AFIAS iFOB with AFIAS-50
FDA 510(k) K163225 · Immunostics Inc.,
510(k) numberK163225
Submission
- Device name
- AFIAS iFOB with AFIAS-50
- Applicant
- Immunostics Inc.,
Ocean, NJ, US - Received
- November 17, 2016
- Decision date
- August 8, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OOX – Automated Occult Blood Analyzer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6550
- Specialty
- Hematology
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.
Other 510(k)s with product code OOX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200754 | Hemosure Accu-Reader A100OOX · Traditional | W.H.P.M., Inc. | 06/02/2022SE |
| K191147 | OC-Auto SENSOR io iFOB TestOOX · Traditional | Eiken Chemical Co., Ltd. | 01/02/2020SE |
| K132167 | I-Chroma Ifob with I-Chroma ReaderOOX · Traditional | Boditech Med, Inc. | 05/02/2014SE |
| K092330 | Oc-Sensor Diana Ifob TestOOX · Traditional | Polymedco Cancer Diagnostics, LLC | 01/08/2010SE |
| K041408 | Polymedco Oc Auto Micro 80 Fob TestOOX · Traditional | Polymedco, Inc. | 10/21/2004SE |
More from Polymedco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K221817 | ALFIS Vitamin D, ALFIS-3 AnalyzerMRG · Traditional | 09/22/2023SE |
| K182298 | hemochroma PLUS SystemGKR · Traditional | 11/16/2018SE |
| K163465 | hemochroma PLUS SystemGKR · Traditional | 09/08/2017SE |
| K171484 | hema-screen SPECIFIC GoldKHE · Special | 06/14/2017SE |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestKHE · Special | 01/17/2017SE |
| K102664 | Hema Screen ErKHE · Special | 01/28/2011SE |
| K060463 | Hema Screen Specific IfobtKHE · Traditional | 06/06/2006SE |
| K041728 | HCG Detector Combi, HCG Detector Stix, HCG Detector CassetteJHI · Traditional | 08/11/2004SE |
| K031490 | RubellacolLQN · Traditional | 07/16/2003SE |
| K992759 | Colon Alert TestKHE · Traditional | 12/06/1999SE |
Questions and answers
When was AFIAS iFOB with AFIAS-50 cleared by the FDA?
AFIAS iFOB with AFIAS-50 (K163225) received a 510(k) decision of Substantially Equivalent on August 8, 2017, 264 days after the submission was received.
What is the product code of K163225?
The FDA product code is OOX – Automated Occult Blood Analyzer, a Class II (moderate risk) device regulated under 21 CFR 864.6550.