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

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.

Device Description

The VITROS Chemistry Products CI Slide assay is performed using the VITROS Chemistry Products Cl DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT Chemistry Systems. The VITROS CI DT 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 CI DT Slide. The slide consists of two ionselective electrodes, each containing a protective laver, a silver laver 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 DT 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 CT 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 chloride ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establish equilibrium. Each electrode produces an electrical potential in response to the activity of chloride ions applied to it. The potential difference poised between the two electrodes is proportional to the chloride concentration in the sample. 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 boyine 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 DT Systems and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and the study conducted.

It's important to note that this document is a 510(k) summary for a modified device, demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" discussed here relate to showing that the modified device performs comparably to the previously cleared predicate, rather than establishing completely new performance benchmarks from scratch.

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on predicate performance)	Reported Device Performance (Modified VITROS Chemistry Products CI DT Slides)
Intended Use	Must be able to quantitatively measure chloride (Cl⁻) concentration in serum and plasma for in vitro diagnostic use.	No Change (from predicate). Quantitatively measures chloride (Cl⁻) concentration in serum and plasma.
Fundamental Scientific Technology	Must utilize dry, multilayered slide and direct potentiometry.	No Change (from predicate). Utilizes dry, multilayered slide and direct potentiometry.
Reactive Ingredients per cm²	Must have reactive ingredients of Silver 0.4 mg and silver chloride 0.2 mg.	No Change (from predicate). Silver 0.4 mg and silver chloride 0.2 mg.
Other Ingredients	Polymer, plasticizer, surfactant, and nickel.	Polymer, plasticizer, surfactant, and nickel-chromium. (Minor change, justified by performance.)
Sample Type	Must be compatible with serum and plasma.	No Change (from predicate). Compatible with serum and plasma.
Instrumentation	Must be compatible with VITROS DT Chemistry Systems.	No Change (from predicate). Compatible with VITROS DT Chemistry Systems.
Manufacturing Process of the ISE Baseweb	Electron beam evaporation (for Ag/AgCl and Support Layers)	Magnetic sputter deposition (Change in manufacturing process, performance demonstrated equivalent).
Composition of ISE Baseweb Component	Ag/AgCl concentration: Silver 0.4 mg and silver chloride 0.2 mg; Nickel Stripes: Ni (99+% Nickel).	Ag/AgCl concentration: No change; Nickel Stripes: NiCr (80% Nickel, 20% Chromium). (Change in nickel stripe composition, performance demonstrated equivalent).
Overall Performance (Substantial Equivalence)	Performance must be substantially equivalent to the cleared predicate device across the assay range.	Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured chloride values spanning the assay range.

Summary of the Study Proving Acceptance Criteria:

The study was designed to demonstrate "substantial equivalence" of the modified VITROS Chemistry Products CI DT Slides to the previously cleared predicate device. This is a common approach for 510(k) submissions when minor modifications are made to an existing device.

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 chloride values spanning the assay range."
- Specific sample size is not provided in this 510(k) summary. This information would typically be in a more detailed technical report.
- Data Provenance: Not explicitly stated, but clinical samples are implied ("patient samples"). It is common for such studies to use retrospective or prospective samples, often from diverse geographic regions for generalizability, but this summary doesn't specify.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. For in vitro diagnostic (IVD) devices like this, "ground truth" is typically established by reference methods or validated comparative methods, not by human experts interpreting results. The predicate device itself acts as the "gold standard" or reference in a substantial equivalence study. The "ground truth" here is the measured chloride values from patients and quality control samples.
Adjudication method for the test set:
- Not applicable. As stated above, this is an IVD device measuring a chemical analyte. There is no human interpretation or adjudication in the sense of image review or clinical decision-making. The comparison is quantitative between the modified and predicate device results.
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:
- No. This is an in vitro diagnostic (IVD) assay for measuring chloride concentration, not an imaging or AI-assisted diagnostic device that involves human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The "standalone" performance is the direct measurement by the modified chemical assay (VITROS Chemistry Products CI DT Slides) compared to the predicate device. There is no human intervention in the actual measurement process of chloride ions by the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" was established by the measured chloride values obtained from the predicate device (VITROS Chemistry Products CI DT Slide, K912844) and/or a comparable referance method using patient and quality control samples. The aim was to show the modified device produces results comparable to these established measurements.
The sample size for the training set:
- For an IVD device substantial equivalence study, particularly for a modification where the fundamental technology is similar, there isn't typically a "training set" in the machine learning sense. The device is calibrated, and its performance is verified and validated. The calibrators themselves (VITROS Chemistry Products DT Calibrator Kit) are used to establish the measurement curve, but this isn't a "training set" for an algorithm. The summary does not specify details about calibrator lots or usage.
How the ground truth for the training set was established:
- As there isn't a "training set" in the typical ML/AI sense, this question is not directly applicable. The calibrator kit (composed of lyophilized standards with known concentrations) is used to establish the instrument's calibration curve. The values assigned to these calibrators would have been established through a primary reference measurement system or by careful gravimetric/volumetric preparation and verification, ensuring accuracy and traceability.

