(240 days)
No
The summary describes a standard immunoassay kit and analyzer, with no mention of AI or ML in the device description, intended use, or performance studies. The analysis focuses on traditional analytical performance metrics and method comparison.
No.
This device is an in vitro diagnostic (IVD) assay intended for quantitative measurement of thyroglobulin, which aids in monitoring patients. It does not directly treat or cure a disease, but rather provides information for diagnostic purposes.
Yes
The device is described as an "in vitro diagnostic use as an aid in monitoring patients who have undergone thyroidectomy," and performs "quantitative measurement of thyroglobulin," which implies diagnosis or disease monitoring.
No
The device description explicitly states it is a "clinical device for use with the IMMULITE Automated Immunoassay Analyzer" and describes it as a "two-site chemiluminescent enzyme-labeled immunometric assay," indicating it is a physical assay kit used with a hardware analyzer, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is "intended strictly for in vitro diagnostic use."
- Device Description: It is described as a "clinical device" and an "in vitro diagnostic use" product.
- Intended User/Care Setting: It is intended for use in a "Clinical laboratory / In vitro diagnostic use."
These points clearly indicate that the device is designed to be used outside of the body to examine specimens (serum or heparinized plasma) for diagnostic purposes.
N/A
Intended Use / Indications for Use
IMMULITE Thyroglobulin is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Analyzer and designed for the quantitative measurement of thyroglobulin in serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in monitoring patients who have undergone thyroidectomy.
Product codes
MSW
Device Description
IMMULITE Thyroglobulin is a clinical device for use with the IMMULITE Automated Immunoassay Analyzer.
IMMULITE Thyroglobulin is a chemiluminescent enzyme-labeled immunometric assay, based on ligand-labeled monoclonal antibody and separation by anti-ligand-coated solid phase.
The patient sample, a ligand-labeled anti-thyroglobulin monoclonal antibody and an alkaline phosphatase-labeled anti-thyroglobulin polyclonal antibody are simultaneously introduced into the Test Unit containing immobilized anti-ligand, and incubated for approximately 60 minutes at 37°C with intermittent agitation. During this time, thyroglobulin in the sample forms an antibody sandwich complex which, in turn, binds to anti-ligand on the solid phase. Unbound conjugate is removed by a centrifugal wash; substrate is then added and the Test Unit is incubated for a further 10 minutes.
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of thyroglobulin in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thyroid gland
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
Method Comparison: The IMMULITE Thyroglobulin procedure was compared to Kit A (ALPCO's ORGenTec), a commercially available indirect solid phase enzyme immunometric assay for thyroglobulin, on 150 samples from patients with Hashimoto's disease, Graves disease, patients who had undergone thyroidectomy, as well as euthyroid individuals. The thyroglobulin concentrations of these specimens covered the entire calibration range of the data were tabulated in reference to the respective assays' suggested cutoffs, with the following results:
Agreement: 94.0%
Sensitivity: 100.0%
Specificity: 93.6%
95% Confidence Limits for Relative Sensitivity and Specificity, respectively: 69.2% - 100%, 88.2% - 97%.
The same data, excluding one specimen in the above analysis due to its thyroglobulin level exceeding both assays' upper calibration limits, yielded the following result in a linear regression analysis:
IMMULITE = 2.16 x Kit A + 0.76 ng/mL r = 0.95
Key Metrics
Agreement: 94.0%
Sensitivity: 100.0%
Specificity: 93.6%
95% Confidence Limits for Relative Sensitivity and Specificity, respectively: 69.2% - 100%, 88.2% - 97%.
r = 0.95
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
0
3/12/99
: ・
510(k) Summary Safety and Effectiveness
This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| Name: | Diagnostic Products Corporation |
|---|---|
| Address: | 5700 West 96th Street |
| Los Angeles, California 90045-5597 | |
| Telephone Number: | (310) 645-8200 |
| Facsimile Number: | (310) 645-9999 |
| Contact Person: | Edward M. Levine, Ph.D. |
| Director of Clinical Affairs | |
| Date of Preparation: | February 12, 1999 |
| Device Name: | |
| Trade: | IMMULITE Thyroglobulin |
| Catalog Number: | LKTYZ (50 tests), LKTY1 (100 tests), LKTY5 (500 tests) |
| Common: | Reagent system for the determination of thyroglobulin in |
| serum or heparinized plasma. | |
| Classification: | Class II device, 82-JZO (21CFR 866.5870) |
| Manufacturer: | EURO/DPC Ltd. (Manufacturing under a Quality System – |
| ISO9001/EN29001/BS 5750 | |
| Sole U.S. Importer: | Diagnostic Products Corporation |
| 5700 West 96th Street | |
| Los Angeles, California 90045-5597 | |
| Establishment Registration | |
| Number | EURO/DPC: Not applicable |
| DPC: 2017183 | |
| Substantially Equivalent | |
| Predicate Device: | ORGenTec Thyroglobulin ELISA (K972190) |
| Manufactured by ORGenTec, and distributed in the USA | |
| by ALPCO, Windham, NH | |
| Description of Device: | IMMULITE Thyroglobulin is a clinical device for use with |
| the IMMULITE Automated Immunoassay Analyzer |
1
Intended Use of the Device:
IMMULITE Thyroglobulin is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Analyzer and designed for the quantitative measurement of thyroglobulin in serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in monitoring patients who have undergone thyroidectomy.
