(153 days)
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No
The device description details a standard immunoassay process and data analysis based on a standard curve, with no mention of AI or ML techniques.
No.
This device is an in vitro diagnostic (IVD) device used for the quantitative measurement of thyroglobulin in human serum to aid in monitoring for the presence of local and metastatic thyroid tissue. It does not directly treat or prevent a disease.
Yes
Explanation: The device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue and for detecting the presence of thyroid tissue in patients with well-differentiated thyroid cancer, which are diagnostic purposes for disease/recurrence.
No
The device description clearly outlines a physical kit containing reagents and requiring a luminometer for analysis, indicating it is a hardware-based assay, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative measurement of thyroglobulin in human serum." This is a measurement performed in vitro (outside the body) on a biological sample (serum).
- Device Description: The description details a laboratory assay using reagents and a luminometer to analyze a serum sample. This is characteristic of an in vitro diagnostic test.
- Performance Studies: The performance studies describe testing performed on "samples" (human serum) in a laboratory setting, comparing results to a predicate method and evaluating clinical performance based on these sample results.
The core function of the device is to analyze a biological sample in vitro to provide diagnostic information (monitoring for the presence of thyroid tissue and detecting thyroid cancer). This aligns directly with the definition of an In Vitro Diagnostic device.
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Intended Use / Indications for Use
The Nichols Institute Diagnostics Chemiluminescence Thyroglobulin is a two-site immunometric assay for the quantitative measurement of thyroglobulin in human serum. The assay is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had prior thyroidectomy (using surgery with or without radioiodine). This assay is also indicated for monitoring thyroglobulin levels in combination with radioiodine whole body scans after either rhTSH administration or thyroid hormone withdrawal for detecting presence of thyroid tissue in patients with well-differentiated thyroid cancer. The assay should only be used on patients who lack thyroglobulin autoantibodies.
The presence of autoantibodies against thyroglobulin (TgAb) can interfere with assays for thyroglobulin; hence, the TgAb status of the patient should be determined and reported. Thyroglobulin antibodies can be quantitated with the Nichols Chemiluminescence Thyroglobulin Autoantibodies kit (catalog 60-4185).
Product codes (comma separated list FDA assigned to the subject device)
MSW
Device Description
The Chemiluminescence Thyroglobulin kit has sufficient reagents for 100 tests. The thyroglobulin assay is a chemiluminescence sandwich immunoassay assay utilizing a biotinylated goat antibody to thyroglobulin for capture and a monoclonal antibody labeled with acridinium for detection. A 0.200-mL serum sample is added to a 12x75 mm polypropylene or seprosillicate glass tube followed by the addition of 0.050 mL of acridinium labeled antithyroglobulin reagents. Samples are also run at a 1/10 dilution (hook detection tube) to check for samples with very high levels of thyroglobulin in the assay. An avidin-coated bead is then added to the potentially mixture. The assay incubates at room temperature for 16-24 hours on top of a horizontal rotator set @ 180 ± 10 rpm. Thyroglobulin in the serum sample binds to the biotinylated antibody and acridinium labeled antibody to form a sandwich-complex. Because of the high affinity between biotin and avidin, the captured sandwich complex binds to the avidin-coated bead. Free and unbound antibody are separated from the complex bound to the bead by aspiration of the reaction mixture and subsequent washing. The tubes containing the washed beads are placed into a luminometer, which automatically injects Trigger 1 and 2, initiating the chemiluminescence reaction. The light is quantified by the luminometer and reported in Relative Light Units (RLU). The amount of acridinium labeled antibody bound is directly proportional to the concentration of thyroglobulin in the sample. A log-log standard curve is generated by plotting the RLU (ordinate) versus the respective concentration of each calibrator (abscissa). The concentration of thyroglobulin is determined directly from the standard curve.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
One hundred twenty-one samples were assayed in parallel between the predicate method and the Nichols Tg assay following the NCCLS EP9-A guidelines. Concordance testing on the entire n=121 samples was performed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison Study: One hundred twenty-one samples were assayed in parallel between the predicate method and the Nichols Tg assay following the NCCLS EP9-A guidelines. Concordance testing on the entire n=121 samples was performed. Agreement for results less than 60 ng/mL = 93.8%. Agreement for results greater than 60 ng/mL = 97.6%. Relative sensitivity using a cut-off of 5.0 ng/mL or greater = 99%. Relative specificity using a cut-off of less than 5.0 ng/mL = 86%.
Clinical Performance in Patients with Well-Differentiated Thyroid Carcinoma: Nichols Institute Diagnostics obtained permission to use the samples from a published clinical study (Haugen BR et al, 1999 JCEM 84: 3877-3885) that evaluated the use of rhTSH in patients with well-differentiated thyroid cancer. The same patient sample cohort used in the Haugen study was also measured using the Nichols Chemiluminescence Thyroglobulin assay (Tg ICMA). Up to 162 patients with eligible whole body scan results were analyzed for disease detection using serum Tg ICMA results, with and without WBS, against a diagnostic standard. All n=162 had negative thyroglobulin antibody results.
The diagnostic sensitivity and specificity, positive and negative predictive values, and the diagnostic accuracy of the Nichols Tg ICMA were determined from this study.
