STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+

K061830 · Nova Biomedical Corp. · CIG · Nov 1, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061830
• Device Name: STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
• Applicant: Nova Biomedical Corp.
• Product Code: CIG · Clinical Chemistry
• Decision Date: Nov 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

The Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COhb), Methemoglobin (MetHb), Reduced Hemoglobin (HHb), Oxygen content (O2Ct), Oxygen capacity (O2Cap), and total Bilirubin (tBil) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples. The intended use of the Nova Stat Profile Critical Care Xpress CO-Oximeter Calibration Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total hemoglobin, oxyhemoglobin, carboxyhemoglobin, methemoglobin, deoxyhemoglobin and total bilirubin in human blood using the Nova Stat Profile Critical Care Xpress Analyzer. Nova Stat Profile Critical Care Xpress CO-Oximeter Controls and Auto cartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Biomedical Stat Profile Critical Care Xpress Analyzers.

Device Story

Stat Profile Critical Care Xpress (CCX) Analyzer performs quantitative total bilirubin measurement in heparinized whole blood; utilizes existing spectrophotometer hardware; adds new software algorithm for direct bilirubin detection at specific wavelength. Device used in point-of-care or clinical settings by healthcare professionals. Input: heparinized whole blood sample. Output: quantitative total bilirubin concentration (mg/dL). Healthcare providers use output for clinical decision-making regarding patient bilirubin levels. Benefits: rapid, point-of-care assessment of bilirubin alongside existing blood gas/electrolyte panels.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Quantitative absorbance assay; spectrophotometry; benchtop analyzer. Measures total bilirubin directly via specific wavelength. Calibrators/controls traceable to NIST SRM 916A. Connectivity: standalone. Software-based algorithm for analyte quantification.

Indications for Use

Indicated for quantitative determination of total bilirubin in heparinized whole blood for adult patients. Not for use on neonates. For prescription use by healthcare professionals in point-of-care or clinical settings.

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Paul W. MacDonald Nova Biomedical Corporation 200 Prospect Street Waltham, MA 02454

NOV - 1 2006

Re: k061830

Rootess Regulation Number: 21 CFR 862.1110 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: Class II Product Code: CIG, JIT, JJY Dated: October 17, 2006 Received: October 18, 2006

Dear Mr. MacDonald:

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 I ou mayy arosses 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 n may ou our 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/industry/support/index.html.

Sincerely vours.

Alberto Gutierrez, Ph.D.

Alberto Guticarez, Ph.D. 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

UNI, 1572 M

510(k) Number: Device Name: Indications for Use:

Kae1850
Nova Stat Profile Critical Care Xpress (CCX 1+) SystemThe Stat Profile Critical Care Xpress Analyzer is intended for in vitro diagnostic use by health care r rofessionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Reduced Hemoglobin (HHb), Oxygen content (O2Ct), Oxygen capacity (02Cap), and total Bilirubin (tBil) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Gu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples.

The intended use of the Nova Stat Profile Critical Care Xpress CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total hemoglobin, oxyhemoglobin, carboxyhemoglobin, methemoglobin, deoxyhemoglobin and total bilirubin in human blood using the Stat Profile Critical Care Xpress CO-Oximeter Analyzer.

Nova Stat Profile Critical Care Xpress CO-Oximeter Controls and Autocartridge QC are intended for in r vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Biomedical Stat Profile Critical Care Xpress Analyzers.

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

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 807 Subpart C) |
|-------------------------------------------------|---|--------|------------------------------------------------|
|-------------------------------------------------|---|--------|------------------------------------------------|

Division Sign-Off

| Offic: | Diagnostic L. . U. |
|-----------------------|--------------------|
| Evaluation and Safety | (Updated Febru. |
| | K061830 |

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