# K970353: Aura Tek FDP

- Pathway: 510(k) (Traditional)
- Applicant: Perimmune, Inc.
- Decided: Apr 30, 1997 after 90 days
- Product code: MMW (System, Test, Tumor Marker, Monitoring, Bladder)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BARD BTA Rapid Urine Test: named in the summary without a submission number

## Most influential descendants
- K994356: Immunocyt (2000), 0 descendants of its own

## Indications for use
AuraTek FDP is a rapid one-step gold dye particle lateral flow immunoassay indicated for the in vitro qualitative measurement of fibrinogen and fibrin/fibrinogen degradation products (FDP) in human urine, to be used with standard cystoscopic examination to aid in the management of patients with a history of bladder cancer.

Source page: https://510kreport.com/device/K970353
Methodology: https://510kreport.com/methodology