OOX · Automated Occult Blood Analyzer
Hematology · 21 CFR 864.6550 · Class 2
Overview
| Product Code | OOX |
|---|---|
| Device Name | Automated Occult Blood Analyzer |
| Regulation | 21 CFR 864.6550 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)
Classification Rationale
Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Special Controls
*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K200754 | Hemosure Accu-Reader A100 | W.H.P.M., Inc. | Jun 2, 2022 | SESE |
| K191147 | OC-Auto SENSOR io iFOB Test | Eiken Chemical Co., Ltd. | Jan 2, 2020 | SESE |
| K163225 | AFIAS iFOB with AFIAS-50 | Immunostics Inc., | Aug 8, 2017 | SESE |
| K132167 | I-CHROMA IFOB WITH I-CHROMA READER | Boditech Med, Inc. | May 2, 2014 | SESE |
| K092330 | OC-SENSOR DIANA IFOB TEST | Polymedco Cancer Diagnostics, LLC | Jan 8, 2010 | SESE |
| K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST | Polymedco, Inc. | Oct 21, 2004 | SESE |
Top Applicants
- Boditech Med, Inc. — 1 clearance
- Eiken Chemical Co., Ltd. — 1 clearance
- Immunostics Inc., — 1 clearance
- Polymedco Cancer Diagnostics, LLC — 1 clearance
- Polymedco, Inc. — 1 clearance
