(225 days)
For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides 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 numerous potentially serious disorders associated with changes in body acid-base balance.
The VITROS ECO2 assay is performed using the VITROS Chemistry Products ECO2 Slides and the VITROS Chemistry Products Calibrator Kit 2 on the VITROS Chemistry Systems. The VITROS ECO2 Slide is a multi-layered, analytical element coated on a polyester support. The method is based on an enzymatic detection. All reactions necessary for a single quantitative measurement of CO2 take place within the multi-layered analytical element of a VITROS Chemistry Products ECO2 Slide. A drop of sample fluid is metered onto the slide and a reaction occurs which ultimately results in a reduction of NADH. The concentration of CO2 in the sample is determined by measuring the absorbance of the unreacted NADH by reflectance spectrophotometry.
Here's a breakdown of the acceptance criteria and study details for the VITROS Chemistry Products ECO2 Slides, based on the provided 510(k) summary (K120763):
Device Overview:
This 510(k) submission is for a modified version of the VITROS Chemistry Products ECO2 Slides. The primary modification is a change in the biological source of Phosphoenolpyruvate carboxylase (PEPC) from wheat germ to a microorganism, aiming to improve enzyme solution stability during manufacturing. The device measures total carbon dioxide (CO2) concentration in serum and plasma using various VITROS Chemistry Systems.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly detailed as numerical ranges in the provided text, but rather described through the types of performance characteristics evaluated and the overarching conclusion that the modified device "met the pre-determined acceptance criteria for all the performance testing."
The performance characteristics considered for potential hazards and subsequently validated are:
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy | Not explicitly stated (e.g., specific bias, error margin) | "met the pre-determined acceptance criteria" |
| Precision | Not explicitly stated (e.g., specific CV%) | "met the pre-determined acceptance criteria" |
| Linearity | Not explicitly stated (e.g., correlation coefficient) | "met the pre-determined acceptance criteria" |
| Potential Interferents | Not explicitly stated (e.g., no significant interference from common substances) | "met the pre-determined acceptance criteria" |
| Long Term Stability | Not explicitly stated (e.g., maintaining performance over specified shelf life) | "met the pre-determined acceptance criteria" |
| On-Analyzer Stability | Not explicitly stated (e.g., maintaining performance during use on the analyzer) | "met the pre-determined acceptance criteria" |
| Limit of Detection | Not explicitly stated (e.g., specific lower detection limit) | "met the pre-determined acceptance criteria" |
| Specimen Type | Valid performance for serum and plasma | "met the pre-determined acceptance criteria" |
Overall Conclusion regarding Acceptance Criteria: The document states, "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."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes used for the validation and verification testing (test set). It only states that "Validation and verification testing were conducted."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that this is a 510(k) summary for a diagnostic device, it is typically expected that studies would be conducted in a controlled laboratory setting, likely in the country of the manufacturer (USA, as inferred from the Rochester, NY address).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of medical device submission. This device is an in vitro diagnostic (IVD) chemistry product, not an imaging or AI-based diagnostic tool requiring expert interpretation of results. The "ground truth" for a CO2 measurement device is established through reference methods and calibrated instruments, not subjective expert consensus.
4. Adjudication Method for the Test Set
This is not applicable as it's an IVD chemistry product, not an imaging or qualitative diagnostic requiring adjudication of human interpretations. The "adjudication" is inherent in the analytical methods and instrument calibration.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered devices where human readers' performance with and without AI assistance is being evaluated. This 510(k) is for a modification to a chemistry diagnostic slide.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A (Not Applicable in the traditional sense of an "algorithm"). This is a chemical assay, not a standalone algorithm. The "performance" is the analytical performance of the device itself (slide and chemistry system) in measuring CO2 concentrations accurately and precisely. The studies conducted (accuracy, precision, linearity, etc.) assess the standalone analytical performance of the modified product.
7. The Type of Ground Truth Used
The ground truth for this device would be established through:
- Reference Methods: Highly accurate and precise analytical methods for CO2 measurement, often traceable to international standards.
- Calibrated Materials: Certified reference materials or calibrators with known CO2 concentrations.
- Comparison to Predicate Device: A key aspect of a Special 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. This implies that the performance of the modified device is compared against the established performance of the predicate.
The document states, "The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products ECO₂ Slides (modified)... is substantially equivalent to the predicate (unmodified VITROS ECO2 Slide) and is safe and effective for the stated intended use."
