FORA PNC100 Digital Pregnancy Test, TD-5301 Pregnancy Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103487 FDA 510(k)
- FDA Product Code
- LCX 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 FORA PNC100 Digital Pregnancy Test and TD-5301 Pregnancy Test are in vitro diagnostic devices classified as pregnancy test kits. They detect human chorionic gonadotropin (hCG) in urine using a two-site sandwich immunoassay lateral flow technology, enabling qualitative pregnancy assessment. The TD-5301 features a reagent-coated test strip in a plastic cassette, while the FORA PNC100 incorporates a digital meter for automated readout of test results.
These devices are intended for home use by lay users and are supplied as single-use, non-sterile diagnostic tools. The FORA PNC100 includes a meter that processes visual signals from the test strip into digital output, enhancing result clarity. Both devices are regulated under FDA 510(k) clearance (K103487) and fall under the product code LCX, classified as Class II medical devices. No MRI safety or reusable components are specified.
Frequently asked questions
What is the FORA PNC100 Digital Pregnancy Test used for?
The FORA PNC100 Digital Pregnancy Test is designed to detect human chorionic gonadotropin (hCG) in urine, enabling a qualitative assessment of pregnancy. It uses a two-site sandwich immunoassay lateral flow technology to provide accurate results for home use by individuals without clinical training.
How is the FORA PNC100 Digital Pregnancy Test supplied and what does it include?
The FORA PNC100 is supplied as a single-use, non-sterile device intended for one-time testing. It includes a digital meter that processes visual signals from the test strip, converting them into a clear digital result. This eliminates ambiguity in interpretation compared to traditional test strips.
Is the FORA PNC100 Digital Pregnancy Test reusable or single-use?
The FORA PNC100 Digital Pregnancy Test is explicitly designed for single-use only. Each test strip and meter combination is intended for one pregnancy test, ensuring accuracy and hygiene for the user. Reusing the device is not recommended or supported.
How does the digital meter enhance the accuracy of the test?
The digital meter in the FORA PNC100 automatically reads and interprets the test strip results, converting visual signals into a clear digital output. This reduces human error in reading faint or ambiguous lines, providing more reliable and consistent pregnancy assessment compared to manual interpretation of traditional test strips.
What regulatory approval does the FORA PNC100 Digital Pregnancy Test hold?
The FORA PNC100 Digital Pregnancy Test is regulated under the FDA 510(k) clearance process, specifically with clearance number K103487. It is classified as a Class II medical device under product code LCX, indicating it meets substantial equivalence standards for safety and performance as determined by the FDA.
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: Fora Pnc100 Digital Pregancy Test, Td-5301 Pregancy Test, FORA PNC100 DIGITAL PREGANCY TEST, TD-5301 PREGANCY TEST by TaiDoc ..., PDF 10(3q - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K103487 | Class II | Active |
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Manufacturer
- Manufacturer
- Taidoc Technology Corporation
Sources (1)
- FDA 510(k) K103487 24 fields · synced Oct 1, 2026