# K051727: Aimstick Urine Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Germaine Laboratories, Inc.
- Decided: Oct 26, 2005 after 120 days
- Product code: CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative))
- Device class: 1
- Regulation: 21 CFR 862.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Bayer MultiStix® 10 SG: named in the summary without a submission number

## Indications for use
The AimStick® Urine Reagent Strips are intended for the qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in urine for persons to test by visual comparison with a color chart on the bottle label. This product is for professional use. Test results may provide information regarding the status of carbohydrate metabolism, kidney function, liver function, acid-base balance, and bacturia.

Source page: https://510kreport.com/device/K051727
Methodology: https://510kreport.com/methodology