ACTIVE T3 RIA

K960550 · Diagnostic Systems Laboratories, Inc. · CDP · Mar 6, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960550
• Device Name: ACTIVE T3 RIA
• Applicant: Diagnostic Systems Laboratories, Inc.
• Product Code: CDP · Clinical Chemistry
• Decision Date: Mar 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1710
• Device Class: Class 2

Intended Use

The DSL ACTIVE™ T3 RIA assay is intended for the quantitative determination of Total T3 in human serum. The measurement of T3 is used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

Device Story

Competitive binding protein radioimmunoassay (RIA) for quantitative measurement of Total T3 in human serum; radio-labeled T3 competes with serum T3 for antibody binding sites; coated tubes used for separation; decanting removes free T3; gamma counter measures bound counts per minute; inverse proportionality between bound radio-labeled T3 and sample T3 concentration; performed in clinical laboratory settings by trained technicians; results used by physicians to diagnose and manage thyroid disorders.

Clinical Evidence

Bench testing only. Comparison study using 30 patient samples with low, intermediate, and high T3 levels; linear regression analysis (Y=1.09(X)-8.8) and correlation coefficient (r=0.90) against predicate device.

Technological Characteristics

Competitive binding protein radioimmunoassay; utilizes radio-labeled T3 and antibody-coated tubes; requires gamma counter for signal detection; in vitro diagnostic kit format.

Indications for Use

Indicated for quantitative measurement of Total T3 in human serum to aid in diagnosis and treatment of thyroid diseases, including hyperthyroidism, in patients requiring thyroid function assessment.

Regulatory Classification

Identification

A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

Predicate Devices

• DPC COAT-A-COUNT TOTAL T3 RIA

Submission Summary (Full Text)

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Dl

K960550

Diagnostic Systems Laboratories, Inc.

445 Medical Center Boulevard

Webster Texas 77598-4217 USA

Tel [phone]

Fax [phone]

Customer Assistance Center

Tel [phone]

Fax [phone]

# SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Device: DSL 3100 ACTIVE™ T3 RIA Kit
Classification Name: Radioimmunoassay, Triiodothyronine
Analyte Code and Name: Total Triiodothyronine
Regulatory Class: II


Submitter: John Willis
Diagnostic Systems Laboratories, Inc.
445 Medical Center Boulevard
Webster, Texas 77598
Phone:[phone]

Date: February 7, 1996

The DSL ACTIVE™ T3 RIA kit was developed for the quantitative measurement of Total T3 in human serum. The RIA format is a competitive binding protein assay. Radio-labeled T3 competes with un-labeled T3 in the serum sample for binding sites to the antibody. Separation of free from bound T3 is achieved by decanting the coated tubes after incubation. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of radio-labeled T3 bound to the antibody is inversely proportional to the concentration of the T3 present in the sample.

The DSL ACTIVE™ T3 RIA assay is intended for the quantitative determination of Total T3 in human serum. The measurement of T3 is used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

The DSL ACTIVE™ T3 RIA is substantially equivalent to the DPC COAT-A-COUNT TOTAL T3 RIA.

To demonstrate substantial equivalence between the two assays, patient samples (n=30) were collected and assayed using both methods. Samples were chosen based on expected T3 levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation $Y = 1.09(X) + -8.8$ with a correlation coefficient of (r) = 0.90.