510(k) · Cleared
ClearedStoneguard II Reagent Strips for Urinalysis and Confirm Control Solutions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uridynamics, Inc. · CEN Dye-Indicator, Ph (Urinary, Non-Quantitative)
Cleared on Apr 14, 2003 as substantially equivalent to K971976 (Dia-Screen Corp., 1997) after a 45-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Apr 14, 2003
- Review
- 45 days
- Class
- Class I
- Product code
- CEN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K940043 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK940043 Bioscan Reagent StripsBioscan Instruments, Inc. · 1994
- 2 generations backK961375 Dia Screen 10 Way Reagent StripsGenesis Labs, Inc. · 1996
- 1 generation backK971976 Diascreen Reagent StripsDia-Screen Corp. · 1997
- This deviceK030650 Stoneguard II Reagent Strips for Urinalysis and Confirm Control…Uridynamics, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K940043 | Bioscan Reagent Strips | Bioscan Instruments, Inc. | 1994 | — |
| −2 | K961375 | Dia Screen 10 Way Reagent Strips | Genesis Labs, Inc. | 1996 | — |
| −1 | K971976 | Diascreen Reagent Strips | Dia-Screen Corp. | 1997 | — |
| 0 (this device) | K030650 | Stoneguard II Reagent Strips for Urinalysis and Confirm Control Solutions | Uridynamics, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CEN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K961374 | FDA’s K961374 is Philips Multidiagnost 4 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…oratory and clinical studies, we conclude that StoneGuard'" I1Test Strips are substantially equivalent to the legally marketed DiaScreen Reagent Strips for Urinalysis (K961374 &K 971976) as well as the Bellingham & Stanley eclipse Handheld Refractometer for specific gravity and the Corning Model 313 pH… | 1996 |
| * | K971976 | Diascreen Reagent StripsSummary page 2…nd clinical studies, we conclude that StoneGuard'" I1Test Strips are substantially equivalent to the legally marketed DiaScreen Reagent Strips for Urinalysis (K961374 &K 971976) as well as the Bellingham & Stanley eclipse Handheld Refractometer for specific gravity and the Corning Model 313 pH Meter. ==… | 1997 |
| * | — | Corning Model 313 pH Meter with 3-in-1 Combination Gel-Filled Electrode Named without a submission number | |
| * | — | eclipse Handheld Refractometer Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K971976.
How does its category compare?
All CEN devicesCEN Dye-Indicator, Ph (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEN
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · CEN
Too few CEN 510(k)s in any year since 2007 to give a median.
Recalls per year · CEN
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEN
1in 2018
MAUDE reports naming product code CEN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030650: Stoneguard II Reagent Strips for Urinalysis and Confirm Control Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030650
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026