The HDLC method is an in vitro diagnostic test for the quantitative measurement of high-density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension Vista® system. Measurements of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases and in the assessment of risk for atherosclerosis and cardiovascular disease.

Device Description

Dimension Vista® HDCL Flex® reagent cartridge is a pre-packaged in-vitro diagnostic test method (assay) that is specifically designed to be used on the Dimension Vista® Integrated system, a floor model, fully automated microprocessor-controlled, integrated instrument system. The reagents contained in the Dimension Vista® Flex® reagent cartridges are the same as those manufactured for the Dimension® clinical chemistry analyzers. The packaging modification does not affect the fundamental scientific technology of the device. The HDLC assay measures serum HDL cholesterol levels directly without the need for sample pretreatment or separation steps, using a two reagent format. In the first reaction, lipoproteins are precipitated with dextran sulfate in the presence of magnesium sulfate. These complexes are resistant to the polyethylene glycol (PEG)-modified cholesterol esterase (CE) and cholesterol oxidase (CO) that react with HDL cholesterol. In the second reaction, in the presence of oxygen, the HDL cholesterol is oxidized to A-4-cholestenone and hydrogen peroxide. The generated hydrogen peroxide then reacts with 4-aminoantipyrine (4-AAP) and N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline (HSDA) in the presence of peroxidase. The resulting quinoneimine dye is measured using a bichromatic (600/700 nm) technique. The color intensity of the dye is directly proportional to the serum HDL-C concentration.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical targets in a formal table outside of the comparison, but it implies that the performance of the new device (Dimension Vista® HDLC Flex® reagent cartridge - K3408A) must be "substantially equivalent" to the predicate device (Dimension® AHDL Flex® reagent cartridge - K073072). The comparison table below highlights key identical features and performance aspects. The "Conclusion" section explicitly states that "Comparative testing also demonstrates substantially equivalent performance."

Table of Acceptance Criteria (Implied Equivalence) and Reported Device Performance:

Feature/Performance Aspect	Acceptance Criteria (Implied via Predicate Equivalence)	Reported Device Performance (Dimension Vista® HDLC - K3408A)
Intended Use	Aid in diagnosis of lipid disorders, various liver and renal diseases, and assessment of risk for atherosclerosis and cardiovascular disease in human serum and plasma for quantitative HDL-C measurement.	Same as predicate device.
Reagent Form	Liquid	Liquid
Calibration	90 days	90 days
Sample Type	Serum and lithium or sodium heparin plasma	Serum and lithium or sodium heparin plasma
Reportable Range	3-150 mg/dL	3-150 mg/dL
Measurement	Bichromatic endpoint @ 600 and 700 nm	Bichromatic endpoint @ 600 and 700 nm
Certification	Evaluated by and met the certification criteria of the Cholesterol Reference Method Laboratory Network (CRMLN)	Evaluated by and met the certification criteria of the Cholesterol Reference Method Laboratory Network (CRMLN)
Final concentration of sample/reagent ratio in test milieu	Same as Dimension® analyzer	Same as Dimension® analyzer
Overall Performance	Substantially equivalent to predicate	Comparative testing demonstrates substantially equivalent performance.

Note on Differences (Not Acceptance Criteria but Design Changes):

Reagents Cartridge: Predicate uses 6-well plastic Flex® cartridges; New device uses 12-well plastic Flex® cartridges.
Total Tests per Cartridge: Predicate provides 30 tests; New device provides 120 tests.
Sample Size: Predicate uses 3 µL; New device uses 1.3 µL.

Study Information:

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than a detailed clinical trial report. As such, specific study details are limited.

