(47 days)
The Dade Behring Dimension® Drug Calibrator II is a device intended for medical purposes for use on the Dade Behring Dimension® clinical chemistry system to establish points of reference that are used in determination of values in the measurement of substances in human specimens. The product is intended for the calibration of the following methods packaged in Dimension® Flex® reagent cartridges: Acetaminophen (ACTM) Carbamazepine (CRBM) Digitoxin (DGTX) Gentamicin (GENT) N-acetylprocainamide (NAPA) Procainamide (PROC) Tobramycin (TOBR) Valproic acid (VALP) Vancomycin (VANC)
The Dimension® Drug Calibrator II is a liquid, bovine serum base product. It is packaged as ten vials, two vials at each of five levels. Each vial contains 5.0 mL.
The provided document is a 510(k) summary for the Dade Behring Dimension® Drug Calibrator II (DC49C). It focuses on establishing substantial equivalence to a predicate device (DC49B) rather than a study proving the device meets specific acceptance criteria in the traditional sense of a diagnostic test for disease.
Here's an analysis based on the information provided, explaining why some of your requested information is not applicable to this type of submission:
This submission is for a calibrator, which is a reference material used to set the scale of a measurement. It is not a diagnostic device that directly measures a patient's condition or provides a diagnosis. Therefore, the concepts of sensitivity, specificity, accuracy, and clinical performance studies (like MRMC) are not directly relevant in the way they would be for a device like an AI algorithm for image analysis.
The "acceptance criteria" here relate to the ability of the calibrator to accurately assign values to its constituents and ensure the continued accurate performance of the assays it calibrates. The "study" mentioned is the comparison to the predicate device, demonstrating that the new calibrator is functionally equivalent and performs its intended role adequately.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for a Calibrator) | Reported Device Performance |
|---|---|
| Matrix Type: Bovine serum base | Bovine serum base (Matches predicate, ensuring appropriate matrix for analytical methods). |
| Form: Liquid | Liquid (Matches predicate, ensuring ease of use and consistency). |
| Package: Ten vials - five levels, two vials/level, 5.0 mL/vial | Ten vials - five levels, two vials/level, 5.0 mL/vial (Matches predicate, ensuring consistent packaging and sufficient material for calibration). |
| Value Assignment Traceability: USP standards or highest-order purity material available | USP standards or highest-order purity material available (Matches predicate, indicating a robust and traceable method for assigning values to the calibrator, which is critical for its function). |
| Intended Use: Calibration of specified Dimension® Flex® methods on clinical chemistry systems | Intended for calibration of the following nine (9) Dimension® Flex® methods: Acetaminophen (ACTM), Carbamazepine (CRBM), Digitoxin (DGTX), Gentamicin (GENT), N-acetylprocainamide (NAPA), Procainamide (PROC), Tobramycin (TOBR), Valproic acid (VALP), Vancomycin (VANC). (Expands upon predicate by including NAPA and PROC calibration, demonstrating its ability to perform this extended function.) |
| Substantial Equivalence: Maintain same design, manufacture, and intended use as the predicate device (DC49B), with the only difference being value assignments for additional analytes. | Conclusion: "Based on the same design, manufacture and intended use as described above, the multianalyte, five level, bovine serum base Dimension® Drug Calibrator II products (DC49C and DC49B) are substantially equivalent. The only difference is the assigned values for the two additional analytes (procainamide and n-acetylprocainamide)." (Confirms it meets the criteria for substantial equivalence, implying it performs its calibrator function equivalently for the common analytes and adequately for the new ones.) |
Additional Information (as applicable to a calibrator submission):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not applicable and not provided in the document. This submission is for a calibrator, which is a reference material itself, not a device being tested against patient samples for diagnostic accuracy. The "test set" in this context would likely refer to internal analytical validation data to establish the values of the calibrator and ensure its stability and consistency, which is not detailed in a 510(k) summary for a calibrator. The summary focuses on its composition and how it relates to a predicate device.
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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):
- This is not applicable to a calibrator. The "ground truth" for a calibrator is established through highly precise analytical methods using primary reference materials (like USP standards) and robust metrological practices, not clinical expert consensus.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in clinical studies, particularly for subjective assessments like image interpretation.
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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. MRMC studies are for evaluating the performance of diagnostic systems (often AI-powered) where human interpretation is involved. This is a calibrator.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a calibrator, "ground truth" refers to the assigned concentration values of the analytes within the calibrator. This is established using pharmacopoeial standards (USP standards) or other highest-order purity materials available, meaning it's based on highly characterized chemical reference materials and analytical methodologies, not clinical outcomes or expert consensus.
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The sample size for the training set:
- Not applicable. Calibrators do not have "training sets" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not applicable for the reasons mentioned above. For this device, the "ground truth" (assigned values) is established through analytical processes traceable to certified reference materials.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.