Oreia Ii B-Hcg, Enzyme Innunoassay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K832801 FDA 510(k)
- FDA Product Code
- JHI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1155 FDA 510(k)
- Regulation Number
- 862.1155 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OREIA II B-HCG Enzyme Immunoassay is an in vitro diagnostic device classified as a visual pregnancy test for prescription use. It quantifies human chorionic gonadotropin (hCG) in serum or urine samples to detect pregnancy, leveraging enzyme-linked immunoassay technology for accurate detection.
This device is intended for single-use in clinical chemistry settings and requires no sterilization beyond manufacturer-provided packaging. Supplied as a kit, it is regulated under FDA 510(k) clearance (K832801) and falls under regulation number 862.1155, with a product code of JHI. No MRI safety or reusable components are specified.
Frequently asked questions
What clinical setting is the OREIA II B-HCG Enzyme Immunoassay intended for, and how is it different from over-the-counter pregnancy tests?
The OREIA II B-HCG Enzyme Immunoassay is designed exclusively for prescription use in clinical chemistry settings, such as hospitals, laboratories, or physician offices. Unlike over-the-counter tests, it quantifies human chorionic gonadotropin (hCG) in serum or urine using enzyme-linked immunoassay technology, providing more precise detection of pregnancy than visual-only home tests. It is not intended for self-administration or point-of-care use outside regulated clinical environments.
Is the OREIA II B-HCG Enzyme Immunoassay single-use, and if so, what does that mean for handling and storage?
Yes, the OREIA II B-HCG is intended for single-use only, meaning each kit is designed for one test procedure. This eliminates the need for sterilization beyond the manufacturer-provided packaging, which ensures sterility for a single application. Storage should follow the manufacturer’s instructions, typically in a cool, dry place away from direct light, to maintain the kit’s integrity until use.
How is the regulatory pathway for this device structured, and what does the product code (JHI) signify?
The OREIA II B-HCG Enzyme Immunoassay follows the FDA 510(k) clearance pathway, classified under product code JHI (In Vitro Diagnostic Products for Clinical Chemistry). This code categorizes it as a visual pregnancy test for prescription use, regulated under FDA regulation number 862.1155. The clearance type is traditional, and it was reviewed by the Clinical Chemistry (CH) Advisory Committee, indicating its specialized use in laboratory settings for accurate hCG quantification.
Are there multiple versions or sizes of the OREIA II B-HCG Enzyme Immunoassay, and how would a buyer determine compatibility?
The device data lists multiple FEI numbers, which typically correspond to different lot or batch identifiers rather than distinct sizes or models. There is no indication of physical size variations (e.g., test strip lengths or kit configurations) in the provided details. Compatibility would depend on the manufacturer’s specifications for the assay protocol and the clinical chemistry system being used. Buyers should confirm compatibility with the manufacturer or consult the device’s labeling for exact test requirements.
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: OREIA II B-HCG, ENZYME INNUNOASSAY - fda.innolitics.com, Oreia Ii B-hcg, Enzyme Innunoassay - Beudamed, OREIA II B-HCG, ENZYME INNUNOASSAY 510(k) K832801 - FDA.report, PDF K832801 - Oreia Ii B-hcg, Enzyme Innunoassay, OREIA II B-HCG PREGNANCY TEST KIT 510(k) K841525 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K832801 | Class II | Active |
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Manufacturer
- Manufacturer
- Organon, Inc.
Sources (1)
- FDA 510(k) K832801 24 fields · synced Sep 19, 2026