N Latex Lp(a) Reagent is an in vitro diagnostic test for the quantitative determination of Lipoprotein(a) [Lp(a)] in human serum or plasma. N Latex Lp(a) aids in the diagnosis of disorders of lipid (fat) metabolism and helps to identify persons at risk from cardiovascular disease in specific populations when used in conjunction with clinical evaluation.

Device Description

Polystyrene latex particles coated with specific antibodies to human Lp(a) are agglutinated when mixed with samples containing Lp(a). The intensity of scattered light in the BN™ Systems depends on the Lp(a) concentration in the sample. The concentration can therefore be determined by comparison with dilutions of a standard of known concentration.

AI/ML Overview

Acceptance Criteria and Device Performance Study for N Latex Lp(a) Reagent

This report details the acceptance criteria and the study conducted to demonstrate the performance of the N Latex Lp(a) Reagent, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Correlation	Strong positive correlation (e.g., r > 0.90) with a legally marketed predicate device. Slope close to 1, y-intercept close to 0.	Correlation coefficient: 0.96 (with Beckman Coulter Array® System LPA assay)
		Y-intercept: -0.005
		Slope: 0.92 (Passing-Bablok)
Precision (Intra-assay)	Low coefficient of variation (CV%) for repeated measurements within the same assay (e.g., < 10%).	CV% range: 1.8 - 4.1% (n=20, across 7 samples/pools with Lp(a) concentrations 0.29 - 1.77 g/L)
Precision (Inter-assay)	Low coefficient of variation (CV%) for repeated measurements across different assays (e.g., < 15%).	CV% range: 2.8 - 5.3% (n=10, across 6 samples/pools with Lp(a) concentrations 0.17 - 1.75 g/L)

Note on Acceptance Criteria: The 510(k) summary does not explicitly state numerical acceptance criteria for correlation and precision. However, substantial equivalence claims in medical device submissions are implicitly based on demonstrating performance comparable to a legally marketed predicate device. The reported values are generally considered acceptable for demonstrating equivalence in in-vitro diagnostic assays of this type.

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

Correlation Study: 86 laboratory serum samples.
Precision (Intra-assay): 7 samples or pools (N Lp(a) Control SY and 6 patient samples). Each sample/pool was tested 20 times (n=20).
Precision (Inter-assay): 6 samples or pools (N Lp(a) Control SY and 5 patient samples). Each sample/pool was tested 10 times (n=10).

Data Provenance: The document does not explicitly state the country of origin for the samples. It mentions "laboratory serum samples" and "patient samples or pools," suggesting these are clinical samples. The study appears to be retrospective as it involves commercially available samples and comparisons with an existing device, rather than a prospectively designed clinical trial.

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

This type of in-vitro diagnostic device (quantitative measurement of a biomarker) does not typically rely on "experts" to establish ground truth in the same way imaging or pathology devices do. The "ground truth" for the correlation study is the measurement obtained from the predicate device, the Beckman Coulter Array® System LPA assay. The ground truth for precision studies is the expected value of the control or pooled sample. Therefore, direct "expert" consensus on individual cases is not applicable here.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is established by the predicate device's measurements for correlation and by predefined values for controls/pools in precision studies. There is no need for human adjudication of results in this context.

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

No. This is an in-vitro diagnostic reagent designed for automated quantitative measurement on BN™ Systems. MRMC studies are typically performed for devices that involve human interpretation of medical images or other complex data.

6. Standalone Performance Study

Yes, the studies described (correlation and precision) demonstrate the standalone performance of the N Latex Lp(a) Reagent on the BN™ Systems without human-in-the-loop interpretation. The reported results are directly from the device's output.

7. Type of Ground Truth Used

Correlation Study: The quantitative measurements of Lp(a) obtained from the legally marketed predicate device (Beckman Coulter Array® System LPA assay) were used as the reference or "ground truth" for comparison.
Precision Studies: The known concentrations of control materials (N Lp(a) Control SY) and the mean values of patient pools served as the reference for evaluating repeatability and reproducibility.

