Get 510(k) Substantial Equivalence Determination Decision Memorandum Assay And Instrument Combination

To demonstrate substantial equivalence, manufacturers must show that the new device performs the same function(s) as the predicate device, is intended for the same use as the predicate device, and that any differences between the two devices do not raise any new safety or efficacy concerns.

4.4. Specimen type: The Nova StatStrip® is designed for use with fresh capillary, arterial, venous, neonatal heel stick or neonatal arterial whole blood. The most common usage is capillary whole blood by finger-stick.

Substantial equivalence means that the new device is as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate it: has the same intended use as the predicate; and. has the same technological characteristics as the predicate; or.

What is the substantial equivalence pathway? Substantial equivalence is a pathway to seek permission to market a new tobacco product that involves comparing the new tobacco product to a legally marketed predicate product.

To establish substantial equivalence, the modified product is tested by the manufacturer for unexpected changes to a targeted set of components such as toxins, nutrients, or allergens, that are present in a similar unmodified food. The manufacturer's data is then assessed by a regulatory agency.

A Substantial Equivalence (SE) Report can be submitted by any manufacturer for any new tobacco product seeking an FDA substantially equivalent order, under section 905(j) of the Federal Food, Drug, and Cosmetic (FD&C) Act.