510(k) · Cleared
ClearedDia Screen 10 Way 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 Jun 18, 1996 as substantially equivalent to K940043 (Bioscan Instruments, Inc., 1994) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1994. 5 later devices descend from it.
- Decided
- Jun 18, 1996
- Review
- 70 days
- Class
- Class II
- Product code
- JIL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K940043 (1994). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK940043 Bioscan Reagent StripsBioscan Instruments, Inc. · 1994
- This deviceK961375 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
- Descendant · cites it directly · 0 of its ownK981555 Diascreen Reagent StripsChronimed, Inc. · 1998 · Recalled
Most influential descendants
Showing 5 of 5 · See all- 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
- K981555Diascreen Reagent StripsChronimed, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940043 | Bioscan Reagent Strips | Bioscan Instruments, Inc. | 1994 | — |
| 0 (this device) | 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 | — |
| +1 | K981555 | Diascreen Reagent Strips | Chronimed, Inc. | 1998 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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 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? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K940043 | Bioscan Reagent StripsSummary page 2…by Dia-Screen. The intended use of the strips which are the subject of this new premarket notification is exactly the same as the strips which were reviewed previously (K940043 and K952971). [f] Substantial Equivalence The intended use of the strips which are the subject of this new premarket notificati… | 1994 |
| * | K952971 | Dia Screen Reagent StripsSummary page 2…iously received determinations of substantial equivalence for complete lines of urine reagent strips which have been marketed under the Bioscan (KS40043) and DIA SCREEN (K952971) label. The DIA SCREEN® Reagent Strips will be manufactured by Genesis Labs for distribution by Dia-Screen. The intended use of… | 1995 |
| * | — | Ames Multistix 10 SG Named without a submission number | |
| * | — | Behring Rapignost Named without a submission number | |
| * | — | Boehringer Mannheim Chemstrip urine test strip system Named without a submission number |
What descends from it? (5)
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?
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 | — |
What is it indicated for?
The DIA SCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semiquantitative urinalysis. DIA SCREEN® Reagent Strips have been developed to allow health care professionals to test semiquantitatively for patient urine levels of specific gravity, ketone, glucose, protein, blood, nitrite, pH, ascorbic acid, bilirubin, and urobilinogen by visual comparison with a color chart.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961375 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961375: Dia Screen 10 Way 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/K961375
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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