510(k) · Cleared
Recalled · Class II · 2021Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control H, Sample Dilution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wako Chemicals USA, Inc. · NSF Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment
Cleared on Feb 23, 2011 as substantially equivalent to K062368 (Wako Chemicals USA, Inc., 2007) after a 370-day review. Its family tree reaches back 1 generation to 2007. It has been recalled 2 times.
- Decided
- Feb 23, 2011
- Review
- 370 days
- Class
- Class II
- Product code
- NSF
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K062368 (2007). No later device cites it as a predicate yet.
- Root · 1 generation backK062368 Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model…Wako Chemicals USA, Inc. · 2007
- This deviceK100464 Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator…Wako Chemicals USA, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062368 | Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551… | Wako Chemicals USA, Inc. | 2007 | — |
| 0 (this device) | K100464 | Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control… | Wako Chemicals USA, Inc. | 2011 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NSF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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 | |
| * | K062368 | Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP…Summary page 2…uTASWako DCP Immunological Test System, including the associated calibrators and controls, was previously cleared as LBA DCP for use with the - LiBASYys instrument under K062368 and was assigned product code OAU for the reagent. The product codes assigned for calibrators and controis were JIT and JJX, resp… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 18, 2021 | Class II | Z-1412-2021 | Under Investigation by firm | 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 | Material/Component Contamination | Product fails to meet the accuracy at the low end of the measuring range. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All NSF devicesNSF Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NSF
1in 2011
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
MAUDE reports naming product code NSF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (420 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K100464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100464: Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control H, Sample Dilution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100464
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026