(170 days)
OAU, JIT, JJX
Not Found
No
The summary describes a traditional in vitro diagnostic test system that measures a specific biomarker (DCP) using immunochemical techniques and an automated analyzer. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies. The risk assessment is based on a simple threshold (DCP ≥ 7.5 ng/mL) and statistical analysis of observed outcomes, not an AI/ML model.
No
The device is an in vitro diagnostic (IVD) test used to measure a biomarker (DCP) as an aid in risk assessment for hepatocellular carcinoma, not a device that directly treats or prevents a disease.
Yes
The device is explicitly stated as being "intended for in vitro diagnostic use as an aid in the risk assessment of patients with chronic liver disease for progression to hepatocellular carcinoma." This directly indicates its diagnostic purpose.
No
The device description explicitly states it consists of "reagents and an automated instrument," indicating hardware components are integral to the system.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Wako LBA DCP immunological test system is an in vitro device... The device is intended for in vitro diagnostic use..."
This clearly identifies the device as being used outside of the body (in vitro) for diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
OAU, JIT, JJX
Device Description
The Wako LBA DCP assay is test kit for the quantitative determination of DCP based on a new method, LBA (Liquid-phase Binding Assay). The method uses a liquid-phase binding reaction between antigen and antibody and separates bound and free forms by column chromatography without a need for a solid phase. LBA DCP can offer fully automatic and highly precise DCP measurement by using an automated analyzer "LiBASys".
This reagent consists of anti-DCP monoclonal antibodies and anti-Prothrombin monoclonal antibodies which are used as Fab' molecules and a substrate for fluorophotometric measurement. When DCP in a sample reacts with anion conjugated anti-Prothrombin monoclonal antibody and peroxidase (horseradish) labeled anti-DCP monoclonal antibody, which binds to all the present DCP molecules it forms an immune complex shown in Fig. 1. The reaction mixture, which includes the above complex, is introduced into an anion-exchange column. The immune complex fractions are eluted into the reaction cup. Then the POD activity of the complex is measured. The POD activity is determined as the increase of fluorescence intensity of 5, 5 diacetoamide-2-2'-bisphenol formed by the reaction of hydrogen peroxide and 4acetoamidophenol. These values are compared to fluorescence intensity of known standards for DCP concentration, in order to obtain the DCP values of samples.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Longitudinal data was collected on 441 subjects, 324 males and 117 females. The risk of developing HCC among patients with an elevation of DCP greater than or equal to 7.5 ng/mL and among patients without such an elevation is calculated, along with their 95% confidence interval.
The risk of developing HCC with an elevated DCP test is 36.5%. The risk of developing HCC with a negative DCP test result is 7.6%.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The risk of developing HCC with an elevated DCP test is 36.5% (95% C.I.: 23.5% - 49.6%). The risk of developing HCC with a negative DCP test result is 7.6% (95% C.I.: 4.4% - 10.8%). Their ratio is 4.8, indicating a 4.8-fold increase of developing HCC given an elevated DCP test result.
| HCC | No HCC | Total | Suspicious* | ||
|---|---|---|---|---|---|
| DCP | greater than or equal to 7.5 ng/mL | 19 | 33 | 52 | 7 |
§ 866.6030 AFP-L3% immunological test system.
(a)
Identification. An AFP-L3% immunological test system is an in vitro device that consists of reagents and an automated instrument used to quantitatively measure, by immunochemical techniques, AFP and AFP-L3 subfraction 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, in conjunction with other laboratory findings, imaging studies, and clinical assessment.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: AFP-L3% Immunological Test Systems.” See § 866.1(e) for the availability of this guidance document.
0
Wako Chemicals USA, Inc. 1600 Bellwood Road, Richmond, VA 23237 U.S.A.
510(k) Summary of Safety and Effectiveness
Intended use
Wako
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.
Summary and explanation of the test
Prothrombin is a vitamin K dependent blood coagulation factor that is formed in the liver. It contains 10 v-carboxy-glutamic acid (Gla) residues on its aminoterminal domain, which are synthesized from glutamic acid (Glu) residues by vitamin K dependent y-glutamyl carboxylase in the posttranslational process. When the deficiency of vitamin K or the ingestion of vitamin K antagonists (Warfarin sodium), the Des-y-carboxy-Prothrombin (DCP) is found in patients. DCP was reported by Liebman, H.A., in 1984 as a specific tumor marker that increases in patients with hepatocellular carcinoma (HCC). A number of reports have shown elevations in serum DCP level in patients with HCC and liver cirrhosis. And DCP does not correlate with AFP and AFP-L3. DCP and AFP-L3% are considered complementary assays for assessing for the risk of developing HCC. When used in combination, a greater number of patients at risk of developing HCC can be identified resulting in more treatment options for a larger number of patients.
The Wako LBA DCP assay is test kit for the quantitative determination of DCP based on a new method, LBA (Liquid-phase Binding Assay). The method uses a liquid-phase binding reaction between antigen and antibody and separates bound and free forms by column chromatography without a need for a solid phase. LBA DCP can offer fully automatic and highly precise DCP measurement by using an automated analyzer "LiBASys".
Principle of the method
This reagent consists of anti-DCP monoclonal antibodies and anti-Prothrombin monoclonal antibodies which are used as Fab' molecules and a substrate for fluorophotometric measurement. When DCP in a sample reacts with anion conjugated anti-Prothrombin monoclonal antibody and peroxidase (horseradish) labeled anti-DCP monoclonal antibody, which binds to all the present DCP molecules it forms an immune complex shown in Fig. 1.
1
Wako USA DCP 510(K) Submission
Fig. 1 [Peroxidase (horseradish) labeled anti-DCP monoclonal antibody]
[DCP]
[Anion conjugated anti-Prothrombin monoclonal antibody]
The reaction mixture, which includes the above complex, is introduced into an anion-exchange column. The immune complex fractions are eluted into the reaction cup. Then the POD activity of the complex is measured. The POD activity is determined as the increase of fluorescence intensity of 5, 5 diacetoamide-2-2'-bisphenol formed by the reaction of hydrogen peroxide and 4acetoamidophenol. These values are compared to fluorescence intensity of known standards for DCP concentration, in order to obtain the DCP values of samples.
Longitudinal data was collected on 441 subjects, 324 males and 117 females. The risk of developing HCC among patients with an elevation of DCP ≥ 7.5 ng/mL and among patients without such an elevation is calculated, along with their 95% confidence interval. The risk of developing HCC with an elevated DCP test is 36.5%. The risk of developing HCC with a negative DCP test result is 7.6%. Their ratio is 4.8, indicating a 4.8-fold increase of developing HCC given an elevated DCP test result.
| HCC | No HCC | Total | Suspicious* | ||
|---|---|---|---|---|---|
| DCP | ≥7.5 ng/mL | 19 | 33 | 52 | 7 |