VITROS CHEMISTRY PRODUCTS ECO2 SLIDES

K120765 · Ortho-Clinical Diagnostics, Inc. · KHS · Oct 24, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120765
• Device Name: VITROS CHEMISTRY PRODUCTS ECO2 SLIDES
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: KHS · Clinical Chemistry
• Decision Date: Oct 24, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1160
• Device Class: Class 2

Intended Use

The VITROS Chemistry Products ECO₂ Slides are intended for the quantitative measurement of carbon dioxide (CO₂) in serum and plasma.

Device Story

VITROS Chemistry Products ECO₂ Slides; in vitro diagnostic reagent slides for quantitative CO₂ measurement in serum/plasma. Modification involves changing biological source of phosphoenolpyruvate carboxylase (PEPC) from wheat germ to microorganism to improve enzyme stability during manufacturing. Device operates via enzymatic reaction on slide; intended for use in clinical laboratory settings by trained personnel. Output is quantitative CO₂ concentration. Modification does not alter fundamental scientific technology, reagent storage, or stability claims compared to predicate.

Clinical Evidence

No clinical data. Bench testing only. Validation included hazard analysis, accuracy, precision, linearity, potential interferents, long-term and on-analyzer stability, and limit of detection. The modified device met all pre-determined acceptance criteria.

Technological Characteristics

Multi-layered analytical element on polyester support. Enzymatic detection principle using Phosphoenolpyruvate carboxylase (microorganism-derived), Malate dehydrogenase, phosphoenolpyruvate, and NADH. Reflectance spectrophotometry measurement. Designed for use on VITROS 250/350/950/5,1 FS, 4600, and 5600 systems. No software algorithm described; device relies on system-level reflectance measurement.

Indications for Use

Indicated for quantitative measurement of carbon dioxide (CO₂) in serum and plasma for clinical diagnostic purposes.

Regulatory Classification

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.

Predicate Devices

• VITROS Chemistry Products ECO₂ Slides (k001133)

Submission Summary (Full Text)

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k120763

## 510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

| Submitter Information | | |
|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Ortho-Clinical Diagnostics, Inc. | |
| Address | 100 Indigo Creek Drive<br>Rochester, New York 14626 | |
| Phone number | [phone] | |
| Fax number | [phone] | |
| Establishment<br>Registration Number | 1319809 | |
| Name of contact<br>person | Gaozhen Hang | |
| Date prepared | March 12, 2012 | |
| Name of device | | |
| Trade or proprietary<br>name | VITROS Chemistry Products ECO2 Slides | |
| Common or usual<br>name | Carbon Dioxide Test | |
| Classification name | Bicarbonate/ carbon dioxide test system | |
| Classification panel | Clinical Chemistry | |
| Regulation | 21 CFR 862.1160 | |
| Product Code(s) | KHS | |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | The VITROS Chemistry Products ECO2 Slides (modified) are<br>substantially equivalent to the VITROS Chemistry Products ECO2<br>Slides (current). The FDA cleared the VITROS Chemistry Products<br>ECO2 Slides on April 24, 2000 (K001133). | |
| Reason for 510(k)<br>submission | A Special 510(k) for a modification to own device which does not<br>include a change in intended use or fundamental technology. The<br>biological source of Phosphoenolpyruvate carboxylase (PEPC), one of<br>the reactive ingredients used in the VITROS Chemistry Products<br>ECO2 Slides is being changing from wheat germ to a microorganism.<br>This change provides improved stability of enzyme solution while<br>being used in the manufacture process. | |
| Device description | The VITROS ECO2 assay is performed using the VITROS Chemistry<br>Products ECO2 Slides and the VITROS Chemistry Products Calibrator<br>Kit 2 on the VITROS Chemistry Systems. The VITROS ECO2 Slide is a<br>multi-layered, analytical element coated on a polyester support. The<br>method is based on an enzymatic detection. All reactions necessary for<br>a single quantitative measurement of CO2 take place within the multi-<br>layered analytical element of a VITROS Chemistry Products ECO2<br>Slide. A drop of sample fluid is metered onto the slide and a reaction<br>occurs which ultimately results in a reduction of NADH. The<br>concentration of CO2 in the sample is determined by measuring the<br>absorbance of the unreacted NADH by reflectance spectrophotometry. | |
| Intended use of the<br>device | For <i>in vitro</i> diagnostic use only.<br>VITROS Chemistry Products ECO2 Slides quantitatively measure total<br>carbon dioxide (CO2) concentration in serum and plasma using<br>VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the<br>VITROS 5600 Integrated System. | |
| Indications for use | For <i>in vitro</i> diagnostic use only. VITROS Chemistry Products ECO₂<br>Slides quantitatively measure total carbon dioxide (CO2) concentration<br>in serum and plasma using VITROS 250/350/950/5,1 FS, and 4600<br>Chemistry Systems and the VITROS 5600 Integrated System.<br>Bicarbonate/carbon dioxide measurements are used in the diagnosis<br>and treatment of numerous potentially serious disorders associated<br>with changes in body acid-base balance. | |
| | Summary of the technological characteristics of the device compared to the predicate device | |
| Characteristic | New Device [VITROS ECO2<br>Slide (Modified)] | Predicate [VITROS ECO2 Slide<br>(Current) [K001133] |
| Intended Use | No Change | For <i>in vitro</i> diagnostic use only.<br>VITROS Chemistry Products ECO2<br>Slides quantitatively measure total<br>carbon dioxide (CO2) concentration in<br>serum and plasma using VITROS<br>250/350/950/5,1 FS, and 4600<br>Chemistry Systems and the VITROS<br>5600 Integrated System. |
| Basic Principle | No Change | Enzymatic Endpoint test type utilizing<br>reflectance spectrophotometry |

