K Number
K970539
Device Name
CHIRON DIAGNOSTICS ACS:180TU P
Date Cleared
1997-03-24

(40 days)

Product Code
Regulation Number
862.1715
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the assessment of unsaturated thyroid binding proteins in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.
Device Description
The thyroid hormones triiodothyronine (T3) and thyroxine (T4) are bound primarily to thyroxine-binding globulin (TBG) and to a lesser extent thyroxine-binding prealbumin (TBPA) and albumin. The ACS:180 T Uptake assay measures the number of unoccupied binding sites on these proteins and is an indirect indicator of thyroid status. T Uptake (TU) and total T4 are used to estimate the amount of circulating free T4. The estimate, or the Free Thyroxine Index (FTI), is a normalized measurement that remains relatively constant in healthy individuals and compensates for abnormal levels of binding proteins, which can occur in many different physical conditions. Drugs or physical conditions that alter the patient's TBG levels or drugs that compete with endogenous T4 and T3 for protein-binding sites alter T Uptake results. When serum contains high levels of T3 or T4, as in hyperthyroidism, fewer unoccupied binding sites are available. Conversely, in hypothyroidism, more binding sites are available. The Chiron Diagnostics ACS:180 TUp assay is a double antibody competitive immunoassay using, chemiluminescent technology. The sample is incubated with Lite Reagent, which is composed of acridinium ester-labeled T3-BGG (bovine gamma globulin) and unlabeled T3. The unlabeled T3 in the Lite Reagent fills available thyroid-binding sites in the sample. The acridinium ester-labeled T3-BGG does not bind to the binding proteins in the sample. The acridinium ester-labeled T3-BGG and unlabeled T3 compete for monoclonal mouse anti-T3 antibody in the Solid Phase. The monoclonal mouse anti-T3 antibody is bound to goat anti-mouse antibody, which is covalently coupled to paramagnetic particles in the Solid Phase. A greater amount of unlabeled T3 binding to the binding proteins in the sample results in more T3-BGG-acridinium ester binding to the monoclonal antibody, an indication of a higher amount of unsaturated binding proteins.
More Information

Not Found

No
The device description and performance studies detail a standard competitive immunoassay using chemiluminescent technology. There is no mention of AI, ML, or any computational methods beyond standard data processing for calculating ratios and indices.

No.
The device is used for assessment and measurement of thyroid binding proteins, serving as an indicator of thyroid status, not for direct treatment or therapy.

Yes

This device is designed to assess unsaturated thyroid binding proteins, and the information states that the measurements are an "indirect indicator of thyroid status" and are used to "estimate the amount of circulating free T4." These are clear indicators of a diagnostic purpose.

No

The device description clearly outlines a competitive immunoassay using chemiluminescent technology, involving reagents (Lite Reagent, Solid Phase) and a specific automated system (Chiron Diagnostics ACS:180®). This indicates a hardware-based laboratory assay, not a software-only device.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use explicitly states it's "For the assessment of unsaturated thyroid binding proteins in serum or plasma". Serum and plasma are biological specimens taken from the human body.
  • Device Description: The description details how the assay measures components within these biological samples (thyroid binding proteins, T3, T4) to provide information about thyroid status.
  • Methodology: The description outlines a "double antibody competitive immunoassay using chemiluminescent technology," which is a common method used in in vitro diagnostic tests to measure substances in biological fluids.
  • Performance Studies: The document includes sections on "Expected Results," "Method Comparison," and "Precision," which are typical performance characteristics evaluated for IVD devices to demonstrate their accuracy and reliability when testing biological samples.

The device is designed to be used in vitro (outside the body) to examine biological specimens (serum or plasma) for the purpose of providing information about a patient's health status (thyroid status). This aligns directly with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

For the assessment of unsaturated thyroid binding proteins in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.

Product codes

Not Found

Device Description

The thyroid hormones triiodothyronine (T3) and thyroxine (T4) are bound primarily to thyroxine-binding globulin (TBG) and to a lesser extent thyroxine-binding prealbumin (TBPA) and albumin. The ACS:180 T Uptake assay measures the number of unoccupied binding sites on these proteins and is an indirect indicator of thyroid status.

T Uptake (TU) and total T4 are used to estimate the amount of circulating free T4. The estimate, or the Free Thyroxine Index (FTI), is a normalized measurement that remains relatively constant in healthy individuals and compensates for abnormal levels of binding proteins, which can occur in many different physical conditions.

Drugs or physical conditions that alter the patient's TBG levels or drugs that compete with endogenous T4 and T3 for protein-binding sites alter T Uptake results.

