# K972297: Amylase-Incorporating Dynamic Stabilization Technology - (DST)

- Pathway: 510(k) (Traditional)
- Applicant: Trace America, Inc.
- Decided: Jul 17, 1997 after 28 days
- Product code: JFJ (Catalytic Methods, Amylase)
- Device class: 2
- Regulation: 21 CFR 862.1070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K070249: Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/H (2007), 11 descendants of its own
- K070146: Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP (2007), 3 descendants of its own
- K123171: Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P Cont (2013), 2 descendants of its own
- K081276: Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H (2008), 2 descendants of its own
- K110530: Abx Pentra Creatinine 120 CP; Abx Pentra Multical;  Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control (2012), 1 descendant of its own

## Indications for use
Intended for the In Vitro, quantitative determination of Amylase in human serum and urine for clinical diagnosis. "This Amylase test system is a device intended to measure the activity of the enzyme amylase in serum, and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas)". , CFR 862.1070

Source page: https://510kreport.com/device/K972297
Methodology: https://510kreport.com/methodology