BILICHEK NON-INVASIVE BILIRUBIN ANALYZER

K983071 · Respironics, Inc. · MQM · Mar 4, 1999 · Clinical Chemistry

Device Facts

• Record ID: K983071
• Device Name: BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
• Applicant: Respironics, Inc.
• Product Code: MQM · Clinical Chemistry
• Decision Date: Mar 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1113
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The Bilichek™ Non-Invasive Bilirubin Analyzer is a computer assisted non-invasive transcutaneous bilirubinometer which is intended as an index to predict serum bilirubin levels in neonates less than eight days old, without regard to gender, gestational age, race, or bodyweight. The Bilichek™ provides a numerical measurement of predicted bilirubin count in mo/dL within a clinically beneficial range that has been correlated with total serum bilirubin concentration measured by High Performance Liquid Chromotography (HPLC). The device is used in the hospital or institutional environment to assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia. Neonates whose Bilichek™ test results are indicative of hyperbilirubinemia are evaluated by their physician(s) for appropriate patient management.

Device Story

Bilichek is a computer-assisted, non-invasive transcutaneous bilirubinometer; used in hospital/institutional settings by clinicians. Device measures light reflectance from neonatal skin to estimate bilirubin levels; utilizes multi-wavelength spectral analysis to account for skin pigmentation and other optical interferences. Output is a numerical bilirubin concentration (mg/dL). Clinicians use these measurements to screen for hyperbilirubinemia; results guide clinical decision-making regarding the need for further diagnostic serum testing or therapeutic intervention. Benefits include non-invasive monitoring, reducing need for frequent blood draws in neonates.

Clinical Evidence

The device performance was validated by correlating transcutaneous bilirubin measurements with total serum bilirubin concentrations measured via High Performance Liquid Chromatography (HPLC). No specific sample sizes or statistical metrics (e.g., sensitivity/specificity) are provided in the summary document.

Technological Characteristics

Non-invasive transcutaneous bilirubinometer; utilizes multi-wavelength optical reflectance spectroscopy to measure bilirubin levels in neonatal skin. Device is computer-assisted; intended for hospital/institutional use. Technical specifications and material standards are not detailed in the provided text.

Indications for Use

Indicated for neonates < 8 days old, regardless of gender, gestational age, race, or bodyweight, to predict serum bilirubin levels and monitor for hyperbilirubinemia.

Regulatory Classification

Identification

A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

Submission Summary (Full Text)

{0}------------------------------------------------

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" arranged around the top half of the circle. Inside the circle is a stylized image of a bird in flight, composed of three overlapping profiles of human faces.

MAR - 4 1999

Mr. Timothy Y. Cowart Respironics, Inc. 3371 Lenora Church Road Snellville, Georgia 30039

Re: K983071

> Trade Name: Bilichek™, Non-Invasive Bilirubin Analyzer Regulatory Class: II Product Code: MQM Dated: January 4, 1999 Received: January 14, 1999

Dear Mr. Cowart:

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 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). 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 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 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 regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

{1}------------------------------------------------

## Page 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/dsma/dsmamain.html".

Sincerely vours.

Steven Sutman

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

{2}------------------------------------------------

510(k) Number (if known) K983071

Device Name: BilichekIM, Non-Invasive Bilirubin Analyzer

Indications for Use:

The Bilichek™ Non-Invasive Bilirubin Analyzer is a computer assisted non-invasive transcutaneous bilirubinometer which is intended as an index to predict serum bilirubin levels in neonates less than eight days old, without regard to gender, gestational age, race, or bodyweight. The Bilichek™ provides a numerical measurement of predicted bilirubin count in mo/dL within a clinically beneficial range that has been correlated with total serum bilirubin concentration measured by High Performance Liquid Chromotography (HPLC). The device is used in the hospital or institutional environment to assist clinicians in monitoring the status of neonates for the development of hyperbilirubinemia. Neonates whose Bilichek™ test results are indicative of hyperbilirubinemia are evaluated by their physician(s) for appropriate patient management.

Jan Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983071

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ে Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _

(Optional Format 1-2-96)