SYNERMED TOTAL BILIRUBIN REAGENT KIT

K972716 · Synermed, Inc. · CIG · Aug 7, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972716
• Device Name: SYNERMED TOTAL BILIRUBIN REAGENT KIT
• Applicant: Synermed, Inc.
• Product Code: CIG · Clinical Chemistry
• Decision Date: Aug 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Synermed® Total Billirubin reagent is intended for use in the quantitative determination of total bilirubin in serum or plasma. The reagent kit is intended for in vitro diagnostic use only.

Device Story

Synermed Total Bilirubin Reagent Kit is an in vitro diagnostic reagent system for quantitative measurement of total bilirubin in human serum or plasma. Used in clinical laboratory settings by trained laboratory personnel. The reagent reacts with bilirubin in the sample to produce a measurable colorimetric change, typically quantified via spectrophotometry. Results assist clinicians in diagnosing and monitoring liver function, biliary obstruction, and hemolytic conditions. The device provides objective data to support clinical decision-making regarding patient jaundice and hepatic health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent kit for colorimetric spectrophotometric analysis of total bilirubin. Chemical-based assay; no software or electronic components.

Indications for Use

Indicated for the quantitative determination of total bilirubin in serum or plasma to assist in the diagnosis and monitoring of conditions associated with elevated bilirubin, including hemolytic disorders, biliary obstruction, cholestasis, hepatitis, cirrhosis, and decreased conjugation (e.g., neonatal jaundice). For in vitro diagnostic use.

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.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Marcia J. Arentz · Vice President - Operations Synermed Inc. 1688 50th Avenue Montreal (Lachine), Quebec Canada H8T 2V5

AUG - 7 1997

K972716 Re : Synermed Total Bilirubin Reagent Kit Requlatory Class: II Product Code: CIG Dated: July 18, 1997 Received: July 21, 1997

Dear Ms. Arentz:

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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 Requlations.

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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 requlation (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 Putman

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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10(k) Number (if known):______________________________________________________________________________________________________________________________________________________

Device Name: Total Bilirubin Reagent Kit

ndications For Use:

The Synermed® Total Billirubin reagent is intended for use in the quantitative determination of total bilirubin in serum or plasma. The reagent kit is intended for in vitro diagnostic use only.

Elevated serum biliruhin levels are observed in a variety of conditions including hemolytic disorders, biliary obstruction, cholestasis, hepatitis, cirrhosis and decreased conjugation (e.g. neonatal jaundice).

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF EDED)

| | | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|-----------------------------------------|---------|--------------------------------------------------------|
| | | |
| cription Use<br>21 CFR 801.109) | | OR |
| | | Over-The-Counter Use |
| (Division Sign-Off) | | (Optional Format 1-2-96) |
| Division of Clinical Laboratory Devices | | |
| 510(k) Number | K972/16 | |