Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart G — Manual Hematology Devices](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices) → [21 CFR 864.6550](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6550) → KHE — Reagent, Occult Blood # KHE · Reagent, Occult Blood _Hematology · 21 CFR 864.6550 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE ## Overview - **Product Code:** KHE - **Device Name:** Reagent, Occult Blood - **Regulation:** [21 CFR 864.6550](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6550) - **Device Class:** 2 - **Review Panel:** [Hematology](/submissions/HE) - **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 (20 of 97) Showing 20 most recent of 97 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K173212](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K173212.md) | Instant-view-PLUS immunochemical Fecal Occult Blood Test | Alfa Scientific Designs, Inc. | Feb 15, 2018 | SESE | | [K170548](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K170548.md) | InSure ONE | Enterix, Inc. | Oct 5, 2017 | SESE | | [K171484](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K171484.md) | hema-screen SPECIFIC Gold | Immunostics Inc., | Jun 14, 2017 | SESE | | [K162333](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K162333.md) | Wondfo One Step Fecal Occult Blood (FOB) Test | Guangzhou Wondfo Biotech Co., Ltd. | May 14, 2017 | SESE | | [K163554](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K163554.md) | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test | Immunostics Inc., | Jan 17, 2017 | SESE | | [K143325](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K143325.md) | OC-Light S FIT | Eiken Chemical Co., Ltd. | Aug 20, 2015 | SESE | | [K121397](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K121397.md) | OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB 50 TEST KIT | SEKISUI Diagnostics, LLC | Dec 28, 2012 | SESE | | [K113506](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K113506.md) | IND ONE STEP OCCULT BLOOD (FOB) TEST | Ind Diagnostics, Inc. | Dec 19, 2012 | SESE | | [K110309](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K110309.md) | FOB ONE STEP RAPID TEST | Orient Gene Biotech | Sep 14, 2011 | SESE | | [K102664](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K102664.md) | HEMA SCREEN ER | Immunostics Inc., | Jan 28, 2011 | SESE | | [K100031](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K100031.md) | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 | Ind Diagnostic, Inc. | Jul 19, 2010 | SESE | | [K100817](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K100817.md) | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | Princeton BioMeditech Corp. | Jul 1, 2010 | SESE | | [K080812](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K080812.md) | HEMOCCULT ICT | Beckman Coulter, Inc. | Jun 25, 2008 | SESE | | [K071242](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K071242.md) | DBEST ONE STEP OCCULT BLOOD TEST KITS | Ameritek USA, Inc. | Mar 6, 2008 | SESE | | [K073431](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K073431.md) | FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T | Tianjin New Bay Bioresearch Co., Ltd. | Jan 14, 2008 | SESE | | [K070660](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K070660.md) | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | Alfa Scientific Designs, Inc. | Jun 21, 2007 | SESE | | [K063693](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K063693.md) | FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST | New Bay Bioresearch Co. , Ltd. | May 11, 2007 | SESE | | [K063673](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K063673.md) | INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE | Innovacon, Inc. | Mar 5, 2007 | SESE | | [K060953](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K060953.md) | OCCULTECH FECAL OCCULT BLOOD RAPID TEST | Yd Diagnostics Corp. | Sep 18, 2006 | SESE | | [K061065](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE/K061065.md) | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25 | Teco Diagnostics | Jul 14, 2006 | SESE | ## Top Applicants - Helena Laboratories — 12 clearances - Immunostics Inc., — 5 clearances - Smithkline Diagnostics, Inc. — 4 clearances - Aerscher Diagnostics — 3 clearances - Alfa Scientific Designs, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/KHE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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