K963493 · Dade Chemistry Systems, Inc. · JIT · Dec 3, 1996 · Clinical Chemistry
Device Facts
Record ID
K963493
Device Name
FERRITIN CALIBRATOR
Applicant
Dade Chemistry Systems, Inc.
Product Code
JIT · Clinical Chemistry
Decision Date
Dec 3, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1150
Device Class
Class 2
Indications for Use
The Ferritin Calibrator is intended to be used to calibrate the ferritin (FERR) method on the Dimension® RxL clinical chemistry system.
Device Story
Ferritin Calibrator; lyophilized bovine serum-based product; kit contains ten vials across five levels. Level 1 contains no detectable ferritin; Levels 2-5 contain human liver ferritin. Used in clinical chemistry laboratory settings to calibrate ferritin assays on Dimension® RxL systems. Provides reference points for quantitative measurement of ferritin levels in patient samples; assists healthcare providers in diagnostic assessment of iron status.
Technological Characteristics
Lyophilized bovine serum-based matrix; five-level calibration kit; reconstituted volume 2.0 mL per vial. Intended for use with Dimension® RxL clinical chemistry system.
Indications for Use
Indicated for use as a calibrator for the ferritin (FERR) method on the Dimension® RxL clinical chemistry system. No specific patient population, age, or gender restrictions defined.
Regulatory Classification
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.)
Special Controls
*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.
Predicate Devices
Abbott Laboratories IMx® Ferritin Calibrator
Submission Summary (Full Text)
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DADE
K963493
Dec. 3, 1996 DADE INTERNATIONAL
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
**Date of Preparation:** 8/29/96
**Name of Product:** Ferritin Calibrator
**FDA Classification Name:** Calibrator
**Predicate Device:** Abbott Laboratories*IMx® Ferritin Calibrator
**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
**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
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