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| Concentrations of VITROS<br>ECO2 Slide Reactive<br>Ingredients per cm-squared | Phosphoenolpyruvate<br>carboxylase<br>(microorganism E.C.<br>4.1.1.31) 0.20 U | Phosphoenolpyruvate carboxylase<br>(wheat germ E.C. 4.1.1.31) 0.20 U |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | No Change | Malate dehydrogennase (porcine heart<br>E.C.1.1.1.37) 0.26 U;<br>phosphoenolpyruvate 0.39 mg and<br>nicotinamide adenine dinucleotide,<br>reduced 0.44 mg |
| Sample volume | No Change | 6 µL |
| Sample type | No Change | Serum, plasma |
| Assay Range Serum, Plasma | No Change | 5.0-40.0 mmol/L |
| Incubation time and<br>temperature | No Change | 5 minutes at 37°C |

Summary of design control activities conducted in relation to the device modification

The Ortho-Clinical Diagnostics, Inc. procedure for risk management is based on ISO 14971, Medical Devices - Application of Risk Management to Medical Devices and references CDRH Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management. The risk analysis method used to assess the impact of the device modification was a Hazard Analysis. The following performance characteristics: accuracy, precision, linearity, potential interferents, long term and on-analyzer stability, limit of detection and specimen type were considered for potential hazards. Validation and verification testing were conducted and the modified device met the pre-determined acceptance criteria for all the performance testing.The modification does not negatively impact the performance of the device or the safety and effectiveness of the device.

## CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products ECO₂ Slides (modified) for use with human serum and plasma is substantially equivalent to the predicate (unmodified VITROS ECO2 Slide) and is safe and effective for the stated intended use.

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10903 New Hampshire Avenue Silver Spring, MD 20993

Ortho-Clinical Diagnostics, Inc c/o Gaozhen Hang 100 Indigo Creek Drive Rochester, NY 14626-5101

Re: k120765

Trade Name: VITROS® Chemistry Products ECO2 Slides Regulation Number: 21 CFR §862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Codes: KHS Dated: September 27, 2012 Received: October 1, 2012

Dear Ms. Hang:

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).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you atent office of In Vitro Diagnostic Devices and Radiological Health at [phone]. 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) 796-576-. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical Devices/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 [phone] or at its Internet address http://www.fda/gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: VITROS® Chemistry Products ECO2 Slides

Indications for Use:

For in vitro diagnostic use only. VITROS Chemistry Products ECO2> Siides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of Dical buildle/carbon "disorders associated with changes in body acid-base balance.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Rute Chuler

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

510(k) K120765

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