Medical Device Link.

Originally Published IVD Technology March 2004

Commentary

An IVAT submission for analytical 510(k) clearance will include the following:

• Device Description and Classification. IVATs are generic devices that are intended for the qualitative or quantitative measurement of an analyte in human body fluids or tissue. They will be classified by their analytical function, consistent with the claims for which they are cleared. 

• Identification of Predicate Device/Substantial Equivalence Comparison. As with other 510(k) submissions, IVAT applications should identify the predicate device to which the new device is being compared, and should discuss the similarities and differences of the new device compared with the predicate device.

• Indications for Use. The indications for use statement should describe the analyte that the IVAT is intended to measure.

• Validation of Specific Performance Characteristics. The IVAT application should provide assurance that the test does what it is supposed to do. In other words, that the test accurately measures either the property or characteristic that it is expected to measure. In addition, as appropriate, the application should assess the following:

• Design and manufacturing. 
• Analytical performance studies, such as validation of accuracy, linear range, precision/reproducibility, analytical sensitivity, analytical specificity,  
interfering substances, limits of quantitation/detection, and high-dose hook effect studies.
• Data processing.
• Qualification of instrumentation. If an IVAT is to be supplied as part of a system, the application should demonstrate that the instruments are 
qualified for use with the assay. 
• Reagent stability. 

• Correlation Studies. Where correlation studies are appropriate, the sponsor may compare the IVAT to another device, a reference method, or peer-reviewed literature; do a resolution of comparison discrepancies; identify analytical false-positive or false-negative results; or evaluate tests by employing quantitative measurement techniques.

• Labeling. In addition to the statutory requirements for labeling of all medical devices, IVAT applications must also consider the following:

• IVAT manufacturers may not make any clinical utility claims in labeling, advertising, or other promotional materials.
• IVAT manufacturers are encouraged to incorporate warnings and disclaimers in their labeling, including a statement providing that a clinical evaluation of the test has not been conducted.
• Labeling must state the validated analytical range for the test, but may not provide diagnostic cutoff values or normal ranges.
• IVATs should only be sold to those clinical laboratories that are certified to perform these tests, according to 42 CFR Part 493.

In addition to the requirements set forth in the analytical 510(k) clearance regulations, IVATs remain subject to the following FDA regulations:

• Device registration and listing.
• Quality system regulation (good manufacturing 
practices).
• Medical device reports.
• Corrections, removals, and recalls. 

Copyright ©2004 IVD Technology