COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM

K061048 · Roche Diagnostics Corp. · CFR · May 17, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061048
• Device Name: COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: CFR · Clinical Chemistry
• Decision Date: May 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF) on COBAS INTEGRA systems. Glucose measurements are used in diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell tumors.

Device Story

The COBAS INTEGRA Glucose HK Gen. 3 is an in vitro diagnostic reagent system for use on COBAS INTEGRA clinical chemistry analyzers. It utilizes an enzymatic hexokinase-based method to measure glucose concentration in serum, plasma, urine, and CSF samples. The system processes samples automatically; the analyzer performs the reaction and provides quantitative glucose results. These results are used by clinicians to diagnose and monitor carbohydrate metabolism disorders. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Performance validation included precision (within-run and between-day CVs), linearity (0.12-40 mmol/L), lower detection limit (0.12 mmol/L), and interference studies (hemolysis, icterus, lipemia, and tetracycline). No clinical trials were required for this modification.

Technological Characteristics

In vitro diagnostic reagent for hexokinase (HK) enzymatic glucose assay. Automated chemistry analyzer format. Reagent composition modified from predicate. No changes to fundamental scientific technology.

Indications for Use

Indicated for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid (CSF) to aid in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell tumors.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• COBAS INTEGRA Glucose HK Liquid (K972250)

Submission Summary (Full Text)

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K061048

## 510(k) Summary – COBAS INTEGRA Glucose HK Gen. 3

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| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence | |
|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] | |
| | Contact person: Corina Harper | |
| | Date prepared: April 11, 2006 | |
| | Device Name | Proprietary name: COBAS INTEGRA Glucose HK Gen. 3 test |
| Common name: Glucose HK Gen. 3 | | |
| Classification name: Glucose Test System | | |
| Device<br>Description | The cassette COBAS INTEGRA Glucose HK Gen. 3 contains an in vitro<br>diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS<br>for the quantitative determination of glucose in serum, plasma, urine, and<br>cerebrospinal fluid (CSF). | |
| | The test principle is an enzymatic reference method with hexokinase. | |
| Intended use | In vitro test for the quantitative determination of glucose in serum, plasma,<br>urine and cerebrospinal fluid (CSF) on COBAS INTEGRA systems. | |
| Predicate<br>Device | We claim substantial equivalence to the COBAS INTEGRA Glucose HK<br>Liquid cleared as K972250. | |
| Substantial<br>equivalency -<br>Similarities | The table below indicates the similarities between the modified COBAS<br>INTEGRA Glucose HK Gen. 3 test and its predicate device (COBAS<br>INTEGRA Glucose HK Liquid, K972250). | |
| Feature | Predicate device: Glucose HK<br>Liquid<br>(K972250) | Modified device: Glucose HK<br>Gen. 3 |
| General | | |
| Intended Use/<br>Indications for<br>Use | The cassette COBAS INTEGRA<br>Glucose HK Liquid contains an in<br>vitro diagnostic reagent system<br>intended for use on COBAS<br>INTEGRA systems for the<br>quantitative determination of<br>glucose concentration in serum,<br>plasma, urine and cerebrospinal<br>fluid (CSF). | In vitro test for the quantitative<br>determination of glucose in serum,<br>plasma, urine and cerebrospinal<br>fluid (CSF) on COBAS INTEGRA<br>systems |
| Specimen type | Serum, plasma, urine, CSF | Same |
| Test principle | | |
| Reference<br>method | Enzymatic reference method with<br>hexokinase. | Same |
| Reagent information | | |
| Stability - shelf<br>life and on-board | 2-8 °C until expiration date<br>COBAS INTEGRA 400<br>8 weeks at 10 to 15° C<br>COBAS INTEGRA 700/800<br>8 weeks at 8°C | Same |
| Calibrator | Calibrator f.a.s.<br>Interval: each lot | Same |
| Quality control | Serum and plasma:<br>Precinom U and Precinorm U Plus<br>Precipath and Precipath U Plus<br>Urine:<br>Quantitative urine controls<br>CSF:<br>Quantitative CSF controls<br>Interval: 24 hrs recommended | Same |
| Traceability | Standardized against Isotope<br>Dilution Mass Spectrometry | Same |
| Performance characteristics | | |
| Measuring range | 0-40 mmol/L (0-720 mg/dL)<br>Extended measuring range with<br>recommended post dilution factor of<br>10: 0-400 mmol/L (0-7200 mg/dL) | 0.12-40 mmol/L (0.12-720 mg/dL)<br>Extended measuring range with<br>recommended post dilution factor<br>of 10: 0.12-400 mmol/L (2.16-7200<br>mg/dL) |
| Expected values<br>(literature<br>reference)<br><br>Additional values<br>are referenced in<br>the method sheet | Plasma (fasting): 3.88-6.38 mmol/L<br>Urine:<br>1st morning urine 0.3-1.1 mmol/L<br>24 h urine 0.11-0.50 mmol/24h<br>Serum/plasma:<br>Adults 4.11-5.89 mmol/L | Plasma (fasting): 3.88-6.38 mmol/L<br>Urine:<br>1st morning urine 0.3-1.1 mmol/L<br>24 h urine 0.3-0.96 mmol/L<br>Same |

