DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE by DADE BEHRING, INC.

Dimension Vista™ Albumin (ALB) Flex® reagent cartridge: The ALB method is an in vitro diagnostic test for the quantitative measurement of albumin in human serum and plasma on the Dimension Vista™ System. Measurements obtained by this device are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge: The AST method is an in vitro diagnostic test for the quantitative measurement of aspartate aminotransferase in human serum and plasma on the Dimension Vista™ System. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge: The CRBM method is an in vitro diagnostic test for the quantitative measurement of carbamazepine in human serum and plasma on the Dimension Vista™ System. Carbamazepine measurements may be used in the diagnosis and treatment of carbamazepine overdose and in therapeutic drug monitoring. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine to ensure appropriate therapy.

Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge: The ALT method is an in vitro diagnostic test for the quantitative measurement of alanine aminotransferase in human serum and plasma on the Dimension Vista™ System. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitis and cirrhosis) and heart diseases.

Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge: The TIBC method is an in vitro diagnostic test for the quantitative measurement of total iron binding capacity in human serum and plasma on the Dimension Vista™ System. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.

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 ALB, AST, CRBM, ALT, and TIBC 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

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission for several reagent cartridges for the Dimension Vista™ system. The primary goal of this submission is to demonstrate substantial equivalence to existing predicate devices (Flex® reagent cartridges used on Dimension® clinical chemistry systems) due to a packaging modification. Therefore, the "acceptance criteria" are implicitly tied to the performance of the predicate devices.

The document states: "Comparative testing described in the protocol included in this submission demonstrates equivalent performance." And in the conclusion: "Comparative testing also demonstrates substantially equivalent performance."

While explicit numerical acceptance criteria are not provided in the publicly available summary, the general acceptance criteria for this type of submission would be that the performance of the new device (Dimension Vista™ Flex® reagent cartridges) must be comparable or equivalent to the predicate device (Dimension® Flex® reagent cartridges). This comparison typically involves analytical performance characteristics such as:

Accuracy: How close the measured values are to the true values.
Precision: The reproducibility of measurements.
Linearity/Measuring Range: The range over which the device accurately measures the analyte.
Interferences: The effect of other substances on the measurement.
Method Comparison: Correlation with the predicate device.

Since the submission states the reagents are the same, and only the packaging is modified for use on a different (but related) instrument, the expectation is that the analytical performance should remain unchanged or within acceptable variations for clinical use.

Table of Acceptance Criteria and Reported Device Performance (Inferred):

Performance Characteristic	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Accuracy	Equivalent to predicate devices (Dimension® Flex®)	Demonstrated equivalent performance
Precision	Equivalent to predicate devices (Dimension® Flex®)	Demonstrated equivalent performance
Linearity/Range	Equivalent to predicate devices (Dimension® Flex®)	Demonstrated equivalent performance
Interferences	Equivalent to predicate devices (Dimension® Flex®)	Demonstrated equivalent performance
Method Comparison	High correlation with predicate devices	Demonstrated equivalent performance
Intended Use	Same as predicate devices	Same as predicate devices
Indications for Use	Same as predicate devices	Same as predicate devices

Study Information:

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided summary. The document mentions "Comparative testing described in the protocol included in this submission," but doesn't detail the sample sizes for comparison studies.
- Data Provenance: Not explicitly stated. For in-vitro diagnostic devices, testing typically involves human serum and plasma samples, likely collected in a clinical laboratory setting. Whether it was retrospective or prospective is not mentioned, but validation studies for IVDs often involve prospective sample collection or the use of archived samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is an in-vitro diagnostic test. Ground truth for such devices is established by the analytical performance against a reference method or validated calibrators, not by expert consensus in the way image analysis or clinical diagnosis might be.
Adjudication method for the test set:
- Not applicable for an in-vitro diagnostic test. Results are quantitative measurements against established analytical standards.
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:
- No. This is an in-vitro diagnostic device (reagent cartridge for laboratory analysis), not an AI-assisted diagnostic imaging or clinical decision support tool that involves "human readers."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is an inherent aspect of an in-vitro diagnostic device. The "algorithm" here is the chemical assay and instrument processing. The performance reported (e.g., accuracy, precision) is the standalone performance of the device without human interpretation of the primary data, beyond standard laboratory quality control and result reporting.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For in-vitro diagnostic devices, the "ground truth" for analytical performance studies is typically established by:
  - Reference Methods: Highly accurate and precise methods (e.g., gas chromatography-mass spectrometry for drugs, isotope dilution mass spectrometry for certain analytes) considered the gold standard.
  - Validated Calibrators/Controls: Materials with known, assigned values traceable to reference standards.
  - Clinical Diagnosis/Patient Outcome: For clinical utility, but analytical performance uses the above.
- The document implies that the ground truth for comparison was the established performance of the legally marketed predicate devices, which would have been validated against such reference methods or standards.
The sample size for the training set:
- Not explicitly stated. For reagent development, a "training set" in the context of machine learning isn't directly applicable. Instead, reagent formulations are optimized through R&D, and their performance is characterized using various samples (e.g., quality control materials, patient samples) during that development phase. The "study" described here is for validation, not training or development.
How the ground truth for the training set was established:
- As noted above, a "training set" linked to a ground truth in the machine learning sense isn't directly relevant here. However, the development of the original reagents (predicate devices) would have involved extensive analytical characterization against reference methods and clinical samples to establish their performance specifications and clinical utility. The current submission leverages the established ground truth of these existing reagents.

