510(k) · Cleared
ClearedUristik H Series Reagent Strips for Urinalysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dirui Industrial Co., Ltd. · JIO Blood, Occult, Colorimetric, In Urine
Cleared on Aug 26, 2004 as substantially equivalent to K861255 (Behring Diagnostics, Inc., 1986) and 2 other predicates after a 162-day review. Its family tree reaches back 1 generation to 1986. 3 later devices descend from it.
- Decided
- Aug 26, 2004
- Review
- 162 days
- Class
- Class II
- Product code
- JIO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K861255 (1986). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK861255 Behring Rapignost Total Screen L Urine Test StripsBehring Diagnostics, Inc. · 1986
- This deviceK040703 Uristik H Series Reagent Strips for UrinalysisDirui Industrial Co., Ltd. · 2004
- Descendant · cites it directly · 1 of its ownK082811 Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and…Urit Medical Electronic Co., Ltd. · 2009
- Descendant · 2 generations on · 0 of its ownK232317 UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips…Urit Medical Electronic Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK111999 Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip…Healgen Scientific,, LLC · 2012 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K082811Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine AnalyzersUrit Medical Electronic Co., Ltd. · 2009 · cites it directly1descendant
- K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine…Urit Medical Electronic Co., Ltd. · 2024 · 2 generations on0descendants
- K111999Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for Urinalysis, and…Healgen Scientific,, LLC · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861255 | Behring Rapignost Total Screen L Urine Test Strips | Behring Diagnostics, Inc. | 1986 | — |
| 0 (this device) | K040703 | Uristik H Series Reagent Strips for Urinalysis | Dirui Industrial Co., Ltd. | 2004 | — |
| +1 | K082811 | Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine… | Urit Medical Electronic Co., Ltd. | 2009 | — |
| +2 | K232317 | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA… | Urit Medical Electronic Co., Ltd. | 2024 | — |
| +1 | K111999 | Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for… | Healgen Scientific,, LLC | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2024 | 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 JIO? 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 JIO device
- #1 K232317 UC-1800 Automatic Urine Analyzer, URIT 11FA…score 8.4 · 5 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K861255 | Behring Rapignost Total Screen L Urine Test StripsSummary page 2…ence: Bayer Corporation MULTISTIX 10 SG Reagent Strips (K-file not identified) Behring Diagnostics RAPIGNOST TOTAL SCREEN L Urine Test Strips (K861255) Boehringer Mannheim CHEMSTRIP 10 with SG Urine Test Strips (K896454) International Newtech Development… | 1986 |
| * | K896454 | Chemstrip (R) 10 with SG Urine Test StripsSummary page 2…dentified) Behring Diagnostics RAPIGNOST TOTAL SCREEN L Urine Test Strips (K861255) Boehringer Mannheim CHEMSTRIP 10 with SG Urine Test Strips (K896454) International Newtech Development Urinalysis Reagent Strips (10 Parameters) (K993850) Device Description:… | 1990 |
| * | K993850 | Urinalysis Reagent Strips (10 Parameters)Summary page 2…Boehringer Mannheim CHEMSTRIP 10 with SG Urine Test Strips (K896454) International Newtech Development Urinalysis Reagent Strips (10 Parameters) (K993850) Device Description: URISTIK H Series Reagent Strips For Urinalysis provide qualitative and semi- qua… | 2000 |
| * | — | Bayer Corporation MULTISTIX 10 SG Reagent Strips 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?
How does its category compare?
All JIO devicesJIO Blood, Occult, Colorimetric, In Urine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JIO
Too few JIO 510(k)s in any year since 2007 to give a median.
Recalls per year · JIO
No recall names JIO since 2007.
Adverse event reports per year · JIO
1in 2025
MAUDE reports naming product code JIO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
URISTIK H Series Reagent Strips provide qualitative and semi-quantitative tests for ascorbic acid, pH, specific gravity, ketones (acetoacetic acid), blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. Dirui H Series Reagent Strips are for single use in professional near-patient…
Read the full statement (122 words)
URISTIK H Series Reagent Strips provide qualitative and semi-quantitative tests for ascorbic acid, pH, specific gravity, ketones (acetoacetic acid), blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.
Dirui H Series Reagent Strips are for single use in professional near-patient screening (point-of-care) and centralized laboratory locations. The strips are intended for use in at-risk patients to assist diagnosis in the following areas:
Kidney function
Urinary tract infections
Carbohydrate metabolism (e.g. diabetes mellitus)
Liver function
Acid-base balance
Urine concentration
Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040703: Uristik H Series Reagent Strips for Urinalysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040703
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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