COBAS INTEGRA CHLORIDE ELCTRODE GEN.2

K060108 · Roche Diagnostics Corp. · CGZ · Feb 16, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060108
• Device Name: COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
• Applicant: Roche Diagnostics Corp.
• Product Code: CGZ · Clinical Chemistry
• Decision Date: Feb 16, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1170
• Device Class: Class 2

Intended Use

The ISE module of the COBAS INTEGRA systems is intended for use for the quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes. This Chloride electrode is recommended to be used if a significant amount of the samples are plasma samples. Serum and urine samples may also be analyzed with this electrode.

Device Story

The COBAS INTEGRA Chloride Electrode Gen. 2 is an ion-selective electrode (ISE) module component used for quantitative chloride measurement in serum, plasma, and urine. It processes undiluted (ISE Direct) or automatically diluted (ISE Indirect/Urine) specimens. The device operates within the COBAS INTEGRA system, utilized in clinical laboratory settings by trained technicians. It measures potential differences across the electrode to determine ion concentration. Results are provided to clinicians to assist in diagnosing and managing electrolyte and metabolic disorders. The Gen. 2 electrode offers improved stability and performance characteristics compared to the predicate, specifically optimized for environments processing high volumes of plasma samples.

Clinical Evidence

Bench testing only; validation protocols addressed hazards identified in FMEA risk analysis; no clinical data provided.

Technological Characteristics

Ion-selective electrode; electro-chemical membrane; modification to substance mediating chloride ion binding to membrane; fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for quantitative determination of chloride in serum, plasma, and urine to aid in the diagnosis and treatment of electrolyte and metabolic disorders. Recommended for use when a significant portion of samples are plasma.

Regulatory Classification

Identification

A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Predicate Devices

• Chloride Electrode (K963627)

Submission Summary (Full Text)

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K 060/08

______________________________________________________________________________________________________________________________________________________________________________

### FEB 1 6 2006

## 510(k) Summary - Chloride Electrode Gen. 2

| 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<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | Contact person: Corina Harper |
| | Date prepared: January 12, 2006 |
| Chloride Electrode Gen. 2 | Proprietary name: COBAS INTEGRA Chloride Electrode Gen. 2 |
| | Common name: Chloride Test System |
| | Classification name: Ion-Specific Electrode Chloride |
| Device description | The ISE module of the COBAS INTEGRA systems is intended for use for the quantitative determination of sodium, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes. |
| | The ion-selective electrode is using undiluted (ISE Direct) or automatically diluted (ISE Indirect, ISE Urine) specimens. |
| | This Chloride electrode is recommended to be used if a significant amount of the samples are plasma samples. Serum and urine samples may also be analyzed with this electrode. |
| | Continued on next page |

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| Intended use |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The ISE module of the COBAS INTEGRA systems is intended for use for the<br>quantitative determination of sodium, potassium, chloride in serum, plasma<br>and urine, and lithium in serum and plasma, using ion-selective electrodes.<br><br>This Chloride electrode is recommended to be used if a significant amount of<br>the samples are plasma samples. Serum and urine samples may also be<br>analyzed with this electrode. |
| Predicate<br>Device |
| We claim substantial equivalence to the currently marketed ISE Chloride<br>Electrode cleared for use under K963627 on October 24, 1996. |
| Substantial<br>equivalency -<br>similarities |
| The table below indicates the similarities between the predicate device<br>(K963627) and the modified Chloride Electrode Gen. 2. |

| Feature | Predicate Device – Chloride<br>Electrode<br>(approved via K963627) | Modified Chloride Electrode Gen. 2 |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Intended Use | ISE Direct:<br>The ISE module of the COBAS INTEGRA<br>systems is intended for use for the quantitative<br>determination of sodium, potassium, chloride<br>and lithium concentrations in undiluted serum<br>and plasma using ion-selective electrode.<br>ISE Indirect:<br>The ISE module of the COBAS INTEGRA<br>systems is intended for use for the quantitative<br>determination of sodium, potassium, chloride<br>concentrations in diluted serum and plasma<br>using ion-selective electrode.<br>ISE in Urine:<br>The ISE module of the COBAS INTEGRA<br>systems is intended for use for the quantitative<br>determination of sodium, potassium, chloride<br>concentrations in diluted urine using ion-<br>selective electrode. | The ISE module of the COBAS INTEGRA<br>systems is intended for use for the quantitative<br>determination of sodium, potassium, chloride<br>in serum, plasma and urine, and lithium in<br>serum and plasma, using ion-selective<br>electrodes.<br>This Chloride electrode is recommended to be<br>used if a significant amount of the samples are<br>plasma samples. Serum and urine samples may<br>also be analyzed with this electrode. |
| Sample type | Serum, plasma, urine | Same |