Summary

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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.

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The assigned 510(k) number is: _082099

1.	Submittername,address,contact	Ortho-Clinical Diagnostics, Inc.100 Indigo Creek DriveRochester, New York 14626-5101(585) 453-4041Contact Person: Marlene A. Hanna
2.	Preparationdate	Date Special 510(k) prepared: July 24, 2008
3.	Devicename	Trade or Proprietary Name:VITROS Chemistry Products CI DT SlidesCommon Name: chloride testClassification Name: Chloride test system (21 CFR 862.1170)VITROS Chemistry Products DT Calibrator KitCommon Name: calibratorClassification Name: Calibrator (21 CFR 862.1150)
4.	Predicatedevice	The VITROS Chemistry Products CI DT Slides (modified) and VITROS ChemistryProducts DT Calibrator Kit are substantially equivalent to the VITROS ChemistryProducts CI DT Slides (current slide: K912844, cleared September 4, 1991) andVITROS Chemistry Products DT Calibrator Kit (Current Kit: K072443, clearedSeptember 24, 2007).

Continued on next page

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510(k) Summary, Continued

The VITROS Chemistry Products CI Slide assay is performed using the VITROS 5. Device Description Chemistry Products Cl DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT Chemistry Systems. The VITROS CI DT 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 CI DT Slide. The slide consists of two ionselective electrodes, each containing a protective laver, a silver laver 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 DT 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 CT 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 chloride ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers and establish equilibrium. Each electrode produces an electrical potential in response to the activity of chloride ions applied to it. The potential difference poised between the two electrodes is proportional to the chloride concentration in the sample. 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 boyine 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 DT Systems and reagents are designed specifically for use with the VITROS Chemistry Products range of products. 6. Device VITROS Chemistry Products Cli DT Slides intended For in vitro diagnostic use only. VITROS CI Slides quantitatively measure chloride use (CI) 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 ALB, ALKP, ALT, AMY, AST, TBIL, NBIL, BUN/CREA, Ca, CHOL, CK, CI, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K , LAC, LDH, LIPA, Mg, Na , NH2, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

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510(k) Summary, Continued

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

VITROS Chemistry Products CI DT Slide: (K912844, cleared September 4, 1991). VITROS Chemistry Products DT Calibrator Kit: (K072443, cleared September 24, 2007).

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

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

DeviceCharacteristic	New DeviceVITROS Chemistry Products CI DT Slide(Modified)	Predicate DeviceVITROS Chemistry Products CI DT Slide(Current)
Intended Use	No Change.	For in vitro diagnostic use only.VITROS CI DT Slides quantitatively measurechloride (Cl⁻) concentration in serum and plasma.
Fundamentalscientifictechnology	No Change.	Dry, multilayered slide utilizing directpotentiometry
ReactiveIngredients percm²	No Change.	Silver 0.4 mg and silver chloride 0.2 mg
Other Ingredients	Polymer, plasticizer, surfactant, and nickel-chromium.	Polymer, plasticizer, surfactant, and nickel.
Sample type	No Change.	Serum, plasma
Instrumentation	No Change.	VITROS DT Chemistry Systems.
ManufacturingProcess of the ISEbaseweb*(Ag/AgCl andSupport Layers ofthe Cl⁻ DT Slide)	Magnetic sputter deposition	Electron beam evaporation
Composition ofISE basewebcomponent	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)

*|SE (Ion-Sclective Electrode) basewcb= Polyethylene tercphthalate film (substrate used for metallized film) oaated 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 CIT DT Slide.

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

Continued on next page

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510(k) Summary, Continued

Conclusions The information presented in the premarket notification demonstrates that the performance of the VITROS Chemistry Products CI 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 chloride values spanning the assay range.

The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products CI 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/4/Picture/1 description: The image shows a circular seal with an emblem in the center. The emblem consists of three stylized, curved lines that resemble a bird in flight. The text around the perimeter of the circle is difficult to read due to the image's resolution, but it appears to be the name of an organization or agency. The seal is black and white.

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 Dr. Rochester, NY 14626

AUG 2 1 2008

Re: K082099

Trade/Device Name: VITROS Chemistry Products Cl- DT Slides, VITROS Chemistry Products DT Calibrator Kit Regulation Number: 21 CFR 862.1170 Regulation Name: Chloride test system Regulatory Class: Class II Product Code: CGZ, JIX Dated: July 24, 2008 Received: July 25, 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 toll-free mumber (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): K082099

Device Name: VITROS Chemistry Products Cl- DT Slides

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

Device Name: VITROS Chemistry Products DT Calibrator Kit

Indication For Use: 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.

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

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082099

Page 1 of 1

Regulation Number and Section

§ 862.1170 Chloride test system.

(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.