(163 days)
Not Found
No
The description details a standard enzymatic assay kit for measuring bile acids, with no mention of AI or ML components in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic (IVD) test kit intended for the quantitative determination of total bile acids in human serum, which serves as a marker for liver function. It is used to diagnose or monitor a condition, not to treat it.
Yes
Explanation: The device is intended for the "in vitro quantitative determination of total bile acids (TBA) in human serum samples," which "serve as a marker for normal and abnormal liver function" and are "increased in patients with liver disease." This information indicates that the device measures physiological markers to assess a patient's health status, which is a diagnostic purpose.
No
The device description explicitly states it is a "clinical test kit" comprised of "Reagent 2, and a calibrator," which are described as "stable liquid formulation." This indicates the device is a chemical assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is "intended for the in vitro quantitative determination of total bile acids (TBA) in human serum samples." The term "in vitro" is a key indicator of an IVD.
- Device Description: The "Device Description" further clarifies that it is a "clinical test kit, intended for quantitative determination of total bile acids in serum by an enzymatic method." This describes a product used to perform tests on biological samples outside of the body.
- Sample Type: The assay is designed to be used with "human serum samples," which are biological specimens.
- Purpose: The purpose is to "quantitatively determine" a specific analyte (total bile acids) in these samples, which is a diagnostic function.
- Components: The kit includes reagents and a calibrator, which are typical components of an IVD assay.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
Total Bile Acids Assay is intended for the in vitro quantitative determination of total bile acids(TBA) in human serum samples.
Total Bile Acids Assay contains a bile acid calibrator. The calibrator is design to be used with the assay for the quantitative determination of TBA in serum.
Total Bile Acids Assay has control design to be used with the assay for the quantitative determination of TBA in serum.
Total Bile Acids Assay is intended for the in vitro quantitative determination of total bile acids (TBA) in human serum samples. Total bile acids are metabolized in the liver and serve as a marker for normal and abnormal liver function. Serum total bile acids are increased in patients with liver disease.
Total Bile Acids Assay contains a bile acid calibrator. The calibrator is design to be used with the assay for the quantitative determination of TBA in serum.
Total Bile Acids Assay has control design to be used with the assay for the quantitative determination of TBA in serum.
Product codes (comma separated list FDA assigned to the subject device)
KWW, JJX
Device Description
The Diazyme's Total Bile Acids assay is a clinical test kit, intended for quantitative determination of total bile acids in serum by an enzymatic method.
The Diazyme's Total Bile Acids assay is comprised of Reagent 2, and a calibrator.
The reagents of the assay kit are stable liquid formulation that allows ease of use coupled with enhanced performance characteristics. In the presence of Thio-NAD, the enzyme 3ox-hydroxysteroid dehydrogenase (3-a-HSD) converts bile acids to 3-keto steroids and Thio-NADH. The reaction is reversible and 3-0-HSD can convert 3-keto steroids and Thio-NADH to bile acids and Thio-NAD. In the presence of excess NADH, the enzyme cycling occurs efficiently and the rate of formation of Thio-NADH is determined by measuring specific change of absorbance at 405nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum samples
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Diazyme's Total Bile Acids Assay is a two reagents based kinetic assay system. The assay offers excellent precision as shown in the table below:
Intra-Assay Precision: 8 μΜ (CV%= 3.9%), 23 μΜ (CV%= 1.3%)
Inter-Assay Precision: 8 μΜ (CV%= 2.9%), 23 μΜ (CV%= 2.6%)
Diazyme's Total Bile Acids Assay has a good correlation with Trinity's method with a correlation coefficient of 0.99. We have conducted interference study by spiking the substances to be tested to the pooled human sera and found less than 1% interference at the indicated concentrations:
Triglyceride: 750 mg/dl
Bilirubin: 50 mg/dl
Ascorbic Acid: 50 mg/dl
Hemoglobin: 500 mg/dl
Comparison analysis presented in the 510K submission for this device in the Comparison section, together with linearity, precision and interference study presented demonstrated that the Diazyme's Total Bile Acids Assay has excellent accuration accuration of Pill demonstated that the DiaLyno of Total Bho between the results obtained by Diazyme's Total Bile enced v. There is to bigally marketed predicate when testing clinical patient samples. Therefore, Actus Assay and Togally manses is substantially similar to the commercially available products to measure bile acids in human serum samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient of 0.99 with Trinity's method.
Interference for Triglyceride, Bilirubin, Ascorbic Acid, Hemoglobin less than 1%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1177 Cholylglycine test system.
(a)
Identification. A cholylglycine test system is a device intended to measure the bile acid cholylglycine in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the word "DIAZYME" in a bold, sans-serif font. Above the word is a four-pointed star-like symbol. The symbol is made up of four diamond shapes that are connected at their points. The image is black and white.
