(55 days)
For in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods.
The Bayer Special Chemistry Calibrators are for one absolute value of calibrator material prepared in human serum with nonserum constituents added. All the analytes currently in the calibrator material are: Acid Phosphatase Lactate Lipase Direct TIBC. The intention of this submission is to add the assigned values to the labeling claims for: Direct TIBC. As with the predicate device, the calibrator materials are lyophilized and require reconstitution with 5.0 mL distilled water. These calibrators are only for use on the Bayer ADVIA 1650 Chemistry Analyzer.
The provided text describes a submission for a Special Chemistry Calibrator from Bayer Healthcare LLC. It focuses on regulatory approval (510(k)) and states that the device is substantially equivalent to a previously cleared predicate device. The key difference in this submission is the addition of assigned values for "Direct TIBC" to the labeling claims.
However, the document does not contain the detailed acceptance criteria or a study proving the device meets those criteria, as typically requested in your prompt. The document is a regulatory submission for premarket notification, establishing substantial equivalence based on the device's similarity to an existing one, rather than presenting a detailed performance study with acceptance criteria.
Therefore, I cannot provide the requested information. The document explicitly states:
- No acceptance criteria: The document does not define specific performance metrics or acceptance criteria for the "Direct TIBC" calibration.
- No study proving acceptance criteria: Since no acceptance criteria are given, there is no study described that proves the device meets them. The basis for approval is substantial equivalence to a predicate device.
- No sample sizes, data provenance, expert details, adjudication methods, MRMC studies, or standalone performance details: These are all elements of a detailed performance study, which is not present in this 510(k) summary. The nature of the submission focuses on demonstrating equivalence, not on extensive de novo performance testing against new criteria.
- Type of ground truth, training set size, and ground truth establishment for the training set: These details are also absent as no new substantial performance study is being presented. The device is a calibrator, and its "ground truth" would be related to its assigned values and stability, which are stated to be similar to the predicate device.
The main points from the document pertinent to its "performance" (as understood in a regulatory context for this type of device) are:
- Device Name: Special Chemistry Calibrator
- Proprietary/Trade Name: Bayer ADVIA 1650 Special Chemistry Calibrator
- Intended Use: Calibrators for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA 1650 Chemistry analyzer.
- Key Change: Addition of assigned values to the labeling claims for "Direct TIBC".
- Substantial Equivalence: The device is stated to be "identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Special Chemistry Calibrators." The only difference is the added analyte value for Direct TIBC.
Due to the nature of the provided text, which is a 510(k) summary focused on substantial equivalence rather than a detailed performance study, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a proving study.
§ 862.1150 Calibrator.
(a)
Identification. A 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. (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.