Syntron Bioresearch Ez Check HCG Pregnancy Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K870751 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 Syntron Bioresearch Ez Check HCG Pregnancy Test is a visual in vitro diagnostic device for qualitative detection of human chorionic gonadotropin (HCG) in urine. It is classified as a pregnancy HCG test and is intended for use in confirming pregnancy by identifying HCG levels, a hormone produced during pregnancy. This device is a rapid, single-use test designed for straightforward, non-invasive early pregnancy detection.
The Syntron Bioresearch Ez Check HCG Pregnancy Test is supplied as a single-use, non-sterile kit intended for use in clinical or home settings. It requires no special storage conditions and is not designed for reuse. The device has received FDA 510(k) clearance (K870751) and is categorized under product code JHI, with no MRI safety information provided. It is authorized for prescription use and adheres to FDA regulation 862.1155.
Syntron Bioresearch Ez Check HCG Pregnancy Test
Frequently asked questions
What is the Syntron Ez Check HCG Pregnancy Test used for?
This test is designed for qualitative detection of human chorionic gonadotropin (HCG) in urine, helping confirm pregnancy by identifying elevated HCG hormone levels. HCG is produced during pregnancy, so a positive result indicates the presence of pregnancy, while a negative result suggests no detectable HCG.
How is the Syntron Ez Check HCG Pregnancy Test supplied and stored?
The test is supplied as a single-use, non-sterile kit intended for either clinical or home use. It does not require refrigeration or special storage conditions, making it convenient for immediate use. Always store in a dry place away from direct sunlight and extreme temperatures.
Is the Syntron Ez Check HCG Pregnancy Test reusable?
No, this test is explicitly designed for single-use only. Reusing the device could compromise accuracy and introduce contamination risks, leading to unreliable results. Each kit is intended for one-time use per urine sample.
What regulatory approval does the Syntron Ez Check HCG Pregnancy Test hold?
The test has received FDA 510(k) clearance under the product code JHI, confirming it meets regulatory standards for prescription use. It adheres to FDA regulation 862.1155 and is categorized under Clinical Chemistry, ensuring compliance with diagnostic device requirements.
Can this test be used at home or only in clinical settings?
The Syntron Ez Check HCG Pregnancy Test is authorized for use in both clinical and home settings. Its design prioritizes simplicity and non-invasive testing, making it accessible for self-administered use at home while maintaining reliability for professional medical evaluation.
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: PDF K870751 - Syntron Bioresearch Ez Check Hcg Pregnancy Test, Pregnancy Test - Syntron Bioresearch, Inc., Syntron Bioresearch, Inc. - Bioresearch, Device Listing 1381724080 - FDA.report, K963341 - Kit, Test, Pregnancy, Hcg, Over The Counter FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K870751 | Class II | Active |
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Manufacturer
- Manufacturer
- Syntron Bioresearch, Inc.
Sources (1)
- FDA 510(k) K870751 24 fields · synced Oct 5, 2026