Osom Ifob 25 Test And Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121397 FDA 510(k)
- FDA Product Code
- KHE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.6550 FDA 510(k)
- Regulation Number
- 864.6550 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OSOM iFOB Test Kits are rapid, qualitative immunochemical reagent devices designed for the detection of fecal occult blood (human hemoglobin) in human fecal specimens. These tests aid in the identification of gastrointestinal disorders, including conditions such as diverticulitis, colitis, polyps, and colorectal cancer, by providing a sensitive and specific diagnostic tool for clinical evaluation.
The kits are supplied as single-use, non-sterile diagnostic reagents intended for use in clinical laboratory settings. They include collection tubes and controls for patient sample processing and testing, with sizes specified as 25-test and 50-test configurations. The devices are classified under FDA 510(k) clearance (K121397) as substantially equivalent to predicate devices, adhering to regulatory standards for reagent-based occult blood detection (regulation number 864.6550).
Frequently asked questions
What clinical conditions can the OSOM iFOB Test Kits help identify through fecal occult blood detection?
The OSOM iFOB Test Kits are designed to detect human hemoglobin in fecal specimens, aiding in the identification of gastrointestinal disorders such as diverticulitis, colitis, polyps, and colorectal cancer. By providing a rapid, qualitative result, these tests support clinical evaluation for potential abnormalities in the digestive tract.
Are the OSOM iFOB Test Kits single-use or reusable, and what does this mean for my workflow?
The OSOM iFOB Test Kits are explicitly labeled as single-use, non-sterile diagnostic reagents. This means each kit is intended for one-time use per patient sample, reducing the risk of cross-contamination and ensuring accurate results. You’ll need to order replacement kits for each new test, which may impact inventory management and workflow planning.
What sizes are available for the OSOM iFOB Test Kits, and how should I choose between them?
The kits are available in two configurations: the 25-test kit and the 50-test kit. The choice depends on your lab’s testing volume and procurement frequency. The 25-test kit is ideal for smaller labs or lower-volume settings, while the 50-test kit offers better cost efficiency for higher-volume or bulk-ordering facilities. Both include collection tubes and controls for patient sample processing.
Do the OSOM iFOB Test Kits require sterile handling, and how should they be stored?
The kits are non-sterile, so sterile handling (e.g., gloves, clean surfaces) is recommended during sample collection and testing to minimize contamination risks. Storage should follow the manufacturer’s guidelines, typically in a cool, dry place away from direct sunlight or extreme temperatures. Always check the packaging for specific storage instructions to maintain test integrity.
What regulatory pathway was followed for the OSOM iFOB Test Kits, and how does this affect their use in clinical settings?
The OSOM iFOB Test Kits received FDA 510(k) clearance (K121397), confirming they are substantially equivalent to predicate devices under regulation number 864.6550 for reagent-based occult blood detection. This clearance ensures compliance with U.S. regulatory standards for diagnostic accuracy and safety, allowing their use in clinical laboratory settings as intended. No additional approvals are required beyond standard FDA-mandated procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: OSOM® iFOB Test - Sekisui Diagnostics, SEKISUI Diagnostics™ OSOM™ iFOB Test - Fisher Sci, Sekisui Diagnostics OSOM® iFOB Test, CLIA Waived (25 Tests/Kit)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121397 | Class II | Active |
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Manufacturer
- Manufacturer
- Sekisui Diagnostics, LLC
Sources (1)
- FDA 510(k) K121397 24 fields · synced Sep 18, 2026