(90 days)
No
The summary describes a standard immunometric assay based on chemical reactions, with no mention of AI/ML terms, image processing, or data-driven algorithms for analysis.
No
The device is an immunometric assay designed to indicate the concentration of TSH in a serum sample, which is a diagnostic function, not a therapeutic one.
Yes
This device is designed to indicate whether a serum sample contains TSH above a certain concentration, which is used for diagnostic purposes (e.g., assessing thyroid function). The performance studies also show its ability to distinguish between samples with different TSH levels, further supporting its diagnostic function.
No
The device is described as an "immunometric assay device" and the performance studies detail laboratory tests on serum samples, indicating a physical assay component rather than purely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it's an "immunometric assay device" designed to "indicate whether a serum sample contains TSH in a concentration > 5 wW/ml." This clearly indicates it's used to test a biological sample (serum) in vitro (outside the body) to provide diagnostic information (the presence and concentration of TSH).
- Device Description: The description reiterates its function as an "immunometric assay device" for use with a "serum sample."
- Performance Studies: The performance studies described (Quantitative Recovery, Serial Dilution, Parallelism, Cross-Reactivity, Interference) are all typical studies conducted to validate the performance of an in vitro diagnostic assay. They involve testing the device's ability to accurately measure or detect a substance in biological samples.
- Predicate Device: The mention of a "Predicate Device(s)" which is an "Immunolite Third Generation TSH Assay" (K930007) further confirms its nature as an IVD, as predicate devices are used for comparison in the regulatory submission process for new medical devices, including IVDs.
Therefore, based on the provided information, this device fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This new immunometric assay device is a single-use Class II medical device for professional use that is designed to indicate whether a serum sample contains TSH in a concentration > 5 wW/ml.
Product codes
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Device Description
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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
professional use
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The document contains the results of a number of validation studies comparing the performance of ThyroChek to Immunolite Third Generation TSH Assay (K930007).
- Quantitative Recovery: Demonstrated the assay's ability to discriminate serum samples containing TSH concentrations of 5.2, 5.7, and 6.5 µlU/ml from samples with 4.1 and 4.5 µIU/ml.
- Serial Dilution: Demonstrated the assay's ability to distinguish serum samples containing TSH > 5 µlU/ml from those diluted below 5 µlU/ml.
- Coefficient of Variation: 5 sets of 30 replicates showed uniform results (30 identical results in 4 of 5 sets, 29 of 30 replicates agreed in 1 of 5 sets). 25 samples measured in duplicate showed 100% agreement. Intra-assay coefficient of variation was less than 3%.
- Parallelism: 328 patient samples were assayed in parallel. 65 of 66 patients with TSH > 5 µIU/ml (as determined by the predicate device) were correctly identified. 262 of 262 patients with TSH 40 mlU/ml) from 17 postmenopausal women showed no interference with ThyroChek performance, or false negative/positive results.
- Interference: Elevated concentrations of glucose, uremic metabolites, lipids, or hemolyzed red blood cells did not interfere with device performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Immunolite Third Generation TSH Assay, 510(k) number K930007
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
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§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.
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14. SMDA Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. This new immunometric assay device is a single-use Class II medical device for professional use that is designed to indicate whether a serum sample contains TSH in a concentration > 5 wW/ml. The intended use, technical characteristics, efficacy, and safety of this new device are substantially equivalent at detecting TSH > 5 µIU/ml to a number of other TSH immunoassays that have been commercially available both before and after 1978, and Franklin believes that demonstration of substantial equivalence to a legally marketed predicate device in accordance with section 510(k) has been demonstrated.
This document contains the results of a number of validation studies which compares the performance of ThyroChek at detecting TSH > > 5 µU/ml to that of a predicate medical device, Immunolite Third Generation TSH Assay, 510(k) number K930007. The validating studies performed and the results obtained are as follows:
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Quantitative Recovery. This demonstrated the ability of this assay to discriminate serum samples containing TSH at concentrations of 5.2, 5.7, and 6.5 µlU/ml, as determined by the predicated device, from samples containing TSH at a concentration of 4.1 and 4.5 µIU/ml.
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Serial Dilution. This demonstrated the ability of this assay to distinguish serum samples containing TSH > 5 µlU/ml from those with a TSH concentration diluted below 5 ulU/ml.
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Coefficient of Variation. 5 sets of 30 replicates showed uniform results, that is 30 identical results, using ThyroChek in 4 of 5 sets and 29 of 30 replicates agreed in 1 of 5 sets. Additionally 25 samples measured in duplicate showed 100% agreement between both replicates. This represents an intra-assay coefficient of variation of less than 3%.
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Parallelism. 328 patient samples were assayed in parallel by the predicate device and by ThyroChek. 65 of 66 patients with TSH > 5 µIU/ml, as determined by the predicate device, were correctly identified using ThyroChek. 262 of 262 patients with TSH 40 mlU/ml, as encountered in 17 postmenopausal women, did not produce false negative or positive test results or affect ThyroChek's ability to determine whether a serum sample contained > 5 ulU/ml.
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- Interference. Elevated concentrations of glucose, uremic metabolites, lipids, or hemolyzed red blood cells as encountered in patient samples did not interfere with device performance.
This 510(k) Summary Statement was revised by J. Ehrenkranz, M.D. on 20 March, 1996.
Y. Henley ds