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 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.

AI/ML Overview

This document describes the VITROS Chemistry Products Na Slides and VITROS Chemistry Products Calibrator Kit 2. The new device is the "modified" VITROS Chemistry Products Na+ Slide, and it is compared to a predicate device, the "current" VITROS Chemistry Products Na+ Slide. The Calibrator Kit 2 is unchanged.

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and matching reported device performance in the format commonly seen for diagnostic accuracy studies. Instead, it states that "Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured sodium values spanning the assay range." This implies that the acceptance criterion was likely substantial equivalence to the predicate device, demonstrated through comparative performance studies.

The provided text focuses on the device's technical specifications and function, rather than detailed performance metrics against predefined acceptance thresholds.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "patient and quality control samples with measured sodium values spanning the assay range" were used. However, it does not specify the sample size for the test set, nor does it provide information on the country of origin of the data or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is a chemical assay for measuring sodium concentration, not an imaging device requiring expert interpretation for ground truth. The "ground truth" for chemical assays is typically established by reference methods or validated laboratory measurements, not by expert consensus from radiologists or similar medical professionals.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation of results (e.g., medical images) is involved and discrepancies need to be resolved. For chemical assays, the "ground truth" is determined by the output of the reference method or established laboratory procedures.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study is not applicable here. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers interpreting results.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not directly applicable in the context of an automated chemical assay. The VITROS Na+ Slides, used with the VITROS Chemistry Systems, inherently operate in a "standalone" manner in that the system provides a quantitative measurement without human interpretation of raw data to derive the sodium concentration. The "performance" refers to the accuracy and precision of the instrument's measurements against a known standard or reference method. The core of the submission is to demonstrate that the modified slide performs equivalently to the predicate slide.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for this device would be established by validated laboratory measurements using a reference method or a legally marketed predicate device. The document implies this by stating "measured sodium values spanning the assay range" were used for comparison. The predicate device's performance would likely serve as the primary reference for demonstrating substantial equivalence.

8. The sample size for the training set

This information is not provided in the document. For in vitro diagnostic assays, especially those based on established chemical principles, the concept of a "training set" in the context of machine learning is not typically applicable in the same way. Development and validation of such assays involve rigorous analytical studies (e.g., linearity, precision, interference) rather than machine learning training.

9. How the ground truth for the training set was established

As the concept of a "training set" in the machine learning sense is not applicable here, the method of establishing ground truth for a training set is not relevant. The device's accuracy is established through analytical performance studies against known standards or reference methods.

Summary

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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 (585) 453-4041 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 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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1. 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

DeviceCharacteristic	New DeviceVITROS Chemistry Products Na+ Slide(Modified)	Predicate DeviceVITROS Chemistry Products Na+ Slide(Current)
Intended Use	No Change.	For in vitro diagnostic use only.VITROS Na+ Slides quantitatively measuresodium (Na+) concentration in serum, plasma,and urine.
Fundamental scientifictechnology	No Change.	Dry, multilayered slide utilizing directpotentiometry
Sample type	No Change.	Serum, plasma, urine
Instrumentation	VITROS 250, 950 and 5,1FS Series Analyzers.The 550 and 750 analyzers will not besupported by OCD as of January 1, 2008.	VITROS 250, 550, 750, 950 and 5,1FS SeriesAnalyzers
Reactive Ingredients percm2	No Change.	Silver 0.4 mg and silver chloride 0.2 mg; sodiumchloride 0.3 mg, methyl monensin 50 µg.
Other Ingredients	Binders, buffer, plasticizers, stabilizer,surfactants and nickel-chromium.	Binders, buffer, plasticizers, stabilizer,surfactants and nickel.
Composition of ISEbaseweb* component	Ag/AgCl concentration: No changeNickel Stripes: NiCr (80% Nickel, 20% Chromium)	Ag/AgCl concentration: Silver 0.4 mg and silverchloride 0.2 mgNickel Stripes: Ni (99+% Nickel)
Manufacturing Processof the ISE baseweb*(Ag/AgCl and SupportLayers 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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Page 2 -

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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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):

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.

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

Page 1 of 1

Regulation Number and Section

§ 862.1665 Sodium test system.

(a)
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.(b)
Classification. Class II.