The ALC method is an in vitro diagnostic test for the measurement of ethyl alcohol in serum on the Dimension Vista™ System. Ethyl alcohol test results may be used in the diagnosis and treatment of alcohol intoxication and poisoning.

The ALP method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma the Dimension Vista™ System.

The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in serum, plasma, and urine on the Dimension Vista™ System.

The Dimension Vista™ Ethyl Alcohol (ALC) Flex® reagent cartridge is a device intended to measure ethyl alcohol in human serum. Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

The Dimension Vista™ Alkaline phosphatase (ALP) Flex® reagent cartridge is a device intended to measure alkaline phosphatase in serum and plasma. Measurements of alkaline phosphatase are used primarily in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases.

The Dimension Vista™ Calcium (CA) Flex® reagent cartridge is a device intended to measure the total calcium level in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

The Dimension Vista™ Lactic Acid (LA) Flex® reagent cartridge is a device intended to measure lactic acid in plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

The Dimension Vista™ Lithium (LI) Flex® reagent cartridge is a device intended to measure lithium in serum and plasma. Measurements of lithium are used to assure the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).

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 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 is a 510(k) Summary for in-vitro diagnostic test cartridges (Dimension Vista™ Flex® reagent cartridges) that measure various analytes like Ethyl Alcohol, Alkaline Phosphatase, Calcium, Lactic Acid, and Lithium. The key point of this submission is a packaging modification to allow these existing, previously cleared reagents to be used with the new Dade Behring Dimension Vista™ Integrated system.

Given that the core reagents and their underlying technology remain the same, and only the packaging is changing to adapt them to a new instrument, the information provided focuses on demonstrating that this packaging change does not negatively impact the performance or intended use of the devices compared to their predicate devices on the older Dimension® clinical chemistry systems.

Therefore, the "acceptance criteria" and "study" are not about demonstrating a new diagnostic capability or a new level of clinical performance for the analytes themselves, but rather about demonstrating substantial equivalence for the cartridges when used on the new Dimension Vista™ system. This means showing that the performance on the Dimension Vista™ system is comparable to the established performance on the Dimension® system for the same reagents.

Based on the provided text, the specific details requested in your prompt regarding acceptance criteria, study design, and ground truth for diagnostic device performance as one might expect for a new AI algorithm or a novel biomarker test are not directly applicable or explicitly stated, because the submission is for a packaging modification of existing, cleared assays.

However, I can infer the "acceptance criteria" for this type of submission to be equivalence in performance to the predicate device, and the "study" would likely be a comparative performance study between the new system and the predicate system using the same reagents.

Here's an interpretation based on the provided text, addressing your points where possible:

Acceptance Criteria and Study for Dimension Vista™ Flex® Reagent Cartridges (Packaging Modification)

The primary acceptance criteria for this 510(k) submission, which concerns a packaging modification for existing in-vitro diagnostic reagents, center on demonstrating that the modified cartridges perform equivalently when used on the new Dimension Vista™ system compared to their predicate versions on the Dimension® clinical chemistry systems.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a packaging modification and not a new diagnostic algorithm, the acceptance criteria would revolve around maintaining the performance characteristics (e.g., accuracy, precision, linearity) that were established and accepted for the predicate devices. The text does not provide a specific table of numerical acceptance criteria or reported performance metrics for each analyte. This kind of detailed performance data is typically found in the full 510(k) submission, not necessarily in the public summary.

However, the implied acceptance criterion is substantial equivalence in performance to the predicate devices. The "reported device performance" would be the demonstration that the assays, when run on the Vista system with the new packaging, yield comparable results to those obtained on the Dimension system with the original packaging.

Implied Acceptance Criteria for Substantial Equivalence:

Performance Metric (Implied)	Acceptance Criteria (Implied)	Reported Device Performance (Inferred from "Substantial Equivalence")
Accuracy/Bias	Results on Dimension Vista™ are comparable to predicate Dimension® system.	Demonstrated to be substantially equivalent.
Precision	Reproducibility of results on Dimension Vista™ is comparable to predicate Dimension® system.	Demonstrated to be substantially equivalent.
Linearity/Range	The measuring range and linearity on Dimension Vista™ are comparable to predicate Dimension® system.	Demonstrated to be substantially equivalent.
Interference	Interference profiles on Dimension Vista™ are comparable to predicate Dimension® system.	Demonstrated to be substantially equivalent.
Intended Use	The intended use and clinical utility remain unchanged.	Confirmed.
Fundamental Technology	No alteration to the fundamental scientific technology of the devices.	Confirmed – "The reagents... are the same."

