The DGTX method is an in vitro diagnostic test for the quantitative measurement of digitoxin in serum and plasma on the Dimension Vista™ System. Measurements of digitoxin are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

The DIG method is an in vitro diagnostic test for the quantitative measurement of digoxin in serum and plasma on the Dimension Vista™ System. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

The GENT method is an in vitro diagnostic test for the quantitative measurement of gentamicin, an aminoglycoside antibiotic, in human serum and plasma on the Dimension Vista™ System. Gentamicin measurements may be used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

The NAPA method is an in vitro diagnostic test for the quantitative measurement of N-acetylprocainamide in serum and plasma on the Dimension Vista™ System. N-acetylprocainamide measurements may be used in therapeutic drug monitoring to maintain adequate procainamide therapy.

The PTN method is an in vitro diagnostic test for the quantitative measurement of phenytoin, (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma on the Dimension Vista™ System. Phenytoin measurements may be used in the diagnosis and treatment of phenytoin overdose and in monitoring levels of phenytoin to ensure appropriate therapy.

The THEO method is an in vitro diagnostic test for the quantitative measurement of theophylline in human serum and plasma on the Dimension Vista™ System.

Device Description

Dade Behring Dimension VistaTM 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 VistaTM 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 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 text describes a 510(k) submission for several Dimension Vista™ Flex® reagent cartridges intended for diagnostic testing. The core of the submission is to demonstrate substantial equivalence to previously cleared predicate devices, primarily focusing on a packaging modification that allows these reagents to be used on the Dimension Vista™ integrated system. The reagents themselves and their fundamental scientific technology are stated to be the same as the predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical "acceptance criteria" or provide a table of "reported device performance" in the typical sense of a clinical study (e.g., sensitivity, specificity, accuracy against a gold standard). Instead, the demonstration of performance relies on comparative testing to show substantial equivalence to the predicate devices. The implicit acceptance criterion is that the performance of the new Dimension Vista™ Flex® reagent cartridges must be substantially equivalent to that of the predicate Dimension® Flex® reagent cartridges.

The text states: "Comparative testing described in the protocol included in this submission demonstrates substantially equivalent performance." and "Comparative testing also demonstrates substantially equivalent performance."

Since the document is a summary and not the full study protocol, specific performance metrics and their comparison values are not detailed. However, the nature of these in-vitro diagnostic tests typically involves:

Precision/Reproducibility: Measuring the consistency of results when the same sample is tested multiple times.
Accuracy/Method Comparison: Comparing the results obtained by the new device against a reference method (in this case, the predicate device results) using patient samples. This often involves statistical methods like regression analysis (e.g., Deming regression) to assess agreement.
Linearity/Measuring Range: Confirming that the device accurately measures analytes across its claimed analytical range.
Interference Studies: Assessing the impact of common interfering substances (e.g., hemoglobin, bilirubin, lipids) on the test results.

The key takeaway is that the "acceptance criteria" here are defined by the established performance characteristics of the predicate devices, and the new devices are deemed acceptable if their performance is statistially similar.

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 substantially equivalent performance." However, it does not specify the sample size used for the comparative testing (test set) or the data provenance (e.g., country of origin, retrospective or prospective nature of the samples).

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

This information is not applicable in the context of this 510(k) submission. For in-vitro diagnostic (IVD) devices measuring specific analytes, the "ground truth" is typically the quantitative concentration of the analyte as determined by a reference method or the predicate device itself, not by expert consensus on qualitative interpretation. No human experts are described as establishing ground truth for the test set.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the submission concerns quantitative measurements of chemical analytes, there is no need for an adjudication method as would be relevant for subjective medical image interpretation or clinical decision-making.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:

This information is not applicable. The device is an in-vitro diagnostic reagent cartridge for laboratory analysis, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

The entire "device" described here (the reagent cartridges used on an automated analyzer) operates in a standalone (algorithm/system only) manner in terms of its measurement process. The Dimension Vista™ system is described as a "floor model, fully automated, microprocessor-controlled, integrated instrument system." The reagents enable this automated system to perform the quantitative measurements without direct human intervention in the measurement execution. Human involvement is in sample preparation, loading, and interpretation of the numerical results delivered by the automated system.

7. The Type of Ground Truth Used:

The ground truth for the performed comparative testing would have been the quantitative concentration of the specific analyte (Digitoxin, Digoxin, Gentamicin, N-acetylprocainamide, Phenytoin, Theophylline) as measured by the predicate device. Since the reagents themselves are stated to be the same as the predicate and only the packaging is modified for a new instrument system, the primary ground truth is established by the well-characterized performance of the predicate device on its intended system for each analyte.

8. The Sample Size for the Training Set:

This document does not mention a "training set" in the context of an algorithm or machine learning model. This is expected as the device is a reagent cartridge for a chemical assay, not a machine learning-based diagnostic. Therefore, information about the training set size is not applicable.

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

As there is no "training set" in the machine learning sense, this information is not applicable. The "training" of such a system involves the development and optimization of the chemical assay reagents and the instrument's detection capabilities during the initial development phases of the predicate devices and the Dimension Vista™ analyzer itself.

