VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

K081411 · Ortho-Clinical Diagnostics, Inc. · JGS · Jun 30, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081411
• Device Name: VITROS CHEMISTRY PRODUCT NA+ SLIDES; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JGS · Clinical Chemistry
• Decision Date: Jun 30, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1665
• Device Class: Class 2

Intended Use

For in vitro diagnostic use only. VITROS Na Slides quantitatively measure sodium (Na*) concentration in serum, plasma, and urine. Measurements used by this device are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other disease involving electrolyte imbalance. 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 Na+ Slides are multilayered analytical elements on polyester support for quantitative sodium measurement in serum, plasma, and urine. Device uses direct potentiometry via two ion-selective electrodes containing methyl monensin ionophore. Operation involves depositing 10 uL of reference and sample fluids onto slide halves; fluids connect via paper bridge to form liquid junction. After 2-minute incubation, system electrometer measures potential difference between electrodes. Microcomputer uses measurement and stored calibration parameters to calculate sodium concentration (mmol/L). Used in clinical laboratory settings on VITROS Chemistry Systems; operated by laboratory technicians. Output provides quantitative sodium values to clinicians for diagnosing/treating electrolyte imbalances. Modified device utilizes magnetic sputter deposition for ISE baseweb manufacturing, replacing electron beam evaporation.

Clinical Evidence

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

Technological Characteristics

Modified slide component; manufacturing process and formulation changes. Fundamental scientific technology unchanged.

Indications for Use

Indicated for quantitative measurement of sodium in serum, plasma, and urine for diagnosis/treatment of electrolyte-related conditions including aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, and SIADH.

Regulatory Classification

Identification

A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

Predicate Devices

• k961099
• k073157

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.

08141! The assigned 510(k) number is: "T

- 1. Submitter Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive name, address, Rochester, New York 14626-5101 [phone] contact Contact Person: Marlene A. Hanna 2. Preparation Date Special 510(k) prepared: May 19, 2008 date 3. Device Trade or Proprietary Name: VITROS Chemistry Products Na Slides name Common Name: Sodium test Classification Name: Sodium test system (21 CFR 862.1665) VITROS Chemistry Products Calibrator Kit 2 Common Name: calibrator Classification Name: Calibrator (21 CFR 862.1150) 4. Predicate The VITROS Chemistry Products Nat Slides (modified) and VITROS Chemistry device Products Calibrator Kit 2 are substantially equivalent to the VITROS Chemistry Products Na Slides (current slide) and VITROS Chemistry Products Calibrator Kit 2. The FDA cleared the VITROS Chemistry Products Na Slides on May 7, 1996 (K961099) under the product name EKTACHEM Clinical Chemistry Slide Sodium (Na ). With the purchase of KODAK Clinical Products Division by Johnson and Johnson, the product branding was later revised to VITROS Chemistry Products Na Slides. The most recent FDA clearance for the VITROS Chemistry Products Calibrator Kit 2 was December 7, 2007 (K073157).

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#### 5. Device Description

The VITROS Na assay is performed using the VITROS Chemistry Products Na "Slide and the VITROS Chemistry Products Calibrator Kit 2 on the VITROS Chemistry Systems. The VITROS Nat Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of ionic sodium. All reactions necessary for a single quantitative measurement of sodium take place within the multi-layered analytical element of a VITROS Chemistry Products Nat slide. The slide consists of two ion-selective electrodes, each containing methyl monensin (an ionophore for sodium), a reference layer, and a silver and a silver chloride layer coated on a polyester support.

VITROS Chemistry Products Na Slides use ion-selective electrodes for potentiometric measurements of ionic sodium. Ionic sodium determinations are made by simultaneously depositing 10 uL each of a reference tluid and a sample fluid on separate halves of the VITROS Chemistry Products Na * 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 sodium 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 sodium 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 sodium 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 lyophilized 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.

