(13 days)
Not Found
No
The device description and performance studies detail a standard clinical chemistry assay based on enzymatic reactions and spectrophotometry, with no mention of AI or ML.
No
The device is an in vitro diagnostic assay used for the quantitative determination of carbon dioxide in human serum or plasma to aid in diagnosis, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that carbon dioxide measurements "are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance." This indicates that the device aids in identifying or determining the nature of a disease or condition, which is the definition of a diagnostic device.
No
The device description clearly states it is an "in vitro diagnostic assay" and describes a chemical reaction involving reagents and measurement of absorbance, indicating it is a physical assay kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the "quantitation of carbon dioxide in human serum or plasma." This indicates that the device is intended to be used in vitro (outside the body) to analyze a biological sample (serum or plasma) for diagnostic purposes (diagnosis and treatment of disorders associated with acid-base balance).
- Device Description: The "Device Description" further clarifies that it is an "in vitro diagnostic assay for the quantitative determination of carbon dioxide in human serum or plasma." It also describes the chemical reactions involved, which are performed on the sample in vitro.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K933461) and the name "Boehringer Mannheim® Carbon Dioxide assay on the Hitachi® 717 Analyzer" strongly suggests that this device is being compared to a previously cleared IVD device. This is a common practice for demonstrating substantial equivalence for IVD submissions to regulatory bodies like the FDA.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Carbon Dioxide (CO2) assay is used for the quantitation of carbon dioxide in human serum or plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Product codes
75CHS
Device Description
Carbon Dioxide (CO2) is an in vitro diagnostic assay for the quantitative determination of carbon dioxide in human serum or plasma. The Carbon Dioxide assay is a clinical chemistry assay in which carbon dioxide, as bicarbonate (HCO2 - ), and phospho(enol)pyruvate (PEP) are converted to oxalacetate and phosphate in the reaction, catalyzed by phospho(enol)pyruvate carboxylase (PEPC). Malate dehydrogenase (MDH) catalyzes the reduction of oxalacetate to malate with the concomitant oxidation of reduced nicotinamide adenine dinucleotide (NADH). The resulting decrease in absorbance at 380 nm is proportional to the CO2 content of the sample.
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)
Comparative performance studies were conducted using the AEROSET™ System. The Carbon Dioxide assay method comparison yielded acceptable correlation with the Boehringer Mannheim Carbon Dioxide assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9906, slope = 0.909, and Y-intercept = 0.088 mEq/L. Precision studies were conducted using the Carbon Dioxide assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 control is 10.2% and Level 2/Panel 102 control is 9.6%. The Carbon Dioxide assay is linear up to 44.8 mEq/L. The limit of quantitation (sensitivity) for the Carbon Dioxide assay is 2.80 mEq/L. These data demonstrate that the performance of the Carbon Dioxide assay is substantially equivalent to the performance of the Boehringer Mannheim Carbon Dioxide assay on the Hitachi 717 Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
correlation coefficient = 0.9906, slope = 0.909, and Y-intercept = 0.088 mEq/L. The total %CV for Level 1/Panel 101 control is 10.2% and Level 2/Panel 102 control is 9.6%. The Carbon Dioxide assay is linear up to 44.8 mEq/L. The limit of quantitation (sensitivity) for the Carbon Dioxide assay is 2.80 mEq/L.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.
0
KC981840
JUN - 8 1998
510(k) Summary
Submitter's Name/Address
Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Linda Morris Sr. Regulatory Specialist MS 1-8 Regulatory Affairs (972) 518-6062 Fax (972) 753-3367
| Date of Preparation of this Summary: | May 22, 1998 |
|---|---|
| Device Trade or Proprietary Name: | CO2 |
| Device Common/Usual Name or Classification Name: | Carbon Dioxide |
| Classification Number/Class: | 75CHS/Class II |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: 1981840
Test Description:
Carbon Dioxide (CO2) is an in vitro diagnostic assay for the quantitative determination of carbon dioxide in human serum or plasma. The Carbon Dioxide assay is a clinical chemistry assay in which carbon dioxide, as bicarbonate (HCO2 - ), and phospho(enol)pyruvate (PEP) are converted to oxalacetate and phosphate in the reaction, catalyzed by phospho(enol)pyruvate carboxylase (PEPC). Malate dehydrogenase (MDH) catalyzes the reduction of oxalacetate to malate with the concomitant oxidation of reduced nicotinamide adenine dinucleotide (NADH). The resulting decrease in absorbance at 380 nm is proportional to the CO2 content of the sample.
Carbon Dioxide 510(k) May 21, 1998 CQ2.Jwp
Section II Page 1
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Substantial Equivalence:
The Carbon Dioxide assay is substantially equivalent to the Boehringer Mannheim® Carbon Dioxide assay (K933461) on the Hitachi® 717 Analyzer.
Both assays vield similar Performance Characteristics.
Similarities to Boehringer Mannheim:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of carbon dioxide. .
- Both assays yield similar clinical results. .
Intended Use:
The Carbon Dioxide (CO2) assay is used for the quantitation of carbon dioxide in human serum or plasma.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Carbon Dioxide assay method comparison yielded acceptable correlation with the Boehringer Mannheim Carbon Dioxide assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9906, slope = 0.909, and Y-intercept = 0.088 mEq/L. Precision studies were conducted using the Carbon Dioxide assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 101 control is 10.2% and Level 2/Panel 102 control is 9.6%. The Carbon Dioxide assay is linear up to 44.8 mEq/L. The limit of quantitation (sensitivity) for the Carbon Dioxide assay is 2.80 mEq/L. These data demonstrate that the performance of the Carbon Dioxide assay is substantially equivalent to the performance of the Boehringer Mannheim Carbon Dioxide assay on the Hitachi 717 Analyzer.
Section II Page 2
Comments of the comments of the comments of
2
Conclusion:
. . . .
11-2-2019.00
The Carbon Dioxide assay is substantially equivalent to the Boehringer Mannheim Carbon Dioxide assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
Carbon Dioxide 510(k) May 21, 1998 CO2.lwp
Section II Page 3
L .- - 1.1 - - - - -
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, conveying a sense of strength and protection.
Public Health Service
JUN 8 1008 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Linda Morris · Senior Regulatory Specialist Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Re : K981840 Carbon Dioxide Requlatory Class: II Product Code: KHS Dated: May 22, 1998 Received: May 26, 1998
Dear Ms. Morris:
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 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 Requlations, Title 21, Parts 800 to 895. ਸੈ 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 Druq 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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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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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
5
510(k) Number (if known): K98184C)
Device Name: _________________________________________________________________________________________________________________________________________________________________ Carbon Dioxide
Indications For Use:
The Carbon Dioxide assay is used for the quantitation of carbon dioxide in human serum or plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number R981840
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
6
510(k) Number (if known): K98184C)
Carbon Dioxide Device Name:
Indications For Use:
The Carbon Dioxide assay is used for the quantitation of carbon dioxide in human serum or plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
(Division Sign-Off)
Division of Clínical Laboratory Devices
510(k) Number K981840
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use 11 OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
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