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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

• 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

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