For in vitro diagnostic use only. VITROS CI Slides quantitatively measure chloride (CI) concentration in serum and plasma. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

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 Chemistry Products Cli Slide assay is performed using the VITROS Chemistry Products Cli Slide and the VITROS Chemistry Products Calibrator Kit 2 on the VITROS Chemistry Systems. The VITROS CI Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry' for measurement of chloride ions. All reactions necessary for a single quantitative measurement of chloride take place within the multi-layered analytical element of a VITROS Chemistry Products Cli slide. The slide consists of two ion-selective electrodes, each containing a protective layer, a silver layer and a silver chloride layer coated on a polyester support. The protective layer inhibits interference from normal levels of bromide and uric acid

VITROS Chemistry Products CI Slides use ion-selective electrodes for potentiometric measurements of ionic chloride. Ionic chloride 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 CI 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 chloride ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establish equilibrium.

After a 2 or 3-minute (depends on the VITROS Chemistry System used) 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 chloride 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 chloride 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

The provided document is a 510(k) summary for the VITROS Chemistry Products CI Slides and VITROS Chemistry Products Calibrator Kit 2. It discusses the substantial equivalence of a modified version of the CI Slides to a predicate device. However, it does not contain detailed information about specific acceptance criteria, a comprehensive study design with reported performance metrics, sample sizes for testing or training, ground truth establishment methods, or expert qualifications as requested in your prompt.

The document states that equivalence was demonstrated using "manufactured slides along with patient and quality control samples with measured chloride values spanning the assay range." However, it does not provide specific details on:

Quantitative acceptance criteria (e.g., specific accuracy, precision, or correlation thresholds).
Reported device performance against such criteria.
Sample sizes used for the test set or training set.
Data provenance (country of origin, retrospective/prospective).
Number or qualifications of experts to establish ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness study details.
Standalone algorithm performance (as this is a chemical assay, not an AI algorithm).
Type of ground truth (beyond "measured chloride values").
How ground truth for the training set was established.

Therefore, I cannot populate the table or provide the requested details using only the information in the provided text.

Based on the content, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured chloride values spanning the assay range." This implies that the acceptance criteria revolved around demonstrating substantial equivalence to the predicate device, likely through performance studies that showed comparable accuracy, precision, and linearity across the assay range for chloride concentration. However, specific numerical acceptance criteria (e.g., bias limits, correlation coefficients, or percentages of samples within agreement) and the actual reported performance values against these criteria are not provided in the summary.

Acceptance Criteria (Implied)	Reported Device Performance (Not explicitly stated in detail)
Substantial equivalence to predicate device (K800054)	Demonstrated equivalence through studies using patient and QC samples.
Performance across the assay range for chloride concentration	Demonstrated performance across the assay range using patient and QC samples.
	(Specific numerical performance data, e.g., accuracy, precision, correlation, bias, are not provided in this summary.)

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

Sample size: Not specified. The document mentions "patient and quality control samples."
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not applicable/Not specified. This is a chemical assay, and the "ground truth" would typically refer to established reference methods or known concentrations in quality control materials, not expert interpretation.

4. Adjudication method for the test set

Not applicable. Adjudication is typically for subjective assessments, not objective chemical measurements.

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 device is a chemical assay for measuring chloride concentration, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

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

Not applicable. This device is a chemical assay. Its performance is inherent to the chemical reactions and measurement system, not an AI algorithm.

7. The type of ground truth used

The ground truth for the test set was based on "measured chloride values" in "patient and quality control samples." This strongly implies:

For quality control samples: Known, certified concentrations.
For patient samples: Chloride concentrations measured by a reference method or the predicate device itself, assuming comparability studies.

8. The sample size for the training set

Not applicable/Not specified. This is a chemical assay. The concept of a "training set" as understood in machine learning (where an algorithm learns from data) does not apply directly here. The development of the assay would involve optimization and validation processes rather than algorithmic training.

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

Not applicable. See point 8.

