FDA product code NRF: Material, Quality Control, Semen Analysis
NRF is the FDA product code for material, quality control, semen analysis. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel. FDA has cleared 3 510(k) submissions under NRF, from 3 different applicants. The average 510(k) review took 30 days (median 25). FDA has posted 1 recall for NRF devices, 1 initiated in the last five years.
Definition
A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as pH, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cells.
Classification
| Field | Value |
|---|---|
| Device name | Material, Quality Control, Semen Analysis |
| Device class | Class II |
| Regulation | 21 CFR 864.8625 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NRF clearance
Top NRF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bioscreen, Inc. | 1 | 2004-10-29 |
| Medical Electronics Systems , Ltd. | 1 | 2004-07-27 |
| Fertility Solutions, Inc. | 1 | 2004-06-02 |
Most recent NRF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K042750 | Bioscreen, Inc. | QC-BEADS | 2004-10-29 | 25 |
| K041600 | Medical Electronics Systems , Ltd. | QWIKCHECK-BEADS | 2004-07-27 | 43 |
| K041240 | Fertility Solutions, Inc. | SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED | 2004-06-02 | 22 |
Recalls for NRF devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-22.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code NRF?
NRF is the FDA product code for material, quality control, semen analysis. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel.
What device class is NRF?
Class II, regulation 21 CFR 864.8625. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NRF?
Across 3 cleared submissions the average was 30 days from receipt to decision (median 25).
Which companies have the most NRF clearances?
Bioscreen, Inc. (1); Medical Electronics Systems , Ltd. (1); Fertility Solutions, Inc. (1).
Have NRF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-11-22.
Next steps
- Run an FDA pathway report with predicate devices for product code NRF
- Run a recall and safety report across every NRF manufacturer
- Watch product code NRF 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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