Quick answer
FDA’s OTC database lists the QuickScreen At Home Digital Ovulation Test under document CR260334 as a luteinizing-hormone test with a 510(k)-exempt number.
FDA entry summary
| Record field | FDA entry |
|---|---|
| Document number | CR260334 |
| Test name | Phamatech, Inc., QuickScreen At Home Digital Ovulation Test |
| Device name | QuickScreen At Home Digital Ovulation Test |
| Test type | Luteinizing hormone (LH) |
| Manufacturer listed | Hangzhou AllTest Biotech Co., Ltd. |
| 510(k)-exempt number | CR260334 |
| Effective date | June 12, 2026 |
This is an FDA OTC device database entry. It describes the named product record and test type; it does not provide personal medical advice or interpret a result.
Record-matching checklist
- Compare the product name and manufacturer with the package.
- Confirm the test type and document number in the FDA entry.
- Read the product insert for the current model’s labeled information.
- Keep regulatory records separate from a personal fertility or health decision.
- Ask your doctor about test results, timing questions or symptoms.
See how ovulation tests work and FDA status checks for at-home tests. Browse ovulation tests.
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Common questions
What does FDA CR260334 identify?
The entry names QuickScreen At Home Digital Ovulation Test and identifies it as a luteinizing hormone test.
Does the entry list a 510(k) number?
It lists a 510(k)-exempt number, CR260334, and an effective date of June 12, 2026.
Does the record interpret a test result?
No. For questions about a result, fertility or symptoms, speak with your doctor.