K Number

Device Name

VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;

Manufacturer

Ortho-Clinical Diagnostics, Inc.

Date Cleared

2010-04-15

(143 days)

Product Code

KHS

Regulation Number

862.1160

Intended Use

VITROS Chemistry Products CO2 DT Slides quantitatively measure carbon dioxide (CO2) concentration in serum and plasma using VITROS DT60 and DT60 II Chemistry Systems. Total carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acidbase balance. For in vitro diagnostic use only.

Device Description

The VITROS Chemistry Products CO2 DT Slide assay is performed using the VITROS Chemistry Products CO2DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/DT60 II Chemistry Systems. The VITROS CO2 DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of jonic carbon dioxide. All reactions necessary for a single quantitative measurement of carbon dioxide take place within the multi-layered analytical element of a VITROS Chemistry Products CO2 DT Slide. The slide consists of two ion-selective electrodes, each containing a buffer layer, an ion-selective membrane layer, a reference layer, and silver and a silver chloride layer coated on a polvester support. VITROS Chemistry Products CO2 DT Slides use ion-selective electrodes for potentiometric measurements of ionic carbon dioxide. Ionic carbon dioxide 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 CO2 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 carbon dioxide ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers 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 carbon dioxide ions in the respective fluids to produce a potential for the concentration cell. The VITROS DT60/DT60II Chemistry System's microprocessor uses this measurement and the stored calibration parameters to determine the concentration value of the carbon dioxide 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/ DT60 II Chemistry System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K802376, K091861, kk811257, K001133

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a chemical assay using ion-selective electrodes and a microprocessor for calculation based on stored calibration parameters. There is no mention of AI or ML in the description of the technology or the performance studies.

Therapeutic

No
The device is an in vitro diagnostic (IVD) product used to measure carbon dioxide in serum and plasma, which aids in diagnosis and treatment monitoring but does not directly provide therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "Total carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. For in vitro diagnostic use only." This clearly indicates its role in diagnosing conditions.

SaMD (Software as a Medical Device)

The device description clearly details physical components (slides, calibrator kit) and a chemistry system (VITROS DT60/DT60 II) that are essential for the device's function. It is not solely software.

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."
Purpose: The device is intended to "quantitatively measure carbon dioxide (CO2) concentration in serum and plasma." This is a measurement performed on biological samples outside of the body.
Clinical Use: The measurements are used "in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acidbase balance." This indicates a clinical diagnostic purpose.
Device Description: The description details how the device analyzes biological samples (serum and plasma) using chemical reactions and electrochemical measurements to determine the concentration of an analyte (CO2).

All of these points align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

KHS

Device Description

VITROS Chemistry Products CO2 DT Slides use ion-selective electrodes for potentiometric measurements of ionic carbon dioxide. Ionic carbon dioxide 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 CO2 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 carbon dioxide ions in the tested reference and sample fluids migrate to the silver/ silver chloride layers 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 carbon dioxide ions in the respective fluids to produce a potential for the concentration cell. The VITROS DT60/DT60II Chemistry System's microprocessor uses this measurement and the stored calibration parameters to determine the concentration value of the carbon dioxide 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/ DT60 II Chemistry 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 carbon dioxide 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.

K802376, K091861, kk811257, K001133

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

§ 862.1160 Bicarbonate/carbon dioxide test system.

(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.

Summary

Summary Information

APR 1 5 2010

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: _ K 0934 / /

1. Submitter Ortho-Clinical Diagnostics, Inc. name. l 00 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 Traditional 510(k) prepared: November 20, 2009 Preparation date
1. Device Trade or Proprietary Name: name VITROS Chemistry Products CO2 DT Slides Common Name: Bicarbonate/ carbon dioxide test Classification Name: Bicarbonate/ carbon dioxide test system (21 CFR 862.1160)

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

1. Predicate The VITROS Chemistry Products CO2 DT Slides (modified) and VITROS Chemistry device Products DT Calibrator Kit are substantially equivalent to the VITROS Chemistry Products CO2 DT Slides (current slide) and VITROS Chemistry Products DT Calibrator Kit. The FDA cleared the VITROS Chemistry Products CO2DT Slides on October 23, 1980 (K802376) under the product name Kodak EKTACHEM DT Clinical Chemistry Slides (CO2). With the purchase of KODAK Clinical Products Division by Johnson and Johnson, the product branding was revised to VITROS Chemistry Products CO2 DT Slides. The most recent FDA clearance for the VITROS Chemistry Products DT Calibrator Kit was September 3, 2009 (K091861). Additional predicate devices for the VITROS CO2 DT assay are the Corning 965 carbon dioxide analyzer (kk811257, cleared 5/27/81) and the VITROS Chemistry Products ECO2 assay (K001133, cleared 4/24/00).
  VITROS Chemistry Products CO2 DT Slides VITROS Chemistry Products DT Calibrator Kit 510(k) Summary

