(90 days)
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.
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.
Here's an analysis of the provided text, extracting the requested information about acceptance criteria and the study that proves the device meets them:
K960195 - ThyroChek TSH Immunoassay
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (ThyroChek) |
|---|---|
| Discrimination of TSH > 5 µIU/ml vs. < 5 µIU/ml (Quantitative Recovery): Ability to distinguish serum samples with TSH concentrations slightly above 5 µIU/ml from those slightly below. | Successfully distinguished samples: - 5.2, 5.7, 6.5 µIU/ml (above 5) - 4.1, 4.5 µIU/ml (below 5) |
| Ability to distinguish TSH > 5 µIU/ml from diluted samples below 5 µIU/ml (Serial Dilution): | Successfully distinguished samples. |
| Intra-Assay Precision (Coefficient of Variation): Reproducibility of results within the same assay run. | - 4 out of 5 sets of 30 replicates showed 30 identical results. - 1 out of 5 sets showed 29 of 30 replicates agreed. - 25 samples in duplicate showed 100% agreement. - Implies an intra-assay coefficient of variation of less than 3%. |
| Accuracy / Agreement with Predicate Device (Parallelism): Correctly identifying TSH levels > 5 µIU/ml and < 5 µIU/ml compared to a legally marketed predicate device. | For TSH > 5 µIU/ml (positive cases): - Predicate identified 66 cases. - ThyroChek correctly identified 65 out of 66 (98.5% sensitivity). For TSH < 5 µIU/ml (negative cases): - Predicate identified 262 cases. - ThyroChek correctly identified 262 out of 262 (100% specificity). |
| Lack of Cross-Reactivity: No interference from high concentrations of structurally similar hormones (hCG, LH, FSH). | - hCG (up to 150,000 mlU/ml) did not produce false negative/positive results or affect TSH determination. - LH / FSH (> 40 mlU/ml from 17 postmenopausal women) did not produce false negative/positive results or affect TSH determination. |
| Lack of Interference: No interference from common physiological substances (glucose, uremic metabolites, lipids, hemolyzed red blood cells). | Elevated concentrations of glucose, uremic metabolites, lipids, or hemolyzed red blood cells did not interfere with device performance. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Quantitative Recovery: Number of samples not explicitly stated, but includes samples determining 5 TSH concentrations (5.2, 5.7, 6.5, 4.1, 4.5 µlU/ml).
- Serial Dilution: Number of samples not explicitly stated.
- Coefficient of Variation:
- 5 sets of 30 replicates (total 150 replicates from 5 samples).
- 25 samples measured in duplicate (total 50 replicates from 25 samples).
- Parallelism:
- Total: 328 patient samples.
- Positive (TSH > 5 µIU/ml): 66 samples (as determined by predicate).
- Negative (TSH < 5 µIU/ml): 262 samples (as determined by predicate).
- Cross-Reactivity:
- Number of samples containing hCG (not specified).
- 17 postmenopausal women for LH/FSH.
- Interference: Number of samples not specified.
Data Provenance: Not explicitly stated, but the "328 patient samples" suggests human patient data. The country of origin and whether it's retrospective or prospective are not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The text does not mention the use of experts to establish ground truth for the test set.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The ground truth (or reference standard) for the "Parallelism" study was established by a single predicate device (Immunolite Third Generation TSH Assay, K930007).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. This study is for an immunoassay device, which typically outputs a single value rather than requiring human interpretation of an image or signal. The "Parallelism" study compares the device's performance to another device, not to human readers.
6. Standalone Performance Study
Yes, the studies described, particularly the "Parallelism" study, represent a standalone (algorithm only without human-in-the-loop) performance evaluation. The ThyroChek device's output (TSH > 5 µIU/ml or < 5 µIU/ml) is directly compared to the output of the predicate device.
7. Type of Ground Truth Used
The primary ground truth (or reference standard) used for the "Parallelism" study was the predicate device, Immunolite Third Generation TSH Assay (K930007). This means the device's performance was evaluated against the measurements of another already-approved TSH immunoassay.
8. The Sample Size for the Training Set
The document does not mention a training set or the sample size for one. This device is an immunoassay, which typically doesn't involve "training" in the machine learning sense. Its performance is based on its chemical and biological design.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for this immunoassay, this question is not applicable.
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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 < 5 wIU/ml, as determined by the predicate device, were correctly identified by ThyroChek.
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Cross-Reactivity. Because of the structural similarity between TSH and hCG, LH, and FSH, studies were performed to determine if maximal concentrations of these hormones would interfere with ThyroChek performance. These studies showed that hCG, in concentrations as high as 150,000 mlU/ml, and LH / FSH > 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
§ 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.