510(k) · Cleared
Recalled · 2010Diascreen Reagent Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chronimed, Inc. · LJX Test, Urine Leukocyte
Cleared on Jun 1, 1998 as substantially equivalent to K943008 (Genesis Labs, Inc., 1994) and 1 other predicate after a 31-day review. Its family tree reaches back 2 generations to 1994. It has been recalled once.
- Decided
- Jun 1, 1998
- Review
- 31 days
- Class
- Class I
- Product code
- LJX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K940043 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
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) | K981555 | Diascreen Reagent Strips | Chronimed, Inc. | 1998 | — |
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 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? (3)
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 |
|---|---|---|---|
| * | K943008 | Bioscan Reagent StripsSummary page 2…ence The intended use of the strips which are the subject of this new pre-market notification is exactly the same as the strips which were reviewed previously (K940043, K943008, K952971, K961375, K971976). SS and E Page 2 The design and function of the new DIASCREEN® Reagent Strips are th… | 1994 |
| * | K961375 | Dia Screen 10 Way Reagent StripsSummary page 2…stantial equivalence for complete lines of ) reagent strips for urinalysis which have been marketed under the Bioscan label (K940043) and the DIASCREEN® label (K952971, K961375). The intended use of the strips that are the subject of this new premarket notification is exactly the same as the Bioscan (K940… | 1996 |
| * | — | Bayer Multistix 10 SG Reagent Strips for Urinalysis 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2010 | Not classified | Z-2634-2010 | Labeling False and Misleading | This recall has been initiated due to a labeling issue with the Hypoguard DiaScreen 4-way pH 100 strips. The front and back panel of the bottle carton lists five reagents when it should only list four reagents. The Ketone reagent should… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 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.
- 1 other device also cites its predicate K943008.
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/K981555 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981555: Diascreen 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/K981555
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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