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.
Kidney stones can contain various components. The most common type of stone contains calcium in combination with either oxalate or phosphate. A less common type of stone is caused by an infection in the urinary tract. This type of stone is called a struvite or infection stone.