(34 days)
Abbott Tumor Marker – MCC (Lyophilized) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Abbott Tumor Marker - MCC (Lyophilized) is prepared from human serum with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability
The provided document is a Premarket Notification (510(k)) for the Abbott Tumor Marker - MCC (Lyophilized). It describes a quality control serum, not a diagnostic device with performance metrics typical of AI/ML or medical imaging studies. Therefore, many of the requested categories (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not applicable (N/A) to this type of submission.
Here's the information that can be extracted and a clear indication of N/A for the others:
Acceptance Criteria and Device Performance for Abbott Tumor Marker - MCC (Lyophilized)
This submission focuses on establishing substantial equivalence for a quality control serum, primarily by demonstrating its stability. The "acceptance criteria" here relate to the duration of stability under different storage and use conditions.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Claimed Stability) | Reported Device Performance (Summary of Performance Data) |
|---|---|---|
| Open Vial Stability | All analytes stable for 14 days at 2-8°C (tightly capped), except Free PSA and PSA (should be assayed immediately after reconstitution). | Met the claimed stability: "Once the control is reconstituted, all analytes will be stable for 14 days when stored tightly capped at 2 - 8℃, with the following exceptions: Free PSA and PSA should be assayed immediately following reconstitution." |
| Reconstituted Frozen Stability | All analytes stable for 30 days at -10°C to -20°C (tightly capped/frozen). Once thawed, do not refreeze. | Met the claimed stability: "After reconstituting and freezing the control, all analytes will be stable for 30 days when stored tightly capped at -10℃ to -20℃. Once thawed, do not refreeze the control; discard remaining material." (Improved from predicate device's 20 days for PSA). |
| Unopened Shelf Life | Stable for 3 years and 3 months when stored unopened at 2-8°C. | Met the claimed stability: "The control is stable for 3 years and 3 months when stored unopened at 2 - 8℃." Note: "Real time studies will be ongoing to support the shelf life of this product." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in terms of number of individual samples, but refers to "stability studies" performed on the control product itself. This is typical for quality control product validation, where samples are tested at various time points and conditions.
- Data Provenance: Not specified, but generally, such studies for device premarket notifications are conducted internally by the manufacturer (Bio-Rad Laboratories in this case) under controlled laboratory conditions, likely in the US as the submission is to the FDA. Retrospective/prospective is not applicable in the context of stability testing (it's a prospective design to observe changes over time).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. Ground truth in this context is not established by human experts interpreting data. Instead, it's determined by analytical testing methods to assess the analyte concentrations and their stability within the control material, measured against established reference values or specifications for the manufacturing process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication is not relevant for stability studies of a quality control product. The "truth" is determined by direct analytical measurement and statistical evaluation of stability data.
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
- N/A. This is not an AI/ML diagnostic device, and thus no MRMC study with human readers or AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. Not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is its measured stability characteristics (e.g., analyte concentrations remaining within acceptable ranges, physical properties unchanged) over time and under specified storage/use conditions, as determined by laboratory analytical methods. It's an internal QC/assay performance metric, not a clinical ground truth.
8. The sample size for the training set
- N/A. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- N/A. Not an AI/ML device.
§ 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.