Device Information
Indications
The Clearblue Early Detection Pregnancy Test is intended for over-the-counter use to detect hCG levels in urine as an early indicator of pregnancy. It can be used as early as six days before the missed period or five days before the expected period.
- MedDRA Code for Pregnancy Detection: 10018362 (Pregnancy detection)
Intended Use
This test is intended for home use to help detect pregnancy by measuring hCG levels in urine. It provides early results and does not require a prescription.
Availability
- Over-The-Counter: The device is available for purchase without a prescription.
Contraindications
This device does not have specific contraindications.
Limitations
The device may not provide accurate results if used too early or if hCG levels are not detectable yet. False negatives or positives could occur depending on the user’s menstrual cycle and hCG levels.
Study Results
The device was modified to harmonize branding and labeling with existing versions. No changes were made to its fundamental scientific technology. The FDA determined it to be substantially equivalent to its predicate device, Clearblue® Early Pregnancy Test (K213379).
Regulatory Information
- The device complies with general controls under the Federal Food, Drug, and Cosmetic Act.
- It is subject to the Quality System (QS) regulation (21 CFR Part 820) and labeling regulations (21 CFR Part 801 and 809).
Manufacturer Information
- Name: SPD Swiss Precision Diagnostics GmbH
- Address: Priory Business Park, Stannard Way, Bedford, Bedfordshire MK44 3UP, United Kingdom
- Contact: Kamila Przedmojska, Principal Regulatory Affairs Specialist
Predicate Device Information
- Predicate Device: Clearblue Early Pregnancy Test
- 510(k) Number: K213379
- Is the Predicate Device an Earlier Version of the Same Device? Yes
- Differences Between Predicate and Current Device: The primary difference is branding and labeling modifications to harmonize different device versions. No changes were made to the fundamental scientific technology of the device. Both devices have the same intended use and detection mechanism.
Implications
The Clearblue Early Detection Pregnancy Test provides an affordable, accessible means of early pregnancy detection. It helps users plan accordingly and seek medical advice when necessary.
References
- Clearblue Early Detection Pregnancy Test. 510(k) Number: K240025. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K240025
- Manufacturer’s Website: https://www.clearblue.com/
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