(80 days)
No
The summary describes a standard in vitro diagnostic analyzer and reagent system that uses established analytical principles (absorbance, fluorescence polarization, ion-selective electrodes) and automation (robotics, barcode readers) for quantitative measurements. There is no mention of AI, ML, or any technology that would suggest learning or adaptive algorithms are used in the analysis or interpretation of results.
No
The device is described as an in vitro diagnostic reagent system used for quantitative determination of carbon dioxide and glucose concentrations in bodily fluids, which is for diagnostic purposes, not therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagent systems are "in vitro diagnostic reagent system[s]" used for the quantitative determination of substances like carbon dioxide and glucose, which are "used in the diagnosis and treatment of carbohydrate metabolism disorders". The "Device Description" also refers to the integrated system for "in vitro diagnostic testing."
No
The device description clearly states that the COBAS INTEGRA system includes both an analyzer (hardware utilizing measuring principles like absorbance, fluorescence polarization, and ion-selective electrodes) and reagent cassettes. This indicates it is a hardware and reagent system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the reagent systems are "intended for use on COBAS INTEGRA for the quantitative determination of the carbon dioxide concentration in serum and plasma" and "intended for use on the COBAS INTEGRA for the quantitative determination of the glucose concentration in serum, plasma, urine and cerebrospinal fluid (CSF)".
Furthermore, the "Device Description" section describes the COBAS INTEGRA Analyzer and Reagent cassettes as providing "an integrated system for in vitro diagnostic testing."
These statements clearly indicate that the device is designed to perform tests on biological samples outside of the body to provide information for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The cassette Roche COBAS INTEGRA Carbon Dioxide (CO2-S) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the carbon dioxide concentration in serum and plasma. Determination of carbon dioxide concentration in blood is most commonly performed as an initial test in the cvaluation of the body's ability to control blood pH by appropriate removal of metabolism byproducts via the lung and kidneys.
The cassette Roche COBAS INTEGRA Glucose HK Liquid contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA for the quantitative determination of the glucose concentration in serum, plasma, urine and cerebrospinal fluid (CSF). In addition, an optional glucose "fast application" for serum and plasma is available. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia.
Product codes (comma separated list FDA assigned to the subject device)
KHS, CFR
Device Description
The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8℃. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents.
Through this submission, it is the intention of Roche to gain clearance for one additional COBAS Reagent Cassette and one optional application for a previously approved COBAS Reagent Cassette. These are the COBAS INTEGRA Carbon Dioxide (CO2-S) and the COBAS INTEGRA Glucose (GLULF), respectively.
COBAS INTEGRA Carbon Dioxide (CO2-S):
The cassette COBAS INTEGRA Carbon Dioxide (CO2-S) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the carbon dioxide concentration in serum and plasma.
COBAS INTEGRA Glucose HK Liquid (GLULF):
The cassette COBAS INTEGRA Glucose HK Liquid contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the glucose concentration in serum, plasma. urine and cerebrospinal fluid (CSF). In addition, an optional glucose "fast application" for serum and plasma is available.
The intended use, clinical utility and methodology of each reagent cassette are further described in the test specific COBAS INTEGRA Method Manual sheets, contained in the test specific sections of this submission.
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)
Tables 3-4 demonstrate the results of clinical and nonclinical studies performed using the COBAS INTEGRA Reagent Cassettes. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this chart. This information concludes that the performance of this device is essentially equivalent to other legally marketed devices of a similar kind.
COBAS INTEGRA Carbon Dioxide (CO2-S):
Assay range: 0 - 50 mmol/L
Sensitivity: 1.5 x 10-2 ΔA per mmol/L of carbon dioxide
Precision:
Level 1 Mean (mmol/L): 19.5
Level 1 % CV (within-run): 1.1
Level 1 % CV (total): 3.1
Level 2 Mean (mmol/L): 33.8
Level 2 % CV (within-run): 1.2
Level 2 % CV (total): 2.5
Accuracy: Sample size (n) 220, Corr. Coefficient (r) 0.999, Linear regression 1.01x - 0.8 mmol/L
COBAS INTEGRA Glucose HK Liquid (GLULF) fast application:
Assay range: 0 - 30 mmol/L
Sensitivity: 5.4 x 102 ΔA per mmol/L of glucose
Precision:
Level 1 Mean (mmol/L): 4.7
Level 1 % CV (within-run): 1.4
Level 1 % CV (total): 2.4
Level 2 Mean (mmol/L): 27.7
Level 2 % CV (within-run): 0.5
Level 2 % CV (total): 1.2
Accuracy: Sample size (n) 216, Corr. Coefficient (r) 0.999, Linear regression 0.99x + 0.01 mmol/L
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Precision (%CV), Accuracy (Correlation Coefficient, Linear Regression) were provided.
