(445 days)
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No
The summary describes a quantitative analyzer for bilirubin using a reagent kit and does not mention any AI/ML components or capabilities.
No
The device is an analyzer for determining bilirubin concentration, which provides information for clinical assessment but does not directly treat or prevent a disease.
Yes
The device is designed to "determine both total and unbound bilirubin concentration in neonatal serum," and this information can be used by the physician to assess "jaundiced neonates and the possible risk of bilirubin encephalopathy." This directly indicates the device provides information for diagnosis and clinical assessment.
No
The device description explicitly mentions "UB analyzer UA-2" and its function of determining concentrations and displaying them on an "LCD" and printing them out. This indicates a physical hardware component is involved in the measurement and output, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to determine the concentration of substances (total and unbound bilirubin) in a biological sample (neonatal serum). This is a core characteristic of IVDs.
- Sample Type: It analyzes a sample taken from the body (serum), but the analysis is performed in vitro (outside the body).
- Clinical Purpose: The results are used to provide information for the clinical assessment of jaundiced neonates and the possible risk of bilirubin encephalopathy. This indicates a medical purpose for the test results.
- Device Description: The description explicitly states it "determine[s] both the total and unbound bilirubin concentrations in neonatal serum quantitatively."
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UB analyzer UA-2 is designed to measure quantitations of total bilirubin and unbound bilirubin in neonatal serum with rapidity and accuracy by the enzymatic method. These concentrations of bilirubin can be used by the physician for clinically assessing jaundiced neonates and for the possible association with bilirubin encephalopathy.
UB analyzer UA-2 and its exclusive reagent kit are designed to determine both total and unbound bilirubin concentration in neonatal serum using exclusive reagent kit, "UB TEST." The total bilirubin and unbound bilirubin concentration in neonatal serum can be used to provide the physician with additional information in the clinical assessment of jaundiced neonates and the possible risk of bilirubin encephalopathy.
Product codes (comma separated list FDA assigned to the subject device)
CIG, JJX
Device Description
The UB analyzer UA-2 is designed to determine both the total and unbound bilirubin concentrations in neonatal serum quantitatively with rapidity and accuracy. Determined concentrations of total bilirubin and unbound bilirubin are digitally displayed on LCD and printed out with UB/TB ratio and determined date. These concentrations of bilirubin can be used by the physician for clinically assessing jaundiced neonates and for the possible association with bilirubin encephalopathy.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
neonatal
Intended User / Care Setting
physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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.
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Image /page/0/Picture/0 description: The image shows the word "Arrows" in a bold, sans-serif font. The first letter, "A", is stylized with horizontal lines inside, resembling an arrow design. The rest of the letters are in a standard bold font, creating a visually striking logo or brand name.
972382
ARROWS Co., Ltd.
2-7-50 Nishimiyahara, Yodogawa-ku. Osaka 532 Japan SEP 1 4 1998 Tel : +81 6 350 0918 Fax : 81 6 350 0892
September 25, 1997
| Document Mail Center (HFZ-401) | ||||
|---|---|---|---|---|
| Center for Devices and Radiological Health | ||||
| Food and Drug Administration | ||||
| 9200 Corporate Boulevard | ||||
| Rockville, Maryland and 20850 USA | ||||
| RECEIVED | ||||
| SEP 30 9 22 AM '9 | ||||
| FDA/CDRH/ODE/D | ||||
| Premarket Notification [510(K)] Number K972385 |
Attention : Document Mail Clerk
Dear Sirs :
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
ARROWS Co., Ltd. is requesting marketing clearance for in vitro diagnostic use of UB analyzer UA-2, its reagent kit and the bilirubin control to be manufactured by ARROWS Co., Ltd. Our UB analyzer UA-2 represents an apparatus for measuring unbound bilirubin as well as total bilirubin in newborns quantitatively. The UB analyzer UA-2 provides effective means for the rapid and accurate determination of unhound bilirubin in the serum of newborns by an enzymatic method utilizing Glucose Oxidase (GOD) and Peroxidase (POD).
