BILIRUBIN ASSAY ON THE OMNI S ANALYZER

K040174 · Roche Diagnostics Corp. · MQM · May 14, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040174
• Device Name: BILIRUBIN ASSAY ON THE OMNI S ANALYZER
• Applicant: Roche Diagnostics Corp.
• Product Code: MQM · Clinical Chemistry
• Decision Date: May 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1113
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The Roche Diagnostics OMNI S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, bilirubin, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate.

Device Story

The OMNI S Analyzer is a fully automated critical care analyzer used in clinical settings. It incorporates an oximeter module, which is an optical sensor module, to measure bilirubin levels in patient samples. The device utilizes spectrophotometric analysis based on Lambert-Beer's law to determine bilirubin concentration. By measuring various hemoglobin derivatives, the instrument provides a bilirubin measurement that is corrected for hemoglobin interference. The output is a quantitative bilirubin value, which assists clinicians in the management of neonatal jaundice and related conditions. The device is intended for prescription use.

Clinical Evidence

Bench testing only. Precision evaluated using Autotrol Plus levels and whole blood (CVs ≤1.67% and ≤7.56% respectively). Linearity demonstrated across 6.86-41.52 mg/dL range (R=0.9996). Method comparison against four commercial methods (Hitachi, Beckman, Kodak, Radiometer) showed strong correlation (R=0.974-0.986). Interference studies conducted per NCCLS EP7-P; methylene blue identified as an interferent.

Technological Characteristics

Fully automated critical care analyzer. Measures bilirubin via spectrophotometric or electrochemical sensing principles (implied by critical care analyzer class). System supports whole blood, serum, plasma, and aqueous solutions. Connectivity and software details not specified. Sterilization and material specifications not provided.

Indications for Use

Indicated for the quantitative measurement of bilirubin in whole blood, serum, plasma, and aqueous solutions in neonates.

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

• Roche Hitachi Analyzers (K981632)
• Radiometer ABL735 (K991417)
• Beckman LX®20 System (K011213)
• Kodak Vitros System (K840880)

Submission Summary (Full Text)

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510(k) Summary ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. 1) Submitter Roche Diagnostics Corporation name, address, 9115 Hague Rd. contact Indianapolis, IN 46250 Contact Person: Jennifer Tribbett Date Prepared: January 23, 2004 2) Device name Proprietary name: Bilirubin Assay on the OMNI S Analyzer Common name: Bilirubin (total and unbound) in the neonate test system Classification name: Bilirubin (total and unbound) in the neonate test system ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------3) Predicate The bilirubin parameter for use on the OMNI S Analyzer is substantially device equivalent to the legally marketed bilirubin assay on the Roche Hitachi Analyzers (K981632), the Radiometer ABL735 (K991417), the Beckman LX®20 System (K011213) and the Kodak Vitros System (K840880). The Roche Diagnostics OMNI S Analyzer is a fully automated critical care 4) Device Description analyzer intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, bilirubin. hemoglobin, oxygen saturation, oxyhemoglobin, total deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate. 5) Intended use The OMNI S bilirubin claim is for the determination of neonatal bilirubin in newborns using whole blood samples.

MAY 1 4 2004

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The bilirubin parameter for use on the OMNI S Analyzer was compared to 6) Substantial equivalence several legally marketed analyzers in the method comparison studies. It was Similarities and compared to the bilirubin assay on the Roche Hitachi Analyzers (K981632), Differences the Radiometer ABL735 (K991417), the Beckman LX®20 System (K011213) and the Kodak Vitros System (K840880).

> The OMNI S bilirubin claim is for the determination of neonatal bilirubin in newborns using whole blood samples. The primary predicate device is the Radiometer ABL735, which determines neonate bilirubin using the same sample type (whole blood).

> The method comparison studies also showed acceptable performance versus other analyzers, the Roche Hitachi Analyzers (K981632), the Beckman LX®20 System (K011213), and the Kodak Vitros System (K840880), which claim the determination of bilirubin in serum and plasma.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 4 2004

Ms. Jennifer Tribbett Regulatory Affairs Principal Roche Diagnostics Corp. 9115 Hague Road Indianapolis, IN 46256

> k040174 Trade/Device Name: Bilirubin Assay on the OMNI S Analyzer Regulation Number: 21 CFR 862.1113 Regulation Name: Bilirubin (total and unbound) in the neonate test system Regulatory Class: Class I Product Code: MQM Dated: April 5, 2004 Received: April 7, 2004

Dear Ms. Tribbett:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K040174

Device Name: Bilirubin Assay on the OMNI S Analyzer

Indications For Use:

The Roche Diagnostics OMNI S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PO2, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urca/BUN, bilirubin, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin and methemoglobin in samples of whole blood, serum, plasma and aqueous solutions as appropriate.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
Division Sign-Off

Office of In Vitro Diagno evice Evaluation and

510(k) K040174

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