Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge: The CO2 method is an in vitro diagnostic test for the quantitative measurement of carbon dioxide in human serum and plasma on the Dimension Vista 100 System. The Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge is a device intended to measure carbon dioxide in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Dimension VistaTM Creatinine (CREA) Flex® reagent cartridge: The CREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista 100 System. The Dimension Vista™ Creatinine (CREA) Flex® reagent cartridge is a device intended to measure creatinine levels in serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge: The LDH method is an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista 100 System. The Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum and plasma. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

Device Description

Dade Behring Dimension Vista™ Flex® reagent cartridges are prepackaged in-vitro diagnostic test methods (assays) that are specifically designed to be used on the Dade Behring Dimension Vista™ Integrated system, a floor model, fully automated, microprocessor-controlled, integrated instrument system. The Dimension Vista™ system was previously cleared with seven associated test methods (K 051087).

This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic devices that have been cleared under the 510(k) process for use on Dimension® clinical chemistry systems. The packaging change is to allow use on the Dimension Vista™ system.

The CO2. CREA, and LDH reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modification, does not affect the intended use of the devices, nor does it alter the fundamental scientific technology of the devices.

AI/ML Overview

The provided 510(k) summary for K061238 describes the clearance of three reagent cartridges (CO2, CREA, and LDH) for the Dade Behring Dimension Vista™ system. This is a "Special 510(k)" submission, which is used for modifications to existing devices where the fundamental scientific technology and intended use remain unchanged. In this case, the modification is a packaging change to allow the use of pre-existing, cleared reagents on a new instrument system (Dimension Vista™).

Because this is a packaging modification for reagents already cleared on other Dimension® systems, the "acceptance criteria" and "device performance" in the traditional sense of a diagnostic algorithm's accuracy are not explicitly detailed in terms of sensitivity, specificity, or AUC. Instead, the focus is on demonstrating substantive equivalence in performance between the new packaging/instrument combination and the previously cleared predicate devices when using the same reagents.

The study described is a comparative testing study to demonstrate equivalent performance.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" in the format of thresholds for sensitivity, specificity, or similar metrics for a diagnostic device that performs classification or detection. Instead, the acceptance criterion for this packaging modification submission is "equivalent performance" to the predicate device.

The "device performance" reported is that the comparative testing "demonstrates equivalent performance" and "substantially equivalent performance". This implies that the results obtained using the Dimension Vista™ with the new Flex® reagent cartridges for CO2, CREA, and LDH are comparable to those obtained with the predicate Dimension® systems using the same reagents.

Acceptance Criterion (Implied)	Reported Device Performance (Implied)
Equivalent performance to predicate devices	Comparative testing demonstrates equivalent performance.
Substantive Equivalence	Substantially equivalent in design, principle, and performance.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Comparative testing described in the protocol included in this submission demonstrates equivalent performance." However, it does not provide any details regarding:

The specific sample size used for the comparative testing.
The data provenance (e.g., country of origin, retrospective or prospective nature of the samples).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable or not provided in this 510(k) summary. For a submission focused on equivalent analytical performance of clinical chemistry reagents, ground truth is typically assessed against established reference methods or by comparing results from the test device to the predicate device using patient samples or quality control materials. It does not involve expert readers establishing ground truth for diagnostic images or complex interpretations.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., radiology studies) to resolve discrepancies in expert opinions. This submission is for analytical chemistry reagents.

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 assesses how human readers' performance improves with or without AI assistance, which is irrelevant for a submission concerning in-vitro diagnostic reagents.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This submission is for IVD reagents used on an automated analyzer. The "standalone" performance here refers to the analytical performance of the combined reagent/instrument system. The document confirms that "Comparative testing...demonstrates equivalent performance," which implies the system's standalone analytical performance was evaluated against the predicate system. However, it's not an "algorithm-only" performance in the sense of AI.

7. The Type of Ground Truth Used

The "ground truth" for this type of submission is typically established by:

Comparison to a legally marketed predicate device: The results from the new device are compared to those obtained from the predicate device using the same patient samples. Equivalence would be demonstrated through statistical methods (e.g., method comparison studies, regression analysis, bias analysis).
Spiked samples or reference materials: To assess accuracy and linearity across the measuring range.

The summary states, "Comparative testing also demonstrates substantially equivalent performance," which strongly implies comparison to the predicate device using relevant samples.

8. The Sample Size for the Training Set

This information is not applicable or not provided. This submission is for IVD reagents, not a machine learning algorithm that requires a training set. The reagents themselves don't "learn" from data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As stated above, this is not an AI/machine learning device that requires a training set and associated ground truth.

Summary

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K061238

510(k) Summary of Safety and Effectiveness Information

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.