8. The Sample Size for the Training Set
This is not applicable to this type of device. The VITROS Chemistry Products ECO2 Slides utilize enzymatic reactions for detection, not a machine learning model that requires a "training set" in the computational sense. The "training" for such a product involves optimizing the chemical formulation and manufacturing process, which is distinct from data-driven AI model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as #8. The "ground truth" for developing this chemical assay would be based on fundamental chemistry principles, enzyme kinetics, and analytical performance characteristics measured through laboratory experiments, not a data-labeling process for a training set.
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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 DriveRochester, New York 14626 | |
| Phone number | (585) 453-3962 | |
| Fax number | (585) 453-3368 | |
| EstablishmentRegistration Number | 1319809 | |
| Name of contactperson | Gaozhen Hang | |
| Date prepared | March 12, 2012 | |
| Name of device | ||
| Trade or proprietaryname | VITROS Chemistry Products ECO2 Slides | |
| Common or usualname | Carbon Dioxide Test | |
| Classification name | Bicarbonate/ carbon dioxide test system | |
| Classification panel | Clinical Chemistry | |
| Regulation | 21 CFR 862.1160 | |
| Product Code(s) | KHS | |
| Legally marketeddevice(s) to whichequivalence is claimed | The VITROS Chemistry Products ECO2 Slides (modified) aresubstantially equivalent to the VITROS Chemistry Products ECO2Slides (current). The FDA cleared the VITROS Chemistry ProductsECO2 Slides on April 24, 2000 (K001133). | |
| Reason for 510(k)submission | A Special 510(k) for a modification to own device which does notinclude a change in intended use or fundamental technology. Thebiological source of Phosphoenolpyruvate carboxylase (PEPC), one ofthe reactive ingredients used in the VITROS Chemistry ProductsECO2 Slides is being changing from wheat germ to a microorganism.This change provides improved stability of enzyme solution whilebeing used in the manufacture process. | |
| Device description | The VITROS ECO2 assay is performed using the VITROS ChemistryProducts ECO2 Slides and the VITROS Chemistry Products CalibratorKit 2 on the VITROS Chemistry Systems. The VITROS ECO2 Slide is amulti-layered, analytical element coated on a polyester support. Themethod is based on an enzymatic detection. All reactions necessary fora single quantitative measurement of CO2 take place within the multi-layered analytical element of a VITROS Chemistry Products ECO2Slide. A drop of sample fluid is metered onto the slide and a reactionoccurs which ultimately results in a reduction of NADH. Theconcentration of CO2 in the sample is determined by measuring theabsorbance of the unreacted NADH by reflectance spectrophotometry. | |
| Intended use of thedevice | For in vitro diagnostic use only.VITROS Chemistry Products ECO2 Slides quantitatively measure totalcarbon dioxide (CO2) concentration in serum and plasma usingVITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and theVITROS 5600 Integrated System. | |
| Indications for use | For in vitro diagnostic use only. VITROS Chemistry Products ECO₂Slides quantitatively measure total carbon dioxide (CO2) concentrationin serum and plasma using VITROS 250/350/950/5,1 FS, and 4600Chemistry Systems and the VITROS 5600 Integrated System.Bicarbonate/carbon dioxide measurements are used in the diagnosisand treatment of numerous potentially serious disorders associatedwith changes in body acid-base balance. | |
| Summary of the technological characteristics of the device compared to the predicate device | ||
| Characteristic | New Device [VITROS ECO2Slide (Modified)] | Predicate [VITROS ECO2 Slide(Current) [K001133] |
| Intended Use | No Change | For in vitro diagnostic use only.VITROS Chemistry Products ECO2Slides quantitatively measure totalcarbon dioxide (CO2) concentration inserum and plasma using VITROS250/350/950/5,1 FS, and 4600Chemistry Systems and the VITROS5600 Integrated System. |
| Basic Principle | No Change | Enzymatic Endpoint test type utilizingreflectance spectrophotometry |
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| Concentrations of VITROSECO2 Slide ReactiveIngredients per cm-squared | Phosphoenolpyruvatecarboxylase(microorganism E.C.4.1.1.31) 0.20 U | Phosphoenolpyruvate carboxylase(wheat germ E.C. 4.1.1.31) 0.20 U |
|---|---|---|
| No Change | Malate dehydrogennase (porcine heartE.C.1.1.1.37) 0.26 U;phosphoenolpyruvate 0.39 mg andnicotinamide adenine dinucleotide,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 andtemperature | 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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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of two main elements: a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter, and a stylized symbol of a human figure. The human figure is composed of three overlapping profiles facing to the right, representing the department's focus on people and their well-being. The seal and the figure are both rendered in black.
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 (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) 796-576-. 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 (301) 796-5680 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
Page 1 of _1
§ 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.