510(k) · Cleared
Recalled · Class III · 2018Acon Urinalysis Reagent Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acon Laboratories Co. · CDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Cleared on Aug 11, 2006 as substantially equivalent to K905396 (Heraeus Kulzer, Inc., 1991) and 1 other predicate after a 67-day review. Its family tree reaches back 1 generation to 1986. It has been recalled once.
- Decided
- Aug 11, 2006
- Review
- 67 days
- Class
- Class I
- Product code
- CDM
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K861255 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK861255 Behring Rapignost Total Screen L Urine Test StripsBehring Diagnostics, Inc. · 1986
- This deviceK061559 Acon Urinalysis Reagent StripsAcon Laboratories Co. · 2006
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) | K061559 | Acon Urinalysis Reagent Strips | Acon Laboratories Co. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 CDM? 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? (2)
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 |
|---|---|---|---|
| * | K905396 | Hemastix Reagent StripsSummary page 2…id, Ascorbic, 2, 4-Dinitrophenylhydrazine (Spectrophotometric) Medical Specialty: Clinical Chemistry Predicate Device: Multistix 10 SG Reagent Strips for Urinalysis, K905396 Bayer Corporation, marketed by Bayer Corporation, located at Elkhart, IN 46515, USA. QuickVue UrinChek 10+SG, K861255 Quidel Co… | 1991 |
| * | K861255 | Behring Rapignost Total Screen L Urine Test StripsSummary page 2…e: Multistix 10 SG Reagent Strips for Urinalysis, K905396 Bayer Corporation, marketed by Bayer Corporation, located at Elkhart, IN 46515, USA. QuickVue UrinChek 10+SG, K861255 Quidel Corporation, marketed by Quidel Corporation, located at San Diego, CA 92121, USA. Device Description: The ACON Urinalys… | 1986 |
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 |
|---|---|---|---|---|
| Jun 22, 2018 | Class III | Z-2786-2018 | Labeling design | Clarity Diagnostics LLC discovered specific lots of Clarity 10SG Strips are not compatible for use in the Clarity Urocheck 120 Urine Analyzers, due to lack of Canister Code Bar Code Label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K905396.
How does its category compare?
All CDM devicesCDM Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDM
FDA has decided no CDM device since 2007.
Median 510(k) review, days · CDM
Too few CDM 510(k)s in any year since 2007 to give a median.
Recalls per year · CDM
No recall names CDM since 2007.
Adverse event reports per year · CDM
3in 2025
MAUDE reports naming product code CDM, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACON Urinalysis Reagent Strips (Urine) are for qualitative and semi-quantitative detection of one or more of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and Ascorbic Acid. The ACON Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations. The strips are intended for…
Read the full statement (127 words)
The ACON Urinalysis Reagent Strips (Urine) are for qualitative and semi-quantitative detection of one or more of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes and Ascorbic Acid.
The ACON Urinalysis Reagent Strips (Urine) are for single use in professional near-patient (point-of-care) and centralized laboratory locations. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas:
Kidney function
Urinary track infections
Carbohydrate metabolism (e.g. diabetes mellitus)
Liver function
Acid-base balance
Urine concentration
The results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The test is to be read visually. It is intended for professional use only.
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/K061559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061559: Acon Urinalysis 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/K061559
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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