510(k) · Cleared
ClearedACR LAB Urine Analysis Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthy.Io, Ltd. · JFY Enzymatic Method, Creatinine
Cleared on Jul 26, 2019 as substantially equivalent to K142391 (ACON Laboratories, Inc., 2014) after a 329-day review. Its family tree reaches back 5 generations to 1989. 1 later device descends from it.
- Decided
- Jul 26, 2019
- Review
- 329 days
- Class
- Class II
- Product code
- JFY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K890577 (1989). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK890577 Kenlor Liquid Urine ControlKenlor Industries, Inc. · 1989
- 4 generations backK965171 Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426)Bio-Rad · 1997
- 3 generations backK031231 Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek…Bio-Rad · 2003
- 2 generations backK070848 Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level…Bio-Rad, Diagnostics Grp. · 2007
- 1 generation backK142391 Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips…ACON Laboratories, Inc. · 2014
- This deviceK182384 ACR LAB Urine Analysis Test SystemHealthy.Io, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK252619 Qscheck UisacrQstag, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252619Qscheck UisacrQstag, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K890577 | Kenlor Liquid Urine Control | Kenlor Industries, Inc. | 1989 | — |
| −4 | K965171 | Liquichek Urianlysis Control (Cat. NO. 420,421,422,425,426) | Bio-Rad | 1997 | — |
| −3 | K031231 | Liquicheck Urinalysis Control Bilevel, Model 435, Liquichek Urinalysis Control… | Bio-Rad | 2003 | — |
| −2 | K070848 | Liquichek Urinalysis Control (BI-Level), Control LEVEL1, Level 2,Minipak… | Bio-Rad, Diagnostics Grp. | 2007 | — |
| −1 | K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (… | ACON Laboratories, Inc. | 2014 | — |
| 0 (this device) | K182384 | ACR LAB Urine Analysis Test System | Healthy.Io, Ltd. | 2019 | — |
| +1 | K252619 | Qscheck Uisacr | Qstag, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 JFY? 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 JFY device
- #1 K252619 Qscheck Uisacrscore 12.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips (…Summary page 4…device: Manufacturer Device 510(k) Number ACON Laboratories Inc. Mission U120 Ultra Urine Analyzer k142391 and Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252619 | Qscheck Uisacr | 2026 | 0 |
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?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K252619 (Qstag, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K142391.
How does its category compare?
All JFY devicesJFY Enzymatic Method, Creatinine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JFY
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JFY
59in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFY
61in 2025
MAUDE reports naming product code JFY, 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 | 8 | 193 | 0 | 1 |
| 2008 | 4 | 170 | 2 | 4 |
| 2009 | 3 | 59 | 3 | 22 |
| 2010 | 0 | — | 3 | 22 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 1 | 39 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 1 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 2 | — | 0 | 34 |
| 2019 | 2 | — | 0 | 56 |
| 2020 | 0 | — | 0 | 34 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 9 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 0 | 61 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ACR | LAB Urine Analysis Test System is comprised of a smartphone application, a proprietary Color-Board, and ACR Reagent Strips. It is intended for the semi-quantitative detection of albumin and creatinine in urine, as well as the presentation of their ratio. The ACR | LAB Urine Analysis Test System is intended for in-vitro diagnostic use by a healthcare professional in a point of care setting. These results may be used in conjunction with clinical evaluation as an aid in the diagnosis for kidney function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182384 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182384: ACR LAB Urine Analysis Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182384
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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