Identifiers
- 510(k) Number
- K884880 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)
Pregnagen is a visual pregnancy test designed to detect human chorionic gonadotropin (hCG) in urine. It is classified as a prescription-use diagnostic device for identifying early pregnancy through qualitative detection of hCG levels, a hormone produced during pregnancy. The device operates as a lateral flow immunoassay, providing a visual result indicating the presence or absence of hCG.
Pregnagen is supplied as a single-use, non-sterile diagnostic kit intended for use in clinical chemistry settings, such as laboratories or physician offices. The device is regulated under FDA 510(k) clearance (K884880) and falls under classification JHI, adhering to regulation 862.1155. It is not intended for MRI use and requires proper storage as specified in the accompanying instructions. No additional regulatory approvals beyond the stated 510(k) clearance are mentioned.
Frequently asked questions
What is Pregnagen used for?
Pregnagen is a prescription-use diagnostic device designed to detect human chorionic gonadotropin (hCG) in urine. It identifies early pregnancy through qualitative detection of hCG levels, a hormone produced during pregnancy. The device provides a visual result indicating whether hCG is present or absent, helping confirm pregnancy in clinical settings like laboratories or physician offices.
How is Pregnagen supplied and what type of use is it intended for?
Pregnagen is supplied as a single-use, non-sterile diagnostic kit. It is intended exclusively for clinical chemistry settings, such as laboratories or physician offices, and is not intended for home use or non-prescription applications. The kit follows standard lateral flow immunoassay technology for accurate detection.
Is Pregnagen sterile and can it be reused?
No, Pregnagen is not sterile and is explicitly designed for single-use only. Reusing the device could compromise accuracy and introduce contamination risks, which is why it is intended for one-time diagnostic use per patient sample.
What regulatory approval does Pregnagen have?
Pregnagen holds FDA 510(k) clearance under the reference number K884880, indicating it is classified as substantially equivalent to a predicate device. It adheres to FDA regulation 862.1155 and is categorized under product code JHI for visual pregnancy tests. No additional regulatory approvals beyond this are mentioned.
How should Pregnagen be stored?
Pregnagen requires proper storage as outlined in the accompanying instructions. While the specific storage conditions (e.g., temperature, humidity) are not detailed in the provided data, it is critical to follow the manufacturer’s guidelines to maintain the device’s integrity and performance. Improper storage could affect test accuracy.
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: PREGNAGEN - Biogenex Laboratories Trademark Registration, PREGNAGEN(TM) (K884880) — FDA 510(k) | Innolitics, PREGNAGEN (TM) 510 (k) K884880 - FDA.report, PREGNAGEN Trademark | Trademarkia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K884880 | Class II | Active |
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Manufacturer
- Manufacturer
- Biogenex Laboratories
Sources (1)
- FDA 510(k) K884880 24 fields · synced Oct 1, 2026