Continued on next page

510(k) Summary, Continued

.5. Device Description The VITROS Chemistry Products CO2 DT Slide assay is performed using the VITROS Chemistry Products CO2DT Slide and the VITROS Chemistry Products DT Calibrator Kit on the VITROS DT60/DT60 II Chemistry Systems. The VITROS CO2 DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of jonic carbon dioxide. All reactions necessary for a single quantitative measurement of carbon dioxide take place within the multi-layered analytical element of a VITROS Chemistry Products CO2 DT Slide. The slide consists of two ion-selective electrodes, each containing a buffer layer, an ion-selective membrane layer, a reference layer, and silver and a silver chloride layer coated on a polvester support.

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

Device VITROS Chemistry Products CO2 DT Slides intended For in vitro diagnostic use only. VITROS CO2 DT Slides quantitatively measure carbon dioxide (CO2) concentration in serum and plasma. use

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.

Continued on next page

.
.

510(k) Summary, Continued

Comparison The VITROS Chemistry Products CO2 DT Slide (modified) and VITROS Chemistry to predicate Products DT Calibrator Kit are substantially equivalent to VITROS Chemistry Products CO2 DT Slide and VITROS Chemistry Products DT Calibrator Kit, which device were Cleared by the FDA for in vitro diagnostic use.

VITROS Chemistry Products CO2 DT Slide: (K802376, cleared October 23, 1980) VITROS Chemistry Products DT Calibrator Kit :( K091861 cleared September 3, 2009).

Table 1 lists the characteristics of the tests performed using the VITROS CO2 DT Slide (modified) and the VITROS CO2 DT Slide (current).

Table 1. VITROS Chemistry Products CO2 DT Slide Characteristics: Comparison to Predicate Device

| Device
Characteristic | New Device
VITROS Chemistry Products CO₂ DT
Slide
(Modified) | Predicate Device
VITROS Chemistry Products CO₂ DT
Slide
(Current) |
|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use . | No Change. | For in vitro diagnostic use only.
VITROS CO₂ DT Slides quantitatively measure
carbon dioxide (CO₂) concentration in serum and
plasma. |
| Fundamental scientific
technology | No Change. | Dry, multilayered slide utilizing direct
potentiometry |
| Reactive Ingredients
per cm² | No Change. | Silver 0.4 mg; silver chloride 0.2 mg; sodium
chloride 0.2 mg; potassium chloride 63 µg;
trioctylpropylammonium chloride 0.5 mg; and
decyltrifluoroacetophenone 0.8 mg. |
| Sample type | No Change. | Serum, plasma |
| Instrumentation | No Change. | VITROS DT Systems |
| Manufacturing Process
of the ISE baseweb*
(Ag/AgCl and Support
Layers of the Na+ DT
Slide) | Magnetic sputter deposition | Electron beam evaporation |
| 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) |

*ISE (Ion-Selective Electrode) baseweb= Polyethyiene terephthalate film (substrate used for metallized film) coated with silver (Ag)/ silver chloride (Ag/C)) 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 CO2 DT Slide.

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

Continued on next page

510(k) Summary, Continued

The information presented in the premarket notification demonstrates that the 8. Conclusions performance of the VITROS Chemistry Products CO2 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 carbon dioxide values spanning the assay range.

The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products CO2 DT Slides (modified) for use with human serum and plasma is safe and effective for the stated intended use.

Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three overlapping wings, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

APR 1 5 2010

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

Re: K093611

Trade Name: Vitros Chemistry Products CO2 DT Slides

' - Regulation Number: 21 CFR §862.1160

Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Codes: KHS Dated: April 7, 2010 Received: April 8, 2010

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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,

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Indication for Use

510(k) Number (if known): K 093611

Device Name: VITROS Chemistry Products CO2 DT Slides

Indications for Use: VITROS Chemistry Products CO2 DT Slides quantitatively measure carbon dioxide (CO2) concentration in serum and plasma using VITROS DT60 and DT60 II Chemistry Systems. Total carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acidbase balance. For in vitro diagnostic use only.

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)

Carol Benson

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

510(k) K093611