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.

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.

Device Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Bionostics Oxyhemoglobin CO-Oximeter Control, based on the provided text:

Acceptance Criteria and Device Performance

The provided text does not contain a specific table of numerical acceptance criteria (e.g., specific thresholds for accuracy, precision, or bias) or direct reporting of the device's performance against such criteria. Instead, the general conclusion is that the device provides "sufficient accuracy and precision" and "suitable" performance.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter/Characteristic	Acceptance Criteria	Reported Device Performance
Accuracy and Precision	Expected to ensure the device is suitable for monitoring performance of CO-oximeters and provides values for total hemoglobin and hemoglobin fractions. To be comparable to predicate devices.	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."
Suitability for different CO-oximeter models	Expected to work across various CO-oximeter models despite differing operating methodologies.	"The test results show suitable [performance] of the product for use on different CO-oximeter models, each of which employ slightly differing operating methodology."
Substantial Equivalence	Performance should be substantially equivalent to predicate products with similar intended uses.	"The data collected shows the product has substantially equivalent performance to the predicate products which have similar intended uses."
Intended Use Fulfillment	Ability to monitor CO-oximetry measurements of hemoglobin and hemoglobin fractions.	The testing verified the control material's ability to fulfill its intended use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The exact sample size (number of control ampuls tested or number of measurements/replicates) is not explicitly stated. It mentions "The Oxyhemoglobin CO-Oximeter Control was tested for performance as a quality control material on 8 of CO-oximeter instrument models." This suggests testing across different instrument types rather than just a large volume of the control material on a single instrument.
Data Provenance: The testing "took place in both the Bionostics' lab as models. well as in clinical laboratories." This indicates both internal testing and external validation in real-world clinical settings. There is no specific country of origin mentioned beyond "Bionostics, Inc" in Acton, MA, USA, and "Instrumentation Laboratory, Lexington, MA" for the predicate device. The study appears to be prospective in nature, as it describes the testing of a newly developed control material.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The concept of "experts" establishing ground truth in the context of a quality control material like this is not directly applicable in the same way it would be for diagnostic imaging or clinical interpretation studies.

For a CO-Oximeter control, the "ground truth" or reference values are established through the precise formulation and characterization of the control material itself, using validated analytical methods. The text describes: "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." These defined values are the ground truth for the control. The "experts" in this context would be the analytical chemists and laboratory personnel who developed and characterized the control, ensuring the accuracy of these defined values. Their specific number or qualifications are not provided in the summary, but it's implicit that they are qualified in analytical chemistry and quality control manufacturing.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies where human interpretation of data (e.g., medical images) requires consensus. This concept is not applicable to the evaluation of a laboratory quality control material. The performance of the control is judged by its analytical measurements on instruments, not by human interpretation requiring adjudication.

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

No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was performed. MRMC studies are used to evaluate the impact of a device on human reader performance, typically in diagnostic tasks. This device is a quality control material, not a diagnostic tool that a human "reads" or interprets to make a clinical decision. Its purpose is to monitor instrument performance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The "BIONOSTICS Oxyhemoglobin CO-Oximeter Control" is the device, and its performance as a standalone quality control material was evaluated. The study assessed how reliably its defined values could be measured by various CO-oximeters and how consistently it performed. Its "performance" refers to its stability and its ability to yield expected results when measured by an instrument.

7. Type of Ground Truth Used

Defined, manufactured values: The ground truth for the control material itself is based on the precise chemical preparation and characterization of the bovine blood solution, where specific concentrations of hemoglobin fractions are "defined" by the manufacturing process. The material is "treated with oxygen, carbon dioxide and carbon monoxide to provide different defined values for the hemoglobin fractions..." These defined values serve as the reference against which the CO-oximeters' measurements are compared.

8. Sample Size for the Training Set

Not Applicable / Not Provided. This device is a chemical control material, not an AI or machine learning algorithm that requires a "training set." The concept of a training set is relevant for devices that learn from data.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for this type of device, this question is not relevant.

Summary

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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

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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.

(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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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 (770)488-7655.

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 (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 at (301) 443-6597 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

This product is for In Vitro Diagnostic Use only.

Indications for Use:

Prescription Use ✓

2/9/98

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

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Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
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.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.