The HDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and heparinized- or EDTA-plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). The device is intended to be used on automated chemistry analyzers in clinical laboratories.

Device Description

The HDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and heparinized- or EDTA-plasma on automated chemistry analyzers. The HDL-EX SEIKEN Assay is a homogeneous method for directly measuring HDL-C levels in serum and plasma without the need for any off-line pretreatment or centrifugation steps.

AI/ML Overview

The provided text describes a 510(k) summary for the "HDL-EX SEIKEN Assay Kit," a device for quantitatively determining high-density lipoprotein cholesterol (HDL-C). The study presented is a comparative performance study against a predicate device.

Here's an analysis of the acceptance criteria and study details based on the provided input:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance criteria through the comparison to the predicate device, Ultra N-Geneous HDL Cholesterol Reagent. The key metrics evaluated are correlation, slope, and y-intercept for comparative performance, and Coefficient of Variation (CVs) for precision.

Acceptance Criterion	Reported Device Performance (HDL-EX SEIKEN Assay)
Comparative Performance (vs. Predicate Device):
Correlation Coefficient (r)	0.991 (considered "high")
Slope	1.041
Y-intercept	0.015
Precision (Within-run and Between-day):
Coefficient of Variation (CVs)	"showed very similar CVs as shown in the kit insert of the predicate device"

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

Test Set Sample Size: 150 donor samples.
Data Provenance: Not explicitly stated, but the submission is from a Japanese company (Denka Seiken Co., Ltd.). It is likely these samples were collected in Japan or a similar region, but this is not confirmed. The study appears to be prospective in the sense that the samples were analyzed specifically for this comparison.

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

This study evaluates an in vitro diagnostic (IVD) assay (a laboratory test), not an imaging device or a clinical outcome-based assessment. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists interpreting images) does not directly apply here.
The "ground truth" for comparison is the performance of the legally marketed predicate device (Ultra N-Geneous HDL Cholesterol Reagent [Genzyme Corp.]) on the same samples. The predicate device itself has established performance characteristics, and its results are used as the reference against which the new device is measured.
No information is provided about experts interpreting the results beyond the intrinsic performance of the predicate device.

4. Adjudication Method for the Test Set:

Not applicable in the context of this type of IVD comparative performance study. The comparison is objective, based on quantitative measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC study was not done. This is an IVD device measuring a biomarker, not a device requiring human interpretation of medical images or diagnostic outputs.

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

Yes, this study represents a standalone performance evaluation of the HDL-EX SEIKEN Assay Kit. As an automated chemistry analyzer test, it operates without human intervention in the interpretive phase. The study directly compares the results of the new assay to the predicate assay.

7. The Type of Ground Truth Used:

The ground truth (or reference standard) used for the comparative performance study is the results obtained from the legally marketed predicate device, the "Ultra N-Geneous HDL Cholesterol Reagent [Genzyme Corp.]." This is a common practice for demonstrating substantial equivalence for IVD devices.

8. The Sample Size for the Training Set:

The document does not mention a "training set" or any machine learning/AI components. This is a traditional IVD assay, not an AI/ML-based device. Therefore, the concept of a training set is not applicable.

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

As there is no training set for this traditional IVD device, this question is not applicable.

Summary

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OCT 2 9 2004

I. 510(k) Summary

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

The assigned 510 (k) number is: _KO41090 (A)(1) Submitter's name: Denka Seiken Co., Ltd. Submitter's address: 3-4-2, Nihonbashi kayabacho, Chuo-ku Tokyo, Japan 103-0025 Submitter's pilot telephone number: +81-3- 3669-9421 Contact Person: Mr. Toshimi Matsunaga Manager Pharmaceutical Affairs Contact Person's telephone number: +81-250- 42-7222

Date Summary Prepared: October 1, 2004

(2) Trade or proprietary device name: HDL-EX SEIKEN Assay Kit Common or usual name: Homogeneous assay for high density lipoprotein cholesterol Classification Name: High density lipoprotein cholesterol test Panel: Clinical Chemistry Class: I Product Code: LBS
(3) Legally marketed predicate device: Ultra N-Geneous HDL Cholesterol Reagent [Genzyme Corp.] (K021316)

(4) Subject device description:

The HDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and heparinized- or EDTA-plasma on automated chemistry analyzers. The HDL-EX SEIKEN Assay is a homogeneous method for directly measuring HDL-C levels in serum and plasma without the need for any off-line pretreatment or centrifugation steps.

(5) Subject device intended use:

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(6) Performance data:

The HDL-EX SEIKEN Assay and the predicate device, Ultra N-Geneous HDL Cholesterol Reagent [Genzyme Corp.] have only relatively minor differences in that the differences do not affect the performance, safety or effectiveness of the measurement.

Comparative performance studies, when conducted on 150 donor samples, yielded a high correlation coefficient upon comparison of the HDL-EX SEIKEN Assay and the Ultra N-Geneous HDL Cholesterol Reagent. The correlation coefficient r = 0.991; slope = 1.041, y intercept = 0.015.

Precision studies were conducted using the HDL-EX SEIKEN Assay Kit. Within run and between day studies were performed using three levels of control material for each. In both studies, the HDL-EX SEIKEN Assay showed very similar CVs as shown in the kit insert of the predicate device.

These findings serve to demonstrate that the performance of the HDL-EX SEIKEN Assay Kit is substantially equivalent to the predicate device, Ultra N-Geneous HDL Cholesterol Reagent [Genzyme Corp.].

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A.", which is arranged in a circular fashion around the symbol.

OCT 2 9 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Toshimi Matsunaga Manager of Regulatory & Pharmaceutical Affairs Denka Seiken Co., Ltd. 1-2-2 Minamihoncho Gosen City Niigata, Japan 959-1695

K041090 Re:

Trade/Device Name: HDL-EX SEIKEN Assay Kit Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBS Dated: October 1, 2004 Received: October 4, 2004

Dear Ms. Matsunaga:

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 for the based or 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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Seain M. Cooper, US. DVM.

Tean M. Cooper, MS, 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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Denka Seiken Co., Ltd. Pre-market Notification HDL-EX SEIKEN Assay Kit

C. Indications for use

510(k) Number (if known): K041090

Device Name: HDL-EX SEIKEN Assay Kit

Indications For Use:

AND/OR Prescription Use __X (Part 21 CFR 801 Subpart D)

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)

Albert
Division Sign-off

Division 6

Office of In Vitro Diagnostic Office of ince of includion and Safety

510(k) K041090

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.