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, CT, ECO2, HDLC, K*, Na*, and TRIG.

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.

AI/ML Overview

The provided text describes a 510(k) submission for VITROS Chemistry Products K+ Slides (modified) and VITROS Chemistry Products Calibrator Kit 2. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present specific numerical acceptance criteria (e.g., a specific correlation coefficient, bias limit, or precision target) in a table format. Instead, the "acceptance criterion" appears to be demonstrating substantial equivalence to the predicate device in terms of performance.

The "reported device performance" is summarized in a qualitative statement:

Acceptance Criterion	Reported Device Performance
Substantial Equivalence to Predicate Device	"Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured potassium values spanning the assay range."

Further details about the performance would typically be found in the full submission, but this summary only provides this high-level statement. The "List of VITROS Chemistry Products K*Slide Characteristics: Comparison to Predicate Device" (Table 1 on page 3) highlights that the intended use, fundamental scientific technology, sample type, and reactive ingredients per cm² are unchanged, which are key aspects supporting equivalence for this type of device.

2. Sample size used for the test set and the data provenance

The document states: "Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured potassium values spanning the assay range."
However, the exact sample size (number of patient and quality control samples) is not specified in the provided summary.
The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For an in vitro diagnostic device measuring potassium concentration, "ground truth" would typically refer to the results obtained from a reference method or a well-established, previously cleared device, not human expert interpretation.

4. Adjudication method for the test set

This is not applicable as the device is for quantitative measurement of potassium, and its performance is assessed against a predicate device or reference method, not through human 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

An MRMC study is not applicable to this device. This is an in vitro diagnostic device for quantitative chemical analysis, not an AI-assisted diagnostic imaging or interpretation tool involving human readers.

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

This refers to the performance of the device itself (the VITROS Chemistry Products K+ Slides and Calibrator Kit 2 combination) without human interpretation in the results generation. Given the nature of a chemical analyzer, the assay output is the standalone performance. The document implies this by stating: "Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured potassium values spanning the assay range." The performance of the system directly outputs the potassium concentration.

7. The type of ground truth used

For this type of in vitro diagnostic device, the "ground truth" would likely be established using a reference method or by comparison to the predicate device's measurements on the same samples. The document states that "Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured potassium values spanning the assay range," implying comparison against established values for these samples. The specific method used to establish these "measured potassium values" is not detailed, but it would typically be a highly accurate and precise method.

8. The sample size for the training set

This information is not provided in the summary. For an IVD device like this, "training set" might refer to data used during the development and optimization of the assay and manufacturing process, rather than a distinct dataset for machine learning model training.

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

This information is not provided in the summary. Similar to point 7, if a "training set" was used (e.g., for method development), the ground truth would likely be established via reference methods or highly characterized samples.

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: 1003157

1.	Submittername,address,contact	Ortho-Clinical Diagnostics, Inc.100 Indigo Creek DriveRochester, New York 14626-5101(585) 453-4041
		Contact Person: Marlene A. Hanna
2.	Preparationdate	Date Special 510(k) prepared: November 7, 2007
3.	Devicename	Trade or Proprietary Name:VITROS Chemistry Products K+ SlidesCommon Name: Potassium testClassification Name: Potassium test system (21 CFR 862.1600)
		VITROS Chemistry Products Calibrator Kit 2Common Name: calibratorClassification Name: Calibrator (21 CFR 862.1150)
4.	Predicatedevice	The VITROS Chemistry Products K+ Slides (modified) and VITROS ChemistryProducts Calibrator Kit 2 are substantially equivalent to the VITROS ChemistryProducts K+ Slides (current slide) and VITROS Chemistry Products Calibrator Kit 2.The FDA cleared the VITROS Chemistry Products K+ Slides on May 7, 1996(K961115) under the product name EKTACHEM Clinical Chemistry Slide Potassium(K+). With the purchase of KODAK Clinical Products Division by Johnson andJohnson, the product branding was later revised to VITROS Chemistry Products K+Slides. The most recent FDA clearance for the VITROS Chemistry Products CalibratorKit 2 was July 20, 2007 (K071801).

Continued on next page

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510(k) Summary, Continued

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.

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

1. 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.

Continued on next page

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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(Modified)	VITROS Chemistry Products K+ Slide(Current)
Intended Use	No Change.	For in vitro diagnostic use only.VITROS K+ Slides quantitatively measurepotassium (K+) 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 SeriesAnalyzers. The 550 and 750 analyzers willnot be supported 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 0.2 mg; potassium chloride 63 μg,valinomycin 55 μg.
Other Ingredients	Binders, plasticizers, stabilizer, surfactantsand nickel-chromium.	Binders, plasticizers, stabilizer, surfactants andnickel.
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 Process ofthe ISE baseweb*(Ag/AgCl and SupportLayers 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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of the usual two.

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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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 toll-free number (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.

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

Page 1 of 2

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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

Page 2 of 2

Regulation Number and Section

§ 862.1600 Potassium test system.

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