← Product Code [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT) · K963493

# FERRITIN CALIBRATOR (K963493)

_Dade Chemistry Systems, Inc. · JIT · Dec 3, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K963493

## Device Facts

- **Applicant:** Dade Chemistry Systems, Inc.
- **Product Code:** [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT.md)
- **Decision Date:** Dec 3, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1150
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## 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.

## Regulatory 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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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K963493](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K963493)

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