Identifiers
- 510(k) Number
- K200754 FDA 510(k)
- FDA Product Code
- OOX 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 Hemosure Accu-Reader A100 is an Automated Occult Blood Analyzer, classified as a Class II device under FDA regulations. It is designed for the qualitative detection of human hemoglobin in stool samples, aiding in the rapid identification of fecal occult blood. This diagnostic system is intended for use in hospital laboratories and professional medical testing facilities, supporting colorectal cancer screening and diagnostic workflows. The device operates as an in-vitro diagnostic tool, providing results based on the presence of hemoglobin in fecal samples.
The Hemosure Accu-Reader A100 is supplied as a reusable analyzer paired with single-use FIT test cartridges and sample collection tubes. It is intended for use in controlled laboratory environments and is not intended for home or point-of-care testing. The device has received FDA 510K clearance under the Traditional pathway, with a decision classification of Substantially Equivalent (SESE) within the Hematology advisory committee. No specific MRI safety or sterility requirements are noted in the regulatory data, though standard laboratory hygiene practices apply. The analyzer operates with a defined set of cartridge reference codes for compatibility.
Frequently asked questions
What is the Hemosure Accu-Reader A100 used for?
The Hemosure Accu-Reader A100 is designed for the qualitative detection of human hemoglobin in stool samples. This automated analyzer helps identify fecal occult blood, supporting colorectal cancer screening and diagnostic workflows in controlled laboratory environments. It is specifically intended for use in hospital laboratories and professional medical testing facilities, not for home or point-of-care testing.
How is the Hemosure Accu-Reader A100 supplied?
The device is supplied as a reusable analyzer paired with single-use FIT (fecal immunochemical test) test cartridges and sample collection tubes. The cartridges are disposable and must be replaced for each test, while the analyzer itself is designed for repeated use in laboratory settings. This setup ensures compatibility and hygiene while maintaining the device’s functionality.
Is the Hemosure Accu-Reader A100 sterile?
The device does not require specific sterility requirements beyond standard laboratory hygiene practices. Since it is a reusable analyzer used in controlled environments, it must be cleaned and maintained according to manufacturer guidelines to prevent contamination. The single-use cartridges and tubes are intended to minimize cross-contamination risks.
Can the Hemosure Accu-Reader A100 be reused?
Yes, the Hemosure Accu-Reader A100 is designed as a reusable analyzer. It is paired with single-use FIT test cartridges and sample collection tubes, ensuring each test is conducted with fresh consumables. The analyzer itself is built for repeated use in laboratory settings, provided it is properly cleaned and maintained between tests.
What cartridge reference codes are compatible with the Hemosure Accu-Reader A100?
The Hemosure Accu-Reader A100 operates with a defined set of cartridge reference codes for compatibility. While the exact codes are not listed in the provided data, the device is designed to work exclusively with FIT test cartridges intended for this analyzer. Always verify cartridge compatibility with the manufacturer’s documentation or support team to ensure accurate and reliable test results.
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: Accu-Reader® A100 - Hemosure, W.H.P.M., Inc.® Industry Leading, Hemosure™ Accu-Reader™ A100 Analyzer - Fisher Sci
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200754 | Class II | Active |
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Manufacturer
- Manufacturer
- W.h.p.m. Inc.
- FDA Applicant
- W.H.P.M., Inc.
Sources (1)
- FDA 510(k) K200754 24 fields · synced Oct 1, 2026