NBIL

K983134 · Abbott Laboratories · MQM · Sep 23, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983134
• Device Name: NBIL
• Applicant: Abbott Laboratories
• Product Code: MQM · Clinical Chemistry
• Decision Date: Sep 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1113
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The Neonatal Bilirubin assay is used for the quantitation of bilirubin in human neonate serum or plasma. Measurements of bilirubin (total and unbound) in newborn infants are used to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

Device Story

Neonatal Bilirubin is an in vitro diagnostic clinical chemistry assay for quantitative bilirubin measurement in neonate serum or plasma. The device utilizes a differential wavelength method, measuring absorbance at 444 nm and 548 nm. The 548 nm wavelength corrects for hemoglobin interference in the sample. The assay is performed on clinical chemistry systems (e.g., AEROSET System) by laboratory professionals. Results are used by clinicians to assess the risk of bilirubin encephalopathy (kernicterus) in newborns, facilitating timely clinical intervention.

Clinical Evidence

Bench testing only. Method comparison study on the AEROSET System against the predicate A-GENT assay showed a correlation coefficient of 0.9995, slope of 0.941, and Y-intercept of 0.275 mg/dL. Precision studies reported total %CV of 3.3% (Level 1) and 3.5% (Level 2). The assay is linear up to 51.11 mg/dL with a limit of quantitation of 0.04 mg/dL.

Technological Characteristics

In vitro diagnostic clinical chemistry assay. Uses differential wavelength spectrophotometry (444 nm and 548 nm) to measure bilirubin concentration and correct for hemoglobin interference. Linear range up to 51.11 mg/dL. Designed for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of bilirubin in human neonate serum or plasma to aid in assessing the risk of bilirubin encephalopathy (kernicterus) in newborn infants.

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

• A-GENT Neonatal Bilirubin assay (K880743)

Submission Summary (Full Text)

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K983134

SEP 2 3 1998

# 510(k) Summary

#### Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Contact Person Linda Morris Senior Regulatory Specialist MS 1-8 Regulatory Affairs [phone] Fax [phone]

| Date of Preparation of this Summary: | September 4, 1998 |
|--------------------------------------------------|--------------------|
| Device Trade or Proprietary Name: | NBil |
| Device Common/Usual Name or Classification Name: | Neonatal Bilirubin |
| Classification Number/Class: | Class I |

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: KT83134

#### Test Description:

Neonatal Bilirubin is an in vitro diagnostic assay for the quantitative determination of bilirubin in human neonate serum or plasma. The Neonatal Bilirubin assay is a clinical chemistry assay which uses a differential wavelength method. The absorbance of bilirubin, measured at 444 and 548 nm, is directly proportional to the bilirubin concentration in serum or plasma. Measurement at a secondary wavelength (548 nm) is used to correct for any hemoglobin present in the sample.

#### Substantial Equivalence:

The Neonatal Bilirubin assay is substantially equivalent to the A-GENT® Neonatal Bilirubin assay (K880743) on the ABBOTT SPECTRUM® Series II" System.

Neonatal Bilirubin 510(k) September 4, 1998 NBil_5_V I Jwp

Section II Page 1

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These assays vield similar Performance Characteristics.

Similarities:

- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of neonatal . bilirubin.
- Both assays yield similar clinical results. .

Differences:

- There is a minor difference in the assay range. .
#### Intended Use:

The Neonatal Bilirubin assay is used for the quantitation of bilirubin in human neonate serum or plasma.

#### Performance Characteristics:

Comparative performance studies were conducted using the AEROSET™ System. The Neonatal Bilirubin assay method comparison yielded acceptable correlation with the A-GENT Neonatal Bilirubin assay on the ABBOTT SPECTRUM Series II System. The correlation coefficient = 0.9995, slope = 0.941, and the Y-intercept = 0.275 mg/dL. Precision studies were conducted using the Neonatal Bilirubin assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 120 is 3.3% and Level 2/Panel 121 is 3.5%. The Neonatal Bilirubin assay is linear up to 51.11 mg/dL. The limit of quantitation (sensitivity) of the Neonatal Bilirubin assay is 0.04 mg/dL. These data demonstrate that the performance of the Neonatal Bilirubin assay is substantially equivalent to the performance of the A-GENT Neonatal Bilirubin assay on the ABBOTT SPECTRUM Series II System.

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## Conclusion:

The Neonatal Bilirubin assay is substantially equivalent to the A-GENT Neonatal Bilirubin assay on the ABBOTT SPECTRUM Series II System as demonstrated by results obtained in the studies.

Neonatal Bilirubin 510(k) September 4. 1998
NBil_5_VI lwp

Section II Page 3

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SEP 2 3 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Linda Morris Senior Requlatory Specialist Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Re : K983134 Neonatal Bilirubin Regulatory Class: I Product Code: MOM Dated: September 4, 1998 Received: September 8, 1998

Dear Ms. Morris:

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 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 requlations.

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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 beqin 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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510(k) Number (if known): K983/34

Device Name: Neonatal Bilirubin

Indications For Use:

The Neonatal Bilirubin assay is used for the quantitation of bilirubin in human neonate serum or plasma. Measurements of bilirubin (total and unbound) in newborn infants are used to aid in indicating the risk of bilirubin encephalopathy (kernicterus).

983134 a

(Division Sign-Off)
Division of Clinical Laborator vices
510(k) Number k983134

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Neonatal Bilirubin 510(k) September 4, 1998 NBil_5_VI.lwp

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