FDA product code NRS: Control Material, Blood Circulating Epithelial Cancer Cell
NRS is the FDA product code for control material, blood circulating epithelial cancer cell. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under NRS. The average 510(k) review took 83 days (median 83). FDA has posted 1 recall for NRS devices.
Definition
The Epithelial Cell Control Kit contains two levels of fixed cells that are stained with a fluorescence marker and are used to verify sample processing and cell analysis of circulating tumor cells. This device is used as an assay quality control to ensure that sample detection and identification systems are able to detect circulating epithelial tumor cells.
Classification
| Field | Value |
|---|---|
| Device name | Control Material, Blood Circulating Epithelial Cancer Cell |
| 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 NRS clearance
Top NRS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Veridex, LLC | 1 | 2004-06-28 |
Most recent NRS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040898 | Veridex, LLC | CELLSEARCH EPITHELIAL CELL CONTROL KIT | 2004-06-28 | 83 |
Recalls for NRS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-11-09.
Frequently asked questions
What is FDA product code NRS?
NRS is the FDA product code for control material, blood circulating epithelial cancer cell. It is a Class II device, regulated under 21 CFR 864.8625 and reviewed by the Hematology panel.
What device class is NRS?
Class II, regulation 21 CFR 864.8625. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NRS?
Across 1 cleared submissions the average was 83 days from receipt to decision (median 83).
Which companies have the most NRS clearances?
Veridex, LLC (1).
Have NRS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code NRS
- Run a recall and safety report across every NRS manufacturer
- Watch product code NRS 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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