(163 days)
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.
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.
Here's a summary of the acceptance criteria and the study details for the "Total Bile Acids Assay" device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a tabular format with specific thresholds before presenting the results. Instead, it presents performance characteristics that were likely used to demonstrate substantial equivalence to the predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit/Inferred) | Reported Device Performance |
|---|---|---|
| Precision | Good precision (low CV%) for both intra-assay and inter-assay measurements, across different concentration levels. | Intra-Assay: 8 μM = 3.9% CV%, 23 μM = 1.3% CV% |
| Inter-Assay: 8 μM = 2.9% CV%, 23 μM = 2.6% CV% | ||
| Correlation with Predicate | "Good correlation" with the legally marketed predicate device (Trinity's method). | Correlation coefficient = 0.99 |
| Interference | "Less than 1% interference" at specified concentrations for common interfering substances. | Triglyceride: 750 mg/dl = <1% interference |
| Bilirubin: 50 mg/dl = <1% interference | ||
| Ascorbic Acid: 50 mg/dl = <1% interference | ||
| Hemoglobin: 500 mg/dl = <1% interference | ||
| Accuracy | (Inferred from combination of correlation, precision, and interference) Device should demonstrate "excellent accuracy" and "good agreement" with the predicate. | Demonstrated by correlation, precision, and interference studies. "Excellent accuration accuration" (typo in original) and "good agreement" claimed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for the test set used in the correlation study with the predicate device. It mentions testing "clinical patient samples" in the conclusion but doesn't provide a number. For the precision studies, two concentrations (8 μM and 23 μM) were tested, but the number of replicates is not stated. For interference, it states "pooled human sera" were used, but not the number of samples.
- Data Provenance: The document does not explicitly state the country of origin for the data. The studies appear to be retrospective in the sense that they are laboratory performance evaluations rather than new clinical trials with patient recruitment, but this is an inference based on the type of data presented (precision, correlation, interference). There's no indication of prospective clinical study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device (in vitro diagnostic assay). For a diagnostic assay, "ground truth" is typically established by reference methods or clinical diagnosis, not by experts reviewing images or other subjective data. The performance is assessed against known values (for precision, linearity) or by comparison with an accepted predicate device (for correlation).
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of expert review or adjudication for the test set. Performance is based on quantitative measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable. This device is an in vitro diagnostic assay for measuring total bile acids, not an imaging-based AI device that would involve human readers or image interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This device is an in vitro diagnostic assay, which inherently operates "standalone" in the sense that it quantifies a specific analyte (total bile acids) without human intervention in the measurement process itself, beyond sample preparation and loading. The results are generated by the assay's chemical/enzymatic reaction and detection system. This isn't an AI algorithm in the typical sense that would have a "human-in-the-loop" component for interpretation of its output.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation includes:
- Known concentrations: For evaluating precision and linearity (though linearity data is not detailed here, it's a standard part of IVD validation).
- Comparison to a legally marketed predicate device: "Trinity's method" was used as the comparator for assessing correlation, implying its results are considered a valid reference for comparison.
- Spiked samples: For interference studies, known interfering substances were added to "pooled human sera" in controlled concentrations.
8. The Sample Size for the Training Set
This information is not applicable. This device is a traditional enzymatic assay, not a machine learning or AI model that requires a "training set" in the context of algorithm development. Its "training" is inherent in the chemical and enzymatic reactions designed by the manufacturer.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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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.
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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 |
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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.
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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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Page 2 -
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
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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
§ 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.