IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES

K980646 · Instrumentation Laboratory CO · MQM · May 6, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980646
• Device Name: IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES
• Applicant: Instrumentation Laboratory CO
• Product Code: MQM · Clinical Chemistry
• Decision Date: May 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1113
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The IL Synthesis™ is a family of fully automatic, microprocessor controlled, blood gas, electrolytes, glucose, hematocrit and co-oximeter analyzers that was cleared for market by K963800. A new measured co-oximeter parameter is being added on the IL Synthesis™ for the semiquantitative determination of total bilirubin in whole blood from neonates. Elevated bilirubin levels in the blood of newborns is used to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

Device Story

IL Synthesis™ is a fully automatic, microprocessor-controlled analyzer for blood gas, electrolytes, glucose, hematocrit, and co-oximetry. This addition enables semiquantitative measurement of total bilirubin in neonate whole blood samples. The device uses spectrophotometric analysis to determine bilirubin levels. It is intended for clinical use by healthcare professionals. Output provides bilirubin concentration (mg/dL), which clinicians use to assess the risk of bilirubin encephalopathy (kernicterus) in newborns.

Clinical Evidence

Comparative performance study using 309 whole blood samples (0 to 20.0 mg/dL bilirubin) compared IL Synthesis™ results against Sigma's Bilirubin, Total and Direct spectrophotometric method. Results showed a slope of 0.925, intercept of 1.097, and correlation coefficient of 0.969. Precision study conducted on three instruments across two sample levels with 5 replicates each.

Technological Characteristics

Microprocessor-controlled co-oximeter analyzer. Measurement principle: spectrophotometry. Analyzes whole blood samples. Fully automatic operation.

Indications for Use

Indicated for semiquantitative determination of total bilirubin in whole blood from neonates to aid in assessing risk of bilirubin encephalopathy (kernicterus).

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).

Predicate Devices

• Sigma's Bilirubin, Total and Direct (K832236)

Submission Summary (Full Text)

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K980646

#### 6 1998 MAY

# Section 3-- 510(k) Summary IL Synthesis™- -- Addition of Bilirubin as a Measured Parameter (Summary of Safety and Effectiveness)

#### Submitted by:

Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: [phone] [phone] Fax:

#### Contact Person:

Carol Marble -- Phone: [phone]

#### Summary Prepared:

February 18, 1998

#### Name of the device:

Addition of Bilirubin as Measured Parameter for Use with IL Synthesis™ Neonate Whole Blood Samples

## Classification name(s):

Bilirubin (total and unbound) in the neonate test system Class I 862.1113

## Identification of predicate devices:

K832236 Sigma's Bilirubin, Total and Direct

## Description of the device/intended use(s):

The IL Synthesis™ is a family of fully automatic, microprocessor controlled, blood gas, electrolytes, glucose, hematocrit and co-oximeter analyzers that was cleared for market by K963800. A new measured co-oximeter parameter is being added on the IL Synthesis™ for the semiquantitative determination of total bilirubin in whole blood from neonates. Elevated bilirubin levels in the blood of newborns is used to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

# Statement of how the Technological Characteristics of the Device compare to the Predicate device:

Bilirubin as a measured parameter for use with neonate whole blood samples on the IL Synthesis™ is substantially equivalent in performance, intended use and safety and effectiveness to the predicate device: Sigma's Bilirubin, Total and Direct.

## Summary of Performance Data:

In a comparative performance study, 309 whole blood samples ranging in bilirubin level from 0 to 20.0 mg/dL were tested using several IL Synthesis™ instruments and Sigma's Bilirubin, Total and Direct on a spectrophotometer. The results showed a slope of 0.925, an intercept of 1.097 and a correlation coefficient of 0.969 indicating that the results are statistically similar.

A precision study on two sample levels assessed on three different IL Synthesis™ instruments in runs of 5 replicates each gave the following results:

| | | | Instrument 1 | | Instrument 2 | | Instrument 3 | |
|-----------|-------|---|--------------|------|--------------|------|--------------|------|
| Parameter | Level | n | mean | SD | mean | SD | mean | SD |
| Bilirubin | 1 | 5 | 1.1 | 0.95 | 0.6 | 0.78 | 1.3 | 0.38 |
| (mg/dL) | 2 | 5 | 2.3 | 0.55 | 1.7 | 0.49 | 3.7 | 0.45 |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Carol Marble Senior Requlatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190

K980646 Re : IL Synthesis™ - Addition of Bilirubin as a Measured -Parameter for Neonate Whole Blood Samples Regulatory Class: I Product Code: MQM February 18, 1998 Dated: Received: February 19, 1998

Dear Ms. Marble:

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. ਰੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further announcements action. 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 16 2019 10 10:20 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 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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# Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: IL Synthesis™ -- Addition of Bilirubin as Measured Parameter for Neonate Whole Blood Samples

# Indications for Use:

The IL Synthesis™ is a family of fully automatic, microprocessor controlled, blood gas, electrolytes, glucose, hematocrit and co-oximeter analyzers that was cleared for market by K963800. A new measured co-oximeter parameter is being added on the IL Synthesis™ for the semiquantitative determination of total bilirubin in whole blood from neonates. Elevated bilirubin levels in the blood of newborns is used to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K980646 |

| Prescription Use<br>(Per 21 CFR 801.019) | OR Over-The-Counter Use |
|------------------------------------------|-------------------------|
|------------------------------------------|-------------------------|

Section 2 IL Synthesis™: Addition of Bilirubin Parameter 510(k) Page 1 of 1