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 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.

AI/ML Overview

The provided 510(k) summary describes a new in vitro diagnostic assay, Neonatal Bilirubin, and demonstrates its substantial equivalence to a previously cleared device, the A-GENT® Neonatal Bilirubin assay (K880743). The study is entirely focused on chemical assay performance rather than AI/ML algorithms. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC, human readers, ground truth methodology involving experts, and training/test set sample sizes in the context of imaging) are not applicable.

Here's an analysis of the available information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device, K880743, demonstrating "substantially equivalent" performance. The specific quantitative acceptance criteria for each performance characteristic are not explicitly stated as numerical cut-offs but are indicated by "acceptable correlation" and "similar" results to the predicate.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Neonatal Bilirubin Assay)
Correlation Coefficient	Acceptable correlation with predicate (K880743)	0.9995 (vs. K880743)
Slope	Acceptable (vs. K880743)	0.941 (vs. K880743)
Y-intercept	Acceptable (vs. K880743)	0.275 mg/dL (vs. K880743)
Total %CV (Level 1)	Acceptable precision	3.3%
Total %CV (Level 2)	Acceptable precision	3.5%
Linearity	Linear across relevant range	Up to 51.11 mg/dL
Limit of Quantitation (Sensitivity)	Appropriate for intended use	0.04 mg/dL
Assay Range	Similar to predicate	Minor difference from predicate

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated for the "comparative performance studies." The document mentions "two levels of control material" for precision studies but does not specify the number of samples or replicates.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

N/A. This is a chemical assay, and the "ground truth" for the comparative study is the performance of the predicate device (K880743) on clinical samples. No expert adjudication or interpretation of images/clinical scenarios is involved.

4. Adjudication Method for the Test Set

N/A. As this is a chemical assay, there is no need for expert adjudication. The comparison is between the quantitative results of the new device and the predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not applicable for this type of in vitro diagnostic device, which is a quantitative chemical assay. It does not involve human readers interpreting clinical cases with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, in the context of an in vitro diagnostic assay. The "Performance Characteristics" section details the standalone performance of the Neonatal Bilirubin assay itself (precision, linearity, limit of quantitation) and its correlation with the predicate device. There is no "human-in-the-loop" for this type of device's core function (quantitative measurement).

7. Type of Ground Truth Used

Reference device performance / Clinical results. The "ground truth" for the comparative study is the quantitative results obtained from the predicate device, A-GENT® Neonatal Bilirubin assay, on the ABBOTT SPECTRUM Series II™ System. For precision, linearity, and sensitivity, the "ground truth" is the expected chemical behavior and analytical performance of the assay itself, verified through laboratory testing.

8. Sample Size for the Training Set

N/A. This is not an AI/ML device that requires a training set in the typical sense. Development of a chemical assay involves extensive R&D and optimization, but not "training data" for an algorithm.

9. How Ground Truth for the Training Set Was Established

N/A. See point 8.

Summary

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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 (972) 518-6711 Fax (972) 753-3367

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:

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
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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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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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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)

Over-The-Counter Use

(Optional Format 1-2-96)

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

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Regulation Number and Section

§ 862.1113 Bilirubin (total and unbound) in the neonate test system.

(a)
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).(b)
Classification. Class I.