(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 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 (positive cases):** - Predicate identified 66 cases.
- ThyroChek correctly identified 65 out of 66 (98.5% sensitivity).
**For TSH 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 or
§ 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.