Dimension Vista® HCYS Flex® reagent cartridge: The HCYS method is an in vitro diagnostic test for the quantitative determination of total homocysteine in human serum, heparinized and EDTA plasma on the Dimension Vista® System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Dimension Vista® Protein 1 Calibrator: PROT 1 CAL is an in vitro diagnostic product for the calibration of the C3 complement (C3), C4 complement (C4), Homocysteine (HCYS), Immunoalobulin A (IGA). Immunoalobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System.

Dimension Vista® Protein 1 Control L, M and H: PROT1 CON L. M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista®.

Device Description

Dimension Vista® HCYS Flex® reagent cartridge: Bound homocysteine in the sample is reduced to free homocysteine by the action of dithiothreitol, and then converted enzymatically to S-adenosyl-homocysteine (SAH). Conjugated S-adenosylcysteine (SAC), added at the onset of the reaction, competes with the SAH in the sample for bonding by anti-SAH antibodies bound to polystyrene particles. In the presence of SAH, there is either no aggregation or a weak aggregation of particles. In the absence of SAH in the sample, an aggregation of the polystyrene particles by the conjugated SAC occurs. The higher the SAH content of the reaction mixture, the smaller the scattered light signal. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista® Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3, C4. Homocysteine (HCYS). Immunoalobulin A (IGA). Immunoalobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin / Transthyretin (PREALB).

Dimension Vista® Protein 1 Control L, M and H: Protein 1 Control L. M and H are multi-analyte, liguid, human serum based products containing C3, C4, Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin / Transthyretin (PREALB).

AI/ML Overview

The provided text describes a 510(k) summary for new in-vitro diagnostic products: the Dimension Vista® HCYS Flex® reagent cartridge, Dimension Vista® Protein 1 Calibrator, and Dimension Vista® Protein 1 Control L, M and H. The primary focus of the performance data in the submission is for the Dimension Vista® HCYS assay.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in the form of numerical thresholds or targets for the method comparison study. Instead, it relies on demonstrating correlation and equivalent performance to a legally marketed predicate device.

The reported device performance in the method comparison study showed:

Metric	Value
Sample Size (n)	215
Slope	1.056
Intercept	0.239
Correlation Coefficient	0.995

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

Sample Size: 215 serum and plasma samples.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, it's implied to be laboratory-based testing of patient samples.

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

This type of information is generally not applicable to a submission for an in-vitro diagnostic assay like the Dimension Vista® HCYS. The "ground truth" for these types of assays is typically established by measurements from a reference method or a legally marketed predicate device, rather than by expert consensus on image interpretation or clinical diagnosis.

4. Adjudication Method for the Test Set

Not applicable. The study is a method comparison between two quantitative assays, not an adjudicated diagnostic study.

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

Not applicable. This submission is for an in-vitro diagnostic reagent and calibrator/controls, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, a form of standalone performance was done for the Dimension Vista® HCYS assay. The study directly compared the new device's measurements (algorithm only in the context of the instrument) against the predicate device's measurements, without human interpretation of the results from either system.

7. The Type of Ground Truth Used

The ground truth was established by comparison to a legally marketed predicate device: the Dade Behring N Latex HCY assay on the BN ProSpec® System. This is a common approach for demonstrating substantial equivalence for new in-vitro diagnostic devices.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" in the context of machine learning or AI. For an in-vitro diagnostic assay, the "training" (e.g., optimization and validation of the assay's reagents and methodologies) would occur internally during product development, prior to the submission of performance data. The reported "215" samples are for the method comparison study, which serves as a validation/test set.

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

As no explicit "training set" in the AI/ML context is mentioned, this question is not directly applicable. For the development of the assay, calibration and reference materials would have been used, with their values likely established through robust analytical methods and traceability to higher-order reference materials or methods.

Summary

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510(k) Summary for Dimension Vista® HCYS Flex® reagent cartridge Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L, M and H

DEC 2 8 2006

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.

The assigned 510(k) number is: 4043800

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
  Manufacturer:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 35001 Marburg, Germany

Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497

Preparation date: October 20, 2006

1. Device Name: Dimension Vista® HCYS Flex® reagent cartridge Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L Dimension Vista" Protein 1 Control L
  Dimension Vista" Protein 1 Control M
  Classification: Class II; Class II; Class I Product Code: LPS; JIX; JJY Panel: Clinical Chemistry (75)

3. ldentification of the Legally Marketed Device:

Dade Behring N Latex HCY -- K052788 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468

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Dade Behring Inc Dimension Vista® HCYS 510(k) Notification

Device Description: 4.

