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.
Quick Facts. 1  Kidney stones are made of salts and minerals in the urine that stick together to form small pebbles.. They can be as small as grains of sand or as large as golf balls. 2  There are different types of kidney stones. Most stones are a combination of calcium and oxalate.