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510(k) Data Aggregation
(56 days)
An Abbott Clinical Chemistry Calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
Abbott Clinical Chemistry Calibrators were used for the calibration of each clinical chemistry reagent on the ALCYON 300/300i. The calibration curve generated was used for the quantitation of each analyte for the purpose of collecting performance data in support of the reagent 510(k) as outlined on the next page.
The provided text describes the submission of a 510(k) for Abbott Clinical Chemistry Calibrators. These are in vitro diagnostic devices intended for use in clinical chemistry assays to establish points of reference for the measurement of substances in human specimens.
However, the document does not contain a detailed study proving the device meets specific acceptance criteria in the way described in your request for AI/medical imaging devices. This is because calibrators, unlike diagnostic algorithms, are typically evaluated through different validation processes.
Here's an breakdown based on the information available and why certain sections of your request cannot be fulfilled:
Acceptance Criteria and Device Performance (Based on provided text)
| Criterion | Reported Device Performance |
|---|---|
| Intended Use Fulfillment | The calibrators (Amm Cal, Bil Cal, CO2 Cal, HDL Cal, Iron/Mg Cal, LDL Cal, MC Cal, UPro Cal, and ISE Calibrator Levels 1 and 2) are intended for in vitro diagnostic use in specific clinical chemistry assays (e.g., Ammonia, Bilirubin, Carbon Dioxide, HDL, Iron, Magnesium, LDL, etc.). |
| Calibration Curve Generation | Abbott Clinical Chemistry Calibrators were used for the calibration of each clinical chemistry reagent on the ALCYON 300/300i. The calibration curve generated was used for the quantitation of each analyte for the purpose of collecting performance data in support of the reagent 510(k). |
| Substantial Equivalence (Regulatory) | The FDA determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use (K981706). |
| Compliance with General Controls | The device is subject to general controls provisions of the Act (annual registration, listing of devices, good manufacturing practice, labeling, prohibitions against misbranding and adulteration). |
| Compliance with QS Regulation (GMP) | A substantially equivalent determination assumes compliance with Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices (21 CFR Part 820). |
Study Information (Based on provided text)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document describes the calibrators' intended use in supporting the performance data for reagents, rather than a direct study on the calibrators themselves with a test set of human specimens. The 510(k) process for calibrators often focuses on their stability, traceability, and ability to produce expected values when used with their respective reagents, which involves different types of testing.
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/Not provided. This type of information is relevant for AI algorithms that diagnose or interpret medical images. For a calibrator, "ground truth" would relate to the accuracy and traceability of the calibrator's assigned values, which is typically established through metrological methods, reference materials, and laboratory testing, not expert consensus on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Pertains to expert review of discrepancies in AI performance evaluation.
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/Not provided. Pertains to AI diagnostic algorithms.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided. Pertains to AI diagnostic algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly detailed in the document. For calibrators, "ground truth" refers to the highly accurate and traceable assigned values for each analyte within the calibrator. This is established through rigorous laboratory methods, often traceable to international reference materials or definitive methods (e.g., mass spectrometry for small molecules). The document states the calibrators generate curves for "quantitation of each analyte," implying their values serve as the reference.
8. The sample size for the training set
- Not applicable/Not provided. This refers to machine learning models.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This refers to machine learning models.
Summary regarding the nature of this submission:
This 510(k) submission is for calibrators, which are reference materials used to ensure the accuracy of other diagnostic tests (reagents). The "study" referenced in the text is not a clinical trial or an AI performance study with patient data, but rather the internal validation demonstrating that these calibrators can successfully generate "calibration curves" for specific reagents on a particular instrument (ALCYON 300/300i). The performance data collected using these calibrators would then be submitted as part of the 510(k) for the individual reagents themselves (as indicated by the list of K numbers for each reagent).
Therefore, the type of detailed performance evaluation requested, particularly concerning expert review and AI-specific metrics, is not present because it's not relevant for this type of in vitro diagnostic calibrator.
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