LP(A)-LATEX SEIKEN ASSAY KIT

K013359 · Denka Seiken'S · DFC · Mar 8, 2002 · Immunology

Device Facts

• Record ID: K013359
• Device Name: LP(A)-LATEX SEIKEN ASSAY KIT
• Applicant: Denka Seiken'S
• Product Code: DFC · Immunology
• Decision Date: Mar 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5600
• Device Class: Class 2

Intended Use

The Lp(a)-Latex SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma samples with Hitachi 917 analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.

Device Story

Lp(a)-Latex SEIKEN Assay Kit is an in vitro diagnostic immunoassay for quantitative determination of Lipoprotein (a) in human serum and plasma. Input: patient serum/plasma samples. Principle: antigen in sample binds to anti-Lp(a) antibody adsorbed to latex particles, causing agglutination. Agglutination detected as absorbance change on Hitachi 917 analyzer; magnitude of change proportional to Lp(a) concentration. Output: concentration value determined by interpolation from calibration curve. Used in clinical laboratory settings by trained personnel. Results assist healthcare providers in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk when combined with clinical evaluation and other lipoprotein tests.

Clinical Evidence

Bench testing only. Comparative study on 105 donor samples showed correlation coefficient r=0.919 against predicate. Precision studies: %CV 2.00% (medium control) and 1.26% (high control). Sensitivity (lower limit of detection) is 2.0 mg/dL; assay range up to 80.0 mg/dL.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay. Reagents consist of anti-Lp(a) antibody adsorbed to latex particles. Designed for use on Hitachi 917 clinical chemistry analyzer. Measures absorbance change proportional to antigen concentration.

Indications for Use

Indicated for quantitative determination of lipoprotein (a) in human serum and plasma to evaluate lipid metabolism disorders and assess atherosclerotic cardiovascular disease in specific populations.

Regulatory Classification

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.

Predicate Devices

• SPQ Test System Antibody Reagent Set for Lp(a) (K982708)

Submission Summary (Full Text)

{0}------------------------------------------------

8 2002 MAR

MAR

## I. 510(k) Summary

The assigned 510 (k) number is:

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

1013359

Denka Seiken Co., Ltd. (A)(1) Submitter's name:

> Submitter's address: 3-4-2. Nihonbashi kavabacho

Chuo-ku Tokyo, Japan 103-0025

Submitter's telephone number: [phone]

Contact Person: Mr. Yousuke Meguro Assistant Manager International Sales and Business Development Dept.

Date Summary Prepared: February 1, 2002

(2) Trade or proprietary device name:

- (3) Common or usual name: Classification Name: Panel: Immunology Class: II
Lp(a)-Latex SEIKEN Assay Lipoprotein (a) assay Low density Lipoprotein Immunological test system

(3) Legally marketed predicate device(s): SPQ Test System Antibody Reagent Set for Lp(a) [DiaSorin Inc.](K982708)

(4) Subject device description:

The Lp(a)-Latex SEIKEN Assay Kit is a latex in vitro diagnostic immunoassay for the quantitative determination of Lipoprotein (a) in human serum and plasma. Antigen in the sample binds to the specific anti-Lp(a) antibody, which has been adsorbed to latex particles, and agglutinates. The agglutination is detected as an absorbance change when read on Hitachi 917 analyzer, with the magnitude of the change being proportional to the quantity of Lp(a) in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentrations.

{1}------------------------------------------------

(5) Subject device intended use:

The Lp(a)-Latex SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma samples with Hitachi 917 analyzer. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease in specific populations, when used in conjunction with clinical evaluation and other lipoprotein tests.

(6) Performance data:

The Lp(a)-Latex SEIKEN Assay and the predicate device, SPQ Test System Antibody Reagent Set for Lp(a) methods and reagents have only minor difference that do not affect the performance, safety or effectiveness of the measurement.

Comparative performance studies, when conducted on 105 donor samples, yielded a correlation coefficient upon comparison of the Lp(a)-Latex SEIKEN and the SPQ Test System Antibody Reagent Set for Lp(a) of r = 0.919.

Precision studies were performed using medium and high control materials. % CV for the medium control was 2.00%; for the high control, the % CV was 1.26.

The lower level of detection (sensitivity of the assay) is at 2.0 mg/dL, with the assay range up to 80.0 mg/dL.

These findings demonstrate that the performance of the Lp(a)-Latex SEIKEN Assay kit is both robust and substantially equivalent to the predicate device, SPQ Test System Antibody Reagent Set for Lp(a).

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Yousuke Meguro Assistant Manager International Sales and Business Development Department Denka Seiken Co., Ltd. 3-4-2, NIHONBASHI-KAYABACHO CHUO-KU, TOKYO JAPAN 103-0025

MAR 8 2002

k013359 Re:

Trade/Device Name: Lp(a)-Latex SEIKEN Assay Kit Regulation Number: 21 CFR 866.5600 Regulation Name: Low density lipoprotein immunological test system Regulatory Class: Class II Product Code: DFC Dated: February 1, 2002 Received: February 4, 2002

Dear Mr. Meguro:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conimered prices that have been reclassified in accordance with the provisions of the Federal Food, DNLS 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 Tou may, dicrorely, mans 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 If your device to such additional controls. Existing major regulations affecting your device can may or babyer to back as a success 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 i lease of actived that i Drivistion that your device complies with other requirements of the Act that I Dr Haral statutes and regulations administered by other Federal agencies. You must or mry 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 CI It Fat 607); adoning (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 -

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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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

{4}------------------------------------------------

## Amendments to Denka Seiken Co., Ltd. Pre-market Notification Lp(a)-Latex SEIKEN Assay Kit

C. Indications for use of the Device Page 1 of 1

| 510(k) Number): | K013359 |
|-----------------|------------------------------|
| Device Name: | Lp(a)-Latex SEIKEN Assay Kit |

Indications for Use:
The Lp(a)-Latex SEIKEN Assay kit is an *in vitro* diagnostic test for the quantitative determina-
tion of lipoprotein (a) [Lp(a)] in human serum and plasma samples with Hitachi 917 analyzer.
The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing ath-
erosclerotic cardiovascular disease in specific populations, when used in conjunction with clini-
cal evaluation and other lipoprotein tests.(Please do not write below this line-continue on another page if needed)

* * * * * * * * * *

Concurrence of CDRH, Office of Device Evaluation (ODE)

11 13

signature

vices

Prescription Use_X _or (Per 21 CFR 801.109) (Optional Format 1-2-96)

Over-the-Counter Use