8. Sample Size for the Training Set

The document does not provide information on a specific "training set" for the N Latex Lp(a) Reagent. In-vitro diagnostic assays based on immunonephelometry typically involve a development phase where reagents are optimized, and calibration curves are established using known standards and calibrators. This process doesn't usually involve a distinct "training set" in the machine learning sense. The "samples" referenced in the performance studies are test or validation samples, not explicit training data.

9. How Ground Truth for the Training Set Was Established

As noted above, a distinct "training set" in the context of machine learning is not described. For the development and calibration of such assays, ground truth for calibrators and controls would be established through:

Assay standardization: Using primary reference materials or secondary standards traceable to reference organizations.
** gravimetric/volumetric methods:** For preparing known concentrations of analytes.
Consensus values: For commercially available control materials established by the manufacturer through rigorous testing.

Summary

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JAN 1 8 2002

510(k) Summary for N Latex Lp(a) Reagent

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: _______________________________________________________________________________________________________________________________________________

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

Manufacturer:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany

Contact Information:

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Rebecca S. Ayash Tel: 302-631-6276

Preparation date:

January 4, 2002

Device Name/ Classification: 2.

N Latex Lp(a) Reagent:	Low-density lipoprotein immunological test system,
	Class II (866.5600)
Product Code:	81 DFC

Identification of the Legally Marketed Device: 3.

Beckman Coulter Array® System LPA assay (K000121)

4. Device Description:

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5. Device Intended Use:

N Latex Lp(a) is an in vitro diagnostic reagent for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and heparinized plasma by means of particle enhanced immunonephelometry using BN™ Systems. Measurement of Lp(a) aids in the identification of individuals at risk from cardiovascular disease in specific populations when used in conjunction with clinical evaluation.

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

There are a number of in vitro diagnostic products in commercial distribution, which employ immunoassay techniques for the quantitative determination Lp(a) in human serum or plasma. One such product is the Beckman Coulter Array® System LPA assay (K000121). The N Latex Lp(a) Reagent is substantially equivalent in intended use and results obtained to the Array System LPA assay. The N Latex Lp(a) Reagent, like the Array® System LPA assay is intended to be used for the quantitative determination of Lp(a) activity in human serum or plasma.

7. Device Performance Characteristics:

Correlation:

The N Latex Lp(a) assay was compared to a commercially available Lp(a) immunonephelometric method by evaluating 86 laboratory serum samples ranging from 0.02 to 1.31 g/L. A correlation coefficient of 0.96 was obtained with a y-intercept value of -0.005 and a slope of 0.92 (Passing-Bablok).

Precision:

The N Latex Lp(a) Reagent was used to measure the N Lp(a) Control SY and 6 patient samples or pools with Lp(a) concentrations between 0.29 and 1.77 g/L and yielded coefficients of variation between 1.8 and 4.1% for the intra-assay precision (n=20). N Lp(a) Control SY and 5 patient samples or pools with Lp(a) concentrations between 0.17 and 1.75 g/L were used to determine the inter-assay reproducibility (n=10) and the coefficients of variation were between 2.8 and 5.3%.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest feathers or wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 8 2002

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

K013128 Trade/Device Name: N Latex Lp (a) Reagent Regulation Number: 21 CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system Regulatory Class: Class II Product Code: DFC Dated: January 4, 2002 Received: January 7, 2002

Dear Ms. Dray-Lyons:

Re:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".

Sincerely yours,

Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4013128 Indications Statement

N Latex Lp(a) Reagent Device Name:

Indications for Use:

(Division Sign-(
Division of Clir. oratory Devices
510(k) Number. K013 128

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

000056

Regulation Number and Section

§ 866.5600 Low-density lipoprotein immunological test system.

(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).