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| Feature | Predicate Device -- Chloride<br>Electrode<br>(approved via K963627) | Modified Chloride Electrode Gen. 2 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Electrode Information | | |
| Calibrator | ISE solutions 1,2,3<br>ISE Calibrator Direct<br>ISE Calibrator Indirect/Urine<br><br>5 hours calibration interval (main<br>calibration), every sample (one-point<br>calibration) | Same |
| Quality<br>control | Serum/Plasma: PreciNorm U,<br>Precipath U<br>Urine: Quantitative Urine Controls | Same |
| Performance Characteristics | | |
| Expected<br>values for<br>adults -<br>mmol/L | ISE Direct Serum/Plasma 101-110<br>ISE Indirect Serum/plasma 98-107<br>ISE Urine 110-250 | Same |

Substantial equivalency - similarities (continued)

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| Feature | Predicate Device – Chloride<br>Electrode<br>(approved via K963627) | Modified Chloride Electrode Gen. 2 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Endogenous<br>Interferences | ISE Direct and Indirect<br>(serum/plasma):<br>Hemolysis – no significant<br>interferences up to a hemoglobin level<br>of 10 g/L<br><br>Lipemia - no significant interferences<br><br>Icterus – no significant interferences | Same |
| | | |
| | | |
| | | |
| | | |
| | | |
| Exogenous<br>Interference | ISE Direct (serum/plasma)<br>Probenecid causes artificially high<br>chloride concentrations. | ISE Direct (serum/plasma)<br>Ca-Dobesilate, Phenylbutazone,<br>Acetylsalicylic acid and Ibuprofen<br>causes artificially high chloride<br>concentrations. |
| | Salicylic acid concentration of 1.2<br>mmol/L increase chloride<br>concentration by aprox. 10% | Same |
| | ISE Indirect (serum/plasma)<br>Acetylsalicylic acid causes artificial<br>high Chloride concentrations. | ISE Indirect(serum/plasma)<br>Acetylsalicylic acid and Ibuprofen<br>causes artificial high chloride<br>concentrations. |
| | ISE Urine<br>Drug panel tested caused no<br>significant interferences up to the<br>indicated concentrations in the label. | ISE Urine:<br>Ascorbic acid, Ca-Dobesilate and<br>Levodopa causes artificially high<br>chloride concentrations. |
| | | |

Substantial equivalency - similarities (continued)

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Substantial equivalency differences

The table below indicates the differences between the predicate device (K963627) and the modified Chloride Electrode Gen. 2.

Modified Chloride Electrode Gen. 2 Predicate Device - Chloride Feature Electrode (approved via K963627) 2 months or 6000 samples Onboard 3 months (serum samples only, reduced when (when majority of plasma samples are Stability used) plasma sample are used) Performance Characteristics Within run CV% (n=21): Within run CV% (n=20): Precision 0.69% @ 86 mmol/L Serum: ISE Direct 0.19% @ 92.9 mmol/L mode 0.46% (@, 99mmol/L 0.19% @ 127.2 mmol/L CV% Plasma (low n=20, high n=21): 0.36% @ 89.2 mmol/L 0.15% @ 125 mmol/L Between day CV% (n=21): Between run CV% (n=20): Serum: 1.3% @ 86 mmol/L 0.9% @ 94.3 mmol/L 0.92%@ 99 mmol/L 1.1% (@, 126.5 mmol/L Plasma: 1.0% (@, 91.6 mmol/L 1.2% @, 126.0 mmol/L Total CV% Serum: 0.9%@ 94.4 mmol/L 1.1% (@, 126.4 mmol/L Plasma: 1.0% @ 91.8 mmol/L 1.4% @ 125.8 mmol/L

