VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2

K073157 · Ortho-Clinical Diagnostics, Inc. · CEM · Dec 7, 2007 · Clinical Chemistry

Device Facts

• Record ID: K073157
• Device Name: VITROS CHEMISTRY PRODUCTS K+ SLIDES AND CALIBRATOR KIT 2
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: CEM · Clinical Chemistry
• Decision Date: Dec 7, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1600
• Device Class: Class 2

Intended Use

For in vitro diagnostic use only. VITROS K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, CI , ECO2, HDLC, K+, Na+, and TRIG.

Device Story

VITROS Chemistry Products K+ Slides are multilayered analytical elements on polyester support for quantitative measurement of ionic potassium in serum, plasma, and urine. Device uses direct potentiometry via ion-selective electrodes containing valinomycin. Operation involves depositing 10 uL of reference fluid and sample fluid onto separate slide halves; a paper bridge facilitates liquid junction. After 2-minute incubation, VITROS Chemistry System electrometer measures potential difference between reference and indicator electrodes. System microcomputer calculates potassium concentration (mmol/L) using stored calibration parameters. Used in clinical laboratory settings by trained personnel. Output assists clinicians in diagnosing and treating electrolyte imbalances. Modified device utilizes magnetic sputter deposition for ISE baseweb manufacturing compared to electron beam evaporation in predicate.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design control activities, risk analysis, and verification/validation testing.

Technological Characteristics

Ion selective electrode (ISE) component. Material: nickel-chromium alloy (80% Ni, 20% Cr). Manufacturing: magnetic sputter deposition. Compatibility: Vitros 250, 350, 950, and 5,1 FS Series Analyzers.

Indications for Use

Indicated for quantitative measurement of potassium in serum, plasma, and urine to monitor electrolyte balance in patients with conditions characterized by abnormal blood potassium levels.

Regulatory Classification

Identification

A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

Predicate Devices

• VITROS Chemistry Products K+ Slides (K961115)
• VITROS Chemistry Products Calibrator Kit 2 (K071801)

Submission Summary (Full Text)

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# Summary Information

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: 1003157

| 1. | Submitter<br>name,<br>address,<br>contact | Ortho-Clinical Diagnostics, Inc.<br>100 Indigo Creek Drive<br>Rochester, New York 14626-5101<br>[phone] |
|----|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Contact Person: Marlene A. Hanna |
| 2. | Preparation<br>date | Date Special 510(k) prepared: November 7, 2007 |
| 3. | Device<br>name | Trade or Proprietary Name:<br>VITROS Chemistry Products K+ Slides<br>Common Name: Potassium test<br>Classification Name: Potassium test system (21 CFR 862.1600) |
| | | VITROS Chemistry Products Calibrator Kit 2<br>Common Name: calibrator<br>Classification Name: Calibrator (21 CFR 862.1150) |
| 4. | Predicate<br>device | The VITROS Chemistry Products K+ Slides (modified) and VITROS Chemistry<br>Products Calibrator Kit 2 are substantially equivalent to the VITROS Chemistry<br>Products K+ Slides (current slide) and VITROS Chemistry Products Calibrator Kit 2.<br>The FDA cleared the VITROS Chemistry Products K+ Slides on May 7, 1996<br>(K961115) under the product name EKTACHEM Clinical Chemistry Slide Potassium<br>(K+). With the purchase of KODAK Clinical Products Division by Johnson and<br>Johnson, the product branding was later revised to VITROS Chemistry Products K+<br>Slides. The most recent FDA clearance for the VITROS Chemistry Products Calibrator<br>Kit 2 was July 20, 2007 (K071801). |

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#### 510(k) Summary, Continued

5. Device Description The VITROS K assay is performed using the VITROS Chemistry Products K Slide and the VITROS Chemistry Products Calibrator Kit 2 on the VITROS Chemistry Systems. The VITROS K* Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of ionic potassium. All reactions necessary for a single quantitative measurement of potassium take place within the multi-lavered analytical element of a VITROS Chemistry Products K*slide. The slide consists of two ion-selective electrodes, each containing valinomycin (an ionophore for potassium), a reference layer, and a silver layer and a silver chloride layer coated on a polyester support.

VITROS Chemistry Products K* Slides use ion-selectrodes for potentiometric measurements of ionic potassium. Ionic potassium determinations are made by simultaneously depositing 10 uL each of a reference fluid and a sample fluid on separate halves of the VITROS Chemistry Products K* slide. The electrode receiving the reference fluid is identified as the reference electrode. A paper bridge connects the reference electrode and the indicator electrode, which receives the sample fluid. A stable liquid junction between the two fluids is formed in the paper bridge in approximately 20 seconds. The potassium ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establish equilibrium.

After a two minute incubation period, the electrometer in the VITROS Chemistry System measures the potential difference between the reference and indicator electrodes. Each electrode responds to the activity of potassium ions in the respective fluids to produce a potential for the concentration cell. The VITROS Chemistry System's microcomputer uses this measurement and the stored calibration parameters to determine the concentration value of the potassium ion in the sample fluid. The test result is reported in millimoles per liter (mmol/L).

