(27 days)
For in vitro diagnostic use in the control of ADVIA 1650 Chemistry system for certain chemistry methods.
The Bayer Special Chemistry Controls are two separate levels of quality control material prepared from human serum with nonserum constituents added. All the analytes currently in the calibrator and control material are: Acid Phosphatase Lactate Pancreatic Amylase Lipase The intention of this submission is to add the assigned values to the labeling claims for: Pancreatic Amylase Lipase
The provided text is a 510(k) summary for the Bayer ADVIA 1650 Special Chemistry Control. It primarily focuses on demonstrating substantial equivalence to a predicate device for the addition of two new analytes (Pancreatic Amylase and Lipase) to the control's labeling claims.
The document does not describe a study that proves the device meets acceptance criteria in the way this request asks. It's a regulatory submission for a quality control material, not a diagnostic or therapeutic device undergoing performance validation with a test set, ground truth established by experts, or MRMC studies.
Therefore, many of the requested sections cannot be filled as they are explicitly not present or applicable to this type of submission.
Here's a breakdown based on the information provided and what is missing/not applicable:
Acceptance Criteria and Reported Device Performance
The document does not detail specific acceptance criteria (e.g., accuracy, precision targets) for the new analytes themselves, nor does it present device performance data against such criteria in the format requested. The "performance" described is the establishment of assigned values for the new analytes within the control material, rather than the performance of the control material in detecting specific conditions.
| Acceptance Criteria (Not Explicitly Stated for Performance) | Reported Device Performance (Implied) |
|---|---|
| Specific acceptance criteria for the performance of Pancreatic Amylase and Lipase as analytes within the quality control material are NOT explicitly stated in the provided text. The document focuses on demonstrating that the control material itself is substantially equivalent to a predicate device and that assigned values for these new analytes will be added to the labeling. | The document implies that assigned values for Pancreatic Amylase and Lipase have been established for the control material. The stated intention is "to add the assigned values to the labeling claims for: Pancreatic Amylase Lipase." This suggests that the values have been determined and meet internal quality standards for a control material. |
Study Information (Applicability for this device is limited)
Given that this is a quality control material and not a diagnostic or therapeutic device, many of the requested study parameters are not relevant or described in the provided 510(k) summary. The submission is a demonstration of "substantial equivalence" for adding new analytes to an existing control material.
1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: The document does not describe a "test set" in the context of clinical performance evaluation of a diagnostic device. It discusses controlling the precision and accuracy of chemistry test procedures, implying internal validation of the control material's stability and assigned values.
2. 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/Not Provided: Ground truth in the context of clinical expert review is not relevant for a quality control material submission.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: No adjudication method is described as there is no "test set" in this context.
4. 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/Not Provided: This type of study is entirely irrelevant for a chemistry quality control material. There are no "human readers" or "AI assistance" involved.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided: This is not an algorithm-based device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implicit for Training/Characterization, Not for a "Test Set": For a quality control material, the "ground truth" for the analytes (Pancreatic Amylase and Lipase) would be established through highly accurate and precise reference methods or certified reference materials, typically in a laboratory setting, to assign the target values for the control. The document states "assigned values," implying such a characterization was performed.
7. The sample size for the training set
- Not Applicable/Not Provided: The concept of a "training set" in the machine learning sense is not applicable here. The control material itself is characterized, not "trained."
8. How the ground truth for the training set was established
- Not Applicable/Not Provided (but implied for value assignment): As mentioned in point 6, the "ground truth" (assigned values) for the control material's analytes would be established through laboratory characterization using validated reference methods.
§ 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.