FDA product code NSF: Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
NSF is the FDA product code for test, alpha fetoprotein l3 subfraction (afp-l3%), for hepatocellular carcinoma risk assessment. It is a Class II device, regulated under 21 CFR 866.6030 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under NSF. The average 510(k) review took 370 days (median 370). 1 De Novo request was granted under it. FDA has posted 1 recall for NSF devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment |
| Device class | Class II |
| Regulation | 21 CFR 866.6030 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NSF clearance
Top NSF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wako Chemicals USA, Inc. | 1 | 2011-02-23 |
Most recent NSF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100464 | Wako Chemicals USA, Inc. | UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION | 2011-02-23 | 370 |
Recalls for NSF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-02-18.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code NSF?
NSF is the FDA product code for test, alpha fetoprotein l3 subfraction (afp-l3%), for hepatocellular carcinoma risk assessment. It is a Class II device, regulated under 21 CFR 866.6030 and reviewed by the Immunology panel.
What device class is NSF?
Class II, regulation 21 CFR 866.6030. Typical premarket route: 510(k).
How long does a 510(k) take for product code NSF?
Across 1 cleared submissions the average was 370 days from receipt to decision (median 370).
Which companies have the most NSF clearances?
Wako Chemicals USA, Inc. (1).
Have NSF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2021-02-18.
Next steps
- Run an FDA pathway report with predicate devices for product code NSF
- Run a recall and safety report across every NSF manufacturer
- Watch product code NSF 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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