LDL-EX SEIKEN ASSAY KIT

K043264 · Denka Seiken Co., Ltd. · MRR · Jan 26, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043264
• Device Name: LDL-EX SEIKEN ASSAY KIT
• Applicant: Denka Seiken Co., Ltd.
• Product Code: MRR · Clinical Chemistry
• Decision Date: Jan 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

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 Story

The LDL-EX SEIKEN Assay Kit is an in vitro diagnostic reagent for quantitative LDL-C measurement. It utilizes a homogeneous assay method, allowing direct measurement in human serum or plasma without off-line pretreatment or centrifugation. The device is designed for use on automated chemistry analyzers in clinical laboratory settings. By providing direct LDL-C quantification, the assay assists healthcare providers in diagnosing and managing lipid-related conditions such as diabetes, atherosclerosis, and liver or renal diseases. The output is a numerical cholesterol concentration value, which clinicians use to assess patient lipid profiles and guide therapeutic decisions.

Clinical Evidence

Bench testing only. Precision/reproducibility studies (N=20-40 per level) showed CV% < 1.7%. Linearity established 1-800 mg/dL (bias < 5%). Analytical sensitivity (LOD) 0.6 mg/dL. Interference testing confirmed no significant interference from hemoglobin, bilirubin, ascorbic acid, or triglycerides up to 1000 mg/dL. Method comparison with predicate (N=100) yielded Y = 0.982X + 1.83, r=0.994. Matrix comparison (serum vs. heparin/EDTA plasma) showed high correlation (R² > 0.99).

Technological Characteristics

Homogenous colorimetric enzymatic assay. Two-reagent system (R1, R2) plus lyophilized human serum-based calibrator. Sensing principle: spectrophotometric detection of purple-red color development. Dimensions/form factor: liquid reagents for automated chemistry analyzers (e.g., Hitachi 917, 911, 717). Connectivity: standalone reagent kit for use on open-platform clinical analyzers. Sterilization: N/A (reagents).

Indications for Use

Indicated for the quantitative determination of LDL-C in human serum and heparinized- or EDTA-plasma. Used in the diagnosis and treatment of lipid disorders including diabetes mellitus, atherosclerosis, and various liver and renal diseases. Intended for use on automated chemistry analyzers in clinical laboratories.

Regulatory Classification

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.

Predicate Devices

• N-Geneous LDL Cholesterol Reagent [Genzyme Corp.] (K971573)

Submission Summary (Full Text)

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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: [phone]

Contact Person: Mr. Toshimi Matsunaga Manager Pharmaceutical Affairs

Contact Person's telephone number: [phone]

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:

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.

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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 [phone]. 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 [phone] or [phone] 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:

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.

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

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