STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR

K993104 · Nova Biomedical Corp. · GLY · Dec 2, 1999 · Hematology

Device Facts

• Record ID: K993104
• Device Name: STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
• Applicant: Nova Biomedical Corp.
• Product Code: GLY · Hematology
• Decision Date: Dec 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7500
• Device Class: Class 2

Indications for Use

The Stat Profile pHOx CO-Oximeter Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of oxyhemoglobin, carboxyhemoglobin, methemoglobin, and deoxyhemoglobin in human blood.

Device Story

Stat Profile pHOx CO-Oximeter Analyzer; in vitro diagnostic device for clinical laboratory use. Inputs: human blood samples. Operation: quantitative measurement of hemoglobin fractions (oxyhemoglobin, carboxyhemoglobin, methemoglobin, deoxyhemoglobin). Output: numerical concentration values for hemoglobin species. Used by healthcare professionals in clinical settings to assess patient oxygenation status and hemoglobin derivatives. Results assist clinicians in diagnosing and monitoring respiratory or circulatory conditions. Benefits: rapid, accurate assessment of blood gas and co-oximetry parameters to guide clinical intervention.

Clinical Evidence

No clinical data provided; 510(k) clearance based on substantial equivalence to existing legally marketed devices.

Technological Characteristics

In vitro diagnostic CO-Oximeter analyzer; utilizes spectrophotometric analysis for hemoglobin fraction quantification. Standalone benchtop device for clinical laboratory use.

Indications for Use

Indicated for in vitro diagnostic use by healthcare professionals for quantitative determination of oxyhemoglobin, carboxyhemoglobin, methemoglobin, and deoxyhemoglobin in human blood.

Regulatory Classification

Identification

A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.

Special Controls

*Classification.* Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Submission Summary (Full Text)

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DEC - 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Paul W. MacDonald Director, Quality Assurance/Regulatory Affairs NOVA Biomedical Corporation 200 Prospect Street Waltham, Massachusetts 02254-9141

Re: K993104 Trade Name: Stat Profile pHOx CO-Oximeter Analyzer Regulatory Class: II Product Code: GLY Dated: September 15, 1999 Received: September 16, 1999

Dear Mr. MacDonald:

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 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). 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 regulations.

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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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

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:** K 993104

Device Name: Stat Profile pHOx CO-Oximeter Analyzer

Indications for Use:

Intended Use

The Stat Profile pHOx CO-Oximeter Analyzer is intended for in vitro diagnostic use by health care professionals in the quantitative determination of oxyhemoglobin, carboxyhemoglobin, methemoglobin, and deoxyhemoglobin in human blood.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Stir E. Madison

(Division Sign-Off) Division of Clinical Laboratory Dev 510(k) Number

(Optional Format 3-10-98)