510(k) · Cleared
ClearedDiascreen Reagent Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dia-Screen Corp. · LJX Test, Urine Leukocyte
Cleared on Jun 17, 1997 as substantially equivalent to K940043 (Bioscan Instruments, Inc., 1994) and 3 other predicates after a 19-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Jun 17, 1997
- Review
- 19 days
- Class
- Class I
- Product code
- LJX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K940043 (1994). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK940043 Bioscan Reagent StripsBioscan Instruments, Inc. · 1994
- 1 generation backK961375 Dia Screen 10 Way Reagent StripsGenesis Labs, Inc. · 1996
- This deviceK971976 Diascreen Reagent StripsDia-Screen Corp. · 1997
- Descendant · cites it directly · 1 of its ownK083184 Tearlab Osmolarity SystemOcusense, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK132066 Inflamma DryRapid Pathogen Screening, Inc. · 2013 · Recalled
- Descendant · cites it directly · 0 of its ownK030650 Stoneguard II Reagent Strips for Urinalysis and Confirm Control…Uridynamics, Inc. · 2003
Most influential descendants
Showing 3 of 3 · See all- K083184Tearlab Osmolarity SystemOcusense, Inc. · 2009 · cites it directly1descendant
- K132066Inflamma DryRapid Pathogen Screening, Inc. · 2013 · 2 generations on0descendants
- K030650Stoneguard II Reagent Strips for Urinalysis and Confirm Control SolutionsUridynamics, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940043 | Bioscan Reagent Strips | Bioscan Instruments, Inc. | 1994 | — |
| −1 | K961375 | Dia Screen 10 Way Reagent Strips | Genesis Labs, Inc. | 1996 | — |
| 0 (this device) | K971976 | Diascreen Reagent Strips | Dia-Screen Corp. | 1997 | — |
| +1 | K083184 | Tearlab Osmolarity System | Ocusense, Inc. | 2009 | — |
| +2 | K132066 | Inflamma Dry | Rapid Pathogen Screening, Inc. | 2013 | 3 |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 LJX? 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 LJX device
- #1 K231045 Healgen URS Test Stripsscore 14.8 · 2 generations · no Class I recall
What was it cleared against? (7)
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…eagent strips. They are K961375 and K952971. The intended use of the strips that are the subject of this new premarket notification is exactly the same as the Bioscan (K940043, K943008) and DIASCREEN® (K952971, K961375) strips which were reviewed previously. [f] Substantial Equivalence The intended use… | 1994 |
| * | K943008 | Bioscan Reagent StripsSummary page 2…ehalf of Chung Do Pharmaceutical Co., Ltd and Bioscan Instruments, Inc.(now defunct) under Dia-Screen Corporation’s former name, Genesis Labs Inc. These are KS840043 and K943008. In addition, Dia-Screen Corporation, which is a FDA registered facility, has received two 510k’s for its own manufactured urine… | 1994 |
| * | K952971 | Dia Screen Reagent StripsSummary page 2…008. In addition, Dia-Screen Corporation, which is a FDA registered facility, has received two 510k’s for its own manufactured urine reagent strips. They are K961375 and K952971. The intended use of the strips that are the subject of this new premarket notification is exactly the same as the Bioscan (K94… | 1995 |
| * | K961375 | Dia Screen 10 Way Reagent StripsSummary page 2…043 and K943008. In addition, Dia-Screen Corporation, which is a FDA registered facility, has received two 510k’s for its own manufactured urine reagent strips. They are K961375 and K952971. The intended use of the strips that are the subject of this new premarket notification is exactly the same as the B… | 1996 |
| * | — | Bayer Multistix 10 SG Named without a submission number | |
| * | — | Behring Rapignost Named without a submission number | |
| * | — | Boehringer Mannheim Chemstrip urine test strip systems Named without a submission number |
What descends from it? (3)
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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K083184 (Ocusense, Inc., 2009) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K940043.
How does its category compare?
All LJX devicesLJX Test, Urine Leukocyte: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LJX
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LJX
Too few LJX 510(k)s in any year since 2007 to give a median.
Recalls per year · LJX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LJX
7in 2025
MAUDE reports naming product code LJX, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip and is intended for use as an in vitro diagnostic aid using urine specimens. The strip contains solid phase reagent areas affixed to a plastic strip and is provided in a dry reagent format. The strip provides qualitative and semi-quantitative tests for specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a…
Read the full statement (130 words)
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip and is intended for use as an in vitro diagnostic aid using urine specimens. The strip contains solid phase reagent areas affixed to a plastic strip and is provided in a dry reagent format.
The strip provides qualitative and semi-quantitative tests for specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart for each concentration range. No additional reagents and laboratory equipment are required. The reagent strips are packaged in a plastic vial containing a desiccant. The test strips must be kept tightly capped in the vial to assure reagent reactivity. The directions must be followed exactly and it is necessary to use fresh, well-mixed, uncentrifuged urine for optimal results.
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/K971976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971976: Diascreen Reagent Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971976
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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