TBI

K232669 · Abbott Laboratories · QAT · Sep 29, 2023 · Immunology

Device Facts

• Record ID: K232669
• Device Name: TBI
• Applicant: Abbott Laboratories
• Product Code: QAT · Immunology
• Decision Date: Sep 29, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5830
• Device Class: Class 2

Indications for Use

The TBI test is an in vitro diagnostic test for the quantitative determination of glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) in human EDTA plasma. The TBI test is to be used as an aid in the evaluation of patients, 18 years of age or older, presenting with suspected mild traumatic brain injury (TBI) (Glasgow Coma Scale score 13-15) to assist in determining the need for further diagnostic evaluation, such as a head CT scan. The TBI test is intended for use in a clinical laboratory setting by trained professionals.

Device Story

TBI test is a panel of two automated, two-step chemiluminescent microparticle immunoassays (CMIA) for quantitative measurement of GFAP and UCH-L1 in human plasma and serum. Device uses ARCHITECT i1000SR System to measure chemiluminescent reaction (RLU) proportional to analyte concentration. Healthcare professionals in clinical laboratories operate the system. Software interprets quantitative results against established cutoffs (35.0 pg/mL for GFAP; 400.0 pg/mL for UCH-L1) to provide a semi-quantitative TBI interpretation (Negative/Positive). Output assists clinicians in evaluating need for head CT scan in mild TBI patients; negative result correlates with absence of acute intracranial lesions on CT. Benefits include potential reduction in unnecessary head CT scans.

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification of labeling modifications to mitigate reagent carryover.

Technological Characteristics

In vitro diagnostic immunoassay; utilizes ARCHITECT i1000SR system platform. Modification is limited to labeling/workflow instructions to manage reagent carryover between 25-OH Vitamin D and GFAP assays. No changes to fundamental scientific technology, reagents, or hardware.

Indications for Use

Indicated for use as an aid in the evaluation of patients 18 years or older with suspected mild traumatic brain injury (GCS 13-15) to determine the need for head CT imaging.

Regulatory Classification

Identification

A brain trauma assessment test is a device that consists of reagents used to detect and measure brain injury biomarkers in human specimens. The measurements aid in the evaluation of patients with suspected mild traumatic brain injury in conjunction with other clinical information to assist in determining the need for head imaging per current standard of care.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) The 21 CFR 809.10(b) compliant labeling must include detailed descriptions of and results from performance testing conducted to evaluate precision, accuracy, linearity, analytical sensitivity, interference, and cross-reactivity. This information must include the following: (i) Performance testing of device precision must, at minimum, use one unmodified clinical specimen from the intended use population with concentration of the brain injury biomarker(s) near the medical decision point. Contrived specimens that have been generated from pooling of multiple samples or spiking of purified analyte to cover the measuring range may be used, but the contrived samples must be prepared to mimic clinical specimens as closely as possible. This testing must evaluate repeatability and reproducibility using a protocol from an FDA-recognized standard. (ii) Device performance data must be demonstrated through a clinical study and must include the following: (A) Data demonstrating clinical validity including the clinical sensitivity and specificity, and positive and negative predictive value of the test in the intended use population of patients with suspected mild traumatic brain injury ( *i.e.,* Glasgow Coma Score (GCS) of 13-15), or equivalent standard of care for determination of severity of traumatic brain injury (TBI).(B) Study must be performed using the operators and in settings that are representative of the types of operators and settings for which the device is intended to be used. (C) All eligible subjects must meet the well-defined study inclusion and exclusion criteria that define the intended use population. The prevalence of diseased or injured subjects in the study population must reflect the prevalence of the device's intended use population, or alternatively, statistical measures must be used to account for any bias due to enrichment of subpopulations of the intended use population. (D) All eligible subjects must have undergone a head computerized tomography (CT) scan or other appropriate clinical diagnostic standard used to determine the presence of an intracranial lesion as part of standard of care and must also be evaluated by the subject device. All clinical diagnostic standards used in the clinical study must follow standard clinical practice in the United States. (E) Relevant demographic variables and baseline characteristics including medical history and neurological history. In addition, head injury characteristics, neurological assessments, and physical evidence of trauma must be provided for each subject. This information includes but is not limited to the following: Time since head injury, time from head injury to CT scan, time from head injury to blood draw, GCS score or equivalent, experience of loss of consciousness, presence of confusion, episodes of vomiting, post-traumatic amnesia characteristics, presence of post-traumatic seizures, drug or alcohol intoxication, mechanism of injury, acute intracranial lesion type, neurosurgical lesion, and cranial fracture. (F) Each CT scan or other imaging result must be independently evaluated in a blinded manner by at least two board-certified radiologists to determine whether it is positive or negative as defined by the presence or absence of acute intracranial lesions. This independent review must be conducted without access to test results of the device. Prior to conducting the review, the criteria and procedures to be followed for scoring the images must be established, including the mechanism for determining consensus. (G) All the clinical samples must be tested with the subject device blinded to the TBI status and the neurological-lesion-status of the subject. (H) Details on how missing values in data are handled must be provided. (I) For banked clinical samples, details on storage conditions and storage period must be provided. In addition, a specimen stability study must be conducted for the duration of storage to demonstrate integrity of archived clinical samples. The samples evaluated in the assay test development must not be used to establish the clinical validity of the assays. (iii) Performance testing of device analytical specificity must include the most commonly reported concomitant medications present in specimens from the intended use population. Additionally, potential cross-reacting endogenous analytes must be evaluated at the highest concentration reported in specimens from the intended use population. (iv) Expected/reference values generated by testing a statistically appropriate number of samples from apparently healthy normal individuals. (2) The 21 CFR 809.10(a) and (b) compliant labeling must include the following limitations: (i) A limiting statement that this device is not intended to be used a stand-alone device but as an adjunct to other clinical information to aid in the evaluation of patients who are being considered for standard of care neuroimaging. (ii) A limiting statement that reads “A negative result is generally associated with the absence of acute intracranial lesions. An appropriate neuroimaging method is required for diagnosis of acute intracranial lesions.” (iii) As applicable, a limiting statement that reads “This device is for use by laboratory professionals in a clinical laboratory setting.”

Predicate Devices

• TBI for Alinity i (K223602)

Submission Summary (Full Text)

{0}

FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K232669

B Applicant

Abbott Laboratories

C Proprietary and Established Names

TBI

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QAT | Class II | 21 CFR 866.5830 - Brain trauma assessment test | IM - Immunology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

This change was for modification of the cleared TBI test for use on the ARCHITECT i1000SR System due to the identification during design evaluation of the potential for reagent carryover with 25-OH Vitamin D assay that may lead to elevated GFAP assay results. A limitation in the package insert for the TBI test for use on the ARCHITECT i1000SR System informs users of a potential risk for false positive TBI results for the GFAP assay when the TBI test is run after the 25-OH Vitamin D assay and provides actions to take to mitigate potential contamination after 25-OH Vitamin D assay testing.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

K232669 - Page 2 of 2