510(k) Report

510(k) · Cleared

Cleared

Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP Calibrator Set, Libasys, Model 999-05401

K062368510(k) TraditionalCleared Jan 31, 2007170-day reviewClass II21 CFR 866.6030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wako Chemicals USA, Inc. · OAU Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma

Cleared on Jan 31, 2007 after a 170-day review. The FDA summary names no predicate by number. 1 later device descends from it.

Decided
Jan 31, 2007
Review
170 days
Class
Class II
Product code
OAU
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared20052010201520202025
  1. This deviceK062368 Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model…Wako Chemicals USA, Inc. · 2007
  2. Descendant · cites it directly · 0 of its ownK100464 Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator…Wako Chemicals USA, Inc. · 2011 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K100464Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control…Wako Chemicals USA, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K062368Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551…Wako Chemicals USA, Inc.2007—
+1K100464Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control…Wako Chemicals USA, Inc.20112

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
FIG. 1 — Lineage of K062368, 2007–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OAU? 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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K100464Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control…Wako Chemicals USA, Inc.20110

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K100464 (Wako Chemicals USA, Inc., 2011) has gone furthest, with 0 descendants of its own.

How does its category compare?

All OAU devices

OAU Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · OAU

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OAU

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

Recalls per year · OAU

No recall names OAU since 2007.

Adverse event reports per year · OAU

No MAUDE report names OAU since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
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—

What is it indicated for?

The Wako LBA DCP immunological test system is an in vitro device that consists of reagents and an automated instrument used 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 progression to hepatocellular carcinoma in conjunction with other laboratory findings, imaging studies and clinical assessment.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Wako Chemicals USA, Inc.

124 FDA decisions under this applicant name. See the company

  • K100464Utaswako I30 (Includes Accessories), Utaswako Afp-L3, Calibrator Set, Control L, Control H, Sample DilutionWako Chemicals USA, Inc. · 20112 recalls
  • K080125Apolowako T-Cho, HDL-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and 993-25201Wako Chemicals USA, Inc. · 2008
  • K080123Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201Wako Chemicals USA, Inc. · 2008
  • K061775Wako L-Type Creatinine-M Test, and Wako Creatinine CalibratorWako Chemicals USA, Inc. · 2007
  • K053131Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191Wako Chemicals USA, Inc. · 20051 recall

https://510kreport.com/device/K062368 · printed Nov 6, 2026

Cite this page

510(k) Report. “K062368: Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP Calibrator Set, Libasys, Model 999-05401.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062368

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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