For in vitro diagnostic use only. VITROS Na DT Slides quantitatively measure sodium (Na ) concentration in serum and plasma. 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 Description

The VITROS Chemistry Products Nat DT Slide assay is performed using the VITROS Chemistry Products Na DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/DT60 II Chemistry Systems. The VITROS Na " DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of sodium ions. All reactions necessary for a single quantitative measurement of sodium take place within the multi-layered analytical element of a VITROS Chemistry Products Na DT Slide. The slide consists of two ion-selective electrodes, each containing methyl monensin (an ionophore for sodium), a reference layer, and a silver layer and a silver chloride layer coated on a polyester support.

VITROS Chemistry Products Na DT 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 fluid and a sample fluid on separate halves of the VITROS Chemistry Products Na DT 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. The sodium ions in the tested reference and sample fluids migrate to the silver silver silver chloride lavers and establishes equilibrium.

After an 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 DT60/DT6011 Chemistry System's microprocessor 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 DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from bovine serum albumin and processed bovine serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added. The companion diluents are prepared from processed water to which inorganic salts have been added.

The VITROS DT60 II Chemistry System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the VITROS Chemistry Products Na+ DT Slides based on the provided document:

This 510(k) pertains to a modified device (VITROS Chemistry Products Na+ DT Slides) and compares it to a predicate device, focusing on demonstrating substantial equivalence, rather than establishing performance against new acceptance criteria. Therefore, the "acceptance criteria" are implicitly the performance of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured sodium values spanning the assay range." It does not provide specific numerical acceptance criteria (e.g., precision, accuracy ranges) or granular performance data for the modified device. Instead, it concludes the modified device is "substantially equivalent" to the predicate.

Characteristic	Acceptance Criteria (Implied by Predicate Device Performance)	Reported Device Performance (Modified Device)
Ability to measure sodium (Na+) concentration in serum and plasma quantitatively.	Successfully measures Na+ concentration in serum/plasma using direct potentiometry. (Performance of K081411 and K083680)	Successfully measures Na+ concentration in serum/plasma using direct potentiometry; demonstrated substantial equivalence to predicate.
Performance across the assay range.	Performance of predicate device (K081411) with patient and quality control samples spanning the assay range.	Demonstrated substantial equivalence to predicate device with patient and quality control samples spanning the assay range.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in terms of an exact number. The document mentions "patient and quality control samples with measured sodium values spanning the assay range."
Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "patient and quality control samples," suggesting a mix of clinical and controlled laboratory samples. It is a retrospective comparison against the performance of the predicate device, although the data collection for the modified device would be prospective for the purpose of this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission is for an in vitro diagnostic device, where ground truth for analyte concentration is typically established by reference methods or validated laboratory instruments, not by expert interpretation of images or clinical scenarios.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or interpretation requiring adjudication.

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

Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting cases.

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

This device is a standalone diagnostic test system (reagents and associated instrument). The performance evaluated is the accuracy and precision of the analytical system itself in measuring sodium concentration. The document demonstrates this through "equivalence" to the predicate, implying standalone performance.

7. The Type of Ground Truth Used

The ground truth for the sodium concentration in the samples would have been established by:

Reference methods for sodium measurement.
Validated laboratory instruments or established values for quality control samples.
The predicate device's cleared performance, against which the modified device was compared for equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its performance is based on the chemical and electrochemical principles of ion-selective electrodes.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for this type of device.

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.

The assigned 510(k) number is: K09186

Submitter Ortho-Clinical Diagnostics, Inc. 1. name, 100 Indigo Creek Drive address. Rochester, New York 14626-5101 (585) 453-4041 contact email: mhanna1(@its.jnj.com
Contact Person: Marlene A. Hanna
1. Date Special 510(k) prepared: June 18, 2009 Preparation date
Trade or Proprietary Name: Device 3. VITROS Chemistry Products Na+ DT Slides name Common Name: sodium test Classification Name: sodium test system (21 CFR 862.1665)

VITROS Chemistry Products DT Calibrator Kit Common Name: calibrator Classification Name: Calibrator (21 CFR 862.1150)

