TBI
by Abbott Laboratories 510(k)
Active
510(k) K232669
Overview
The TBI is a traumatic brain injury assessment test that detects brain trauma without the need for a CT scan. This device provides faster results and is designed to be used in medical settings for evaluating patients with suspected traumatic brain injuries.
The TBI test is supplied for use in laboratory settings and runs on Abbott's Alinity i and Architect i1000SR laboratory instruments. It is authorized under FDA 510K clearance with product code QAT and is classified as a Class II medical device. The device is intended for use in major hospitals and laboratories for the assessment of traumatic brain injuries.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK232669 | Date29 Sep 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QAT
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5830
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the TBI test used for?
The TBI is a traumatic brain injury assessment test designed to detect brain trauma without requiring a CT scan. It provides faster results and is intended for use in medical settings for evaluating patients with suspected traumatic brain injuries.
How is the TBI test supplied and what instruments does it run on?
The TBI test is supplied for use in laboratory settings and runs specifically on Abbott's Alinity i and Architect i1000SR laboratory instruments. It is designed for use in major hospitals and laboratories for the assessment of traumatic brain injuries.
What is the regulatory classification of the TBI test?
The TBI test is authorized under FDA 510K clearance with product code QAT and is classified as a Class II medical device. It received FDA clearance on September 29, 2023, with decision code SESE indicating it is substantially equivalent to other devices.
Is the TBI test single-use or reusable?
The device information does not specify whether the TBI test is single-use or reusable. As a laboratory test, it may be designed for single-use applications to ensure accuracy and prevent cross-contamination, but this detail is not explicitly stated in the provided data.