Summary

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K062024

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
Date of Preparation:	July 17, 2006

JUL 2 8 2006

Name of Products:

Dimension Vista™ Digitoxin (DGTX) Flex® reagent cartridge Dimension Vista™ Digoxin (DIG) Flex® reagent cartridge Dimension Vista™ Gentamicin (GENT) Flex® reagent cartridge Dimension VistaTM N-acetylprocainamide (NAPA) Flex® reagent cartridge Dimension Vista™ Phenytoin (PTN) Flex® reagent cartridge Dimension Vista™ Theophylline (THEO) Flex® reagent cartridge

FDA Classification Name:

Classification Name:	Common/Usual Name:
862.3300 Enzyme Immunoassay, Digitoxin	Digitoxin test system
862.3320 Enzyme Immunoassay, Digoxin	Digoxin test system
862.3450 Enzyme Immunoassay, Gentamicin	Gentamicin test system
862.3320 Enzyme Immunoassay, N-Acetylprocainamide	N-Acetylprocainamide test system
862.3350 Enzyme Immunoassay, Diphenylhydantoin	Diphenylhydantoin (phenytoin) test system
862.3880 Enzyme Immunoassay, Theophylline	Theophylline test system

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™DGTX Flex® reagentcartridge	Dimension® DGTXFlex® reagentcartridge	K990251	II	862.3300	LFM
Dimension Vista™DIG Flex® reagentcartridge	Dimension® DGNAFlex® reagent cartridge	K946153	II	862.3320	KXT
Dimension Vista™GENT Flex® reagentcartridge	Dimension® GENTFlex® reagent cartridge	K962819	II	862.3450	LCD
Dimension Vista™NAPA Flex® reagentcartridge	Dimension® NAPAFlex® reagentcartridge	K032564	II	862.3320	LAN

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New Product	Predicate	Predicate510(k) #	Deviceclass	Regulation	ProductCode
Dimension Vista™PTN Flex® reagentcartridge	Dimension® PTNFlex® reagentcartridge	K911056	II	862.3350	DIP
Dimension Vista™THEO Flex® reagentcartridge	Dimension® THEOFlex® reagentcartridge	K862955	II	862.3880	KLS

Device Description:

Intended Use:

Digitoxin

Digoxin

Gentamicin

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N-acetylprocainamide

Phenytoin

Theophylline

The THEO method is an in vitro diagnostic test for the quantitative measurement of theophylline in human serum and plasma on the Dimension Vista™ System.

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 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 substantially equivalent performance.

Conclusion:

The Flex® reagent cartridges, containing reagents for testing DGTX, DIG, GENT, NAPA, PTN, and THEO 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. Piatrak

Lorraine H Piestrak Regulatory Affairs & Compliance Manager July 17, 2006

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Profic Houte Service

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JUL 2 8 2006

Food and Drug Administrator 2098 Gammer 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

Re: K062024

Trade/Device Name:	Dimension Vista™ Digitoxin (DGTX) Flex® reagent cartridge
	Dimension Vista™ Digoxin (DIG) Flex® reagent cartridge
	Dimension Vista™ Gentamicin (GENT) Flex ® reagent cartridge
	Dimension Vista™ N-acetylprocainamide (NAPA)
	Flex® reagent cartridge
	Dimension Vista™ Phenytoin (PTN) Flex® reagent cartridge
	Dimension Vista™ Theophylline (THEO) Flex® reagent cartridge
Regulation Number:	21 CFR§862.3300
Regulation Name:	Digitoxin test system
Regulatory Class:	Class II
Product Code:	LFM, KXT. LCD, LAN, DIP, KLS
Dated:	July 17, 2006
Received:	July 18, 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 (QS) 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 Guti

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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510(k) Number (if known):

Device Name: Dimension Vista™ Digitoxin (DGTX) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Digitoxin (DGTX) Flex® reagent cartridge is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.

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)

Adipating

Page 1 of 2

K062024

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510(k) Number (if known):

Device Name: Dimension Vista™ Digoxin (DIG) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Digoxin (DIG) Flex® reagent cartridge is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements of digoxin are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.

Prescription Use × (Part 21 CFR 801 Subpart D)

and the comments of the comments of the comments of the comments of the comments of

AND/OR

Over-The-Counter Use (21 CFR 801)

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

Page of l'

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510(k) Number (if known):

Device Name: Dimension Vista™ Gentamicin (GENT) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Gentamicin (GENT) Flex® reagent cartridge is a device intended to measure gentamicin, an antibiotic drug, in human serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

X Prescription Use (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 of ريز of ريز

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510(k) Number (if known):

Device Name: Dimension Vista™ N-acetylprocainamide (NAPA) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ N-acetylprocainamide (NAPA) Flex® reagent cartridge is a device intended to measure N-acetylprocainamide in human serum and plasma. Measurements obtained by this device maybe used in therapeutic drug monitoring to maintain adequate procainamide therapy.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801)

and the many of the many of the many of the many of the many of the many of the may be

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

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510(k) Number (if known):

Device Name: D Dimension Vista™ Phenytoin (PTN) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Phenytoin (PTN) Flex® reagent cartridge is a device intended to measure diphenylhydantoin (phenytoin), an antiepileptic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin (phenytoin) overdose and in monitoring levels of diphenylhydantoin (phenytoin) to ensure appropriate therapy.

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)

Page 5 of 6

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510(k) Number (if known):

Dimension Vista™ Theophylline (THEO) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Theophylline (THEO) Flex® reagent cartridge is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems), in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.

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)

Page of 6

Regulation Number and Section

§ 862.3300 Digitoxin test system.

(a)
Identification. A digitoxin test system is a device intended to measure digitoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digitoxin overdose and in monitoring levels of digitoxin to ensure appropriate therapy.(b)
Classification. Class II.