Submission Details
| 510(k) Number | K191147 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 30, 2019 |
| Decision Date | January 02, 2020 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
Cleared
Traditional
OC-Auto SENSOR io iFOB Test
Jan 2020
Decision
247d
Days
Class 2
Risk
About This 510(k) Submission
K191147 is an FDA 510(k) clearance for the OC-Auto SENSOR io iFOB Test, a Automated Occult Blood Analyzer (Class II — Special Controls, product code OOX), submitted by Eiken Chemical Co., Ltd. (Taito-Ku, JP). The FDA issued a Cleared decision on January 2, 2020, 247 days after receiving the submission on April 30, 2019. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6550.
Device Classification
| Product Code | OOX — Automated Occult Blood Analyzer |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.6550 |
| 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. |
Manufacturer
Similar Devices — OOX Automated Occult Blood Analyzer
K200754 · W.H.P.M., Inc.
· Jun 2022
K163225 · Immunostics Inc.,
· Aug 2017
K132167 · Boditech Med, Inc.
· May 2014
K092330 · Polymedco Cancer Diagnostics, LLC
· Jan 2010
K041408 · Polymedco, Inc.
· Oct 2004