COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)

K980996 · Roche Diagnostic Systems, Inc. · KHS · Jun 5, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980996
• Device Name: COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
• Applicant: Roche Diagnostic Systems, Inc.
• Product Code: KHS · Clinical Chemistry
• Decision Date: Jun 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

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 evaluation 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.

Device Story

COBAS INTEGRA Reagent Cassettes are in vitro diagnostic consumables used with the COBAS INTEGRA Analyzer. The analyzer utilizes absorbance, fluorescence polarization, and ion-selective electrodes to perform clinical chemistry, TDM, and hematology tests. Cassettes are loaded onto the analyzer, which uses barcode readers for identification and calibration. The system provides automated, random-access testing with a throughput of up to 600 tests/hour. Healthcare providers (laboratory technicians/pathologists) use the quantitative results to assess metabolic status, specifically blood pH regulation (CO2) and carbohydrate metabolism (glucose). The system streamlines workflow via robotics and integrated sample management, benefiting patients through rapid, accurate diagnostic data for clinical decision-making.

Clinical Evidence

Bench testing only. Performance evaluated via precision (within-run and total CV) and accuracy (correlation with predicate). CO2-S: n=220, r=0.999. Glucose HK Liquid (fast application): n=216, r=0.999. Results confirm performance is equivalent to legally marketed predicates.

Technological Characteristics

In vitro diagnostic reagent cassettes for use on the COBAS INTEGRA Analyzer. Methodology: Enzymatic (phosphoenolpyruvate carboxylase/malate dehydrogenase for CO2; hexokinase for glucose). System utilizes absorbance, fluorescence polarization, and ion-selective electrodes. Connectivity: Barcode-enabled for calibration/control data. Storage: 2-8°C on-board stability.

Indications for Use

Indicated for quantitative determination of carbon dioxide in serum/plasma and glucose in serum, plasma, urine, and CSF. Used for evaluating blood pH control and diagnosing/treating carbohydrate metabolism disorders like diabetes mellitus and idiopathic hypoglycemia.

Regulatory Classification

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.

Predicate Devices

• COBAS INTEGRA Carbon Dioxide (CO2) (K954992)
• COBAS INTEGRA Glucose HK Liquid (GLUCL) (K972250)

Submission Summary (Full Text)

{0}------------------------------------------------

K980996

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: [phone] [phone] 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<br>Code | Regulation<br>Number |
|--------------------------------------------|---------------------------------------------|-----------------|----------------------|
| COBAS INTEGRA Carbon Dioxide<br>(CO2-S) | Bicarbonate / carbon dioxide<br>test system | KHS | 862.1160 |
| COBAS INTEGRA Glucose HK Liquid<br>(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<br>substantial<br>equivalence |
|--------------------------------------------|--------------------------------------------|----------|---------------------------------------|
| COBAS INTEGRA Carbon Dioxide<br>(CO2-S) | COBAS INTEGRA Carbon Dioxide<br>(CO2) | K954992 | 1/25/96 |
| COBAS INTEGRA Glucose HK Liquid<br>(GLULF) | COBAS INTEGRA Glucose HK Liquid<br>(GLUCL) | K972250 | 8/12/97 |

| able<br>2<br>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<br>Dioxide (CO2-S)<br>(proposed) | COBAS INTEGRA Carbon<br>Dioxide (CO2)<br>(cleared) |
|------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Intended Use | quantitative determination of the<br>carbon dioxide concentration in<br>serum and plasma | quantitative determination of the<br>carbon dioxide concentration in<br>serum and plasma |
| Methodology | enzymatic methodology with<br>phosphoenolpyruvate carboxylase<br>and malate dehydrogenase | enzymatic methodology with<br>phosphoenolpyruvate carboxylase<br>and malate dehydrogenase |
| Sample type | Serum and Plasma | Serum and Plasma |
| Calibrator | Roche Ammonia / Ethanol / CO2<br>Calibrator (K952282) | Roche Ammonia / Ethanol / CO2<br>Calibrator |
| Controls | Roche Ammonia / Ethanol / CO2<br>Control Normal and Abnormal<br>(K942048) | Roche Ammonia / Ethanol / CO2<br>Control Normal and Abnormal |
| Reagents | Mono reagent in vial B (granulate) | Substrates in vial A (liquid)<br>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<br>carbon dioxide | $5.2 x 10-2 AA$ per mmol/L of<br>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<br>HK Liquid (GLULF)<br>(fast application)<br>(modification) | | COBAS INTEGRA Glucose<br>HK Liquid (GLUL)<br>(standard application)<br>(cleared) | |
|------------------------------|------------------------------------------------------------------------------------|-----------------|----------------------------------------------------------------------------------|-----------------|
| Methodology | Enzymatic reference method with<br>hexokinase | | Enzymatic reference method with<br>hexokinase | |
| Sample type | Serum and plasma | | Serum, plasma, urine and CSF | |
| Calibrator | Roche Calibrator (human)<br>(K942706) | | Roche Calibrator (human) | |
| Controls | Roche Control Serum N and P<br>(human) (K972214) | | Roche Control Serum N and P<br>(human) | |
| Reagents | Mono reagent in vial A and B<br>(liquid) | | Mono reagent in vial A and B<br>(liquid) | |
| Performance Characteristics: | | | | |
| Assay range | 0 - 30 mmol/L | | 0 - 40 mmol/L | |
| Sensitivity | 5.4 x 102 ΔA per mmol/L of<br>glucose | | 5.4 x 102 ΔA per mmol/L of<br>glucose | |
| Precision:<br>Mean (mmol/L) | Level 1<br>4.7 | Level 2<br>27.7 | Level 1<br>5.3 | Level 2<br>33.2 |
| % CV (within-run) | 1.4 | 0.5 | 1.7 | 0.72 |
| % CV (total) | 2.4 | 1.2 | 2.6 | 1.5 |
| Accuracy:<br>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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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}------------------------------------------------

したわいい。 しった。 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1

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)