# K030650: Stoneguard II Reagent Strips for Urinalysis and Confirm Control Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Uridynamics, Inc.
- Decided: Apr 14, 2003 after 45 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
Longest line of descent: 3 generations back to K940043 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971976: Diascreen Reagent Strips, Dia-Screen Corp. (1997) Summary page 2.
- (no number) Corning Model 313 pH Meter with 3-in-1 Combination Gel-Filled Electrode: named in the summary without a submission number
- (no number) eclipse Handheld Refractometer: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K961374: Philips Multidiagnost 4, Philips Medical Systems, Inc. (1996). Our reading of the summary gave K961374, FDA’s number for Philips Multidiagnost 4 (Philips Medical Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “DiaScreen Reagent Strips for Urinalysis”. Kept off the family tree. Summary page 2.

## Indications for use
UriDynamics StoneGuardTM II Test Strips are intended for semiquantitative measurement of pH and specific gravity in fresh urine. They can be used to monitor conditions that may cause the formation of kidney stones, namely trends in urinary pH and hydration status. Confirm LowTM and Confirm HighTM Control Solutions are intended for in vitro (external) use only, for use as control materials for StoneGuardTM II Test Strips only.

Source page: https://510kreport.com/device/K030650
Methodology: https://510kreport.com/methodology