510(k) · Cleared
ClearedOn Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Cleared on Jul 6, 2017 as substantially equivalent to K801270 (Miles Laboratories, Inc., 1980) after a 128-day review. Its family tree reaches back 1 generation to 1980.
- Decided
- Jul 6, 2017
- Review
- 128 days
- Class
- Class I
- Product code
- JIN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K801270 (1980). No later device cites it as a predicate yet.
- Root · 1 generation backK801270 Test for Ketone in Urine (Acetoacetic ACMiles Laboratories, Inc. · 1980
- This deviceK170587 On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone…ACON Laboratories, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801270 | Test for Ketone in Urine (Acetoacetic AC | Miles Laboratories, Inc. | 1980 | — |
| 0 (this device) | K170587 | On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips… | ACON Laboratories, Inc. | 2017 | — |
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 JIN? 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 JIN device
- #1 K192957 VivaChek Blood Glucose and B-Ketone Monitoring…score 1.6 · 8 generations · no Class I recall
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 |
|---|---|---|---|
| * | K801270 | Test for Ketone in Urine (Acetoacetic ACSummary page 6…1 Panel: 75 Clinical Chemistry Predicate Device: Predicate 510(k) number & device name: k801270 - Bayer Ketostix reagent strips, Urine Dipstick or tablet analysis, non- automated Device Description: On Call & Healthy Me™ K… | 1980 |
| † | K061559 | Acon Urinalysis Reagent Strips | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All JIN devicesJIN Nitroprusside, Ketones (Urinary, Non-Quant.): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JIN
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · JIN
192in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIN
3in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIN
4in 2025
MAUDE reports naming product code JIN, 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 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 192 | 0 | 5 |
| 2019 | 0 | — | 0 | 52 |
| 2020 | 2 | — | 0 | 37 |
| 2021 | 0 | — | 0 | 43 |
| 2022 | 0 | — | 1 | 14 |
| 2023 | 0 | — | 3 | 17 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Healthy Me™ Ketone Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative detection of Ketone (Acetoacetic acid) in urine. The identification of ketones is used in the diagnosis of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets. The Healthy Me™…
Read the full statement (214 words)
The Healthy Me™ Ketone Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative detection of Ketone (Acetoacetic acid) in urine. The identification of ketones is used in the diagnosis of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets.
The Healthy Me™ Ketone Reagent strips are intended for Over the Counter use by lay people with Diabetes and/or people on low carb diets at home to check for the ketones in urine. This product is not intended for the management of diabetes.
The On Call Ketone Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative detection of Ketone (Acetoacetic acid) in urine. The identification of ketones is used in the diagnosis of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets.
The On Call Ketone Reagent strips are intended for Over the Counter use by lay people with Diabetes and/or people on low carb diets at home to check for the ketones in urine. This product is not intended for the management of diabetes.
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/K170587 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170587: On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone 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/K170587
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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