510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NSFClass II

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

21 CFR 866.6030 / Immunology
FDA source (opens on fda.gov)

NSF is the FDA product code for Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment, a class II device type, regulated under 21 CFR 866.6030. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
NSF
Device name
Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
FDA definition
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 existing hcc practice guidelines in oncology.
Regulation
21 CFR 866.6030
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
1

Clearances, product code NSF

By decision year
2 clearances under product code NSF with a decision year between 2005 and 2011, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NSF by decision year
YearClearances
20051
20111

Applicants with the most clearances

Product code NSF
Applicants holding the most 510(k) clearances under product code NSF
ApplicantClearances
FUJIFILM Healthcare Americas Corporation2

Companies listing this code with FDA

Companies whose registered establishments list this code