Device VITROS Chemistry Products Na + Slides 6. intended For in vitro diagnostic use only. VITROS Na" Slides quantitatively measure sodium (Na +) concentration in serum, plasma, and urine. use

> 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+, Nat, and TRIG.

Ortho Clinical Diagnostics, Inc. Special 510(k) VITROS Chemistry Products Na+ Slides VITROS Chemistry Products Calibrator Kit 2

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- 7. Comparison The VITROS Chemistry Products Na * Slide (modified) and VITROS Chemistry to predicate Products Calibrator Kit 2 are substantially equivalent to VITROS Chemistry Products Na + Slide and VITROS Chemistry Products Calibrator Kit 2, which were device Cleared by the FDA for in vitro diagnostic use.
VITROS Chemistry Products Na Slide: (K961099, cleared May 7, 1996) VITROS Chemistry Products Calibrator Kit 2: (K073157, cleared December 7, 2008).

Table 1 lists the characteristics of the tests performed using the VITROS Na * Slide (modified) and the VITROS Na Slide (current).

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

| Device<br>Characteristic | New Device<br>VITROS Chemistry Products Na+ Slide<br>(Modified) | Predicate Device<br>VITROS Chemistry Products Na+ Slide<br>(Current) |
|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | No Change. | For <i>in vitro</i> diagnostic use only.<br>VITROS Na+ Slides quantitatively measure<br>sodium (Na+) 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 Analyzers.<br>The 550 and 750 analyzers will not be<br>supported by OCD as of January 1, 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 0.3 mg, methyl monensin 50 µg. |
| Other Ingredients | Binders, buffer, plasticizers, stabilizer,<br>surfactants and nickel-chromium. | Binders, buffer, plasticizers, stabilizer,<br>surfactants and nickel. |
| Composition of ISE<br>baseweb* component | Ag/AgCl concentration: No change<br>Nickel Stripes: NiCr (80% Nickel, 20% Chromium) | Ag/AgCl concentration: Silver 0.4 mg and silver<br>chloride 0.2 mg<br>Nickel Stripes: Ni (99+% Nickel) |
| Manufacturing Process<br>of the ISE baseweb*<br>(Ag/AgCl and Support<br>Layers of the Na+ Slide) | Magnetic sputter deposition | Electron beam evaporation |

* ISE (Ion-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 Nat 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 Na+ Slide is used in conjunction with VITROS Calibrator Kit 2, and together is considered to be to the "VITROS Na+ assay".

Ortho Clinical Diagnostics, Inc. Special 510(k) VITROS Chemistry Products Na+ Slides VITROS Chemistry Products Calibrator Kit 2

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- The information presented in the premarket notification demonstrates that the 8. Conclusions performance of the VITROS Chemistry Products Na * 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 sodium values spanning the assay range.

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

Ortho Clinical Diagnostics, Inc. Special 510(k) VITROS Chemistry Products Na+ Slides VITROS Chemistry Products Calibrator Kit 2

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The symbol is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in a circular arrangement. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ortho-Clinical Diagnostics, Inc. c/o Ms. Marlene A. Hanna Regulatory Affairs Manager 100 Indigo Creek Drive Rochester, NY 14626-4041

JUN 3 0 2008

Re: k081411

> Trade Name: VITROS Chemistry Products Na+ Slides, VITROS Chemistry Products Calibrator Kit 2 Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System Regulatory Class: Class II Product Codes: JGS, JJX Dated: May 19, 2008 Received: May 20, 2008

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 tolloffen an [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.

Yean 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):

1. Device Name: VITROS Chemistry Products Na Slides

Indication For Use: For in vitro diagnostic use only. VITROS Na Slides quantitatively measure sodium (Na*) concentration in serum, plasma, and urine. Measurements used by this device are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other disease involving electrolyte imbalance.

2. 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, CI, 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 (OVD)

Division Sign-Off acting

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 81411

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