510(k) Report

FDA product code · Hematology

Control Material, Blood Circulating Epithelial Cancer Cell

NRSClass II21 CFR 864.8625510(k) exempt1 decision since 20041 recall

FDA lists NRS as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 864.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2004. 1 recall names this code; it is not Class I.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, hematology panel

Twenty years of NRS at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · NRS

FDA has decided no NRS device since 2007.

Median 510(k) review, days · NRS

Too few NRS 510(k)s in any year since 2007 to give a median.

Recalls per year · NRS

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NRS

No MAUDE report names NRS since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—10
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — NRS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NRS? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which NRS devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K040898Cellsearch Epithelial Cell Control KitVeridex, LLC · 20041generation

What has FDA decided in NRS lately?

  • K040898Cellsearch Epithelial Cell Control KitVeridex, LLC · 20041 recall

The one NRS decision →

What has been recalled in NRS lately?

  • K040898Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003Veridex, LLC · Nov 9, 2010

Related product codes

Other codes under 21 CFR 864.8625.

GFS Standards And Controls, Hemoglobin, Normal And…MZG Test, Residual, Wbc In Leukoreduced BloodGJR Control, Red-CellJCN Control, Cell Counter, Normal And AbnormalGJP Control, PlateletGLK Control, HematocritNRF Material, Quality Control, Semen AnalysisGGL Control, White-CellGGM Control, HemoglobinJPK Mixture, Hematology Quality ControlGLQ Mixture, Control, White-Cell And Red-Cell…