UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL

K972382 · Arrows Co., Ltd. · CIG · Sep 14, 1998 · Clinical Chemistry

Device Facts

• Record ID: K972382
• Device Name: UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
• Applicant: Arrows Co., Ltd.
• Product Code: CIG · Clinical Chemistry
• Decision Date: Sep 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

The UB analyzer UA-2 is an in vitro diagnostic device for neonatal serum analysis. It utilizes an enzymatic method with Glucose Oxidase (GOD) and Peroxidase (POD) to measure total and unbound bilirubin concentrations. The device is operated by clinical laboratory personnel. Input consists of neonatal serum samples; the device processes these samples to calculate bilirubin levels and the UB/TB ratio. Outputs are displayed on an integrated LCD screen and printed via a built-in printer. These results assist physicians in assessing jaundiced neonates and evaluating the risk of bilirubin encephalopathy.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and functional comparison to the predicate device.

Technological Characteristics

Enzymatic bilirubin measurement (GOD/POD method). Features an LCD display and integrated printer. Designed for neonatal serum analysis. Standalone benchtop analyzer.

Indications for Use

Indicated for the quantitative determination of total and unbound bilirubin in neonatal serum to assist physicians in the clinical assessment of jaundiced neonates and the potential risk of bilirubin encephalopathy.

Regulatory Classification

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.

Predicate Devices

• UB ANALYZER, MODEL UA-1 / REAGENT KIT / BILIRUBIN CON. (K871115)

Submission Summary (Full Text)

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972382

# ARROWS Co., Ltd.

2-7-50 Nishimiyahara, Yodogawa-ku. Osaka 532 Japan SEP 1 4 1998 Tel : [phone] Fax : [phone]

#### 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<br>SEP 30 9 22 AM '9<br>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 : [phone] Fax Number : [phone] 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 :

- 1. Display was changed from LED to LCD (liquid crystal display).
- 2. 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 [phone].

Sincerely yours,

Yoshimasa Ogoshi President

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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Prescription Use.