Immunoassay, Pregnanediol Glucuronide, Over The Counter
The Immunoassay, Pregnanediol Glucuronide, Over The Counter is a Class 1 over-the-counter clinical chemistry test intended for the detection of pregnanediol glucuronide in urine for the confirmation of ovulation, assisting users in identifying their fertile window. It is exempt from 510(k) premarket notification and is regulated under 21 CFR 862.1620 within the Clinical Chemistry medical specialty. The product code is QKE. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QKE
- Device Class
- FDA class 1
- Regulation Number
- 862.1620
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
Definition
Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K191462 | Proov Test | Feb 27, 2020 | Substantially Equivalent | Mfb Fertility, Inc. |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.