Performance Equivalence:
Diagnostic Products Corporation (DPC) asserts that the IMMULITE Thyroglobulin produces substantially equivalent results to other commercially marketed thyroglobulin assays, such as the ORGenTec Thyroglobulin ELISA. Each product is intended strictly for in vitro diagnostic use to aid in the clinical diagnosis of thyroid diseases.
Summary and Explanation of the Test:
Thyroglobulin (TG) is a heterogeneous iodoglycoprotein which has a molecular mass of approximately 660,000 daltons. Thyroglobulin is normally synthesized in the follicular cells of the thyroid gland, under the influence of thyrotropin, and represents the precursor to thyroxine and the other iodothyronines.
The expected upper limit of normal for circulating thyroglobulin is approximately 40 to 60 ng/mL, with a median of 5 to 10 ng/mL. Somewhat higher values are encountered in newborns and during the third trimester of pregnancy. Thyroglobulin levels also tend to be elevated in regions of endemic goiter.
The major clinical applications for measurement of this prohormone derive from the fact that functioning thyroid tissue, whether normal or neoplastic, appears to be the only source of circulating thyroglobulin. Accordingly, thyroglobulin determinations have been widely used to complement radioiodine scanning and other techniques (such as ultrasound or immunohistochemical staining) as an aid in identifying the presence or absence of functioning thyroid tissue, or an increase in such tissue relative to an individually established baseline. The differential diagnosis of congenital hypothyroidism and the management of nonmedullary differentiated thyroid carcinoma constitute two well-established contexts of use for this application of serum thyroglobulin measurements. ..
Congenital Hypothyroidism
Thyroglobulin determinations have been used, sometimes in conjunction with ultrasound and radioiodine scanning, to help clarify the type of thyroid defect in previously diagnosed congenital hypothyroidism. Very low or undetectable thyroglobulin levels are expected in infants born without thyroid tissue (thyroid agenesis), whereas higher, but widely varying levels are generally encountered in infants with hypoplastic thyroid glands, ectopic thyroid tissue, dyshormonogenic goiter, congenital TBG deficiency or transient hypothyroidism.
2
Summary and Explanation of the Test (continued):
Other Applications
Thyroglobulin measurements may also be of value in helping to distinguish subacute thyroiditis from thyrotoxicosis caused by covert administration of thyroid hormones. In the latter event, low levels of thyroglobulin are expected due to thyroid hormone suppression of thyrotropin.
Technological Comparison to Predicate:
IMMULITE Thyroglobulin is a chemiluminescent enzyme-labeled immunometric assay, based on ligand-labeled monoclonal antibody and separation by anti-ligand-coated solid phase.
The patient sample, a ligand-labeled anti-thyroglobulin monoclonal antibody and an alkaline phosphatase-labeled anti-thyroglobulin polyclonal antibody are simultaneously introduced into the Test Unit containing immobilized anti-ligand, and incubated for approximately 60 minutes at 37°C with intermittent agitation. During this time, thyroglobulin in the sample forms an antibody sandwich complex which, in turn, binds to anti-ligand on the solid phase. Unbound conjugate is removed by a centrifugal wash; substrate is then added and the Test Unit is incubated for a further 10 minutes.
The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to vield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is proportional to the concentration of thyroglobulin in the sample.
The ORGenTec Thyroglobulin assay is an indirect solid phase enzyme immunometric assay based on precoated microplates in strip format (12x8 wells), ideal for smaller runs, or economical batch processing. The Thyroglobulin assay takes place in three separate phases:
Phase 1:
Microplate wells are coated with highly specific anti-TG antibodies. Standards, controls and undiluted patient samples are pipetted into the wells of the first microplate. Sample buffer is added to appropriate wells. Recovery control is added to patient sample for recovery test. Anv thyroglobulin molecules present bind to the inner well surfaces. After a 60 minute incubation, the microplate is washed with wash buffer to remove non-reactive serum components.
Phase 2:
An anti-thyroglobulin peroxidase conjugate solution is pipetted into the microplate wells which recognizes the thyroglobulin bound to the immobilized antibody. After a 60 minute incubation, excess conjugate is washed away.
、
3
Technological Comparison to Predicate (continued):
Phase 3:
A chromogenic substrate solution containing TMB (3,3',5,5'-tetramethyl-benzidine) is pipetted into the microplate wells. During a 15 minute incubation, the solution changes to a blue color. 1 M hydrochloric acid is added to stop color development.
The amount of color is directly proportional to the concentration of TG present in the original The optical density for each standard may be graphically plotted against the sample. concentration of TG and unknowns extrapolated from the curve. Optical density is read at 450 nm. Bichromatic measurement with a 650 nm reference is recommended.
Method Comparison:
The IMMULITE Thyroglobulin procedure was compared to Kit A (ALPCO's ORGenTec), a commercially available indirect solid phase enzyme immunometric assay for thyroglobulin, on 150 samples from patients with Hashimoto's disease, Graves disease, patients who had undergone thyroidectomy, as well as euthyroid individuals. The thyroglobulin concentrations of these specimens covered the entire calibration range of the data were tabulated in reference to the respective assays' suggested cutoffs, with the following results:
| IMMULITE | N | 150 | |||
|---|---|---|---|---|---|
| Kit A | >50 | 10 | 0 | Agreement | 94.0% |
| 55 |