Dimension Vista® HCYS Flex® reagent cartridge

Bound homocysteine in the sample is reduced to free homocysteine by the action of dithiothreitol, and then converted enzymatically to S-adenosyl-homocysteine (SAH). Conjugated S-adenosylcysteine (SAC), added at the onset of the reaction, competes with the SAH in the sample for bonding by anti-SAH antibodies bound to polystyrene particles. In the presence of SAH, there is either no aggregation or a weak aggregation of particles. In the absence of SAH in the sample, an aggregation of the polystyrene particles by the conjugated SAC occurs. The higher the SAH content of the reaction mixture, the smaller the scattered light signal. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista® Protein 1 Calibrator

Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3, C4. Homocysteine (HCYS). Immunoalobulin A (IGA). Immunoalobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin / Transthyretin (PREALB).

Dimension Vista® Protein 1 Control L, M and H

Protein 1 Control L. M and H are multi-analyte, liguid, human serum based products containing C3, C4, Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin / Transthyretin (PREALB).

5. Device Intended Use:

Dimension Vista® HCYS Flex® reagent cartridge:

The HCYS method is an in vitro diagnostic test for the quantitative determination of total homocysteine in human serum. heparinized and EDTA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Dimension Vista® Protein 1 Calibrator:

PROT 1 CAL is an in vitro diagnostic product for the calibration of the C3 complement (C3), C4 complement (C4), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG). Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System.

Dimension Vista® Protein 1 Control L, M and H:

PROT1 CON L. M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista®.

Medical device to which equivalence is claimed and comparison information: 6.

The Dimension Vista® HCYS Flex® reagent cartridge, Dimension Vista® Protein 1 Calibrator and Dimension Vista Protein 1 Control L. M and H are substantially equivalent to the Dade Behring N Latex HCY assay (K052788), N Protein Standard SL (K012470), and N/T Protein Control SL (K012468), respectively.

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7. Device Performance Characteristics:

The Dimension Vista " HCYS assay was compared to the Dade Behring N Latex HCY
assay on the BN ProSpec" System by evaluating serum and plasma samples with yielded the following equation:

n	Slope	Intercept	Correlation Coefficient
Dimension Vista ® HCYS	215	1.056	0.239	0.995

Method Comparison Study

8. Conclusion:

These studies demonstrate correlation and equivalent performance between the Dade
Behring N Latex HCY assay and the Dimension Vista® HCYS assay.

Image /page/2/Picture/7 description: The image displays the word "CONFIDENTIAL" in large, bold, sans-serif font. The letters are evenly spaced and aligned horizontally. The text appears to be a stamp or watermark applied to a document, indicating its sensitive nature.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen Dray-Lyons Dade Behring Inc. Glasgow Site, P.O. Box 6101 Newark, DE 19714

DEC 2 8 2006

Re: K063206 Trade/Device Name: Dimension Vista Homocysteine Flex Reagent, Dimension Vista Protein 1 Calibrator and Controls Regulation Number: 21 CFR §862.1377, §862.1150, §862.1660 Regulation Name: Urinary homocystine (non-quantitative) test system, multi-analyte calibrators, and multi-analyte controls Regulatory Class: Class II Product Codes: LPS, JIX, JJY Dated: October, 20, 2006 Received: October, 23, 2006

Dear Ms. Dray-Lyons:

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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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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K063206

Indications Statement

Device Name:

Dimension Vista® HCYS Flex® reagent cartridge Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L Dimension Vista® Protein 1 Control M Dimension Vista® Protein 1 Control H

Indications for Use:

Dimension Vista® HCYS Flex® reagent cartridge:

The HCYS method is an in vitro diagnostic test for the quantitative determination of total homocysteine in human serum, heparinized and EDTA plasma on the Dimension Vista® System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Dimension Vista® Protein 1 Calibrator

PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Homocysteine (HCYS), lmmunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System.

Dimension Vista® Protein 1 Control L, M and H

PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), Homocysteine (HCYS), lmmunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista®

Prescription Use × (Per 21 CFR 801 Subpart D)

Over-The-Counter-Use (21 CFR 801)

June 150

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Divisiod Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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Regulation Number and Section

§ 862.1377 Urinary homocystine (nonquantitative) test system.

(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.