(106 days)
This product is to be used in a diagnostic laboratory setting, by qualified laboratory personnel, for the quantitative determination of direct and total bilirubin in human serum. It is intended for in vitro diagnostic use only. Studies suggest that direct and total bilirubin measurements provide information to assist in the assessment of liver function and conditions such as hemolytic and obstructive jaundice.
Not Found
This is a premarket notification for a Class II medical device, not a study. Therefore, the information requested in the prompt (acceptance criteria, study design, sample sizes, ground truth establishment, etc.) is not applicable in the typical sense of a clinical or performance study. The 510(k) process is about demonstrating substantial equivalence to a predicate device, not necessarily proving new performance against set acceptance criteria through a standalone study.
However, based on the provided text, I can extract information relevant to the device and its intended use, and explain why the study-related questions are not directly answerable from this document.
Device Name: Hitachi Direct Bilirubin/Hitachi Total Bilirubin
Regulation Number: 21 CFR 862.1110
Regulation Name: Bilirubin (total or direct) test system
Regulatory Class: Class II
Product Code: CIG
Here's an attempt to address the prompt, noting the limitations of the provided document:
- A table of acceptance criteria and the reported device performance
- This document does not specify quantitative "acceptance criteria" in the way a clinical study protocol would, nor does it present "reported device performance" against such criteria. The 510(k) submission mechanism demonstrates substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device performs as well as, or comparably to, the predicate device across various metrics (e.g., precision, accuracy, linearity, interferences). However, the specific data for this comparison is not included in this FDA clearance letter.
| Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Not Included in Document) |
|---|---|
| (Performance standards for bilirubin assays, e.g., precision, accuracy, linearity, dynamic range, interference studies, comparison with predicate device, typically established by the manufacturer and FDA guidance documents). | (Performance data demonstrating substantial equivalence to a predicate device for direct and total bilirubin measurement in human serum, as submitted by Pointe Scientific, Inc. in K040391). |
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not available in the provided FDA clearance letter. Such details would be part of the manufacturer's 510(k) submission, which is not publicly disclosed in this summary form. The clearance letter only states that the device was found substantially equivalent based on the submitted information.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. For an in vitro diagnostic (IVD) assay like bilirubin measurement, the "ground truth" would typically be established by reference methods or highly accurate laboratory methods, not by expert consensus in the way a diagnostic imaging study might. The specifics of how accuracy/truth was ascertained for the test samples used in the 510(k) submission are not in this document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This typically refers to adjudication of discrepancies among human readers or expert interpretations, which is not directly relevant for an automated IVD assay's performance evaluation against a reference method.
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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
- Not applicable. This device is an automated in vitro diagnostic test for bilirubin, not an AI-assisted diagnostic imaging device or an AI tool meant to improve human reader performance. Its purpose is to quantitatively measure bilirubin levels in serum.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in a sense. The device is a "standalone" automated assay intended for use "in a diagnostic laboratory setting, by qualified laboratory personnel, for the quantitative determination of direct and total bilirubin in human serum." The performance shown in the 510(k) submission would have been the device's output (quantitative bilirubin levels) compared to reference methods or a predicate device. It is not an "algorithm only" in the modern AI sense, but an automated chemical analysis system. The human involvement is in operating the instrument and interpreting the results within a clinical context, not in directly forming the diagnostic output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For an IVD bilirubin assay, the "ground truth" for evaluating accuracy would typically be established by:
- Reference methods: Highly accurate and precise laboratory methods (e.g., ID-LC-MS/MS, or established spectrophotometric methods).
- Comparison to a legally marketed predicate device: This is the primary method for a 510(k) submission, where the new device's results are compared to those of an already cleared device across a range of samples.
- The specific method used for the Hitachi device is not detailed in this clearance letter.
- For an IVD bilirubin assay, the "ground truth" for evaluating accuracy would typically be established by:
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The sample size for the training set
- Not applicable. This device is a chemical analyzer, not a machine learning or AI model that requires a "training set" in the computational sense. The "development" would involve chemical and engineering principles, calibration, and optimization, not data-driven machine learning training.
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How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of this type of device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is made up of three curved lines, and it is facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 2 2004
Mr. Ron Jamison Technical Service Manager Pointe Scientific, Inc. 1025 John A. Papalas Drive Lincoln Park, MI 48146
K040391 Re:
Ko 16571
Trade/Device Name: Hitachi Direct Bilirubin/Hitachi Total Bilirubin Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG Dated: May 6, 2004 Received: May 19, 2004
Dear Mr. Jamison:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases) 75 the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1970, as easonance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costinetter (110) that to the vice, subject to the general controls provisions of the Act. The r ou may, increrere, mains 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 your device is classified divinal controls. Existing major regulations affecting your device n may be subject to sach about 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 r lease be devilsed that I Drivision that your device complies with other requirements of the Act that I Dr has made a and regulations administered by other Federal agencies. You must or any I catal statutes and registements, 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) I mis lotter will and in your e FDA finding of substantial equivalence of your device to a legally premated predicated. " ceresults 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, If you desire operation and advertising of your device, please contact the Office of or questions on the promote and Safety at (301) 594-3084. 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 Tou may oount outer generers, 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, U.S. Div.
Jean M. Cooper, MS, D.V.M. 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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Indications for Use
510(k) Number (if known): K040391 - - - -
Device Name: Hitachi Direct Bilirubin/Hitachi Total Bilirubin
Indications For Use:
This product is to be used in a diagnostic laboratory setting, by qualified laboratory t mo proguets, for the quantitative determination of direct and total bilirubin in human serum. It is intended for in vitro diagnostic use only. Studies suggest that direct and total bilirubin measurements provide information to assist in the assessment of liver function and conditions such as hemolytic and obstructive jaundice.
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 an
510(k)
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§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.