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

AI/ML Overview

The provided text describes the 510(k) summary for the "LDL-EX SEIKEN Assay Kit." Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Correlation with Predicate Device	r = 0.994
- Slope	0.982
- Y-intercept	-1.83
Precision (Within-run and Between-day CVs)	Very similar to the predicate device's kit insert.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: 100 donor samples
Data Provenance: The document does not specify the country of origin for the donor samples or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the ground truth was established by comparison with a legally marketed predicate device, not through expert consensus on diagnostic images or pathology.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. The study involved direct comparison of quantitative results between the new device and a predicate device, not human review and adjudication of findings.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic assay, 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

A standalone performance study was done for the device, where its measurements were directly compared against a predicate device. The device itself (the "LDL-EX SEIKEN Assay Kit") is an automated assay, meaning it operates without human intervention once the sample is loaded.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth was established by comparison to a legally marketed predicate device (N-Geneous LDL Cholesterol Reagent [Genzyme Corp.]). The assumption is that the predicate device provides accurate measurements of LDL-C, thereby serving as the "ground truth" for the new device's performance evaluation.

8. The sample size for the training set

This information is not applicable. This device is a chemical assay kit, not a machine learning or AI model, thus it does not have a "training set" in the conventional sense. Its performance is characterized through direct comparison and precision studies.

9. How the ground truth for the training set was established

This information is not applicable as there is no "training set" for this type of device.

Summary

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re-market Noulication LDL-EX SEIKEN Assay Kit

I. 510(k) Summary

JAN 2 6 2005

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: K043264

(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: November 22, 2004

(2) Trade or proprietary device name: LDL-EX SEIKEN Assay Kit Common or usual name: Homogeneous assay for low-density lipoprotein cholesterol Classification Name: Low-density lipoprotein cholesterol test Panel: Clinical Chemistry Class: I Product Code: MRR

(3) Legally marketed predicate device: N-Geneous LDL Cholesterol Reagent [Genzyme Corp.] (K971573)

(4) Subject device description:

The LDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum and heparinized- or EDTA-plasma on automated chemistry analyzers. The LDL-EX SEIKEN Assay Kit is a homogeneous method for directly measuring LDL-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 LDL-EX SEIKEN Assay Kit and the predicate device, N-Geneous LDL 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 100 donor samples, yielded a high correlation coefficient upon comparison of the LDL-EX SEIKEN Assay Kit and the N-Geneous LDL Cholesterol Reagent. The correlation coefficient r = 0.994; slope = 0.982, y intercept = - 1.83.

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

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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JAN 2 6 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Toshimi Matsunaga Manager, Pharmaceutical Affairs Denka Seiken Co., Ltd. 1-2-2, Minamihoncho, Gosen City Nigata, Japan 959-1695

Re: K043264

Trade/Device Name: LDL-EX SEIKEN Assay Kit Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: MRR Dated: November 22, 2004 Received: December 14, 2004

Dear Mr. 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 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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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,

Sean M. Cooper, MS, DUM

Jean 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 LDL-EX SEIKEN Assay Kit

C. Indications for use of the Device

Page 1 of 1

510(k) Number):

LDL-EX SEIKEN Assay Kit Device Name:

Indications for Use:

Prescription Use ___X AND/OR (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)
Carol Benson
Division Sign-Off

affires " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " ond Safety

SNOOK K043264

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.