ACS FRT4 IMMUNOASSAY

K961510 · Ciba Corning Diagnostics Corp. · JJX · Jun 17, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961510
• Device Name: ACS FRT4 IMMUNOASSAY
• Applicant: Ciba Corning Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jun 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

For the quantitative determination of free thyroxine (FT4) in serum using the Ciba Corning Automated Chemiluminescence Systems.

Device Story

Competitive chemiluminescence immunoassay; measures free thyroxine (FT4) in serum samples. FT4 competes with acridinium ester-labeled T4 for polyclonal rabbit anti-T4 antibody coupled to paramagnetic particles. Indirect relationship between FT4 concentration and relative light units (RLUs). Used in clinical laboratory settings with Ciba Corning Automated Chemiluminescence Systems. Output provides quantitative FT4 levels to assist clinicians in evaluating thyroid status.

Clinical Evidence

Bench testing only. Correlation study (n=74) against RIA reference method showed r=0.97, equation: ACS FrT4 = 1.06(RIA) - 0.33. Sensitivity: 0.1 ng/dl (range up to 11.0 ng/dl). Precision: Total % CV 2.81-4.65%.

Technological Characteristics

Competitive chemiluminescence immunoassay. Solid phase: paramagnetic particles with covalently coupled polyclonal rabbit anti-T4 antibody. Tracer: acridinium ester-labeled T4. Analyte: free thyroxine (FT4). Platform: Ciba Corning Automated Chemiluminescence Systems.

Indications for Use

Indicated for quantitative measurement of free thyroxine (FT4) in human serum to assess thyroid function.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Amerlex-MAB FT4 (510(k) number not known)

Submission Summary (Full Text)

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Company Confidential
K961510
JUN 17 1996

# Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

## 1. Submitter Information

Contact person: Thomas F. Flynn

Address: Ciba Corning Diagnostics Corp.
63 North Street
Medfield, MA 02052

Phone: [phone]
e-mail: [e-mail]

Date Summary Prepared: April 19. 1996

## 2. Device Information

Proprietary Name: ACS FrT4 Immunoassay
Common Name: FrT4 Immunoassay
Classification Name: Class II, Free Thyroxine Test Kit, 21 CFR 862.1695


## 3. Predicate Device Information

Name: Amerlex-MAB FT4
Manufacturer: Amerlex
510(k) Number: Not Known

## 4. Device Description

The Ciba Corning ASC FrT4 Immunoassay is a competitive immunoassay. FT4 in the sample competes with the acridinium ester (AE-labeled T4 (Lite Reagent) for a limited amount of polyclonal rabbit anti-T4 antibody, which is covalently coupled to paramagnetic particles (solid phase). An indirect relationship exists between the FT4 in a sample and the relative light units (RLUs) detected.

## 5. Statement of Intended Use

For the quantitative determination of free thyroxine (FT4) in serum using the Ciba Corning Automated Chemiluminescence Systems.

## 6. Summary of Technological Characteristics

The Ciba Corning ACS FrT4 procedure is a competitive chemiluminescence immunoassay.

ACS FrT4 510(k) Notification
April 19, 1996
2

{1}

Company Confidential

# 7. Performance Data

## Sensitivity

The ACS FrT4 immunoassay measures FT4 concentrations up to 11.0 ng/dl with a minimum detectable concentration of 0.1 ng/dl.

## Accuracy

For 74 samples in the range of 0.62 to 4.26 ng/dl, the correlation between the ACS FrT4 immunoassay and the RIA reference method assay is described by the equation:

$$
\text{ACS FrT4} = 1.06 \, (\text{RIA}) - 0.33
$$

Correlation coefficient (r) = 0.97

## Precision

Total precision (Total % CV) ranged from 2.81 to 4.65.

ACS FrT4 510(k) Notification
April 19, 1996
3