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| Feature | Predicate Device - Chloride<br>Electrode<br>(approved via K963627) | Modified Chloride Electrode Gen. 2 |
|-----------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Characteristics | | |
| ISE Indirect<br>mode<br>CV% | Within run CV% (n=20):<br>0.77% @ 87 mmol/L<br>0.72% @ 101 mmol/L | Within run CV%(n=21):<br>Serum:<br>0.65% @ 90.3 mmol/L<br>0.25% @ 124.1 mmol/L<br>Plasma:<br>0.29% @ 86.4 mmol/L<br>0.23% @ 121.9 mmol/L |
| | Between run CV% (n=20):<br>1.5% @ 87 mmol/L<br>1.2% @ 101 mmol/L | Between day CV%(n=21):<br>Serum:<br>1.0% @ 92.0 mmol/L<br>0.9% @ 122.8 mmol/L<br>Plasma:<br>1.1% @ 88.7 mmol/L<br>1.0% @ 121.6 mmol/L |
| | | Total CV%:<br>Serum:<br>1.0%@ 92.1mmol/L<br>1.0% @ 122.8 mmol/L<br>Plasma:<br>1.1% @ 88.8 mmol/L<br>1.0% @ 121.6 mmol/L |

#### Substantial equivalency - differences (continued)

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ース | アイトレストー | アイト | アイト | アイト | アイト | アイト | アイト | アイト | アート | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Feature | Predicate Device - Chloride<br>Electrode | Modified Chloride Electrode Gen. 2 |
|----------------------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| | (approved via K963627) | |
| ISE Urine<br>mode<br>CV% | Within run CV% (n=20):<br>0.97% @ 53 mmol/L<br>1.2% @ 267 mmol/L | Within run CV% (low n=21, high n=20):<br>0.5% @ 61.4 mmol/L<br>0.5% @ 194.4 mmol/L |
| | Between run CV% (n=20):<br>2.8% @ 53 mmol/L<br>2.2% @ 267 mmol/L | Between day (n=21):<br>2.3% @ 64.9 mmol/L<br>4.3% @ 186.4 mmol/L |
| | | Total:<br>2.8% @ 65.1mmol/L<br>4.4% @ 186.5 mmol/L |
| Linearity<br>(mmol/L) | ISE Direct - Serum/plasma: 20-250<br>ISE Indirect - Serum/plasma: 20-250<br>ISE Urine: 20-350 | ISE Direct -- Serum/Plasma: 60-140<br>ISE Indirect - Serum/Plasma: 60-140<br>ISE Urine: 20-250 |
| Sensitivity for<br>electrode:<br>slope | -42 to -56 mV/dec | ISE Direct: -35 to -56 mV/dec<br>ISE Indirect: -38 to -56 mV/dec |

#### Substantial equivalency - differences (continued)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 6 2006

Ms. Corina Harper Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46256

k060108 Re: Trade/Device Name: Chloride Electrode Gen. 2 Regulation Number: 21 CFR§ 862.1170 Regulation Name: Chloride test system Regulatory Class: Class II Product Code: CGZ Dated: January 12, 2006 Received: January 27, 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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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I mb lotter will and myour your e FDA finding of substantial equivalence of your device to a legally promated nearly and the 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 guestions 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 Guti

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):

Chloride Electrode Gen. 2: Chloride Electrode Gen. 2

Indications For Use:

The ISE module of the COBAS INTEGRA systems is intended for use for the The 15L module of the 00DTro iive, potassium, chloride in serum, plasma and urine, and lithium in serum and plasma, using ion-selective electrodes.

This Chloride electrode is recommended to be used if a significant amount of the samples I mis Chornia samples. Serum and urine samples may also be analyzed with this electrode.

Chloride measurements are used in diagnosis and treatment of electrolyte and metabolic disorders.

Prescription Use XXX

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 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)

Carol Benem
Sign-On

ിfice of In Vitro Diagnostic Device ivaluation and Safety