FDA product code OOX: Automated Occult Blood Analyzer
OOX is the FDA product code for automated occult blood analyzer. It is a Class II device, regulated under 21 CFR 864.6550 and reviewed by the Hematology panel. FDA has cleared 6 510(k) submissions under OOX, 1 in the last five years, from 6 different applicants. The average 510(k) review took 318 days (median 256).
Definition
The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.
Classification
| Field | Value |
|---|---|
| Device name | Automated Occult Blood Analyzer |
| 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 OOX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 264 |
| 2020 | 1 | 247 |
| 2022 | 1 | 801 |
Compare with all 510(k) review times · Search every OOX clearance
Top OOX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| W.H.P.M., Inc. | 1 | 2022-06-02 |
| Eiken Chemical Co., Ltd. | 1 | 2020-01-02 |
| Immunostics Inc., | 1 | 2017-08-08 |
| Boditech Med, Inc. | 1 | 2014-05-02 |
| Polymedco Cancer Diagnostics, LLC | 1 | 2010-01-08 |
1 more applicants have OOX clearances. See the full list in Caduvo.
Most recent OOX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200754 | W.H.P.M., Inc. | Hemosure Accu-Reader A100 | 2022-06-02 | 801 |
| K191147 | Eiken Chemical Co., Ltd. | OC-Auto SENSOR io iFOB Test | 2020-01-02 | 247 |
| K163225 | Immunostics Inc., | AFIAS iFOB with AFIAS-50 | 2017-08-08 | 264 |
| K132167 | Boditech Med, Inc. | I-CHROMA IFOB WITH I-CHROMA READER | 2014-05-02 | 294 |
| K092330 | Polymedco Cancer Diagnostics, LLC | OC-SENSOR DIANA IFOB TEST | 2010-01-08 | 157 |
Recalls for OOX devices
openFDA lists no recalls for product code OOX.
Frequently asked questions
What is FDA product code OOX?
OOX is the FDA product code for automated occult blood analyzer. It is a Class II device, regulated under 21 CFR 864.6550 and reviewed by the Hematology panel.
What device class is OOX?
Class II, regulation 21 CFR 864.6550. Typical premarket route: 510(k).
How long does a 510(k) take for product code OOX?
Across 6 cleared submissions the average was 318 days from receipt to decision (median 256).
Which companies have the most OOX clearances?
W.H.P.M., Inc. (1); Eiken Chemical Co., Ltd. (1); Immunostics Inc., (1); Boditech Med, Inc. (1); Polymedco Cancer Diagnostics, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OOX
- Run a recall and safety report across every OOX manufacturer
- Watch product code OOX 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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