(29 days)
Not Found
No
The summary describes a standard enzymatic assay for bicarbonate measurement and does not mention any AI or ML components.
No
This device is an in vitro diagnostic (IVD) reagent system used for quantitative determination of bicarbonate concentration in human serum and plasma, which aids in diagnosis and treatment, but it is not a therapeutic device itself.
Yes.
The device is described as an "in vitro diagnostic reagent system" and its measurements are "used in the diagnosis and treatment of numerous potentially serious disorders."
No
The device is an in vitro diagnostic reagent system, which is a chemical substance used in a laboratory test, not a software-only medical device.
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 device is an "in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the bicarbonate (HCO3) concentration in human serum and plasma." This directly aligns with the definition of an IVD, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a "ready-to-use liquid enzymatic assay," which is a common format for IVD reagents used in laboratory testing.
- Predicate Device: The mention of a "Predicate Device" with a K number (K980996) indicates that this device has been compared to a previously cleared IVD device, which is a standard part of the regulatory process for IVDs.
N/A
Intended Use / Indications for Use
The cassette COBAS Integra Bicarbonate liquid (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the bicarbonate (HCO3) concentration in human serum and 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
KHS
Device Description
The COBAS Integra Bicarbonate liquid is a ready-to-use liquid enzymatic assay with phosphenolpyruvate carboxylase and malate dehydrogenase. A decrease in absorbance at 409 nm is proportional to the concentration of bicarbonate in 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
Not Found
Key Metrics
Not Found
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
510(k) Summary - COBAS Integra Bicarbonate liquid
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence | |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46250
(317) 521-3831 | |
| | Contact person: Sherri L. Coenen | |
| | Date prepared: June 13, 2003 | |
| Device Name | Proprietary name: Roche Diagnostics COBAS Integra Bicarbonate liquid | |
| | Common name: Enzymatic Bicarbonate Assay | |
| | Classification name: enzymatic bicarbonate/carbon dioxide test system | |
| Device
description | The COBAS Integra Bicarbonate liquid is a ready-to-use liquid enzymatic
assay with phosphenolpyruvate carboxylase and malate dehydrogenase. A
decrease in absorbance at 409 nm is proportional to the concentration of
bicarbonate in the sample. | |
| Intended use | The cassette COBAS Integra Bicarbonate liquid (CHOL2) contains an in vitro
diagnostic reagent system intended for use on COBAS Integra systems for the
quantitative determination of the bicarbonate ( $HCO_3^-$ ) concentration in human
serum and plasma. | |
| Predicate
Device | We claim substantial equivalence to the currently marketed COBAS Integra
Carbon Dioxide Assay. (K980996). | |
1
510(k) Summary - COBAS Integra Creatinine plus ver.2, continued
Reagent Summary The following table describes the similarities and differences between the COBAS Integra Bicarbonate liquid and the predicate device.
| Topic | COBAS Integra Carbon Dioxide
(K980996) | COBAS Integra Bicarbonate liquid
(Modified Device) |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The cassette COBAS Integra Carbon
Dioxide (CO2-S) contains an in vitro
diagnostic reagent system intended
for use on COBAS Integra systems
for the quantitative determination of
the carbon dioxide concentration in
serum and plasma. | The cassette COBAS Integra
Bicarbonate liquid (CO2-L) contains
an in vitro diagnostic reagent system
intended for use on COBAS Integra
systems for the quantitative
determination of the bicarbonate
$(HCO_3^-)$ concentration in human
serum and plasma. |
| Method | Enzymatic, colorimetric test | Same |
| Sample type | Human Serum and Plasma | Same |
| Measuring
range | 0 - 50 mmol/L | Same |
| Expected
values | Anaerobic venous plasma or serum:
23 - 29 mmol/L | 22 - 29 mmol/L |
24
2
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 eagle faces right and is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 17 2003
Ms. Sherri L. Coenen MT(ASCP) Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K031879
Trade/Device Name: COBAS Integra Bicarbonate liquid Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: KHS Dated: June 13, 2003 Received: June 18, 2003
Dear Ms. Coenen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: COBAS Integra Bicarbonate liquid
Indications For Use:
The cassette COBAS Integra Bicarbonate liquid (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the bicarbonate (HCO3) concentration in human serum and 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.
Sean Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K031875
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrentee of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use · / (Per 21 CFR 801.109)
(Optional Format 1-2-96)