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.
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.
K951595, K961824, K963292, K964457, K952282, K942048, K942706, K972214
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
§ 862.1160 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
5 1998 JUN
Image /page/0/Picture/2 description: The image shows the Roche logo. The logo consists of the word "Roche" in bold, sans-serif font, enclosed within a hexagon shape. The hexagon is oriented horizontally, with the word "Roche" centered inside it.
510(k) Summary
Roche COBAS® INTEGRA Reagent Cassettes
In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.
The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________
I. Identification of 510(k) Sponsor:
Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
510(k) Submission dated March 16, 1997
Contact: James W. Haynes Regulatory Affairs Associate Phone: (908) 253-7569 (908) 253-7547 Fax:
1
Device Name: II.
The device name, including both the trade/proprietary name and the classification name are provided in the table below.
Table 1
| Proprietary Name | Classification Name | Product
Code | Regulation
Number |
|--------------------------------------------|---------------------------------------------|-----------------|----------------------|
| COBAS INTEGRA Carbon Dioxide
(CO2-S) | Bicarbonate / carbon dioxide
test system | KHS | 862.1160 |
| COBAS INTEGRA Glucose HK Liquid
(GLULF) | Glucose test system | CFR | 862.1345 |
2
Identification of the legally marketed device to which the 510(k) sponsor claims III. equivalence:
The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.
| Product Name | Predicate Product Name | K number | Date of
substantial
equivalence |
|--------------------------------------------|--------------------------------------------|----------|---------------------------------------|
| COBAS INTEGRA Carbon Dioxide
(CO2-S) | COBAS INTEGRA Carbon Dioxide
(CO2) | K954992 | 1/25/96 |
| COBAS INTEGRA Glucose HK Liquid
(GLULF) | COBAS INTEGRA Glucose HK Liquid
(GLUCL) | K972250 | 8/12/97 |
| able
2
| Ti | |
|---|---|
| ----------------- | -- |
IV. Description of the Device/Statement of Intended Use:
The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer along with 107 Roche COBAS INTEGRA Reagent Cassettes were previously cleared on September 8, 1995 (K951595); January 25, 1996 (K954992); July 23, 1996 (K961824); October 31, 1996 (K963292); January 21, 1997 (K964457); and August 12, 1997 (K972250).
The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8℃. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents. For additional information on the COBAS INTEGRA Analyzer and its constituent modules, please refer to the Operator's Manual in Volumes 1 through 2, pages 92-703, of the original 510(k) submission (K951595).
3
Through this submission, it is the intention of Roche to gain clearance for one additional COBAS Reagent Cassette and one optional application for a previously approved COBAS Reagent These are the COBAS INTEGRA Carbon Dioxide (CO2-S) and the COBAS Cassette, INTEGRA Glucose (GLULF), respectively.
COBAS INTEGRA Carbon Dioxide (CO2-S):
The cassette COBAS INTEGRA Carbon Dioxide (CO2-S) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the carbon dioxide concentration in serum and plasma.
COBAS INTEGRA Glucose HK Liquid (GLULF):
The cassette COBAS INTEGRA Glucose HK Liquid contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the glucose concentration in serum, plasma. urine and cerebrospinal fluid (CSF). In addition, an optional glucose "fast application" for serum and plasma is available.
The intended use, clinical utility and methodology of each reagent cassette are further described in the test specific COBAS INTEGRA Method Manual sheets, contained in the test specific sections of this submission.
Summary of the technological characteristics of the new device in comparison to V. those of the predicate.
Tables 3-4 outline the technological characteristics (methodologies) of the COBAS INTEGRA Reagents in comparison to those of legally marketed predicate products.
VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:
Tables 3-4 demonstrate the results of clinical and nonclinical studies performed using the COBAS INTEGRA Reagent Cassettes. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this chart. This information concludes that the performance of this device is essentially equivalent to other legally marketed devices of a similar kind.