VITROS Chemistry Products Calibrator Kit 2 contains four levels of Iyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum to which bovine cholesterol, chicken egg yolk, inorganic salts, electrolytes, buffers, stabilizers, and preservatives have been added. The companion diluents are prepared from processed water to which inorganic salts have been added. In addition. Calibrator 4 Diluent contains 0.5 M diethylaminoethanol and 0.01 M (ethylenedinitrilo) tetraacetic acid.

The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

- 6. Device VITROS Chemistry Products K+ Slides For in vitro diagnostic use only. VITROS K+ Slides quantitatively measure potassium intended use (K+) concentration in serum, plasma, and urine.
VITROS Chemistry Products Calibrator Kit 2 For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, CI , ECO2, HDLC, K+, Na+, and TRIG.

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### 510(k) Summary, Continued

- The VITROS Chemistry Products K+ Slide (modified) and VITROS Chemistry 7. Compariso Products Calibrator Kit 2 are substantially equivalent to VITROS Chemistry Products K+ Slide and VITROS Chemistry Products Calibrator Kit 2, which were n to predicate Cleared by the FDA for in vitro diagnostic use. device VITROS Chemistry Products K+ Slide: (K961115, cleared May 7, 1996) VITROS Chemistry Products Calibrator Kit 2: (K071801, cleared July 20, 2007).
Table 1 lists the characteristics of the tests performed using the VITROS K * Slide (modified) and the VITROS K+ Slide (current).

#### Table 1. List of VITROS Chemistry Products K*Slide Characteristics: Comparison to Predicate Device

| Device | New Device | Predicate Device |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | VITROS Chemistry Products K+ Slide<br>(Modified) | VITROS Chemistry Products K+ Slide<br>(Current) |
| Intended Use | No Change. | For <i>in vitro</i> diagnostic use only.<br>VITROS K+ Slides quantitatively measure<br>potassium (K+) concentration in serum, plasma,<br>and urine. |
| Fundamental scientific<br>technology | No Change. | Dry, multilayered slide utilizing direct<br>potentiometry |
| Sample type | No Change. | Serum , plasma, urine |
| Instrumentation | VITROS 250, 950 and 5,1FS Series<br>Analyzers. The 550 and 750 analyzers will<br>not be supported by OCD as of January 1,<br>2008. | VITROS 250, 550, 750, 950 and 5,1FS Series<br>Analyzers |
| Reactive Ingredients per<br>cm2 | No Change. | Silver 0.4 mg and silver chloride 0.2 mg; sodium<br>chloride 0.2 mg; potassium chloride 63 μg,<br>valinomycin 55 μg. |
| Other Ingredients | Binders, plasticizers, stabilizer, surfactants<br>and nickel-chromium. | Binders, plasticizers, stabilizer, surfactants and<br>nickel. |
| Composition of ISE<br>baseweb* component | Ag/AgCl concentration: No change<br>Nickel Stripes: NiCr (80% Nickel, 20%<br>Chromium) | Ag/AgCl concentration: Silver 0.4 mg and silver<br>chloride 0.2 mg<br>Nickel Stripes: Ni (99+% Nickel) |
| Manufacturing Process of<br>the ISE baseweb*<br>(Ag/AgCl and Support<br>Layers of the K+ Slide) | Magnetic sputter deposition | Electron beam evaporation |

* ISE (lon-Selective Electrode) baseweb= Polyethylene terephthalate film (substrate used for metallized film) coated with silver (Ag)/ silver chloride (Ag/Cl) and striped with nominal nickel (Ni) stripes. The "ISE baseweb" refers to the Ag/ AgCl with nickel stripes layer and support layer of the VITROS Chemistry Products K* Slide.

NOTE: No modifications were made to VITROS Chemistry Products Calibrator Kit 2. VITROS Calibrator Kit 2 is included in this submission, since the VITROS K+ Slide is used in conjunction with VITROS Calibrator Kit 2, and together are considered to be to the "VITROS K+ assay".

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### 510(k) Summary, Continued

The information presented in the premarket notification demonstrates that the 8. Conclusions performance of the VITROS Chemistry Products K* Slides (modified) for use with human serum, plasma, and urine is substantially equivalent to the cleared predicate device.

> Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured potassium values spanning the assay range.

> The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products K* Slides (modified) for use with human serum, plasma, and urine is safe and effective for the stated intended use.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## DEC 0 7 2007

Ortho-Clinical Diagnostics, Inc. c/o Ms. Marlene Hanna Regulatory Affairs Manager MC00881 100 Indigo Creek Drive Rochester, New York 14626-5101

k073157 Re:

> Trade/Device Name: Vitros Chemistry Product K+ Slides and Vitros Chemistry Products Calibrator Kit 2 Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium Test System Regulatory Class: Class II Product Code: CEM, JIX Dated: November 07, 2007 Received: November 08, 2007

Dear Ms. Hanna:

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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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## Indication for Use

510(k) Number (if known): K073157

Device Name: VITROS Chemistry Products K+ Slides

Indication For Use: For in vitro diagnostic use only. VITROS K* Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073157

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#### Indication for Use

510(k) Number (if known): K073157

Device Name: VITROS Chemistry Products Calibrator Kit 2

Indication For Use: For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, CT, ECO2, HDLC, K*, Na*, and TRIG.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073157

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