Search Results
Found 1 results
510(k) Data Aggregation
(90 days)
Traumatic brain injury (TBI) test
The TBI test is a panel of in vitro diagnostic chemiluminescent microparticle immunoassays (CMIA) used for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in human plasma and serum and provides a semi-quantitative interpretation of test results derived from these measurements using the Alinity i system.
The interpretation of test results is used, in conjunction with other clinical information, to aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15) within 12 hours of injury, to assist in determining the need for a CT (computed tomography) scan of the head. A negative test result is associated with the absence of acute intracranial lesions visualized on a head CT scan.
The TBI test is intended for use in clinical laboratory settings by healthcare professionals.
The TBI test is a panel of in vitro diagnostic quantitative measurements of GFAP and UCH-L1 and provides a semi-quantitative interpretation of GFAP and UCH-L1 in human plasma and serum.
The GFAP assay (subject device) is an automated immunoassay for the quantitative measurement of GFAP in plasma and serum using chemiluminescent microparticle immunoassay (CMIA) technology on the Alinity i system.
The UCH-L1 assay (subject device) is an automated immunoassay for the quantitative measurement of UCH-L1 in plasma and serum using chemiluminescent microparticle immunoassay (CMIA) technology on the Alinity i system.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the Abbott Laboratories TBI test:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the TBI test are implicitly defined by the clinical performance observed in the pivotal study, particularly regarding its ability to aid in determining the need for a head CT scan in patients with suspected mild TBI. The key performance metrics are Sensitivity and Negative Predictive Value (NPV) as these are critical for a rule-out test for a serious condition like intracranial lesions.
| Acceptance Criteria Category | Metric (Target/Requirement) | Reported Device Performance (Pivotal Study - Archived Samples) | Reported Device Performance (Supplemental Study - Fresh Samples) |
|---|---|---|---|
| Clinical Performance (Rule-Out Test) | High Sensitivity (to minimize false negatives for acute intracranial lesions) | 96.7% (95% CI: 91.7%, 98.7%) | 100.0% (95% CI: 78.5%, 100.0%) |
| High Negative Predictive Value (NPV) (to ensure negative results reliably indicate absence of acute intracranial lesions) | 99.4% (95% CI: 98.6%, 99.8%) | 100.0% (95% CI: 85.7%, 100.0%) | |
| Adjusted NPV (for 6% CT scan positive prevalence) | 99.5% (95% CI: 98.6%, 99.8%) | 99.2% (95% CI: 89.1%, 99.9%) | |
| Other Clinical Metrics | Specificity (percentage of true negatives) | 40.1% (95% CI: 37.8%, 42.4%) | 27.7% (95% CI: 19.2%, 38.2%) |
| Positive Predictive Value (PPV) | 9.8% (95% CI: 8.2%, 11.6%) | 18.9% (95% CI: 11.6%, 29.3%) | |
| Adjusted PPV (for 6% CT scan positive prevalence) | 9.3% (95% CI: 8.9%, 9.8%) | 8.1% (95% CI: 7.2, 9.1%) | |
| Likelihood Ratio Negative (LR-) | 0.08 (95% CI: 0.03, 0.22) | 0.12 (95% CI: 0.01, 1.91) | |
| Likelihood Ratio Positive (LR+) | 1.61 (95% CI: 1.53, 1.70) | 1.38 (95% CI: 1.21, 1.58) | |
| Analytical Performance | Limit of Quantitation (LoQ) for GFAP and UCH-L1 must be suitable for clinical application. | GFAP: 6.1 pg/mL; UCH-L1: 26.3 pg/mL | N/A (Analytical performance is consistent across sample types) |
| Linearity across the analytical measuring interval. | GFAP: 6.1 - 42,000.0 pg/mL; UCH-L1: 26.3 - 25,000.0 pg/mL | N/A | |
| Overall Within-Laboratory Precision (for GFAP and UCH-L1) | GFAP CV |
Ask a specific question about this device
Page 1 of 1