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| Substantial | The table below indicates the similarities between the modified COBAS |
|---------------|-----------------------------------------------------------------------|
| equivalency - | INTEGRA Glucose HK Gen. 3 test and its predicate device (COBAS |
| Differences | INTEGRA Glucose HK Liquid, K972250). |

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| Feature | Predicate device: Glucose HK<br>Liquid<br>(K972250) | Modified device: Glucose HK<br>Gen.3 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagent information | | |
| R1 | Mono reagent in vial A and B<br>(liquid) | R1:<br>5.0 mmol/L MES, ≥4.5 mmol/L<br>ATP, 24 mmol/L Mg++, ≥7.0<br>mmol/L NADP, pH 6.0 |
| R2 | 100 mmol/L MOPS, 12 mmol/L<br>ATP, 6 mmol/L NAD+, 10 mmol/L Mg++, ≥50 µcat/L HK(yeast), ≥50<br>µcat/L G6PDH (microbial), 0.09%<br>Sodium azide, pH 7.1 | R2:<br>4.0 mmol/L Mg++, 200 mmol/L<br>HEPES, ≥300 µcat/L HK (yeast),<br>≥300 µcat/L G6PDH (microbial),<br>pH 8.0 |
| Performance characteristics | | |
| Precision | Serum and plasma:<br>Within run:<br>1.7% @ 5.3 mmol/L<br>0.72% @ 33.2 mmol/L<br>Between run:<br>2.6% @ 5.3 mmol/L<br>1.5% @ 33.2 mmol/L | Serum and plasma:<br>Within run CV%:<br>0.41% @ 4.48 mmol/L<br>0.47% @ 12.48 mmol/L<br>Between day:<br>1.09% @ 4.44 mmol/L<br>0.90% @ 12.46 mmol/L |
| | Urine application<br>Within run:<br>1.7% @ 1.7 mmol/L<br>1.8% @ 37.1 mmol/L<br>Between run:<br>4.3% @ 1.7 mmol/L<br>2.9% @ 37.1 mmol/L | Urine application<br>Within run:<br>1.35% @ 0.83 mmol/L<br>0.64% @ 2.42 mmol/L<br>Between day:<br>0.75% @ 0.84 mmol/L<br>0.83% @ 2.43 mmol/L |
| | CSF application<br>Within run:<br>1.6% @ 1.7 mmol/L<br>1.8% @ 3.3 mmol/L<br>Between run:<br>2.3% @ 1.7 mmol/L<br>1.9% @ 3.3 mmol/L | CSF application<br>Within run:<br>1.13% @ 3.20 mmol/L<br>1.49% @ 9.31 mmol/L |
| Linearity | 0-40 mmol/L<br>(before dilution) | 0.12-40 mmol/L<br>(before dilution) |
| Lower detection<br>limit | Serum and plasma:<br>0.033 mmol/L<br>Urine application:<br>0.22 mmol/L<br>CSF application:<br>0.023 mmol/L | Serum, plasma, urine and CSF:<br>0.12 mmol/L |
| Endogenous<br>interferences | Hemolysis no significant<br>interferences<br>Icterus no significant interferences | Hemolysis: up to 1200 H Index<br>Icterus: up to 60 I Index |
| | Lipemia no significant interferences | Lipemia: up to 1900 L Index |
| Exogenous<br>Interferences | Falsely low results may be caused<br>by elevated pyruvates levels | Tetracyclin at therapeutic<br>concentration gives falsely low<br>results in urine samples |
| | Gammopathy, in particular IgM,<br>may cause unreliable results in rare<br>cases | Same |
| Proposed<br>Labeling | Proposed labeling sufficient to describe the device, its intended use, and the<br>directions for use can be found in Section V. We believe the proposed version<br>of the device labeling presented contains all of the technical information<br>required per 21 CFR 809.10. | |
| Validation and<br>Design Control | Development activities were conducted under appropriate design control<br>procedures and the overall product specifications were met. The Declaration<br>of Conformity with Design Controls and Results of Risk Analysis are<br>provided in Section 5.1. Analytical Performance. | |
| Confidentiality | Roche Diagnostics Corporation requests that the FDA not disclose the nature<br>or existence of this submission until the substantial equivalence decision has<br>been reached. | |
| Closing | Modification of the COBAS INTEGRA Glucose HK Gen.3 does not affect<br>the intended use or indications for use of the device as described in the<br>labeling, nor does it alter the fundamental scientific technology of the device.<br>Therefore, we trust the information provided in this Special 510(k) will<br>support a decision of substantial equivalence of the COBAS INTEGRA<br>Glucose HK Gen.3 to the predicate.<br><br>If you have any questions or require further information, please do not<br>hesitate to contact this office.<br><br>• Phone: [phone]<br>• FAX: [phone]<br>• email: [e-mail] | |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 emblem featuring an abstract design that resembles an eagle or a bird in flight.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 17 2006

Ms. Corina Harper Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250-0416

k061048 Re: Trade/Device Name: COBAS INTEGRA Glucose HK Gen 3 Regulation Number: 21 CFR\$ 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: April 14, 2006 Received: April 17, 2006

Dear Ms. Harper:

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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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Setti, Ph.D.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known):

# 61048

Device Name: COBAS INTEGRA Glucose HK Gen 3

Indications For Use:

In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF) on COBAS INTEGRA systems.

Glucose measurements are used in diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell tumors.

Prescription Use XXXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

CLL

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safe

s106(k) K661048