Atlas Home Pregnancy Test (Midstream Format) Model 70172001
by Atlas Medical Jordan(FDA 510(k) applicant) EUDAMED510(k)
510(k) K102760 Product code LCX
Overview
The Atlas Home Pregnancy Test (Midstream Format) Model 70172001 is a diagnostic kit designed to detect human chorionic gonadotropin (hCG) in urine, confirming pregnancy. It operates as an over-the-counter in vitro diagnostic device, providing qualitative results for home use based on midstream urine collection.
This single-use, non-sterile device is intended for home testing and requires no special storage conditions beyond room temperature. It has received FDA 510(k) clearance and IVDD authorization, classified as a Class II medical device under regulation number 862.1155. The test is supplied as a ready-to-use kit and is not intended for reuse or professional clinical settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK102760 | Date3 Aug 2011 | StatusActive |
| European Union | CE/IVDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- LCX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Atlas Medical
Questions
What is the Atlas Home Pregnancy Test (Midstream Format) Model 70172001 used for and how does it work?
The Atlas Home Pregnancy Test (Midstream Format) Model 70172001 is designed to detect the presence of human chorionic gonadotropin (hCG) in urine, which is a hormone produced during pregnancy. It provides a qualitative result—either positive or negative—indicating whether pregnancy has occurred. This test is intended for home use with midstream urine collection, allowing users to obtain results quickly and conveniently without clinical supervision.
Is the Atlas Home Pregnancy Test (Midstream Format) Model 70172001 sterile and can it be reused?
The Atlas Home Pregnancy Test (Midstream Format) Model 70172001 is explicitly labeled as non-sterile, meaning it is not intended for sterile procedures or clinical settings. Additionally, it is designed as a single-use device, so reuse is not recommended or supported by the manufacturer.
What storage conditions are required for the Atlas Home Pregnancy Test (Midstream Format) Model 70172001?
No special storage conditions are required for this device. It can be stored at room temperature, making it convenient for home use without the need for refrigeration or controlled environments.
How is the Atlas Home Pregnancy Test (Midstream Format) Model 70172001 supplied, and what does the packaging include?
The Atlas Home Pregnancy Test (Midstream Format) Model 70172001 is supplied as a ready-to-use kit, meaning it comes pre-packaged with all necessary components for immediate testing. The exact contents are not detailed in the provided data, but it is designed for straightforward home use without additional preparation.
What regulatory approvals does the Atlas Home Pregnancy Test (Midstream Format) Model 70172001 have, and how does it classify under medical device regulations?
The Atlas Home Pregnancy Test (Midstream Format) Model 70172001 has received FDA 510(k) clearance and IVDD authorization, classifying it as a Class II medical device under regulation number 862.1155. This indicates it has undergone regulatory review to ensure safety and performance for its intended use as an over-the-counter diagnostic device.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K102760
- EUDAMED