Test, Luteinizing Hormone (Lh), Over The Counter
The Test, Luteinizing Hormone (LH), Over The Counter (product code NGE) is an in vitro diagnostic test for consumer home use that detects the LH surge in urine, used to predict ovulation timing to assist women in identifying their fertile window for conception or contraception purposes. It is classified as an FDA Class 1 device within the Clinical Chemistry specialty, the lowest risk category, subject to general controls and exempt from 510(k) premarket notification. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- NGE
- Device Class
- FDA class 1
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K020808 | FERTILITE OV | Sep 23, 2002 | Substantially Equivalent | Pheromone Sciences Corp. |
| K990223 | MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR | Feb 24, 1999 | Substantially Equivalent | Unipath , Ltd. |
| K981207 | CLEARPLAN EASY FERTILITY MONITOR | Oct 28, 1998 | Substantially Equivalent | Unipath , Ltd. |
| K973860 | OVULON MONITOR | Jan 07, 1998 | Substantially Equivalent | Conception Technology, Inc. |
| K863121 | PEAK OVULATION PREDICTOR | Oct 14, 1986 | Substantially Equivalent | Micron Technology, Inc. |
| K850579 | CUE FERTILITY MONITOR | Mar 22, 1985 | Substantially Equivalent | Zetek, Inc. |
FEI Numbers
This FDA classification entry is associated with 104 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 104 registration numbers. Click on an entry to view related FDA registrations.