JEC ? 2005
KOSV7/4
Summary
Submitter's name:
Submitter's address:
Phone: Fax:
Name of Contact Person:
Diazyme Laboratories Division, General Atomics
3550 General Atomics Court San Diego, CA 92121 858-455-4754 858-455-4750
Huan Tran Diazyme Laboratories Division General Atomics 3550 General Atomics Court San Diego, CA 92121 Phone: 858-455-4761 Fax: 858-455-4750
Date the summary was prepared:
June 17, 2005
| Name of the device: | Total Bile Acids Assay |
|---|---|
| Trade Name: | Total Bile Acids Assay |
| Common/Usual Name: | Enzymatic Assay, TBA |
| Classification Name: | Radioimmunoassay, Cholyglycine, Bile acid |
| Device Class: | II |
Predicate Device:
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Bile Acids Reagent (K872296) manufactured by Trinity Biotech, USA, 1930 Innerbelt Business Center Drive, St. Louis, MO, 63114.
Description of the device
The Diazyme's Total Bile Acids assay is a clinical test kit, intended for quantitative determination of total bile acids in serum by an enzymatic method.
The Diazyme's Total Bile Acids assay is comprised of Reagent 2, and a calibrator.
The reagents of the assay kit are stable liquid formulation that allows ease of use coupled with enhanced performance characteristics. In the presence of Thio-NAD, the enzyme 3ox-hydroxysteroid dehydrogenase (3-a-HSD) converts bile acids to 3-keto steroids and Thio-NADH. The reaction is reversible and 3-0-HSD can convert 3-keto steroids and Thio-NADH to bile acids and Thio-NAD. In the presence of excess NADH, the enzyme cycling occurs efficiently and the rate of formation of Thio-NADH is determined by measuring specific change of absorbance at 405nm.
1
Image /page/1/Picture/1 description: The image shows a diagram of the conversion of bile acids to oxidized bile acids. The reaction is catalyzed by the enzyme 3-alpha-HSD. Thio-NAD is converted to Thio-NADH in the process. NAD is converted to NADH in the process.
Intended Use of the Device:
Total Bile Acids Assay is intended for the in vitro quantitative determination of total bile acids(TBA) in human serum samples.
Total Bile Acids Assay contains a bile acid calibrator. The calibrator is design to be used with the assay for the quantitative determination of TBA in serum.
Total Bile Acids Assay has control design to be used with the assay for the quantitative determination of TBA in serum.
Performance Characteristics
Diazyme's Total Bile Acids Assay is a two reagents based kinetic assay system. The assay offers excellent precision as shown in the table below:
| 8 μΜ | 23 μΜ | |
|---|---|---|
| Intra-Assay Precision | CV%= 3.9% | CV%= 1.3% |
| Inter-Assay Precision | CV%= 2.9% | CV%= 2.6% |
Diazyme's Total Bile Acids Assay has a good correlation with Trinity's method with a correlation coefficient of 0.99. We have conducted interference study by spiking the substances to be tested to the pooled human sera and found less than 1% interference at the indicated concentrations:
| Interference | Concentration |
|---|---|
| Triglyceride | 750 mg/dl |
| Bilirubin | 50 mg/dl |
| Ascorbic Acid | 50 mg/dl |
| Hemoglobin | 500 mg/dl |
2
Conclusion: Comparison analysis presented in the 510K submission for this device in the Comparison section, together with linearity, precision and interference study presented demonstrated that the Diazyme's Total Bile Acids Assay has excellent accuration accuration of Pill demonstated that the DiaLyno of Total Bho between the results obtained by Diazyme's Total Bile enced v. There is to bigally marketed predicate when testing clinical patient samples. Therefore, Actus Assay and Togally manses is substantially similar to the commercially available products to measure bile acids in human serum samples.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
2005 DEC 7
Mr. Huan Tran Quality Assurance Manager Diazyme Laboratories Division General Atomics 3550 General Atomics Court San Diego, CA 92121
Re: K051714
Trade/Device Name: Total Bile Acids Assay Regulation Number: 21 CFR 862.1177 Regulation Name: Cholylglycine test system Regulatory Class: Class II Product Code: KWW, JJX Dated: November 18, 2005 Received: November 18, 2005
Dear Mr. Tran:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and with you we substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or you coon on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I bu may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Guti
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
510(k) Number: K051714
Device Name: Total Bile Acids Assay
Indications For Use:
Total Bile Acids Assay is intended for the in vitro quantitative determination of total bile acids (TBA) in human serum samples. Total bile acids are metabolized in the liver and serve as a marker for normal and abnormal liver function. Serum total bile acids are increased in patients with liver disease.
Total Bile Acids Assay contains a bile acid calibrator. The calibrator is design to be used with the assay for the quantitative determination of TBA in serum.
Total Bile Acids Assay has control design to be used with the assay for the quantitative determination of TBA in serum.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Safety