(37 days)
Abbott Lyophilized Assayed Chemistry Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet.
Not Found
The provided text is a 510(k) clearance letter from the FDA for an "Abbott Lyophilized Assayed Chemistry Control" device. This document primarily focuses on regulatory clearance based on substantial equivalence to a predicate device, rather than presenting detailed study results or acceptance criteria for device performance.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not available in the provided text. The document does not describe a study that "proves the device meets the acceptance criteria" in terms of clinical or technical performance metrics.
However, I can extract what is implicitly stated about the device's intended use and regulatory status.
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state numerical acceptance criteria or reported device performance data. The clearance is based on the device being "substantially equivalent" to a legally marketed predicate device. The general "acceptance criteria" here implicitly refer to meeting the regulatory requirements for substantial equivalence.
| Acceptance Criteria Category | Reported Device Performance (Implicit/Stated in document) |
|---|---|
| Intended Use | For use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the value sheet. |
| Safety and Effectiveness | Determined to be "substantially equivalent" to legally marketed predicate devices, implying it meets established safety and effectiveness profiles for similar devices. |
| Compliance | Expected to comply with general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Compliance with Current Good Manufacturing Practice requirements (21 CFR Part 820) is assumed. |
| CLIA Complexity Categorization | May require a CLIA complexity categorization (to be determined by contacting CDC). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available. The document does not describe any specific test set or clinical study data.
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 available. The document does not describe the establishment of ground truth by experts for a test set. The substantial equivalence determination is made by the FDA based on the submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not available. There is no described test set or adjudication method.
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 chemistry control, not an imaging or diagnostic device typically evaluated with MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a chemistry control. It is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not available/Applicable in traditional sense. For a chemistry control, "ground truth" generally refers to the certified or assigned values for the analytes within the control material, established through rigorous analytical methods and calibration traceable to recognized standards. The document does not detail how these values were established, only that the device has "analytes listed in the value sheet."
8. The sample size for the training set:
- Not applicable. This device is a chemistry control, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is a chemistry control, not a machine learning model.
§ 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.