Sample size used for the test set and the data provenance:
- The document states "Comparative testing also demonstrates substantially equivalent performance." However, it does not explicitly state the sample size used for this comparative testing or the data provenance (e.g., country of origin, retrospective/prospective).
- Given the nature of an in-vitro diagnostic device for cholesterol measurement, it would typically involve human serum/plasma samples, but the specifics are not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. For this type of in-vitro diagnostic device, ground truth is typically established through a reference method or comparison to a predicate device's established performance, rather than expert interpretation of results. The device and its predicate were "Evaluated by and met the certification criteria of the Cholesterol Reference Method Laboratory Network (CRMLN)," which implies adherence to a highly standardized and validated reference method for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. Adjudication methods are typically used in imaging or clinical interpretation studies where there is subjective assessment. This is an IVD device measuring a quantitative analyte.
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 is an in-vitro diagnostic device for quantitative measurement of High-Density Lipoprotein Cholesterol (HDL-C), not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device itself is an automated assay system (Dimension Vista® Integrated system) designed for quantitative measurement. Its performance, as demonstrated by "comparative testing," refers to the algorithm's ability to accurately measure HDL-C concentrations on the new system compared to the predicate, in a standalone fashion without human intervention in the measurement process itself. Human involvement would be in operating the instrument and interpreting the numerical results, not in the direct measurement by the device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is established through adherence to the Cholesterol Reference Method Laboratory Network (CRMLN) certification criteria. This indicates that the device's measurements are traceable to a highly accurate and standardized reference method for cholesterol, which serves as the "gold standard" for quantitative cholesterol measurement.
The sample size for the training set:
- Not applicable/Not mentioned. This device is not an AI/machine learning device that requires a separate "training set" in the conventional sense. It's a new formulation/packaging of an existing chemical reagent for a known analytical method. The development would involve analytical validation rather than machine learning training.
How the ground truth for the training set was established:
- Not applicable. As noted above, there's no "training set" in the context of machine learning. The analytical performance (accuracy, precision) is validated against established reference methods (CRMLN).

Summary

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510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K081300

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

Manufacturer:	Siemens Healthcare Diagnostics Inc.P.O. Box 6101Newark, DE 19714-6101
Contact Information:	Siemens Healthcare Diagnostics Inc.P.O. Box 6101Newark, DE 19714-6601Attn: Pamela A. JurgaTel: 302-631-8891
Date of Preparation:	May 7, 2008

Device Name / Classification 2.

Dimension Vista® HDLC Flex® reagent cartridge (K3408A) / Class I .

Identification of the Predicate Device 3.

Dimension® AHDL Flex® reagent cartridge (K073072) t

FDA Guidance Document(s):

"Replacement Reagent and Instrument Family Policy" 12/11/2003 .
"Guidance on Informed Consent for In Vitro Diagnostic Device Studies . Using Leftover Human Specimens that are Not Individually Identifiable -Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff " - 4/25/2006

Device Description(s): 4.

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(K051087). This Special 510(k) is submitted for a packaging modification to in-vitro diagnostic (1001007). This bpeofal 270(t), 10 sthe 510(k) process for use on Dimension® clinical de vices mat nave occir evackaging 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 The Cagon's contained in the Dimendions manufactured for the Dimension® clinical chemistry contained in the I leagens analyzers. The packaging modification does not affect the systems, anomer lannity of themele sites the fundamental scientific technology of the device.

The HDLC assay measures serum HDL cholesterol levels directly without the need for sample I he IIDLC assury neasured seraillingation steps, using a two reagent format. In the first reaction, predeathene or spoculation communities with dextran sulfate in the presence of magnesium sulfate. These complexes are resistant to the polyethylene glycol (PEG)-modified cholesterol esterase (CE) and cholesterol oxidase (CO) that react with HDL cholesterol. In the second reaction, in the presence of oxygen, the HDL cholesterol is oxidized to A-4-cholestenone second readon, in the proomer of the generated hydrogen peroxide then reacts with 4-aminoantipyrine (4and IIyarogen percentive 3-sulfopropyl)-3,5-dimethoxyaniline (HSDA) in the presence of Art / and IN (2 hyrony 3 sairoped is measured using a bichromatic (600/700 nm) technique. The color intensity of the dye is directly proportional to the serum HDL-C concentration.

Device Intended Use: ડ.

