A study on the claims of the test is unnecessary if they are unchanged from the predicate test. Thus these studies are shorter, can be retrospective, and are considerably less expensive ($1-2 million). However, it is unlikely that any new test developed by a UCSF researcher can be approved through the 510K route.
Kidney stones (renal lithiasis, nephrolithiasis) are small, hard mineral deposits that form inside your kidneys. The stones are made of mineral and acid salts.idney stones (renal lithiasis, nephrolithiasis) are small, hard mineral deposits that form inside your kidneys. The stones are made of mineral and acid salts.
1 Most kidney stones are calcium stones, usually in the form of calcium oxalate. 2  Oxalate is a naturally occurring substance found in food. 3  Some fruits and vegetables, as well as nuts and chocolate, have high oxalate levels. 4  Your liver also produces oxalate.nowing the type of kidney stone helps determine the cause and may give clues on how to reduce your risk of getting more kidney stones. Types of kidney stones include: 1  Calcium stones. 2  Most kidney stones are calcium stones, usually in the form of calcium oxalate.