Identifiers
- 510(k) Number
- K041297 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 Polymedco OC Light FOBT Test is an immunological reagent designed for the detection of fecal occult blood in stool samples. It functions as a fecal immunochemical test (FIT), leveraging antibody-based technology to identify human hemoglobin in feces, aiding in the screening for gastrointestinal bleeding or colorectal cancer.
This test is intended for use in professional laboratories or physician office settings. Supplied as a single-use reagent, it requires no sterilization beyond its sterile packaging. The device is classified as Class II under FDA regulations (864.6550) and has received a 510(k) clearance (K041297) for substantial equivalence. Multiple lot and reference codes are associated with its distribution, ensuring traceability and compliance with regulatory standards.
Frequently asked questions
What is the primary purpose of the Polymedco OC Light FOBT Test, and where can it be used?
The Polymedco OC Light FOBT Test is designed as a fecal immunochemical test (FIT) to detect human hemoglobin in stool samples, helping identify gastrointestinal bleeding or potential colorectal cancer. It is intended for use in professional laboratories or physician office settings to screen patients for occult blood in their stool.
Is the Polymedco OC Light FOBT Test single-use or reusable, and what does that mean for handling?
The Polymedco OC Light FOBT Test is supplied as a single-use reagent, meaning each test kit is intended for one-time use only. This eliminates the need for sterilization beyond the sterile packaging provided, ensuring safety and consistency for each test.
How do I verify the authenticity and traceability of the Polymedco OC Light FOBT Test I receive?
The device includes multiple lot and reference codes (e.g., 3012516456, 3005174594, etc.) for traceability, ensuring compliance with regulatory standards. These codes help verify authenticity and track the device’s distribution history, which is useful for quality control and recall purposes if needed.
What regulatory pathway was followed for the FDA clearance of the Polymedco OC Light FOBT Test?
The Polymedco OC Light FOBT Test received FDA clearance through a 510(k) submission (K041297) under the traditional review pathway, demonstrating substantial equivalence to a predicate device. It is classified as a Class II medical device under FDA regulations (864.6550) and falls under the Hematology advisory committee.
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: POLYMEDCO OC LIGHT FOBT TEST (K041297) — FDA 510(k) | Innolitics, Polymedco Colorectal Cancer (CRC) Screening FIT Solutions - Polymedco, PDF OC-LighLightt Ò Manual iFOBT Ki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041297 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Polymedco, Inc.
Sources (1)
- FDA 510(k) K041297 24 fields · synced Sep 19, 2026