(63 days)
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No
The summary describes a standard chemiluminescence immunoassay for measuring TPOAb levels and does not mention any AI or ML components in the device description or performance studies.
No.
This device is an immunoassay kit for the quantitative determination of Thyroid Peroxidase Autoantibodies, intended as an aid in diagnosis and assessment. It does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the immunoassay is "as an aid in the diagnosis and assessment of patients with autoimmune thyroid disease."
No
The device description clearly states it is a "two-site chemiluminescence assay for use with the Nichols Advantage™ Specialty System," indicating it is a laboratory assay kit that requires a specific hardware system for operation, not a standalone software product.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of Thyroid Peroxidase Autoantibodies (TPOAb) in human serum as an aid in the diagnosis and assessment of patients with autoimmune thyroid disease." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information for diagnosis and assessment.
- Device Description: It describes a "two-site chemiluminescence assay," which is a common type of laboratory test performed in vitro.
- Performance Studies: The performance characteristics listed (Intra-Assay, Inter-Assay, Recovery, Parallelism, Specificity, Sensitivity, Specificity, Agreement) are all metrics relevant to the performance of an in vitro diagnostic test.
- Predicate Device: The mention of a predicate device (K931311; Nichols Institute Diagnostics Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
All these elements point to the device being used to analyze a biological sample in vitro to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nichols Advantage™ Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay is intended for use on the Nichols Advantage™ Specialty System for the quantitative determination of Thyroid Peroxidase Autoantibodies (TPOAb) in human serum as an aid in the diagnosis and assessment of patients with autoimmune thyroid disease.
Product codes
JZQ
Device Description
The Nichols Advantage™ Anti-TPO is a two-site chemiluminescence assay for use with the Nichols Advantage™ Specialty System
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics:
Intra-Assay (Mean (IU/mL), n, %CV): 3.4, 20, 5.4; 8.6, 20, 5.0; 52.9, 20, 3.9
Inter-Assay (Mean (IU/mL), n, %CV): 3.4, 20, 14.3; 8.5, 20, 9.6; 54.0, 20, 9.1
Recovery: 94 - 107%
Parallelism: 88 - 117%
High Dose Hook Effect: > 4,000 IU/mL
Specificity and Cross-Reactivity:
Anti-Thyroglobulin: Undetectable
Thyroglobulin: Undetectable
Method Comparison: Preliminary Reference Range: Normal
§ 866.5870 Thyroid autoantibody immunological test system.
(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).
0
K982866 11.0 510(k) SUMMARY
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
not known 510(k) Number:
1. Name of Submitter, Contact Person and Date Summary Prepared:
Nichols Institute Diagnostics 33051 Calle Aviador San Juan Capistrano, CA 92675-4703 Phone: 949-240-5260 Fax: 949-240-5313
Contact Person: Jimmy Wong Date Prepared: July 31, 1998
2. Device Name
| Trade/Proprietary Name: | Nichols Advantage™ Chemiluminescence Thyroid
Peroxidase Autoantibodies Immunoassay |
|-------------------------|---------------------------------------------------------------------------------------|
| Common/Usual Name: | Anti-TPO Assay |
| Classification Name: | Thyroid, Autoantibody Immunological Test System |
3. Predicate Device:
substantial equivalence the Nichols Institute Diagnostics We claim to Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay (K931311, Cleared 5/14/93).
4. Device Description:
The Nichols Advantage™ Anti-TPO is a two-site chemiluminescence assay for use with the Nichols Advantage™ Specialty System
1
5. Intended Use
The Nichols Advantage™ Chemiluminescence Thyroid Peroxidase Autoantibodies Immunoassay is intended for use on the Nichols Advantage™ Specialty System for the quantitative determination of Thyroid Peroxidase Autoantibodies (TPOAb) in human serum as an aid in the diagnosis and assessment of patients with autoimmune thyroid disease.
6. Comparison to predicate device:
The Nichols Advantage™ Anti-TPO is substantially equivalent to other products in commercial distribution for similar use. Most notably, it is substantially equivalent to the NID Chemi Anti-TPO Immunoassay kit.
The following tables compare the Nichols Advantage Anti-TPO with the predicate device. NID Chemi Anti-TPO Immunoassay kit.
Similarities:
- Intended Use: For the quantitative determination of Anti-TPO in human serum. ●
- Both assays use recombinant TPO to bind specific Anti-TPO autoantibodies. ●
- Both assays use human serum for the test sample. .
- The sensitivity of both assays is sufficient to measure Anti-TPO autoantibody levels . found in patients with autoimmune disease.
| Feature | Nichols Advantage™
Anti-TPO | Nichols Institute
Diagnostics
Chemiluminescence
Anti-TPO |
|-------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Sample Size | 15 uL of sample diluted with
435 uL of Assay Diluent
(1:30 dilution).
65 uL of diluted sample
assayed. | 50 uL of sample diluted with
1000 uL of Assay Diluent
(1:21 dilution).
100 uL of diluted sample
assayed. |
| Calibration | Two point calibration every two
weeks (maximum) of stored
working calibration curve; or
when controls out of range. | Full calibration curve with
every run. |
| Solid Phase | Streptavidin-coated magnetic
particles. Streptavidin-biotin
separation technology. | 6 mm bead |
| Incubation | 30 minutes at 37°C | 2 hours at room temperature |
| Sensitivity | 0.5 IU/mL in serum | 0.2 IU/mL in serum |
Differences:
2
Performance Characteristics:
| FEATURE | Nichols AdvantageTM
Chemiluminescence Anti-TPO | | | Nichols Institute Diagnostics
Chemiluminescence Anti-TPO | | |
|--------------------------------------|---------------------------------------------------|----------------------------------------------------|------|-------------------------------------------------------------|----|------|
| | Mean
(IU/mL) | n | %CV | Mean
(IU/mL) | n | %CV |
| Intra-Assay | 3.4 | 20 | 5.4 | 2.4 | 21 | 10.7 |
| | 8.6 | 20 | 5.0 | 77 | 22 | 7.5 |
| | 52.9 | 20 | 3.9 | | | |
| Inter-Assay | Mean
(IU/mL) | n | %CV | Mean
(IU/mL) | n | %CV |
| | 3.4 | 20 | 14.3 | 9.6 | 23 | 9.7 |
| | 8.5 | 20 | 9.6 | 30 | 10 | 9.1 |
| | 54.0 | 20 | 9.1 | | | |
| Recovery | | 94 - 107% | | 92 - 113% | | |
| Parallelism | 88 - 117% | | | Not Done | | |
| High Dose Hook Effect | | > 4,000 IU/mL | | Not Done | | |
| Specificity and
Cross-Reactivity: | | | | | | |
| Anti-Thyroglobulin | | Undetectable | | Not Done | | |
| Thyroglobulin | | Undetectable | | Not Done | | |
| Method Comparison | | Preliminary Reference Range:
Normal