The VITROS Chemistry Products Nat DT Slides (modified) and VITROS Chemistry 4. Predicate Products DT Calibrator Kit are substantially equivalent to the VITROS Chemistry device Products Na Slides (K081411, cleared on June 30, 2008) and VITROS Chemistry Products DT Calibrator Kit (K083680, cleared February 26, 2009).
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510(k) Summary, Continued

Device Description The VITROS Chemistry Products Nat DT Slide assay is performed using the VITROS Chemistry Products Na DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/DT60 II Chemistry Systems. The VITROS Na " DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of sodium ions. All reactions necessary for a single quantitative measurement of sodium take place within the multi-layered analytical element of a VITROS Chemistry Products Na DT Slide. The slide consists of two ion-selective electrodes, each containing methyl monensin (an ionophore for sodium), a reference layer, and a silver layer and a silver chloride layer coated on a polyester support.

The VITROS DT60 II Chemistry System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

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Device intended use

VITROS Chemistry Products Na DT Slides

For in vitro diagnostic use only. VITROS Nat DT Slides quantitatively measure sodium (Na ) concentration in serum and plasma.

VITROS Chemistry Products DT Calibrator Kit

For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, CI-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

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510(k) Summary, Continued

The VITROS Chemistry Products Na DT Slide (modified) and VITROS Chemistry 7. Comparison to predicate Products DT Calibrator Kit are substantially equivalent to VITROS Chemistry Products Na Slide and VITROS Chemistry Products DT Calibrator Kit, which were device · Cleared by the FDA for in vitro diagnostic use.

VITROS Chemistry Products Na Slide: (K081411, cleared June 30, 2008) VITROS Chemistry Products DT Calibrator Kit: (K083680, cleared February 26, 2009).

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

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

DeviceCharacteristic	New DeviceVITROS Chemistry Products Na+ DT Slide(Modified)	Predicate DeviceVITROS Chemistry Products Na+ Slide(Current)
Intended Use	No Change.	For in vitro diagnostic use only.VITROS Na+ DT Slides quantitatively measuresodium (Na+) concentration in serum andplasma.
Fundamentalscientific technology	No Change.	Dry, multilayered slide utilizing directpotentiometry
Reactive Ingredientsper cm2	No Change.	Silver 0.4 mg; silver chloride 0.2 mg; sodiumchloride 0.3 mg; and methyl monensin 50 ug.
Sample type	No Change.	Serum, plasma
Instrumentation	VITROS 250/350/950 and 5,1 FS ChemistrySystems and the VITROS 5600 Integrated System	VITROS DT60 and DT60II Chemistry Systems
ManufacturingProcess of the ISEbaseweb* (Ag/AgCland Support Layersof the Na+ DT Slide)	Same	Magnetic sputter deposition
Composition of ISEbaseweb component	Same	Ag/AgCl concentration: Silver 0.4 mg andsilver chloride 0.2 mgNickel Stripes: NiCr (80% Nickel, 20%Chromium).

*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 Na+ DT Slide.

NOTE: No modifications were made to VITROS Chemistry Products DT Calibrator Kit.

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510(k) Summary, Continued

8. Conclusions

The information presented in the premarket notification demonstrates that the performance of the VITROS Chemistry Products Na DT Slides (modified) for use with human serum and plasma 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 DT Slides (modified) for use with human serum and plasma is safe and effective for the stated intended use.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ortho-Clinical Diagnostics, Inc. c/o Ms. Marlene Hanna, RAC 100 Indigo Drive, Rochester, NY 14626-5101

SEP - 3 2009

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Re: K091861 Trade/Device Name: VITROS Chemistry Products Na+ DT Slides Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System Regulatory Class: Class II Product Code: JGS, JIX Dated: June 18, 2009 Received: June 19, 2009

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).

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.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part . 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

G.C.H.

Courtney C. Harper, Ph.D. Acting 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 DT Slides

Indication For Use: For in vitro diagnostic use only. VITROS Na DT Slides quantitatively measure sodium (Na ) concentration in serum and plasma. 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.

K091861

Device Name: VITROS Chemistry Products DT Calibrator Kit

VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems. For in vitro diagnostic use only.

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 (OV/D)

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

510(k) K091861

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.