The Dimension Vista™ Ammonia (AMON) Flex® reagent cartridge is an in vitro device intended to measure ammonia levels in plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

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 (K051087). This Special 510(k) is submitted for a packaging modification to the Dimension® Ammonia (AMON) Flex® reagent cartridge (K863840), an in-vitro diagnostic device that has been cleared under the 510(k) process. The packaging change is to allow use on the Dimension Vista™ system.

The reagents contained in the Dimension Vista™ Ammonia (AMON) Flex® reagent cartridges are the same as those contained in the Ammonia (AMON) 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 device, nor does it alter the fundamental scientific technology of the device.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Dimension Vista™ Ammonia (AMON) Flex® reagent cartridge). It focuses on establishing substantial equivalence to a predicate device, rather than presenting a standalone study with detailed acceptance criteria and performance data for a new device.

Therefore, much of the requested information cannot be found in the provided text. The document is about a packaging change for an already cleared device, allowing it to be used on a new instrument system. The "study" mentioned is comparative testing to demonstrate substantially equivalent performance to the predicate device.

However, I can extract what is available:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for performance as it's a submission for a packaging change and not a new diagnostic algorithm. The primary "criterion" for this submission is substantial equivalence to the predicate device.

Feature	Acceptance Criterion (Implied for Substantial Equivalence)	Reported Device Performance (Dimension Vista™ AMON Flex®)
Reagents	Same as predicate	Same reagents as Dimension® AMON Flex® reagent cartridge
Intended Use	Same as predicate	in vitro diagnostic use
Indications for Use	Same as predicate	Same as Dimension® analyzer
Tablet Sizes	Same as predicate	7/32"
Calibration	Same as predicate	90 days
Sample Type	Same as predicate	plasma
Reportable Range	Comparable to predicate	25 - 1000 µmol/L
Sample Size	Not required to be identical, but comparable function	20 µL
Measurement	Same as predicate	Bichromatic rate @ 340 & 383 nm

2. Sample size used for the test set and the data provenance:

Sample size: Not specified in the provided text. The document mentions "comparative testing described in the protocol included in this submission," but the protocol details (including sample size) are not part of this summary.
Data provenance: Not specified (e.g., country of origin of data, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided in the context of this 510(k) submission. This submission is for an in vitro diagnostic device (a reagent cartridge), whose "ground truth" would typically refer to the accuracy of its measurement capability against known standards or reference methods. The evaluation here is for chemical measurement performance, not expert-interpreted images or clinical decisions.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable and not provided. Adjudication methods like 2+1 are typically used for expert consensus in image interpretation or clinical outcomes, which is not the nature of this device's evaluation.

5. 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:

This is not applicable as the device is an in vitro diagnostic reagent cartridge for chemical analysis, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device itself is the "algorithm" (the chemical assay). The performance is inherent to the assay and the instrument system it runs on. The "standalone" performance is its ability to accurately measure ammonia levels. The document states "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance" regarding this, but the specific performance metrics (e.g., accuracy, precision) are not detailed in the summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for an in vitro diagnostic for ammonia levels would typically be:

Reference methods for ammonia measurement.
Known concentration standards.
Correlation with clinically relevant ammonia levels in patient samples, often compared to an existing, cleared diagnostic device (the predicate).

While not explicitly stated as "ground truth," the comparison to the Dimension® AMON Flex® reagent cartridge (K863840) serves as the primary reference point (predicate device) for establishing equivalent performance.

8. The sample size for the training set:

This is not applicable as this is not an AI/machine learning device with a training set.

9. How the ground truth for the training set was established:

This is not applicable as this is not an AI/machine learning device with a training set.

Summary

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510(k) Summary of Safety and Effectiveness Informat

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	SEP - 6 2006
Date of Preparation:	August 8, 2006

Name of Products:

Dimension VistaTM Ammonia (AMON) Flex® reagent cartridge

FDA Classification Name:

Classification Name:------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Common/Usual Name:
862.1065 Enzymatic Method, Ammonia	Ammonia test system

Product code: JIF

Predicate Device:

Dimension® Ammonia (AMON) Flex® reagent cartridge (K863840)

Device Description:

Intended Use:

The AMON method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension Vista™ System.

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Comparison to Predicate Device:

Both the Dimension VistaTM AMON Flex® reagent cartridges and the predicate Dimension® AMON 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™ AMONFlex® reagent cartridge	Dimension® AMONFlex® reagent cartridgeK863840
Reagents	Prepackaged, 12-well plastic, DadeBehring Flex® reagent cartridges	Prepackaged, 8 well plastic, DadeBehring Flex® reagent cartridges
Intended Use	in vitro diagnostic use	in vitro diagnostic use
Indications for Use	Same as Dimension® analyzer	The Ammonia (AMON) Flex®reagent cartridge is an in vitrodevice intended to measureammonia levels in plasma.Ammonia measurements are usedin the diagnosis and treatment ofsevere liver disorders, such ascirrhosis, hepatitis, and Reye'ssyndrome.
Tablet Sizes	7/32"	7/32"
Total tests containedin each Flex®cartridge	20	15
Calibration	90 days	90 days
Sample Type	plasma	plasma
Reportable Range	25 - 1000 µmol/L	0 - 1000 µmol/L
Sample Size	20 µL	53 µL
Measurement	Bichromatic rate@ 340 & 383 nm	Bichromatic rate@ 340 & 383 nm

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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 reagents contained in the Dimension Vista™ Ammonia (AMON) Flex® reagent cartridges are the same as those contained in the Ammonia (AMON) 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 device, nor do they alter the fundamental scientific technology of the device.

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

Conclusion:

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

Soraine H Pastrale

Lórraine H Piestrak Regulatory Affairs & Compliance Manager August 8, 2006

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lorraine Piestrak Dade Behring, Inc. Glasgow Business Community P.O. Box 6101, M/S 514 Newark, DE 19714-6101

Re: K062316

Trade/Device Name: Dimension Vista™ Ammonia (AMON) Flex® Regulation Number: 21 CFR 862.1065 Regulation Name: Ammonia test system Regulatory Class: Class I Product Code: JIF Dated: August 8, 2006 Received: August 9, 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. Iisting 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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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 Garcia

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): K062316

Dimension Vista™ Ammonia (AMON) Flex® reagent cartridge Device Name:

Indications For Use:

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)

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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(a) K062316

Regulation Number and Section

§ 862.1065 Ammonia test system.

(a)
Identification. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.(b)
Classification. Class I.