inui In-Home Urine Analysis Test System
FDA 510(k) K180356 · Scanadu, Inc.
510(k) numberK180356
Submission
- Device name
- inui In-Home Urine Analysis Test System
- Applicant
- Scanadu, Inc.
Sunnyvale, CA, US - Received
- February 8, 2018
- Decision date
- May 25, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1340
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193514 | AUTION MAX AX-4060 Urinalysis SystemJIL · Traditional | Arkray, Inc. | 04/13/2023SE |
| K183432 | cobas u 601 urinalysis test systemJIL · Traditional | Roche Diagnostics | 05/07/2019SE |
| K173327 | DIP/U.S. Urine Analysis Test SystemJIL · Traditional | Healthy.Io, Ltd. | 07/18/2018SE |
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsJIL · Traditional | DFI Co., Ltd. | 05/23/2018SE |
| K171521 | DUS R-50S (Urine Chemistry system)JIL · Traditional | DFI Co., Ltd. | 02/16/2018SE |
| K171083 | iChemVELOCITY Automated Urine Chemistry SystemJIL · Traditional | Iris Diagnostics, A Division of Iris… | 05/12/2017SE |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis SystemJIL · Traditional | Arkray, Inc. | 10/07/2016SE |
| K160372 | Uritek TC-201 Urine Chemistry Test SystemJIL · Traditional | Teco Diagnostics, Inc. | 07/22/2016SE |
| K141289 | Tc-Thunderbolt Automated Urine Analyzer System and Tc-Thunderbolt URS-10 StripsJIL · Traditional | Teco Diagnostics | 07/24/2015SE |
| K131600 | URS-2GP (Glucose Protein) Urine StripsJIL · Traditional | Teco Diagnostics | 05/29/2014SE |
Questions and answers
When was inui In-Home Urine Analysis Test System cleared by the FDA?
inui In-Home Urine Analysis Test System (K180356) received a 510(k) decision of Substantially Equivalent on May 25, 2018, 106 days after the submission was received.
What is the product code of K180356?
The FDA product code is JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative), a Class II (moderate risk) device regulated under 21 CFR 862.1340.