# K100464: Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control H, Sample Dilution

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Feb 23, 2011 after 370 days
- Product code: NSF (Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment)
- Device class: 2
- Regulation: 21 CFR 866.6030
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K062368 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062368: Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP Calibrator Set, Libasys, Model 999-05401, Wako Chemicals USA, Inc. (2007) Summary page 2.

## Cited in the summary but kept off the family tree
- K041847: Lba Afp-L3. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Recalls of this device
- Feb 18, 2021 · Class II · Z-1412-2021: Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
- Apr 30, 2013 · Class II · Z-1831-2013: Product fails to meet the accuracy at the low end of the measuring range.

## Indications for use
The yTASWako AFP-L3 Immunological Test System is an in vitro device that consists of reagents used with the ytTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, AFP-L3% in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies and clinical assessment. Patients with elevated AFP-L3% values (= 10%) have been shown to be associated with an increase in the risk of developing HCC within the next 21 months and should be more intensely evaluated for evidence of HCC according to the existing HCC practice guidelines in oncology. The yTASWako DCP Immunological Test System is an in vitro device that consists of reagents used with the yTASWako i30 Immunoanalyzer to quantitatively measure, by immunochemical techniques, DCP in human serum. The device is intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for development of hepatocellular carcinoma (HCC) in conjunction with other laboratory findings, imaging studies, and clinical assessment. The yTASWako i30 Immunoanalyzer is an in vitro diagnostic automated instrument intended for use to quantitatively measure analytes in clinical chemistry by immunochemical techniques. The yTASWako i30 Immunoanalyzer is indicated for use by healthcare professionals. It is intended for assays cleared or approved for use on this instrument. The Wako yTASWako AFP-L3 Calibrator Set is designed to be used with the Wako yTASWako AFP-L3 Immunological Test System for the quantitative determination of AFP-L3% in human serum. The Wako uyTASWako AFP-L3 Control L is designed to be used as quality control material for the quantitative determination of AFP-L3% in human serum using the Wako pTASWako AFP-L3 Immunological Test System. The Wako yTASWako AFP-L3 Control H is designed to be used as quality control material for the quantitative determination of AFP-L3% in human serum using the Wako uyTASWako AFP-L3 Immunological Test System. The Wako yTASWako DCP Calibrator Set is designed to be used with the Wako uTASWako DCP Immunological Test System for the quantitative determination of DCP in human serum. The Wako yTASWako DCP Control L is designed to be used as a quality control material for the quantitative determination of DCP in human serum using the Wako puTASWako DCP Immunological Test System. The Wako uyTASWako DCP Control H is designed to be used as a quality control material for the quantitative determination of DCP in human serum using the Wako uTASWako DCP Immunological Test System.

Source page: https://510kreport.com/device/K100464
Methodology: https://510kreport.com/methodology