is provided in lyophilized form for increased stability.
This 510(k) submission (K981532) for the Lyphochek Immunoassay Plus Control does not contain a detailed study with acceptance criteria and device performance results in the way a typical medical device algorithm or diagnostic test submission might. Instead, it is a submission for a quality control material, and its clearance is based on demonstrating substantial equivalence to a previously cleared device.
Therefore, many of the requested elements of your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or would not be found in this type of submission.
Here's an analysis based on the provided text, focusing on what is available and explaining why other elements are not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" and "reported device performance" in the typical sense of a diagnostic test (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is claimed based on the characteristics and intended use being the same as the predicate device, with added analytes.
| Feature/Characteristic | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as demonstrated by comparison) |
|---|---|---|
| Intended Use | "An assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert." (Identical to predicate) | Met, as the new device shares the same intended use. |
| Form | Lyophilized (Identical to predicate) | Met. |
| Matrix | Human Serum (Identical to predicate) | Met. |
| Storage | 2-8°C (Identical to predicate) | Met. |
| Reconstituted Stability Claim | 7 days at 2-8°C (with specific exceptions for C-Peptide, Folate, PSA, ACTH, Calcitonin, Gastrin) (Identical to predicate) | Met. |
| Added Analytes | Product has added claims for Total Estrogens, Flecainide, IgA, IgG, IgM, Iron, TIBC, Netilmicin, SHBG. (This is a difference from the predicate, but implicitly accepted as an improvement/addition without altering fundamental safety or effectiveness for the control material). | Demonstrated these analytes can be measured by the control material, aligning with its role as a quality control. (Specific performance data for these added analytes is not provided in this summary but would be part of the full submission's justification for equivalence). |
Explanation: For a quality control material, the "performance" is its ability to consistently provide known values for various analytes, allowing laboratories to monitor the precision of their assays. The substantial equivalence argument relies on the new device having equivalent formulation, stability, and intended use to a previously cleared control, with the addition of more analytes being an expansion of utility rather than a change in fundamental function.
2. Sample size used for the test set and the data provenance
- Not Applicable in this summary. This document is a 510(k) summary for a quality control material, not a diagnostic test that measures patient samples. Therefore, there is no "test set" of patient data in the conventional sense. The "testing" involved would typically be characterization of the control material (e.g., lot-to-lot consistency, stability studies, assigned values) rather than a clinical accuracy study. Data provenance would relate to manufacturing and internal validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As there is no "test set" of clinical samples with a "ground truth" to be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set or adjudication process is described.
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 material, not an AI-powered diagnostic tool, and involves no human "readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Implied by product type. For a quality control material, the "truth" is established by precise laboratory measurements using reference methods and/or expert assignments, which define the expected ranges for the analytes within the control. This is intrinsic to the manufacturing and characterization of the control itself and not an external "ground truth" established for a separate test set.
8. The sample size for the training set
- Not Applicable. Quality control materials do not use "training sets" in the context of machine learning. The "training" in this context would refer to internal validation and manufacturing processes to ensure the control material performs as expected.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.