Directigen1-2-3 Bhcg Pregnancy Test
FDA 510(k)Class II (US FDA 510(k))
by Quidel Corp.
Identifiers
- 510(k) Number
- K890615 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 Directigen 1-2-3 hCG Pregnancy Test is a visual, in vitro diagnostic immunoassay designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. It is classified under clinical chemistry and operates as a prescription-use device. The test relies on antibody-antigen binding to produce a visible result indicating the presence or absence of hCG.
This single-use device is supplied as a ready-to-use kit and is intended for professional or clinical settings under appropriate supervision. It is not evaluated for MRI safety, and no specific storage conditions beyond standard laboratory practice are detailed in the available data. The test was authorized under FDA 510(k) number K890615 with a substantially equivalent decision, and it falls under regulation 862.1155.
Frequently asked questions
What is the Directigen 1-2-3 hCG Pregnancy Test used for?
It is a visual, in vitro diagnostic immunoassay designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum. Its primary purpose is to aid in the early detection of pregnancy by indicating the presence or absence of hCG through antibody-antigen binding that produces a visible result.
How is the Directigen 1-2-3 test supplied?
The device is supplied as a ready-to-use, single-use kit. It is intended for professional or clinical settings under appropriate supervision and is not packaged for over-the-counter consumer use.
Is the Directigen 1-2-3 test sterile or single-use?
The available data confirms it is a single-use device. Specific sterilization methods or sterility claims are not detailed in the provided device record, so users should refer to the manufacturer's labeling for handling and disposal instructions.
What are the storage requirements for this test?
No specific storage conditions beyond standard laboratory practice are detailed in the available device data. Users should follow the storage instructions provided on the product packaging or by the manufacturer to maintain integrity.
What regulatory pathway did this test follow?
The test was authorized under the FDA 510(k) premarket notification pathway with number K890615, receiving a substantially equivalent decision. It is classified under regulation 862.1155 and falls within the Clinical Chemistry advisory committee category.
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: DIRECTIGEN1-2-3 BHCG PREGNANCY TEST 510(k) K890615 - FDA.report, QUICKVUE+™ hCG Combo Test | QuidelOrtho, Directigen 1-2-3 (tm) Hcg Test 510 (k) FDA Premarket Notification ..., 510(k) K913122 — DIRECTIGEN 1-2-3(TM) HCG TEST - RegDataLab
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K890615 | Class II | Active |
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Manufacturer
- Manufacturer
- Quidel Corp.
Sources (1)
- FDA 510(k) K890615 24 fields · synced Sep 23, 2026