The UB analyzer UA-2 is designed to determine both the total and unbound bilirubin concentrations in neonatal serum. These concentrations of bilirubin can be used by the physician for clinically assessing jaundiced neonates and for the possible association with bilirubin encephalopathy.
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: ARROWS Co., Ltd. Submitter's Name : 2-7-50 Nishimiyahara, Yodogawa-ku, Osaka 532 Japan Address Telephone Number : +81 6 350 0918 Fax Number : +81 6 350 0892 Contact Person : Yoshimasa Ogoshi
Proprietary Name : UB analyzer UA-2
UB analyzer reagent kit and bilirubin control
Common/Usual Name : Bilirubinometer for the detection of total and unbound concentrations of bilirubin in neonatal serum, its reagent kit, and bilirubin control
Classification : II
Classification Name : DIAZO COLORIMETRY, BILIRUBIN
Substantial Equivalence :
UB analyzer UA-2 is similar in design and function to UB ANALYZER , MODEL UA-1 / REAGENT KIT / BILIRUBIN CON. which was approved with Premarket notification 510(K) number K871115 by FDA and marketed in USA by LABO SCIENCE-USA INC. We had been the original manufacturer of UB ANALYZER , MODEL UA-1 / REAGENT KIT / BILIRUBIN CON. and modified this device in design, adopting the state-of-the-art technology. As the comparison table and scientific literature show, the modifications are not substantial and do not affect any safety, effectiveness and the intended use of the device.
The description of the device :
The UB analyzer UA-2 is designed to determine both the total and unbound bilirubin concentrations in neonatal serum quantitatively with rapidity and accuracy. Determined concentrations of total bilirubin and unbound bilirubin are digitally displayed on LCD and printed out with UB/TB ratio and determined date. These concentrations of bilirubin can be used by the physician for clinically assessing jaundiced neonates and for the possible association with bilirubin encephalopathy.
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The intended use of the device :
The UB analyzer UA-2 is designed to measure quantitations of total bilirubin and unbound bilirubin in neonatal serum with rapidity and accuracy by the enzymatic method. These concentrations of bilirubin can be used by the physician for clinically assessing jaundiced neonates and for the possible association with bilirubin encephalopathy.
The technological characteristics of the device compared to the predicative device : The UB analyzer UA-2 was modified in design of UB ANALYZER UA-1 adopting the state -of -the art technology. As "Comparison on the specifications of UB ANALYZER UA-1 and UB analyzer UA-2" shows, the technological characteristics of the UB analyzer UA-2 are basically the same with the predicative device, UB ANALYZER UA-1.
The followings are the modified technological characteristics :
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- Display was changed from LED to LCD (liquid crystal display).
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- As printer was built in with UB analyzer UA-2, the measurement results are automatically printed out together with LCD display.
If you have any question or require any further information, please fell free to contact me at fax +81 350 0892.
Sincerely yours,
Yoshimasa Ogoshi President
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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is a stylized image of a human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 4 1998
Nobuo Hisa . Tradinq Manager Arrows Co., Ltd. 2-7-50 Nishimiyahara, Yodogawa-ku Osaka 532 Japan
K972382 Re : UB Analyzer UA-2, Reagent Kit, and Bilirubin Control Requlatory Class: I, II Product Code: CIG, JJX Dated: Auqust 28, 1997 Auqust 31, 1997 Received:
Dear Mr. Hisa:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note:
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Paqe 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
UB analyzer UA-2 and its exclusive reagent kit are designed to determine both total and unbound bilirubin concentration in neonatal serum using exclusive reagent kit, "UB TEST." The total bilirubin and unbound bilirubin concentration in neonatal serum can be used to provide the physician with additional information in the clinical assessment of jaundiced neonates and the possible risk of bilirubin encephalopathy.
Division Sign-Off)
Division of Clinical Laboratory Devices
10/k) Number K 972382
Prescription Use.