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

The provided text does not specify the sample size used for any comparative testing or the data provenance (e.g., country of origin, retrospective/prospective). For in-vitro diagnostic devices, testing would typically involve patient samples (often spanning the clinical range of the analyte) and/or control materials.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is not applicable in the context of this 510(k) submission. This type of submission is for in-vitro diagnostic (IVD) reagents, which measure specific analytes in biological samples. The "ground truth" for chemical measurements is typically established through reference methods, calibrated standards, or comparative analysis with an established, cleared device (the predicate). It does not involve expert readers assessing images or clinical scenarios for a consensus.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are characteristic of studies involving human interpretation (e.g., radiology image reading), where multiple readers assess a case and a tie-breaking mechanism is needed. For IVD measurements, the comparison is typically quantitative, directly comparing instrument outputs or calculated values, not subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This question is not applicable. MRMC studies are specific to evaluating observer performance, particularly in medical imaging, and assessing the impact of a device (like AI assistance) on human interpretation. This 510(k) is for chemical reagents used on an automated analyzer, not a device intended to assist human readers in, for instance, interpreting images.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable in the sense of an "algorithm" being evaluated for diagnostic output that would otherwise require human interpretation. The devices are chemical reagents that interact with an automated analyzer to produce a quantitative measurement. The analyzer performs the "algorithm" for measuring the analyte. The "standalone performance" is essentially the analytical performance of the combined reagent-instrument system, which is what the comparison to the predicate device would demonstrate.

7. Type of Ground Truth Used

For this type of IVD device, the "ground truth" for the performance evaluation would typically be established by:

Reference Methods: Highly accurate, standardized methods for measuring the target analyte.
Certified Reference Materials: Materials with precisely known concentrations of the analyte.
Comparison to Predicate Device: The performance of the new device (or the modified version) is compared directly to a legally marketed predicate device, which itself has established performance characteristics. This is the most likely "ground truth" used in this specific 510(k) for substantial equivalence.

8. Sample Size for the Training Set

This question is not applicable. These are chemical reagents for an in-vitro diagnostic device. There is no "training set" in the context of machine learning or AI algorithms as the terms are typically used for imaging or predictive diagnostics. The reagents are chemical formulations designed to react with analytes, and the instrument uses established analytical principles, not learned patterns from a training set.

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

This question is not applicable for the reasons stated in point 8.

Summary

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K061792

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	JUL 1 8 2006
Date of Preparation:	June 23, 2006

Name of Products:

Dimension Vista™ Ethyl Alcohol (ALC) Flex® reagent cartridge Dimension Vista™ Alkaline phosphatase (ALP) Flex® reagent cartridge Dimension Vista™ Calcium (CA) Flex® reagent cartridge Dimension Vista™ Lactic Acid (LA) Flex® reagent cartridge Dimension Vista™ Lithium (LI) Flex® reagent cartridge

FDA Classification Name:

Classification Name:	Common/Usual Name:
862.3040 Alcohol Dehyrdogenase, specific reagent forEthanol Enzyme method	Alcohol test system
862.1050 Alkaline phosphatase	Alkaline phosphatase test system
862.1145 Calcium	Calcium test system
862.1450 Lactic acid	Lactic acid test system
862.3560 Lithium	Lithium 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™ALC Flex® reagentcartridge	Dimension® ALCFlex® reagent cartridge	K904302	II	862.3040	DIC
Dimension Vista™ALP Flex® reagentcartridge	Dimension® ALPFlex® reagentcartridge	K860021	II	862.1050	CJE
Dimension Vista™CA Flex® reagentcartridge	Dimension® CAFlex® reagentcartridge	K860021	II	862.1145	CIC

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New Product	Predicate	Predicate510(k) #	DeviceClass	Regulation	ProductCode
Dimension Vista™LA Flex® reagentcartridge	Dimension® LAFlex® reagentcartridge	K914508	I*	862.1450	KHP
Dimension Vista™LI Flex® reagentcartridge	Dimension® LI Flex®reagent cartridge	K011033	II	862.3560	JIH

Not exempt from premarket notification per 862.9 or per Reserved Medical Devices list

Device Description:

Intended Use:

Alcohol (Ethyl)

Alkaline Phosphatase

The ALP method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma the Dimension Vista™ System.

Calcium

The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in serum, plasma, and urine on the Dimension Vista™ System.

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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

JUL 1 8 2006

Re: K061792

Trade/Device Name: Dimension Vista™ Ethyl Alcohol (ALC) Flex® reagent cartridge Dimension Vista™ Alkaline phoshatase (ALP) Flex® reagent cartridge Dimension Vista™ Calcium (CA) Flex® reagent cartridge Dimension Vista™ Lactic Acid (LA) Flex® reagent cartridge Dimension Vista™ Lithium (LI) Flex® reagent cartridge Regulation Number: 21 CFR§862.3040 Regulation Name: Alcohol test system Regulatory Class: Class II Product Code: DIC, CJE, CJE, JIH, KHP Dated: June 23, 2006 Received: June 26, 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): K061792

Dimension Vista™ Ethyl Alcohol (ALC) 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)

Page 1 of

Carol Benson

Division Sign-Off

310(k) K061792

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510(k) Number (if known): K061792

Dimension Vista™ Alkaline phosphatase (ALP) 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)

Carol Benson

Division Sign-Off

512(K) K061792

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510(k) Number (if known): K061792

Dimension Vista™ Calcium (CA) 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)

Carol C Benson

Division Sign-

K061792

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Indications for Use 510(k) Number (if known): KOlo1792

Dimension Vista™ Lactic Acid (LA) 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)

Carol Benam

Division Sign-Off

) K061792

Page 4 of 5

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510(k) Number (if known): K061792

Dimension Vista™ Lithium (LI) 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)

Carol Benam
Division Sign-Off

K061792

Page 5 of 5

Regulation Number and Section

§ 862.3040 Alcohol test system.

(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.