Summary

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Summary Information

510(k) Summary

JUL 2 0 2007

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: Ko7180

Ortho-Clinical Diagnostics, Inc. 1. Submitter name, 100 Indigo Creek Drive address, Rochester. New York 14626-5101 contact (585) 453-4041
Contact Person: Marlene A. Hanna
Date Special 510(k) prepared: June 29, 2007 2. Preparation date
Trade or Proprietary Name: 3. Device VITROS Chemistry Products Cl Slides name Common Name: chloride test Classification Name: Chloride test system (21 CFR 862.1170)

VITROS Chemistry Products Calibrator Kit 2 Common Name: calibrator Classification Name: Calibrator (21 CFR 862.1150)

The VITROS Chemistry Products CI Slides (modified) and VITROS Chemistry 4. Predicate Products Calibrator Kit 2 are substantially equivalent to the VITROS Chemistry device Products CI Slides (current slide) and VITROS Chemistry Products Calibrator Kit 2.
Continued on next page

Ortho-Clinical Diagnostics VITROS Chemistry Products Cl Slides VITROS Chemistry Products Calibrator Kit 2

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510(k) Summary, Continued

The VITROS Chemistry Products Cli Slide assay is performed using the VITROS 5. Device Chemistry Products Cli Slide and the VITROS Chemistry Products Calibrator Kit 2 on Description the VITROS Chemistry Systems. The VITROS CI Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry' for measurement of chloride ions. All reactions necessary for a single quantitative measurement of chloride take place within the multi-layered analytical element of a VITROS Chemistry Products Cli slide. The slide consists of two ion-selective electrodes, each containing a protective layer, a silver layer and a silver chloride layer coated on a polyester support. The protective layer inhibits interference from normal levels of bromide and uric acid

VITROS Chemistry Products CI Slides use ion-selective electrodes for potentiometric measurements of ionic chloride. Ionic chloride 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 CI 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 chloride ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establish equilibrium.

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

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VITROS Chemistry Products CI Slides 6. Device For in vitro diagnostic use only. VITROS CT Slides quantitatively measure chloride intended (CI) concentration in serum and plasma. 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*, Na*, and TRIG.

Continued on next page

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510(k) Summary, Continued

The VITROS Chemistry Products Cli Slide (modified) and VITROS Chemistry 7. Comparison Products Calibrator Kit 2 are substantially equivalent to VITROS Chemistry to predicate Products Cl Slide and VITROS Chemistry Products Calibrator Kit 2, which were device Cleared by the FDA for in vitro diagnostic use.

VITROS Chemistry Products Cli Slide: (K800054, cleared February 5, 1980) VITROS Chemistry Products Calibrator Kit 2: (K012593, cleared August 30, 2001).

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

DeviceCharacteristic	New DeviceVITROS Chemistry Products CI Slide(Modified)	Predicate DeviceVITROS Chemistry Products CI Slide(Current)
Intended Use	No Change.	For in vitro diagnostic use only.VITROS CI Slides quantitatively measure chloride(CI) concentration in serum and plasma.
Fundamental scientifictechnology	No Change.	Dry, multilayered slide utilizing directpotentiometry
Reactive Ingredientsper cm2	No Change.	Silver 0.4 mg and silver chloride 0.2 mg
Sample type	No Change.	Serum , plasma
Instrumentation	No Change.	VITROS 250, 550, 750, 950 and 5, 1FS SeriesAnalyzers
ManufacturingProcess of the ISEbaseweb* (Ag/AgCland Support Layers ofthe CI Slide)	Magnetic sputter deposition	Electron beam evaporation
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)

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

*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 CT Slide.

No modifications were made to VITROS Chemistry Products Calibrator Kit 2.

Continued on next page

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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 CI 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 chloride values spanning the assay range.

The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products CT 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 3 2007

Ortho-Clinical Diagnostics, Inc. c\o Ms. Marlene A. Hanna Regulatory Affairs Manager 100 Indigo Creek Drive Rochester. New York 14626-5101

Re: K071801

Trade Name: Vitros Chemistry Products CI Slides Vitros Chemistry Products Calibrator Kit 2 Regulation Number: 21 CFR 862.1170 Regulation Name: Chloride test system Regulatory Class: Class II Product Code: CGZ, JIX Dated: June 29, 2007 Received: July 02, 2007

Dear Ms. Hanna:

This letter corrects our substantially equivalent letter of July 20, 2007.

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. Ilsting 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.

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): K071801

Device Name: VITROS Chemistry Products CI Slides

Indication For Use: For in vitro diagnostic use only. VITROS CI Slides quantitatively measure chloride (CI) concentration in serum and plasma. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

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)

Patricia Bernhardt for Carol Benson

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

510(k) K 071801

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Indication for Use

510(k) Number (if known):K071801

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 _____________________________________________________________________________________________________________________________________________________________ (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)

Patricia Bernhart for Carol Benson

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

510(k) K07/80/

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.