(23 days)
K832066A, K861901
Not Found
No
The device is a quality control material for CO-oximeters, not an instrument that performs analysis or incorporates computational methods.
No.
This device is an In Vitro Diagnostic (IVD) control material used to verify the performance of instruments measuring blood properties, not to directly treat or diagnose a patient.
No
This device is a control material used to verify the performance of CO-oximeters, not to diagnose a patient. Control materials are used in in vitro diagnostic testing to ensure the accuracy and precision of instruments, rather than directly providing diagnostic information about a patient's health.
No
The device description clearly states it is a prepared solution packaged in sealed glass ampuls, indicating it is a physical material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This product is for In Vitro Diagnostic Use only."
- Intended Use: The device 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." This involves testing a sample (whole blood) in vitro (outside the body) to obtain diagnostic information.
- Purpose: The purpose is to "verify instrument performance" and "assist in identifying instrument calibration or operating problems" for instruments used to measure clinically significant values in blood. This is a core function of IVD quality control materials.
- Device Description: The device is a "Control" material prepared from purified bovine blood, designed to be used with instruments that analyze blood samples.
All these points align with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
75JJY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Oxyhemoglobin CO-Oximeter Control was tested for performance as a quality control material on 8 of CO-oximeter instrument models. The testing has took place in both the Bionostics' lab as well as in clinical laboratories. The test data is summarized in Chart B.
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 methodology. Finally, the data collected shows the product has substantially equivalent performance to the predicate products which have similar intended uses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K832066A, K861901
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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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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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Page 2
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
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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