FDA product code NGE: Test, Luteinizing Hormone (Lh), Over The Counter
NGE is the FDA product code for test, luteinizing hormone (lh), over the counter. It is a Class I device, regulated under 21 CFR 862.1485 and reviewed by the Clinical Toxicology panel. FDA has cleared 6 510(k) submissions under NGE, from 5 different applicants. The average 510(k) review took 104 days (median 76). FDA has posted 10 recalls for NGE devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Test, Luteinizing Hormone (Lh), Over The Counter |
| Device class | Class I |
| Regulation | 21 CFR 862.1485 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NGE clearance
Top NGE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Unipath , Ltd. | 2 | 1999-02-24 |
| Pheromone Sciences Corp. | 1 | 2002-09-23 |
| Conception Technology, Inc. | 1 | 1998-01-07 |
| Micron Technology, Inc. | 1 | 1986-10-14 |
| Zetek, Inc. | 1 | 1985-03-22 |
Most recent NGE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K020808 | Pheromone Sciences Corp. | FERTILITE OV | 2002-09-23 | 195 |
| K990223 | Unipath , Ltd. | MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR | 1999-02-24 | 30 |
| K981207 | Unipath , Ltd. | CLEARPLAN EASY FERTILITY MONITOR | 1998-10-28 | 209 |
| K973860 | Conception Technology, Inc. | OVULON MONITOR | 1998-01-07 | 90 |
| K863121 | Micron Technology, Inc. | PEAK OVULATION PREDICTOR | 1986-10-14 | 61 |
Recalls for NGE devices
10 product recalls in 4 recall events; 9 initiated in the last five years and 9 still open. Most recent: 2025-11-22.
| Year | Recalls |
|---|---|
| 2023 | 7 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code NGE?
NGE is the FDA product code for test, luteinizing hormone (lh), over the counter. It is a Class I device, regulated under 21 CFR 862.1485 and reviewed by the Clinical Toxicology panel.
What device class is NGE?
Class I, regulation 21 CFR 862.1485. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NGE?
Across 6 cleared submissions the average was 104 days from receipt to decision (median 76).
Which companies have the most NGE clearances?
Unipath , Ltd. (2); Pheromone Sciences Corp. (1); Conception Technology, Inc. (1); Micron Technology, Inc. (1); Zetek, Inc. (1).
Have NGE devices been recalled?
Yes: 10 product recalls across 4 recall events; the most recent began 2025-11-22.
Next steps
- Run an FDA pathway report with predicate devices for product code NGE
- Run a recall and safety report across every NGE manufacturer
- Watch product code NGE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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