FDA product code JIL: Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
JIL is the FDA product code for method, enzymatic, glucose (urinary, non-quantitative). It is a Class II device, regulated under 21 CFR 862.1340 and reviewed by the Clinical Chemistry panel. FDA has cleared 81 510(k) submissions under JIL, 1 in the last five years, from 39 different applicants. The average 510(k) review took 152 days (median 106). FDA has posted 7 recalls for JIL devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) |
| Device class | Class II |
| Regulation | 21 CFR 862.1340 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JIL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 31 |
| 2018 | 4 | 170 |
| 2019 | 1 | 147 |
| 2023 | 1 | 1211 |
Compare with all 510(k) review times · Search every JIL clearance
Top JIL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syn-Kit, Inc. | 11 | 1984-12-18 |
| Tanabe U.S.A., Inc. | 8 | 1994-01-13 |
| Teco Diagnostics | 7 | 2015-07-24 |
| Kyoto Diagnostics, Inc. | 4 | 1986-07-25 |
| Arkray, Inc. | 3 | 2023-04-13 |
34 more applicants have JIL clearances. See the full list in Caduvo.
Most recent JIL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193514 | Arkray, Inc. | AUTION MAX AX-4060 Urinalysis System | 2023-04-13 | 1211 |
| K183432 | Roche Diagnostics | cobas u 601 urinalysis test system | 2019-05-07 | 147 |
| K173327 | Healthy.Io, Ltd. | DIP/U.S. Urine Analysis Test System | 2018-07-18 | 271 |
| K180356 | Scanadu, Inc. | inui In-Home Urine Analysis Test System | 2018-05-25 | 106 |
| K181024 | DFI Co., Ltd. | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips | 2018-05-23 | 35 |
Recalls for JIL devices
7 product recalls in 5 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code JIL?
JIL is the FDA product code for method, enzymatic, glucose (urinary, non-quantitative). It is a Class II device, regulated under 21 CFR 862.1340 and reviewed by the Clinical Chemistry panel.
What device class is JIL?
Class II, regulation 21 CFR 862.1340. Typical premarket route: 510(k).
How long does a 510(k) take for product code JIL?
Across 81 cleared submissions the average was 152 days from receipt to decision (median 106).
Which companies have the most JIL clearances?
Syn-Kit, Inc. (11); Tanabe U.S.A., Inc. (8); Teco Diagnostics (7); Kyoto Diagnostics, Inc. (4); Arkray, Inc. (3).
Have JIL devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code JIL
- Run a recall and safety report across every JIL manufacturer
- Watch product code JIL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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