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.
The most common kidney stone type contains calcium in combination with either oxalate or phosphate. These are called calcium oxalate stones or calcium phosphate kidney stones, respectively.Calcium is a normal part of a healthy diet and makes up important parts of the body, such as bones and muscles.he most common kidney stone type contains calcium in combination with either oxalate or phosphate. These are called calcium oxalate stones or calcium phosphate kidney stones, respectively.