When serum contains high levels of T3 or T4, as in hyperthyroidism, fewer unoccupied binding sites are available. Conversely, in hypothyroidism, more binding sites are available.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

  1. Expected Results: Serum samples from 100 apparently healthy individuals were analyzed to confirm the ACS:180 TUp serum reference range. Total T4 values were generated using the ACS:180 T4 test method. A reference range for Euthyroid patients was established based on a 95% confidence interval for euthyroid samples.
  2. Specificity: The specificity of the T3 antiserum used in the ACS:180 TUp assay was determined in the ACS:180 T3 assay, showing cross-reactivity percentages for various compounds.
  3. Method Comparison: For 245 samples with T Uptake ratios in the range of 0.57 to 1.68 (17.1 to 50.4% Uptake) and total T4 values in the range of 3.7 to 14.1 µg/dL (47.73 to 181.89 nmol/L), the correlation between the ACS:180 TUp assay and an alternate chemiluminescent method is 0.95. The correlation of FTI values (n = 245) is described by the equation: ACS:180 TUp FTI = 1.07 (alternate chemiluminescent method) + 0.04 FTI, with a correlation coefficient (r) = 0.97.
  4. Precision: Three samples were assayed 3 times in 6 assays, on each of 4 systems (n = 72 for each sample), over a period of 3 days. Total precision (% CV) ranged from 4.9 to 6.2.

Key Metrics

Specificity:

  • L-thyroxine:

§ 862.1715 Triiodothyronine uptake test system.

(a)
Identification. A triiodothyronine uptake test system is a device intended to measure the total amount of binding sites available for binding thyroid hormone on the thyroxine-binding proteins, thyroid-binding globulin, thyroxine-binding prealbumin, and albumin of serum and plasma. The device provides an indirect measurement of thyrkoxine levels in serum and plasma. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders.(b)
Classification. Class II. 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.

0

Company Confidential

K970539

Summary of Safety and Effectiveness

MAR 2 4 1997

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

1. Submitters Information

| Contact person: | William J. Pignato
Director of Regulatory Affairs |
|------------------------|-------------------------------------------------------------------------|
| Address: | Chiron Diagnostics Corporation
63 North Street
Medfield, MA 02052 |
| Phone: | (508) 359-3825 |
| Date Summary Prepared: | February 10, 1997 |

2. Device Information

Proprietary Name:Chiron Diagnostics ACS:180 TUp
Common Name:Triiodothyronine uptake test system
Device Classification:Class 11, 21 CFR 862.1715

3. Predicate Device Information

Name:ACS:180 TU Assay
Manufacturer:Chiron Diagnostics Corporation (Formally Ciba
Corning Diagnostics Corp.)
Document Control #K925257

4. Device Description

The thyroid hormones triiodothyronine (T3) and thyroxine (T4) are bound primarily to thyroxine-binding globulin (TBG) and to a lesser extent thyroxine-binding prealbumin (TBPA) and albumin. The ACS:180 T Uptake assay measures the number of unoccupied binding sites on these proteins and is an indirect indicator of thyroid status.

T Uptake (TU) and total T4 are used to estimate the amount of circulating free T4. The estimate, or the Free Thyroxine Index (FTI), is a normalized measurement that remains relatively constant in healthy individuals and compensates for abnormal levels of binding proteins, which can occur in many different physical conditions.

Drugs or physical conditions that alter the patient's TBG levels or drugs that compete with endogenous T4 and T3 for protein-binding sites alter T Uptake results.

1

When serum contains high levels of T3 or T4, as in hyperthyroidism, fewer unoccupied binding sites are available. Conversely, in hypothyroidism, more binding sites are available.

5. Statement of Intended Use

For the assessment of unsaturated thyroid binding proteins in serum or plasma using the Chiron Diagnostics ACS:180® Automated Chemiluminescence Systems.

6. Summary of Technological Characteristics

The Chiron Diagnostics ACS:180 TUp assay is a double antibody competitive immunoassay using, chemiluminescent technology. The sample is incubated with Lite Reagent, which is composed of acridinium ester-labeled T3-BGG (bovine gamma globulin) and unlabeled T3. The unlabeled T3 in the Lite Reagent fills available thyroid-binding sites in the sample. The acridinium ester-labeled T3-BGG does not bind to the binding proteins in the sample.

The acridinium ester-labeled T3-BGG and unlabeled T3 compete for monoclonal mouse anti-T3 antibody in the Solid Phase. The monoclonal mouse anti-T3 antibody is bound to goat anti-mouse antibody, which is covalently coupled to paramagnetic particles in the Solid Phase. A greater amount of unlabeled T3 binding to the binding proteins in the sample results in more T3-BGG-acridinium ester binding to the monoclonal antibody, an indication of a higher amount of unsaturated binding proteins.

6. Performance Characteristics

Expected Results

To confirm the ACS:180 TUp serum reference range, serum samples from 100 apparently healthy individuals were analyzed. Total T4 values were generated on all of these samples using the ACS:180 T4 test method. Based on a 95% confidence interval for euthyroid samples, the following reference range was established:

| Clinical

ConditionTU Ratio% TUFTI
Euthvroid
  •    | 0.75–1.23 | 22.5-37.0 | 1.4-3.1
    

of the property of the program and the county of the county of the county of the |

As with all diagnostic assays, each laboratory should determine its own reference range(s) for the diagnostic evaluation of patient results.

2

Performance Characteristics

Specificity

The specificity of the T3 antiserum used in the ACS:180 TUp assay has been determined in the ACS:180 T3 assay.

Compound% Cross-reactivity
L-thyroxine