OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY

K980178 · Bionostics, Inc. · JJY · Feb 12, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980178
• Device Name: OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY
• Applicant: Bionostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Feb 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Oxyhemoglobin Control for CO-Oximetry is intended for use to monitor CO-oximetry measurements of hemoglobin and hemoglobin fractions in instruments which measure the optical absorption characteristics of whole blood at specific wavelengths. To make possible verification of instrument performance at different points for each analyte, the Control has different clinically significant values for total hemoglobin, oxyhemoglobin, carboxyhemoglobin and methemoglobin. This product is for In Vitro Diagnostic Use only.

Device Story

Device is an in vitro diagnostic quality control material; used to monitor performance of CO-oximeter instruments. Input: purified bovine blood treated with oxygen, carbon dioxide, and carbon monoxide to achieve defined hemoglobin fraction values. Output: stable control material with known concentrations of total hemoglobin, oxyhemoglobin, carboxyhemoglobin, and methemoglobin. Used in clinical laboratories to verify instrument calibration and accuracy; helps identify operating problems. Healthcare providers use control results to ensure reliability of patient sample measurements, which inform clinical decisions regarding tissue oxygenation and oxygen transport. Benefits patient by ensuring accuracy of diagnostic data used for therapeutic management.

Clinical Evidence

Bench testing only. Performance testing conducted on 8 different CO-oximeter instrument models in both Bionostics' laboratory and clinical laboratories. Results verified that the control material provides sufficient accuracy and precision in measurements of total hemoglobin and hemoglobin fractions to monitor CO-oximeter performance across varying operating methodologies.

Technological Characteristics

Quality control material composed of purified bovine blood treated with oxygen, carbon dioxide, and carbon monoxide. Packaged in sealed glass ampuls to ensure stability. Contains no human-based materials. Functions as a multi-analyte control for optical absorption-based CO-oximetry instruments.

Indications for Use

Indicated for use as an in vitro diagnostic quality control material to monitor the precision and accuracy of CO-oximeter instruments measuring total hemoglobin, oxyhemoglobin, carboxyhemoglobin, and methemoglobin concentrations in whole blood.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Bionostics 282 CO-Oximeter Control (K832066A)
• Multi-4 C0-Oximeter Control (K861901)

Submission Summary (Full Text)

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# K980178 , 1998

# BIONOSTICS

## 510(k) Summary

| (a)(1) Submitter's name, address | Contact Person |
|----------------------------------|---------------------|
| Bionostics, Inc | Bruce Williams |
| 2 Craig Road | Ex. Vice President |
| Acton, MA 01720 | 978 263 3856 Ex 212 |

Date of preparation of this summary: 16 January 1998

Oxyhemoglobin CO-Oximeter Control (2) Device trade name:

Device common name or classification name: Multi Analyte Control Classification number and Class: 75JJY, Class I

- (3) Substantial Equivalence:
Oxyhemoglobin CO-oximeter Control is substantially equivalent in function, safety and efficacy to at least two products currently marketed:

- a. Bionostics 282 CO-Oximeter Control (510(k) clearance K832066A, 6/22/83), and,
- b. Multi-4 C0-Oximeter Control manufactured by Instrumentation Laboratory, Lexington, MA 02173 (510(k) clearance K861901).

Both materials have as their intended use, the quality control of certain analytical instruments.

#### (4) Description of the new device

Oxyhemoglobin CO-Oximeter Control is prepared by purifying bovine blood to different to different concentrations of hemoglobin. The solution is then treated with oxygen, carbon dioxide and carbon monoxide to provide different defined values for the hemoglobin fractions of oxyhemoglobin, carboxyhemoglobin and methemoglobin. The solution is packaged in sealed glass ampuls to assure the integrity of all control values. The material contains no human based materials.

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### 510(k) Summary (continued)

#### Intended use of the device (5)

The Oxyhemoglobin CO-Oximeter Control is intended for use to monitor CO-oximetry measurements of hemoglobin and hemoglobin fractions in instruments which measure the optical absorption characteristics of whole blood at specific wavelengths.

#### Technological characteristics of the device (6)

Oxyhemoglobin CO-Oximeter Control is equivalent in its technology to the currently marketed devices to which substantial equivalence is claimed. The process for purifying the treating the bovine blood makes it possible to have stable hemoglobin species, including oxyhemoglobin.

- (b)
### (1, 2) Summary of performance testing submitted with the premarket notification for the device.

The Oxyhemoglobin CO-Oximeter Control was tested for performance as a quality control material on 8 of CO-oximeter instrument The testing has took place in both the Bionostics' lab as models. well as in clinical laboratories. The test data is summarized in Chart B.

### (b)(3) Conclusions drawn from the clinical and non-clinical testing

The testing verification that the Oxyhemoglobin CO-Oximeter Control provides sufficient accuracy and precision in measurements of total hemoglobin and hemoglobin fractions to be suitable for monitoring the performance of CO-oximeters. Also, the test results show suitable of the product for use on different COoximeter models, each of which employ slightly differing operating Finally, the data collected shows the product has methodology. substantially equivalent performance to the predicate products which have similar intended uses.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bruce R. Williams Executive Vice President BIONOSTICS 2 Craig Road 01720-5405 Acton, MA

FEB 1 2 1998

Re: K980178 Trade Name: Oxyhemoglobin Control for CO-oximetry Regulatory Class: I Product Code: JJY 75 Dated: January 16, 1998 Received: January 20, 1998

Dear Mr. Williams:

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 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 The general controls provisions of the Act include Act. 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 Requlations, 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 Reqister. 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.qov/cdrh/dsmamain.html"

Sincerely yours,

steven Putman

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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**BIONOSTICS**

510(k) Number: K980178 (Not yet assigned)

INDICATIONS FOR USE

Oxyhemoglobin Control for CO-oximetry Device Name:

January 16, 1998 Date of Premarket Submission:

A. INTENDED USE

The Oxyhemoglobin Control for CO-Oximetry is intended for use to monitor CO-oximetry measurements of hemoglobin and hemoglobin fractions in instruments which measure the optical absorption characteristics of whole blood at specific wavelengths.

To make possible verification of instrument performance at different points for each analyte, the Control has different clinically significant values for total hemoglobin, oxyhemoglobin, carboxyhemoglobin and methemoglobin.

This product is for In Vitro Diagnostic Use only.

Indications for Use:

The measurement of the concentrations of total hemoglobin, oxyhemoglobin, carboxyhemoglobin, and methemoglobin can serve to monitor tissue oxygenation and therefore the various metabolic factors which effect oxygen transport of blood. Since therapeutic regimes are often determined by the result obtained in patient samples, the instruments used for these analyses must meet clinical requirements for precision and accuracy. The use of control materials are designed to verify test results and assist in identifying instrument calibration or operating problems.

Prescription Use ✓

2/9/98

*Tenarder for Al Montgomery*
(Division Siv
Division of
510(k) Number K980178

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