Summary

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Kocloro

510(k) Summary of Safety and Effectiveness Information

NAY 10 2005

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
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Date of Preparation: April 12, 2005

Name of Product:

Dimension Vista™ Albumin (ALB) Flex® reagent cartridge Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge

FDA Classification Name:

Methods (Class II) Albumin, Aspartate amino transferase, and Carbamazepine test systems.

Methods (Class I) Alanine amino transferase and Iron-binding capacity test systems

Predicate Device:

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

Product	Dade BehringPredicate	Predicate510(k) #	Deviceclass	Regulation	ProductCode
Dimension Vista™ALB Flex® reagentcartridge	Dimension® ALBFlex® reagentcartridge	K861700	II	862.1035	CJW
Dimension Vista™AST Flex® reagentcartridge	Dimension® ASTFlex® reagentcartridge	K860021	II	862.1100	CIT

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Dimension Vista™CRBM Flex® reagentcartridge	Dimension®CRBM Flex®reagent cartridge	K962820	II	862.3645	KLT
Dimension Vista™ALT Flex® reagentcartridge	Dimension® ALTFlex® reagentcartridge	K862359	I*	862.1030	CKA
Dimension Vista™TIBC Flex® reagentcartridge	Dimension®IBCT Flex®reagent cartridge	K994115	I	862.1415	JMO

Not exempt when indications include diagnosis of cardiovascular (heart) diseases

Device Description:

Intended Use:

Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge:

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The ALT method is an in vitro diagnostic test for the quantitative measurement of alanine aminotransferase 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.

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.

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The ALB, AST, CRBM, ALT, and TIBC reagents contained in the Dimension VistaTM 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 ALB, AST, ALT, CRBM, and TIBC 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 April 27, 2006

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird in a circular fashion.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

MAY 10 2006

Re: K061020

Trade/Device Name: Dimension Vista™ Albumin (ALB) Flex® reagent cartridge Dimension Vista™ Aspartate amino transferase (AST) Flex reagent cartridge Dimension Vista™ Carbarmazepine (CRBM) Flex® reagent cartridge Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge

Regulation Number: 21 CFR§ 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CJW, CIT, KLT, CKA, JMO Dated: April 12, 2006 Received: April 13, 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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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 Gutz

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):

K061020

Dimension Vista™ Albumin (ALB) Flex® reagent cartridge Device Name:

Indications For Use:

The Dimension Vista™ Albumin Flex® reagent cartridge (ALB) is a device intended to measure the albumin concentration in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of numerous diseases involving primarily the liver 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 1 of 1

Division Sign-Off

K061020

003

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510(k) Number (if known):

Device Name: Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge

K061020

Indications For Use:

The Dimension Vista™ Aspartate amino transferase (AST) Flex® reagent cartridge is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

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

(k) 1061020

005

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510(k) Number (if known):

K061020

Device Name:

Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Carbamazepine (CRBM) Flex® reagent cartridge is a device intended to measure carbamazepine, an anticonvulsant drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of carbamazepine overdose and in monitoring levels of carbamazepine 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)

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

Page 1 of 1

Division Sign-Off

006

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510(k) Number: (if known): K061020

Device Name: Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Alanine amino transferase (ALT) Flex® reagent cartridge is intended to measure the activity of the enzyme pyruvic transaminase (ALT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g. viral hepatitis and cirrhosis) and heart diseases.

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

/061020

007

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510(k) Number: (if known):

K061020

Device Name: Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge

Indications For Use:

The Dimension Vista™ Total Iron-binding capacity (TIBC) Flex® reagent cartridge is intended to quantitatively measure total iron binding capacity in human serum and plasma. Measurements of total iron binding capacity are used in the diagnosis and treatment of iron deficiency anemia and chronic inflammatory disorders.

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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CACL

Division Sign-Off

Regulation Number and Section

§ 862.1030 Alanine amino transferase (ALT/SGPT) test system.

(a)
Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.