(20 days)
Not Found
No
The summary describes a standard enzymatic assay for bicarbonate measurement, with no mention of AI or ML technologies.
No.
This device is an in vitro diagnostic (IVD) test for quantitative determination of bicarbonate, used in the diagnosis and treatment of disorders associated with acid-base balance, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements obtained from this device "are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance." This indicates its role in identifying and understanding a patient's medical condition, which is the definition of a diagnostic device.
No
The device description clearly states it is a "ready-to-use liquid enzymatic assay," which is a chemical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's an "In vitro test for the quantitative determination of bicarbonate (HCO3-) in human serum and plasma". This clearly indicates it's used to test samples taken from the human body outside of the body.
- Device Description: The description details an "enzymatic assay" that measures a substance in a sample, which is characteristic of an in vitro diagnostic test.
- Predicate Device: The mention of a "Predicate Device" with a K number (K031879) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
The information provided aligns perfectly with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
In vitro test for the quantitative determination of bicarbonate (HCO3-) in human serum and plasma on Roche automated clinical chemistry analyzers.
Product codes
KHS
Device Description
The Roche/Hitachi Bicarbonate liquid is a ready-to-use liquid enzymatic assay with phosphenolpyruvate carboxylase and malate dehydrogenase. A decrease in absorbance at 415 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
AUG 2 1 2003
く032377
510(k) Summary - Roche/Hitachi 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: July 30, 2003 |
| Device Name | Proprietary name: Roche Diagnostics Hitachi Bicarbonate liquid
Common name: Bicarbonate Assay
Classification name: Enzymatic bicarbonate/carbon dioxide test system |
| Device description | The Roche/Hitachi Bicarbonate liquid is a ready-to-use liquid enzymatic assay with phosphenolpyruvate carboxylase and malate dehydrogenase. A decrease in absorbance at 415 nm is proportional to the concentration of bicarbonate in the sample. |
| Intended use | In vitro test for the quantitative determination of bicarbonate (HCO3-) in human serum and plasma on Roche automated clinical chemistry analyzers. |
| Predicate Device | We claim substantial equivalence to the currently marketed COBAS Integra Bicarbonate liquid Assay. (K031879). |
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510(k) Summary - Roche/Hitachi Bicarbonate liquid, continued
| Reagent | The following table describes the similarities and differences between the |
|---|---|
| Summary | Roche/Hitachi Bicarbonate liquid and the predicate device. |
| Topic | COBAS Integra Bicarbonate liquid (K031879) | Roche/Hitachi Bicarbonate liquid (Modified Device) |
|---|---|---|
| Intended Use | 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 | ||
| (HCO3-) concentration in human | ||
| serum and plasma. | In vitro test for the quantitative | |
| determination of bicarbonate (HCO3-) | ||
| in human serum and plasma on | ||
| Roche clinical chemistry analyzers. | ||
| Method | Enzymatic, colorimetric test | Same |
| Sample type | Human Serum and Plasma | Same |
| Measuring range | 0.46 - 50 mmol/L | 1.5 - 50 mmol/L |
| Expected values | 22 - 29 mmol/L | Same |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, depicted with flowing lines to suggest movement or flight.
AUG 2 1 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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
Re: K032377
Trade/Device Name: Roche/Hitachi Bicarbonate liquid Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: KHS Dated: July 30, 2003 Received: August 1, 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, 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 (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 Putman
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
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Indications for Use Statement
510(k) Number (if known): N/A
032377
Device Name: Roche/Hitachi Bicarbonate liquid
Indications For Use:
In vitro test for the quantitative determination of bicarbonate (HCO3) in human serum and plasma on Roche automated clinical chemistry analyzers. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Carol C Benson (G. Jean Cooper, DVM
==Division Sign-Off==
Division Sign-C
Office of In Vitro Diagnostic Devise Evaluation and Safety
510(k) K032377
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)