Results:
THT (baseline): Sensitivity = 42%, Specificity = 98%, PPV = 98%, NPV = 40%, Accuracy = 58%
Post 72-hr rhTSH administration: Sensitivity = 71%, Specificity = 98%, PPV = 99%, NPV = 57%, Accuracy = 79%
Post 72-hr rhTSH plus rhTSH WBS: Sensitivity = 92%, Specificity = 91%, PPV = 96%, NPV = 82%, Accuracy = 92%
Withdrawal Tg testing (alone): Sensitivity = 88%, Specificity = 100%, PPV = 100%, NPV = 77%, Accuracy = 91%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Method Comparison:
Agreement for results less than 60 ng/mL = 93.8%
Agreement for results greater than 60 ng/mL = 97.6%
Relative sensitivity using a cut-off of 5.0 ng/mL or greater = 99%
Relative specificity using a cut-off of less than 5.0 ng/mL = 86%
Clinical Performance:
THT (baseline): Sensitivity = 42%, Specificity = 98%, PPV = 98%, NPV = 40%, Accuracy = 58%
Post 72-hr rhTSH administration: Sensitivity = 71%, Specificity = 98%, PPV = 99%, NPV = 57%, Accuracy = 79%
Post 72-hr rhTSH plus rhTSH WBS: Sensitivity = 92%, Specificity = 91%, PPV = 96%, NPV = 82%, Accuracy = 92%
Withdrawal Tg testing (alone): Sensitivity = 88%, Specificity = 100%, PPV = 100%, NPV = 77%, Accuracy = 91%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Kronus OptiQuant Thyroglobulin kit
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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510(k) Summary 11.0
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Name of Manufacturer, Contact Person and Date Summary Prepared: 1.
Nichols Institute Diagnostics 33047 Calle Aviador San Juan Capistrano, CA 92675 Phone: 949-240-5260 FAX: 949-240-5313 Contact Person: Jimmy Wong, Manager Clinical and Technical Affairs Date Prepared: April 19, 2000
- Device Name:
Device Name: Nichols Institute Diagnostics Chemiluminescence Thyroglobulin Common Name: Thyroglobulin Immunoassay Common Name: Tityroglobulin inimanoussa)
Classification Name:Reagent system for the determination of thyroglobulin in human serum.
- Class II 3. Classification: Regulation Number: 866.6010 Product Code: MSW, Immunology
Kronus OptiQuant Thyroglobulin kit Predicate Device: 4.
Device Description: 5.
The Chemiluminescence Thyroglobulin kit has sufficient reagents for 100 tests. The throglobulin assay is a chemiluminescence sandwich immunoassay assay utilizing a biotinylated goat antiassay 1s a cheinnummicscented sunding monoclonal antibody labeled with acriding for detection. thyrogloutin for captare and a modio monomal and seprosilicate glass tube followed by the A U.200-IIL Serum Sample 1s added to a 12×10 uline and 0.050 mL of acridinium labeled antithyroglobulin reagents. Samples are also run at a 1/10 dilution (hook detection tube) to check for t thyroglountif teagents. Butiples are also in the assay. An avidin-coated bead is then added to the polentially mixture. The assay incubates at room temperature for 16-24 hours on top of a horizontal rotator set & 180 ± 10 rpm. Thyroglobulin in the serum sample binds to the biotinylated antibody and acridinium labeled antibody to form a sandwich-complex. Because of the high affinity between biotin and avidin, the captured sandwich complex binds to the avidin-coated bead. Free oetween brom and avidin, the capitaled antibody are separated from the complex bound to the bead by aspiration of the reaction mixture and subsequent washing. The tubes containing the washed beads are placed into a luminometer, which automatically injects Trigger 1 and 2, initiating the chemiluminescence reaction. The light is quantified by the luminometer and minating the onomianinessonts (RLU). The amount of acridinium labeled antibody bound is directly proportional to the concention of thyroglobulin in the sample. A log-log standard curve uncectly proportional to the concentration of the ordinate versus the respective concentration of each IS gelleration of proting the mount NFO shecissa. The concentration of thyroglobulin is determined directly from the standard curve.
Intended Use: 6.
The Nichols Institute Diagnostic Chemiluminescence Thyroglobulin is a two-site immunometric The Neiners Institute Diegnood of thereglobulin in human serum. The assay is intended to assay for the qualitative for the presence of local and metastatic thyroid tissue in patients who have had prior thyroidectory (using surgery with or without radioiodine). This assay is also indicated for monitoring thyroglobulin levels in combination with radioiodine whole body scans after cations The administration or thyroid hormone withdrawal for detecting presence of thyroid tissue in patients with well-differentiated thyroid cancer. The assay should only be used on patients who lack thyroglobulin autoantibodies.
1
The presence of autoantibodies against thyroglobulin (TgAb) can interfere with assays for thyroglobulin; hence, the TgAb status of the patient should be determined and reported. Thyroglobulin antibodies can be quantitated with the Nichols Chemiluminescence Thyroglobulin Autoantibodies kit (catalog 60-4185).
The concentration of thyroglobulin (Tg) in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, reagent specificity, and presence of thyroglobulin autoantibodies. The results reported by the laboratory to the physician must include the identity of the Tg assay used. Values obtained with different assay methods cannot be used interchangeably. If in the course of serially monitoring a patient, the assay method used for determining Tg levels is changed, additional sequential testing should be carried out to confirm baseline values.
7. Comparison to Predicate Device:
The Nichols Institute Diagnostics Chemiluminescence Thyroglobulin is substantially equivalent to another product in commercial distribution with similar intended use. We assert it is substantially equivalent to the Kronus OptiQuant™ Thyroglobulin kit. The following are similarities and differences for each product.
Method Comparison Study: One hundred twenty-one samples were assayed in parallel between the predicate method and the Nichols Tg assay following the NCCLS EP9-A guidelines. Concordance testing on the entire n=121 samples was performed.
| Nichols
Tg (Y) |