Submitter's Name:	Lorraine H PiestrakDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101	MAY 2 5 2006
Date of Preparation:	May 2, 2005
Name of Product:	Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridgeDimension Vista™ Creatinine (CREA) Flex® reagent cartridgeDimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge
FDA Classification Name:	Methods (Class II); Bicarbonate/Carbon Dioxide,Creatinine, Lactate dehydrogenase test systems

Predicate Device:

The following table describes the predicate devices, device classification, regulation and product code associated with this pre-market notification:

New Product	Predicate	Predicate510(k) #	Deviceclass	Regulation	ProductCode
Dimension Vista™ CO2 Flex® reagent cartridge	Dimension® ECO2 Flex® reagent cartridge	K010206	II	862.1160	KHS
Dimension Vista™ CREA Flex® reagent cartridge	Dimension® CREA Flex® reagent cartridge	K925668	II	862.1125	CGX
Dimension Vista™ LDH Flex® reagent cartridge	Dimension® LDH Flex® reagent cartridge	K860021	II	862.1440*	CFJ

Not exempt from premarket notification per 862.9(c)(3)

Device Description:

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Intended Use:

Comparison to Predicate Device:

Both the Dimension Vista™ Flex® reagent cartridges and the predicate Dimension® Flex® reagent cartridges contain prepackaged reagents in flexible plastic, cartridges. A comparison of the important similarities and differences between the two Flex® cartridges is provided in the following table:

Feature	Dimension Vista™Flex® reagent cartridge	Dimension® AnalyzerFlex® reagent cartridge
Reagents	Prepackaged, 12-well plastic, DadeBehring Flex® reagent cartridges	Prepackaged, 6 & 8 well plastic, DadeBehring Flex® reagent cartridges
Intended Use	in vitro diagnostic use	in vitro diagnostic use
Indications for Use	Same as Dimension® analyzer	As described in 510(k)s for eachpreviously cleared method.
Final concentrationof sample/reagentratio in test milieu	Same as Dimension® analyzer	As described in 510(k)s for eachpreviously cleared method
Tablet Sizes	7/32"	7/32" & 9/32"
Total tests containedin each Flex®cartridge	Approximately three times morethan contained in Dimension®Flex® reagent cartridges	As described in 510(k)s for eachpreviously cleared method.
Calibration	30 to 90 days(determined for each method)	30 to 90 daysAs described in 510(k)s for eachpreviously cleared method.

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Comments on Substantial Equivalence:

The Dade Behring Dimension Vista™ Flex® reagent cartridges and the Dimension® Flex® reagent cartridges are designed similarly for the same purpose. Both contain prepackaged reagents for in-vitro diagnostic tests that are processed on microprocessorcontrolled, integrated instrument systems to analyze a variety of analytes in human specimens.

The CO2, CREA, and LDH reagents contained in the Dimension Vista™ Flex® reagent cartridges are the same as those contained in the Flex® reagent cartridges manufactured for the Dimension® clinical chemistry systems, another family of Dade Behring analyzers. The packaging modifications, do not affect the intended use of the devices, nor do they alter the fundamental scientific technology of the devices.

Comparative testing described in the protocol included in this submission demonstrates equivalent performance.

Conclusion:

The Flex® reagent cartridges, containing reagents for testing CO2, CREA, and LDH on the Dimension® Vista™ Integrated system are substantially equivalent in design, principle, and performance to the Dimension® system Flex® reagent cartridges. They have the same intended use and indications for use. Comparative testing also demonstrates substantially equivalent performance.

Lorraine H Piestrak Regulatory Affairs & Compliance Manager May 2, 2006

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

MAY 2 5 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lorraine H. Piestrak Regulatory Affairs & Compliance Manager Dade Behring, Inc. PO Box 6101, M/S 514 Newark, DE 19714-6101

K061238 Re:

Trade/Device Name: Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge Dimension Vista™ Creatinine (CREA) Flex® reagent cartridge Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge Regulation Number: 21 CFR§862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: Class II Product Code: KHS, CGX, CFJ Dated: May 2, 2006 Received: May 3, 2006

Dear Ms. Piestrak:

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 (OS) 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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Alberto G.

Alberto Gutierrez, Ph.D. 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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Indications for Use

510(k) Number (if known): K061238

Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Carbon Dioxide (CO2) Flex® reagent cartridge is a device intended to measure carbon dioxide in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

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

Over-The-Counter Use (21 CFR 801)

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

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

Division Sign Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

5100k061238

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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Indications for Use

510(k) Number (if known): K061238

Dimension Vista™ Creatinine (CREA) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Creatinine (CREA) Flex® reagent cartridge is a device intended to measure creatinine levels in serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

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

Over-The-Counter Use (21 CFR 801)

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

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

Page 1 of 1

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

100(k) /K061238

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Indications for Use

510(k) Number (if known): | K061238

Device Name: Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Lactate dehydrogenase (LDH) Flex® reagent cartridge is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum and plasma. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

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

Over-The-Counter Use (21 CFR 801)

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

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

Page I of

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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.