(91 days)
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No
The document describes a chemical calibrator for a clinical chemistry system and contains no mention of AI or ML.
No
The device is a calibrator for a diagnostic test, not a device used to treat or prevent disease.
No
The device is a calibrator for a ferritin assay, not a diagnostic device itself. Its purpose is to ensure the accuracy of the ferritin measurement on a clinical chemistry system, which is then used for diagnosis.
No
The device description clearly states it is a "lyophilized bovine serum-based product" and contains "human liver ferritin," indicating it is a physical reagent, not software.
Based on the provided information, the device described, the "Ferritin Calibrator," is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's used to "calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system." This system is used for clinical chemistry testing, which involves analyzing biological samples (like serum) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description mentions it's a "lyophilized bovine serum-based product" containing "human liver ferritin." These are components used in laboratory testing to establish a known reference point for measuring ferritin levels in patient samples.
- Predicate Device: The mention of a predicate device, "Abbott Laboratories*IMx® Ferritin Calibrator (K963493)," further supports its classification as an IVD. Predicate devices are typically other legally marketed IVDs that the new device is compared to for regulatory purposes.
While the document doesn't contain information about image processing, AI/ML, patient demographics, or performance studies, the core function and context of the device clearly align with the definition of an In Vitro Diagnostic. It's a reagent used in a laboratory setting to ensure the accuracy of a diagnostic test performed on biological samples.
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Intended Use / Indications for Use
The Ferritin Calibrator is intended to be used to calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Abbott Laboratories*IMx® Ferritin Calibrator
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/0 description: The image shows the word "DADE" in large, bold, black letters. The letters are sans-serif and appear to be slightly distressed or textured. The word is horizontally oriented and fills most of the frame.
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