510(k) · Cleared
ClearedDia Screen Reagent Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesis Labs, Inc. · JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Cleared on Aug 11, 1995 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Aug 11, 1995
- Review
- 45 days
- Class
- Class II
- Product code
- JIL
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK952971 Dia Screen Reagent StripsGenesis Labs, Inc. · 1995
- Descendant · cites it directly · 5 of its ownK961375 Dia Screen 10 Way Reagent StripsGenesis Labs, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK971976 Diascreen Reagent StripsDia-Screen Corp. · 1997
- Descendant · 2 generations on · 1 of its ownK083184 Tearlab Osmolarity SystemOcusense, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK132066 Inflamma DryRapid Pathogen Screening, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK030650 Stoneguard II Reagent Strips for Urinalysis and Confirm Control…Uridynamics, Inc. · 2003
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K961375Dia Screen 10 Way Reagent StripsGenesis Labs, Inc. · 1996 · cites it directly5descendants
- K971976Diascreen Reagent StripsDia-Screen Corp. · 1997 · cites it directly3descendants
- K083184Tearlab Osmolarity SystemOcusense, Inc. · 2009 · 2 generations on1descendant
- K132066Inflamma DryRapid Pathogen Screening, Inc. · 2013 · 3 generations on0descendants
- K030650Stoneguard II Reagent Strips for Urinalysis and Confirm Control SolutionsUridynamics, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952971 | Dia Screen Reagent Strips | Genesis Labs, Inc. | 1995 | — |
| +1 | K961375 | Dia Screen 10 Way Reagent Strips | Genesis Labs, Inc. | 1996 | — |
| +1 | K971976 | Diascreen Reagent Strips | Dia-Screen Corp. | 1997 | — |
| +2 | K083184 | Tearlab Osmolarity System | Ocusense, Inc. | 2009 | — |
| +3 | K132066 | Inflamma Dry | Rapid Pathogen Screening, Inc. | 2013 | 3 |
| +2 | K030650 | Stoneguard II Reagent Strips for Urinalysis and Confirm Control Solutions | Uridynamics, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JIL device
- #1 K193514 AUTION MAX AX-4060 Urinalysis Systemscore 6.1 · 4 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K961375 (Genesis Labs, Inc., 1996) has gone furthest, with 5 descendants of its own.
How does its category compare?
All JIL devicesJIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIL
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JIL
187in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIL
15in 2025
MAUDE reports naming product code JIL, 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 | 3 | 284 | 0 | 20 |
| 2008 | 0 | — | 0 | 20 |
| 2009 | 1 | — | 0 | 16 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 1 | — | 0 | 14 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 32 |
| 2014 | 1 | — | 4 | 47 |
| 2015 | 1 | — | 0 | 45 |
| 2016 | 2 | — | 1 | 40 |
| 2017 | 1 | — | 0 | 33 |
| 2018 | 4 | 187 | 0 | 68 |
| 2019 | 1 | — | 0 | 67 |
| 2020 | 0 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 1 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 0 | — | 1 | 15 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K952971 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952971: Dia Screen Reagent Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952971
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026