The HDLC method is an in vitro diagnostic test for the quantitative measurement of high density lipoprotein cholesterol (HDL-C) in human serum and plasma on the Dimension Vista " System. If your of of HDL-C are used as an aid in the diagnosis of lipid disorders (such as diabetes mellitus), various liver and renal diseases, and in the assessment of risk for atherosclerosis and cardiovascular disease.

Medical device to which equivalence is claimed: 6.

Substantial Equivalence:

This product is substantially equivalent to other HDL-C test systems, such as the Dimension® AHDL Flex® reagent cartridge (K073072).

Comparison to Predicate Device:

Both the Dimension Vista® HDLC Flex® reagent cartridges and the predicate Dimension® Doth the Dimension + 1.0 Lostain prepackaged reagents in flexible plastic cartridges. A AHDL I reass teagent cararteges contains and differences between the two Flex® cartridges is provided in the following table.

Feature	Dimension Vista® HDLCFlex® reagent cartridge(K3408A)	Dimension® analyzer AHDLFlex® reagent cartridge(DF48B) K073072
Reagents	Prepackaged, 12 well plastic Flex®reagent cartridges	Prepackaged, 6 well plastic Flex®reagent cartridges

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Intended Use	The HDLC method is an in vitrodiagnostic test for the quantitativemeasurement of high-densitylipoprotein cholesterol (HDL-C) inhuman serum and plasma on theDimension Vista® system.Measurements of HDL-C are usedas an aid in the diagnosis of lipiddisorders (such as diabetesmellitus), various liver and renaldiseases and in the assessment ofrisk for atherosclerosis andcardiovascular disease.	The AHDL method is an in vitrodiagnostic test for the quantitativemeasurement of high-densitylipoprotein cholesterol (HDL-C)in human serum and plasma on theDimension® clinical chemistrysystem. Measurements of HDL-Care used as an aid in the diagnosisof lipid disorders (such as diabetesmellitus), various liver and renaldiseases and in the assessment ofrisk for atherosclerosis andcardiovascular disease.
Final concentrationof sample/reagentratio in test milieu	Same as Dimension® analyzer	As described in K073072
Reagent form	Liquid	Liquid
Total testcontained in eachFlex® cartridge	120 tests	30 tests
Calibration	90 days	90 days
Sample Type	Serum and lithium or sodiumheparin plasma	Serum and lithium or sodiumheparin plasma
Reportable Range	3-150 mg/dL	3-150 mg/dL
Sample Size	1.3 µL	3 µL
Measurement	Bichromatic endpoint@ 600 and 700 nm	Bichromatic endpoint@ 600 and 700 nm
Certification	Evaluated by and met thecertification criteria of theCholesterol Reference MethodLaboratory Network (CRMLN)	Evaluated by and met thecertification criteria of theCholesterol Reference MethodLaboratory Network (CRMLN)

Conclusion:

The proposed Siemens Dimension Vista® HDLC method (K3048A) and the predicate Dimension® I the proposod Diomens Dikorian 2) are substantially equivalent in design, principle, and ATIDL mealou (121 40D) (1875011) the backers and indications for use. Comparative testing also demonstrates substantially equivalent performance.

Signature

Pamela A. Jurga Regulatory Affairs & Compliance Manager May 7, 2008

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 2 2008

Siemens Healthcare Diagnostics, Inc. c/o Pamela A. Jurga. Regulatory Affairs and Compliance Manager Glasgow Business Community P.O. Box 6101, Mail Stop 514 Newark, DE 19714-6101

Re: K081300

Trade/Device Name: Dimension Vista® HDLC Flex® reagent cartridge Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, subject to 21 CFR sec. 862.9(c)(4) Product Code: JHM Dated: June 23, 2008 Received: June 24, 2008

Dear Ms. Jurga:

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 1egally 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 not 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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Indications for Use

1681300 510(k) Number (if known):

Indications For Use:

Prescription Use V (Per 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

(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

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081300

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal 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.