AminCheck is an at home water break detection test. Our client, who is also a mom, came to IDP with the idea to create a
medical device prototype. The product is simple testing system for pregnant women that would save them extra trips to the doctor or hospital at the end of pregnancy. If you are a first-time mom or even experienced mom, it is often tricky to tell if your water has broken and labor is in fact starting. Also during the end of pregnancy, other fluids can be present and bladder leaks are also common!
IDP worked with this client to develop a revolutionary at home testing kit to inform the woman if her water had broken or if the liquid was something else and not a reason to call the doctor or go to the hospital. The product works similar to an at home pregnancy test- a concept that pregnant women are very familiar with. Included in the kit is a swab to collect some of the liquid. The liquid is then brushed onto a diagnostic patch that corresponds to a color wheel. In under 5 seconds, the patch changes color to inform the user if the fluid is from a water break or not. If the fluid is from the woman’s water breaking, she would know to seek medical attention and if not, she could continue to stay at home and avoid unnecessary trips or phone calls.
IDP assigned an expert team to this
medical device engineering project! First, we worked with our chemical engineer to develop the pH test strip for the device. There was a lot of lab testing involved in perfecting this medical device product and how the results were read.
We also thought a lot about the user experience of how the liquid would be captured and how easy it needed to be for the pregnant woman to take and read the test. We were very pleased that the test was able to provide accuracy at 99% once we completed our final round of medical device prototyping.
Also assigned to the project was IDP’s expert FDA consultant. Because this product is diagnostic in nature and non-invasive, we were able to register with the FDA as opposed to doing more involved FDA regulatory work. IDP assisted our client in the compilation of the design history file that was submitted to the FDA.
Finally, we assisted this client with manufacturing coordination. We were able to locate clean room and medical product approved factories and co-packers that were able to mass produce the test kits. The client went on to be successful online and ultimately sell her company to a larger entity!
In general, Medical Device product development takes a very long time from concept to market. This case study shows all the ways a limited number of medical devices that meet certain qualifications – can be fast tracked.
FAQs
1. What is AminCheck and how did IDP help develop this at-home water break test?
AminCheck is an at-home water break detection test designed to help pregnant women determine whether their amniotic sac has ruptured. IDP partnered with the inventor to transform the concept into a fully functional, FDA-registered medical device. The kit includes a swab to collect fluid and a diagnostic pH test strip engineered through extensive lab validation. When the liquid is applied to the test patch, it changes color within five seconds, allowing women to quickly determine whether they should seek medical attention or remain at home.
2. How accurate is an at-home amniotic fluid detection test like AminCheck?
AminCheck achieved 99% accuracy after extensive laboratory validation and medical device prototyping. The diagnostic patch was engineered using a specialized pH detection system refined through chemical testing and performance validation. Accuracy depends on proper sample collection and following the kit instructions, but when used correctly, it provides highly reliable preliminary results for determining if labor may be starting.
3. How did IDP support FDA registration and regulatory compliance for AminCheck?
IDP provided full regulatory guidance for AminCheck, including FDA registration support and preparation of the Design History File (DHF). Because the product is a non-invasive diagnostic device, it qualified for FDA registration rather than a more complex premarket approval pathway. IDP’s FDA consultant ensured that documentation, labeling, risk analysis, and quality controls met regulatory standards before commercialization.
4. Who should use an at-home water break detection kit?
An at-home water break detection kit like AminCheck is ideal for women in late pregnancy who are unsure whether fluid leakage indicates ruptured membranes or common conditions such as bladder leaks. It is especially helpful for first-time mothers who may not recognize early signs of labor. While the test supports informed decision-making, women should always contact their healthcare provider if results are positive or if symptoms such as contractions, bleeding, or discomfort occur.
