Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a chemistry assay using ion-selective electrodes and a microcomputer to calculate results based on calibration parameters. There is no mention of AI or ML algorithms for data processing, interpretation, or decision-making.

Therapeutic

No
The device is for in vitro diagnostic use only, meaning it analyzes samples outside the body, and its purpose is to measure sodium levels for diagnostic purposes rather than directly treating a condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and further elaborates that the measurements 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."

SaMD (Software as a Medical Device)

No

The device description clearly details physical components like slides, electrodes, and calibrator kits, indicating it is a hardware-based in vitro diagnostic device, not software-only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
Measurement of Analytes in Biological Samples: The device measures sodium (Na*) concentration in serum, plasma, and urine, which are biological samples.
Use in Diagnosis and Treatment: The measurements are used in the diagnosis and treatment of various conditions involving electrolyte imbalance, which is a core function of IVD devices.
Device Description: The description details the components and mechanism for performing a quantitative measurement of sodium in a sample, consistent with an IVD assay.
Calibrator Kit: The inclusion of a calibrator kit is standard for quantitative IVD assays to ensure accurate measurements.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

JGS, JJX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K961099, K073157

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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 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

2

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

| Device
Characteristic | New Device
VITROS Chemistry Products Na+ Slide
(Modified) | Predicate Device
VITROS Chemistry Products Na+ Slide
(Current) |
|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | No Change. | For in vitro diagnostic use only.
VITROS Na+ Slides quantitatively measure
sodium (Na+) concentration in serum, plasma,
and urine. |
| Fundamental scientific
technology | No Change. | Dry, multilayered slide utilizing direct
potentiometry |
| Sample type | No Change. | Serum, plasma, urine |
| Instrumentation | VITROS 250, 950 and 5,1FS Series Analyzers.
The 550 and 750 analyzers will not be
supported by OCD as of January 1, 2008. | VITROS 250, 550, 750, 950 and 5,1FS Series
Analyzers |
| Reactive Ingredients per
cm2 | No Change. | Silver 0.4 mg and silver chloride 0.2 mg; sodium
chloride 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 ISE
baseweb* component | Ag/AgCl concentration: No change
Nickel Stripes: NiCr (80% Nickel, 20% Chromium) | Ag/AgCl concentration: Silver 0.4 mg and silver
chloride 0.2 mg
Nickel Stripes: Ni (99+% Nickel) |
| Manufacturing Process
of the ISE baseweb*
(Ag/AgCl and Support
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 (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

6

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

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