510(k) Report

FDA product code · Immunology

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

NSFClass II21 CFR 866.6030510(k) required2 decisions since 20050 recalls

2 FDA decisions since 2005. No recall names this code.

In vitro diagnostic test intended as a risk assessment test for the development of hepatocellular carcinoma (hcc) in patients with chronic liver diseases (cld). Elevated afpl3% values (= 10%) have been shown to be associated with a nine-fold increase in the risk of developing hcc in the next 6-12 months. Patients with elevated serum afpl3% should be more intensely evaluated for evidence of hcc according to the…

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, immunology panel

Twenty years of NSF 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 · NSF

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NSF

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

Recalls per year · NSF

No recall names NSF since 2007.

Adverse event reports per year · NSF

1in 2013

2011: 12013: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code NSF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—01
20120—00
20130—01
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 — NSF by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NSF? 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 NSF devices have the deepest lineage?

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

  • K100464Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control H, Sample DilutionWako Chemicals USA, Inc. · 20111generation

What has FDA decided in NSF lately?

  • K100464Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control H, Sample DilutionWako Chemicals USA, Inc. · 20112 recalls
  • DEN050002Lba Afp-L3, Afp-L3 Calibrator Set, Afp-L3 Control Set and LibasysWako Chemicals USA, Inc. · 2005

All 2 NSF decisions →

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