510(k) · Cleared
ClearedChemstrip 101 Urine Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · KQO Automated Urinalysis System
Cleared on Oct 27, 1998 as substantially equivalent to K943592 (Boehringer Mannheim Corp., 1994) after a 20-day review. Its family tree reaches back 1 generation to 1994. 13 later devices descend from it.
- Decided
- Oct 27, 1998
- Review
- 20 days
- Class
- Class I
- Product code
- KQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943592 (1994). 13 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK943592 Chemstrip Mini UA Urine AnalyzerBoehringer Mannheim Corp. · 1994
- This deviceK983510 Chemstrip 101 Urine AnalyzerBoehringer Mannheim Corp. · 1998
- Descendant · cites it directly · 11 of its ownK013783 Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems · 2002
- Descendant · 2 generations on · 4 of its ownK093098 Aution Max Model AX-4030 Urinalysis SystemArkray, Inc. · 2009
- Descendant · 2 generations on · 3 of its ownK101852 Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 2011 · Recalled
- Descendant · 3 generations on · 2 of its ownK171083 iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK030600 Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems · 2003
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K013783Aution Max AX-4280 Urinalysis SystemInternational Remote Imaging Systems · 2002 · cites it directly11descendants
- K093098Aution Max Model AX-4030 Urinalysis SystemArkray, Inc. · 2009 · 2 generations on4descendants
- K101852Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitIris International Inc., A Division of Iris Iris I · 2011 · 2 generations on3descendants
- K171083iChemVELOCITY Automated Urine Chemistry SystemIris Diagnostics, A Division of Iris International, Inc. · 2017 · 3 generations on2descendants
- K030600Aution Jet AJ-4270 Urine AnalyzerInternational Remote Imaging Systems · 2003 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943592 | Chemstrip Mini UA Urine Analyzer | Boehringer Mannheim Corp. | 1994 | — |
| 0 (this device) | K983510 | Chemstrip 101 Urine Analyzer | Boehringer Mannheim Corp. | 1998 | — |
| +1 | K013783 | Aution Max AX-4280 Urinalysis System | International Remote Imaging Systems | 2002 | — |
| +2 | K093098 | Aution Max Model AX-4030 Urinalysis System | Arkray, Inc. | 2009 | — |
| +2 | K101852 | Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit | Iris International Inc., A Division of Iris Iris I | 2011 | 11 |
| +3 | K171083 | iChemVELOCITY Automated Urine Chemistry System | Iris Diagnostics, A Division of Iris International, Inc. | 2017 | — |
| +1 | K030600 | Aution Jet AJ-4270 Urine Analyzer | International Remote Imaging Systems | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 KQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K943592 | Chemstrip Mini UA Urine AnalyzerSummary page 2…5) Intended use In-vitro semi-quantitative determination of urine analytes. This is the same intended use as previously cleared for the Chemstrip Mini Urine Analyzer (K943592). 6) Comparison The table below indicates the similarities between the Chemstrip 101 Urine to predicate Analyzer and the predi… | 1994 |
What descends from it? (13)
See all 133 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?
- Its one ancestor has no recall.
- Of its descendants, K013783 (International Remote Imaging Systems, 2002) has gone furthest, with 11 descendants of its own.
How does its category compare?
All KQO devicesKQO Automated Urinalysis System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KQO
2in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KQO
Too few KQO 510(k)s in any year since 2007 to give a median.
Recalls per year · KQO
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KQO
12in 2025
MAUDE reports naming product code KQO, 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 | 1 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 2 | — | 7 | 3 |
| 2011 | 2 | — | 2 | 8 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 1 | — | 1 | 92 |
| 2014 | 1 | — | 0 | 106 |
| 2015 | 2 | — | 0 | 238 |
| 2016 | 0 | — | 1 | 373 |
| 2017 | 0 | — | 0 | 20 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 0 | — | 2 | 64 |
| 2020 | 0 | — | 0 | 21 |
| 2021 | 0 | — | 1 | 13 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Roche Diagnostics, Boehringer Mannheim Chemstrip 101 Urine Analyzer is a reflectance photometer for in-vitro semi-quantitative determination of the following urine analytes: specific gravity, pH, leukocytes, nitrite, glucose, ketones, urobilinogen, bilirubin and blood.
According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.2900, an automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device 1s used in conjunction with certain materials to measure a variety of urinary analytes.
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/K983510 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983510: Chemstrip 101 Urine Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983510
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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