4
| | COBAS INTEGRA Carbon
Dioxide (CO2-S)
(proposed) | COBAS INTEGRA Carbon
Dioxide (CO2)
(cleared) |
|------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Intended Use | quantitative determination of the
carbon dioxide concentration in
serum and plasma | quantitative determination of the
carbon dioxide concentration in
serum and plasma |
| Methodology | enzymatic methodology with
phosphoenolpyruvate carboxylase
and malate dehydrogenase | enzymatic methodology with
phosphoenolpyruvate carboxylase
and malate dehydrogenase |
| Sample type | Serum and Plasma | Serum and Plasma |
| Calibrator | Roche Ammonia / Ethanol / CO2
Calibrator (K952282) | Roche Ammonia / Ethanol / CO2
Calibrator |
| Controls | Roche Ammonia / Ethanol / CO2
Control Normal and Abnormal
(K942048) | Roche Ammonia / Ethanol / CO2
Control Normal and Abnormal |
| Reagents | Mono reagent in vial B (granulate) | Substrates in vial A (liquid)
Enzymes in vial C (liquid) |
| Performance Characteristics: | | |
| Assay range | 0 - 50 mmol/L | 0 - 40 mmol/L |
| Sensitivity | $1.5 x 10-2 ΔΑ$ per mmol/L of
carbon dioxide | $5.2 x 10-2 AA$ per mmol/L of
carbon dioxide |
| Precision: | Level 1 | Level 2 |
| Mean (mmol/L) | 19.5 | 33.8 |
| | Level 1 | Level 2 |
| | 18.9 | 33.0 |
| % CV (within-run) | 1.1 | 1.2 |
| % CV (total) | 3.1 | 2.5 |
| | 2.5 | 1.9 |
| | 1.2 | 1.1 |
| Accuracy: | | |
| Sample size (n) | 220 | 200 |
| Corr. Coefficient (r) | 0.999 | 0.997 |
| | 1.01x - 0.8 mmol/L | 1.04x + 0.4 mmol/L |
Table 3 - COBAS INTEGRA Carbon Dioxide (CO2-S)
5
: .
| | COBAS INTEGRA Glucose
HK Liquid (GLULF)
(fast application)
(modification) | | COBAS INTEGRA Glucose
HK Liquid (GLUL)
(standard application)
(cleared) | |
|------------------------------|------------------------------------------------------------------------------------|-----------------|----------------------------------------------------------------------------------|-----------------|
| Methodology | Enzymatic reference method with
hexokinase | | Enzymatic reference method with
hexokinase | |
| Sample type | Serum and plasma | | Serum, plasma, urine and CSF | |
| Calibrator | Roche Calibrator (human)
(K942706) | | Roche Calibrator (human) | |
| Controls | Roche Control Serum N and P
(human) (K972214) | | Roche Control Serum N and P
(human) | |
| Reagents | Mono reagent in vial A and B
(liquid) | | Mono reagent in vial A and B
(liquid) | |
| Performance Characteristics: | | | | |
| Assay range | 0 - 30 mmol/L | | 0 - 40 mmol/L | |
| Sensitivity | 5.4 x 102 ΔA per mmol/L of
glucose | | 5.4 x 102 ΔA per mmol/L of
glucose | |
| Precision:
Mean (mmol/L) | Level 1
4.7 | Level 2
27.7 | Level 1
5.3 | Level 2
33.2 |
| % CV (within-run) | 1.4 | 0.5 | 1.7 | 0.72 |
| % CV (total) | 2.4 | 1.2 | 2.6 | 1.5 |
| Accuracy:
Sample size (n) | 216 | | 220 | |
| Corr. Coefficient (r) | 0.999 | | 0.999 | |
| Linear regression | 0.99x + 0.01 mmol/L | | 1.05x - 0.2 mmol/L | |
Table 4 - COBAS INTEGRA Glucose HK Liquid (GLULF)
6
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. 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
5 1898 JUN
James W. Haynes . Requlatory Affairs Associate Roche Diagnostic Systems 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
K980996 Re: Roche COBAS® INTEGRA Carbon Dioxide Reagent Cassette and Roche COBAS® INTEGRA Glucose HK Liquid Reagent Regulatory Class: II Product Code: KHS, CFR March 16, 1998 Dated: Received: March 17, 1998
Dear Mr. Haynes:
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 The general controls provisions of the Act 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. ಗ 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 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 .
7
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 Bitman
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
8
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012
Page ד of 1
510(k) Number (if known)
Roche COBAS INTEGRA Carbon Dioxide-(CO2-S) Reagent Cassette Device Name:
Roche COBAS INTEGRA Glucosc HK Liquid Reagent Cassette
Indications for Use:
The cassette Roche COBAS INTEGRA Carbon Dioxide (CO2-S) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the carbon dioxide concentration in serum and plasma. Determination of carbon dioxide concentration in blood is most commonly performed as an initial test in the cvaluation of the body's ability to control blood pH by appropriate removal of metabolism byproducts via the lung and kidneys.
The cassette Roche COBAS INTEGRA Glucose HK Liquid contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA for the quantitative determination of the glucose concentration in serum, plasma, urine and cerebrospinal fluid (CSF). In addition, an optional glucose "fast application" for serum and plasma is available. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 980996
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)