Clinical Chemistry · 510(k) · 2019
ACR LAB Urine Analysis Test System
Healthy.io Ltd. Cleared by FDA on 26 July 2019 under submission K182384, product code JFY (enzymatic method, creatinine). What FDA's record says, in FDA's words.
Device record · K182384
- Device. ACR LAB Urine Analysis Test SystemDEVICE
- Company. Healthy.io Ltd (IL)COMPANY
- Decision. 26 July 2019, 510(k), substantially equivalent (traditional review); received 31 August 2018DECISION
- Panel. Clinical ChemistryPANEL
- Product code. JFY, Enzymatic Method, CreatinineCODE
- Regulation. 21 CFR 862.1225, Class IIREG
- Source. FDA database entry · decision document (10 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
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. Comparison of ACR | LAB and ACON Laboratories’ Mission U120 Ultra Urine Analyzer: Table 1 below summarizes similarities and variabilities between the ACR | LAB and its predicate device, ACON Laboratories’ Mission U120 Ultra Urine Analyzer and Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) (k142391). 1 Backend will henceforth refer to the system’s cloud-based servers, which run the server-side algorithms, and turn the algorithms’ analysis into clinical results. These are then securely transmitted to a patient Electronic Medical Record. The ACR | LAB Backend is HIPAA compliant and uses advanced security protocols for data handling and transmission. 3 Table 1: Comparison between ACR | LAB Urine Analysis Test System and the ACON Laboratories’ Mission U120 Ultra Urine Analyzer (k142391) Feature Healthy.io’s ACR | LAB Urine Analysis Test System (k182384) ACON Laboratories' Mission U120 Ultra Urine Analyzer and strips (k142391) Intended Use The ACR | LAB Urine […]
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 572 reports filed against devices carrying product code JFY. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · Creatinine plus ver.2 · Roche Diagnostics · report 1823260-2026-04039
29 September 2026 · Malfunction · Creatinine plus ver.2 · Roche Diagnostics · report 1823260-2026-03996
There was an allegation of questionable Creatinine plus ver.2 results for several patient samples on a cobas c (b)(4) analytical unit.An interference with monoclonal gammopathy IgM was suspected.Three patient examples were provided.Patient 1:The initial results were 337 µmol/L (serum) and 314 µmol/L (heparin plasma).The sample was tested in another laboratory on another module (cobas c 503), and the result was approximately 60 µmol/L The sample was repeated on the same module as the initial […]
22 September 2026 · Malfunction · Creatinine plus ver.2 · Roche Diagnostics · report 1823260-2026-03887
18 September 2026 · Malfunction · VITROS Chemistry Products CREA Slides · Ortho-Clinical Diagnostics, Inc. · report 1319809-2026-00132
A customer contacted the Ortho Clinical Diagnostics (Ortho) Technical Solution Center (TSC) to report a non-reproducible, higher than expected VITROS Creatinine (CREA) result was obtained from a single patient sample tested using VITROS CREA slide lot 1520-3584-1928 on a VITROS XT3400 Chemistry System. Patient sample VITROS CREA result of 172 umol/L vs. the expected result of 76 umol/L Biased results of the magnitude and direction observed may lead to inappropriate physician action if they […]
16 September 2026 · Malfunction · Creatinine plus ver.2 · Roche Diagnostics · report 1823260-2026-03783
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code JFY, in Clinical Chemistry, from Healthy.io Ltd, or cleared in 2019. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.