ACA PLUS FT4 CALIBRATOR

K962594 · Dade Intl., Inc. · JIT · Aug 15, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962594
• Device Name: ACA PLUS FT4 CALIBRATOR
• Applicant: Dade Intl., Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The aca® plus FT4 Calibrator is intended to be used on the aca® plus immunoassay system to calibrate the Free Thyroxine (FT4) Method.

Device Story

The aca® plus FT4 Calibrator is a lyophilized, human serum-based product used to calibrate the Free Thyroxine (FT4) method on the aca® plus immunoassay system. The kit contains six vials across three levels, with the Level 1 calibrator containing no detectable thyroxine. It is used in clinical laboratory settings by laboratory personnel to ensure the accuracy and standardization of FT4 immunoassay measurements. By providing known reference points for the assay, the calibrator enables the system to quantify patient thyroxine levels, supporting the diagnosis and monitoring of thyroid function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lyophilized human serum-based product; contains thyroxine (except Level 1); 3.0 mL per vial when reconstituted; 3 levels; intended for use with aca® plus immunoassay system.

Indications for Use

Indicated for use as a calibrator for the Free Thyroxine (FT4) method on the aca® plus immunoassay system. No specific patient population, age, or gender restrictions apply as this is an in vitro diagnostic accessory.

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® Free T4 Calibrator

Submission Summary (Full Text)

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DADE
AUG 15 1996
K962594
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:** 6/28/96
**Name of Product:** aca® plus FT4 Calibrator
**FDA Classification Name:** Calibrator
**Predicate Device:** Abbott Laboratories*IMx® Free T4 Calibrator

**Device Description:** The FT4 Calibrator is a lyophilized human serum-based product. The Level 1 calibrator contains no detectable thyroxine. The kit consists of six vials two at each of three levels.

**Intended use:** The aca® plus FT4 Calibrator is intended to be used on the aca® plus immunoassay system to calibrate the Free Thyroxine (FT4) Method.

## Comparison to Predicate Device:

| Item | aca® plus FT4 Calibrator | IMx® Free T4 Calibrator |
| --- | --- | --- |
| Intended Use | Calibrator | Calibrator |
| Analytes | thyroxine | thyroxine |
| Matrix | human serum base | human serum base |
| Form | lyophilized | liquid |
| Volume | 3.0 mL per vial, reconstituted | 4.0 mL per vial |
| Levels | 3 levels | 6 levels |

* IMx® is a trademark of Abbott Laboratories, Abbott Park, IL 60064

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