(91 days)
The Ferritin Calibrator is intended to be used to calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system.
The Ferritin Calibrator is a lyophilized bovine serum-based product. The Level 1 calibrator contains no detectable ferritin. Levels 2 through 5 contain human liver ferritin. The kit consists of ten vials; two at each of five levels.
This document is a 510(k) summary for a Ferritin Calibrator and does not contain the detailed information required to fulfill your request regarding acceptance criteria and a study proving device performance. The document focuses on establishing substantial equivalence to a predicate device.
Here's why the requested information cannot be extracted from this document:
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Acceptance Criteria and Reported Device Performance: The document provides a comparison table between the new device and a predicate device, focusing on features like intended use, analytes, matrix, form, volume, and levels. It does not present specific performance metrics (e.g., accuracy, precision, linearity) with defined acceptance criteria that the new device had to meet. It states that the "Ferritin Calibrator is substantially equivalent to the IMx® Ferritin Calibrator based on the comparison discussed above," implying that equivalence in design and intended use is the primary claim, not a separate performance study against pre-defined metrics.
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Sample Size and Data Provenance: This information is not present. There's no mention of a test set, its size, or the origin of any data.
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Number and Qualifications of Experts for Ground Truth: Not applicable as there's no mention of a study involving expert assessment for establishing ground truth.
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Adjudication Method: Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This document pertains to a calibrator, not an AI-assisted diagnostic tool for human readers.
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Standalone Performance Study: The document doesn't describe a standalone performance study with detailed results for the new Ferritin Calibrator. Its claim is based on comparison to the predicate.
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Type of Ground Truth Used: Not applicable. For a calibrator, "ground truth" would typically relate to the accuracy of the ferritin concentration itself, which is not detailed here as a study outcome.
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Sample Size for Training Set: Not applicable. Calibration materials are generally manufactured to specifications, not "trained" in the machine learning sense.
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How Ground Truth for Training Set Was Established: Not applicable for the same reason as above.
In summary, this document is a regulatory submission for substantial equivalence based on product characteristics and intended use, not a detailed performance study report with acceptance criteria and clinical/technical study results as you've outlined in your query.
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Dec. 3, 199, DADE INTERNATIONA
Interoffice Memorandum
Summary of Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter's Name:
Cathy P. Craft Dade International Inc. P.O. Box 6101 Newark, DE 19714-6101
8/29/96 Date of Preparation:
Ferritin Calibrator Name of Product:
Calibrator FDA Classification Name:
Abbott Laboratories*IMx® Ferritin Calibrator Predicate Device:
Device Description: The Ferritin Calibrator is a lyophilized bovine serum-based product. The Level 1 calibrator contains no detectable ferritin. Levels 2 through 5 contain human liver ferritin. The kit consists of ten vials; two at each of five levels.
Intended use: The Ferritin Calibrator is intended to be used to calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system.
Comparison to Predicate Device:
| Item | Ferritin Calibrator | IMx® Ferritin Calibrator |
|---|---|---|
| Intended Use | Calibrator | Calibrator |
| Analytes | ferritin | ferritin |
| Matrix | bovine serum base | buffered aqueous base |
| Form | lyophilized | liquid |
| Volume | 2.0 mL per vial, reconstituted | 4.0 mL per vial |
| Levels | 5 levels | 6 levels |
- IMx® is a trademark of Abbott Laboratories, Abbott Park, IL 60064
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Comments on Substantial
Cominents on Substantial
Equivalence: Both the Ferritin Calibrator and the Abbott IMx® Ferritin Calibrator are intended to be used as calibrators for ferritin methods.
Conclusion: The Ferritin Calibrator is substantially equivalent to the IMx® Ferritin Calibrator based on the comparison discussed above.
Cathy P. Craft Regulatory Affairs and Compliance Manager Date: 8/29/96
§ 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.