FDA product code JIO: Blood, Occult, Colorimetric, In Urine
JIO is the FDA product code for blood, occult, colorimetric, in urine. It is a Class II device, regulated under 21 CFR 864.6550 and reviewed by the Hematology panel. FDA has cleared 11 510(k) submissions under JIO, 1 in the last five years, from 10 different applicants. The average 510(k) review took 189 days (median 162); 267 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Blood, Occult, Colorimetric, In Urine |
| Device class | Class II |
| Regulation | 21 CFR 864.6550 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JIO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 267 |
Compare with all 510(k) review times · Search every JIO clearance
Top JIO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Urit Medical Electronic Co., Ltd. | 2 | 2024-04-26 |
| Healgen Scientific,, LLC | 1 | 2012-04-17 |
| ACON Laboratories, Inc. | 1 | 2012-01-18 |
| Wiener Laboratorios Saic | 1 | 2009-09-02 |
| Dirui Industrial Co., Ltd. | 1 | 2004-08-26 |
5 more applicants have JIO clearances. See the full list in Caduvo.
Most recent JIO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232317 | Urit Medical Electronic Co., Ltd. | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips | 2024-04-26 | 267 |
| K111999 | Healgen Scientific,, LLC | HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL | 2012-04-17 | 279 |
| K111221 | ACON Laboratories, Inc. | MISSION U500 URINE ANALYZER | 2012-01-18 | 261 |
| K082811 | Urit Medical Electronic Co., Ltd. | URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS | 2009-09-11 | 352 |
| K083724 | Wiener Laboratorios Saic | WIENER LAB. URINE STRIP 10 AND 11 | 2009-09-02 | 261 |
Recalls for JIO devices
openFDA lists no recalls for product code JIO.
Frequently asked questions
What is FDA product code JIO?
JIO is the FDA product code for blood, occult, colorimetric, in urine. It is a Class II device, regulated under 21 CFR 864.6550 and reviewed by the Hematology panel.
What device class is JIO?
Class II, regulation 21 CFR 864.6550. Typical premarket route: 510(k).
How long does a 510(k) take for product code JIO?
Across 11 cleared submissions the average was 189 days from receipt to decision (median 162).
Which companies have the most JIO clearances?
Urit Medical Electronic Co., Ltd. (2); Healgen Scientific,, LLC (1); ACON Laboratories, Inc. (1); Wiener Laboratorios Saic (1); Dirui Industrial Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JIO
- Run a recall and safety report across every JIO manufacturer
- Watch product code JIO 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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