(14 days)
Liquichek Tumor Markers Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Liquichek Tumor Markers Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. This control is substantially equivalent to the following quality control material that is currently in the market: Lyphochek Tumor Markers Control Bio-Rad Laboratories Irvine, California 92618 510 (k) Number: K011579. The new device is in liquid form with a matrix of human and animal serum albumin, contains preservatives, has Level 1, 2 and 3, and has different storage and open vial claims compared to the predicate device. It also contains claims for a different set of analytes.
This document is a 510(k) premarket notification for the Bio-Rad Laboratories Liquichek Tumor Markers Control. The purpose of a 510(k) is to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study" described here are focused on establishing substantial equivalence rather than traditional performance metrics like sensitivity, specificity, or AUC as might be seen for a diagnostic or AI device.
1. A table of acceptance criteria and the reported device performance
The core "acceptance criteria" for a 510(k) in this context is demonstrating substantial equivalence to a predicate device. This is achieved by comparing characteristics and showing that any differences do not raise new questions of safety or effectiveness. The "reported device performance" primarily refers to stability studies supporting the product claims.
| Acceptance Criteria (Demonstrates Substantial Equivalence) | Reported Device Performance (Supporting Substantial Equivalence) |
|---|---|
| Intended Use: Match the predicate device's intended use. | Both the Liquichek Tumor Markers Control (new device) and Lyphochek Tumor Markers Control (predicate) are intended as assayed quality control materials to monitor the precision of laboratory testing procedures for listed analytes. |
| Similarities: Identify key characteristics that are the same as the predicate. | Similarities stated: Identical intended use. |
| Differences: Identify differences from the predicate and provide data or justifications that these differences do not raise new safety or effectiveness concerns. | Differences identified: |
- Form: Liquid (new) vs. Lyophilized (predicate)
- Matrix: Human and animal serum albumin (new) vs. Human serum (predicate)
- Levels: Level 1, 2, and 3 (new) vs. Level 1 and 2 (predicate)
- Preservatives: Contains preservatives (new) vs. Does not contain preservatives (predicate)
- Storage (Unopened): -20°C to -70°C, until expiration date (new) vs. 2°C to 8°C, until expiration date (predicate)
- Open Vial Claim / After reconstitution: All analytes 30 days at 2-8°C (exception: IGF-1 15 days) (new) vs. All analytes 14 days at 2-8°C (various exceptions) (predicate)
- After reconstituting and freezing: No claims (new) vs. 30 days at -10 to -20°C (predicate)
- Analytes: Some differences in the specific list of claimed analytes (new device contains claims for some analytes not in predicate and vice versa). |
| Stability: Support claims for shelf life and open vial stability with relevant studies. | Stability Studies Performed: - Open Vial Stability: All analytes stable for 30 days at 2-8℃, except IGF-1 (15 days).
- Shelf Life: 2 Years at -20°C to -70°C. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document is for a quality control material and does not involve a "test set" in the sense of clinical samples for a diagnostic or AI device. The "study" mentioned refers to stability studies of the control material itself.
- Sample size for stability studies: Not explicitly stated in this summary. It mentions "Stability studies have been performed," implying internal testing of the control material batches.
- Data provenance: Not explicitly stated, but it's internal Bio-Rad Laboratories data. Given the address, it's likely originating from Irvine, California, USA.
- Retrospective or prospective: Stability studies are inherently prospective, following the material over time under defined conditions.
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. This is a quality control material, not a diagnostic device requiring expert interpretation of clinical data to establish a ground truth. The "ground truth" for a QC material is its established analyte concentrations and stability profiles.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no clinical test set requiring adjudication in this submission.
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 a quality control material, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a quality control material, not an algorithm/AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a quality control material, the "ground truth" is established through:
- Assigned Values/Target Concentrations: These are determined by the manufacturer through rigorous analytical testing using reference methods and/or highly characterized calibrators.
- Stability Profiles: Determined by real-time and accelerated stability studies under various storage and usage conditions, measuring changes in analyte concentrations over time.
8. The sample size for the training set
Not applicable. This is a quality control material, not an AI device trained on a dataset.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/algorithm is involved.
§ 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.