CRP-LATEX (II)X2 SEIKEN ASSAY KIT by DENKA SEIKEN CO., LTD.

The CRP-Latex (II)X2 SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of C-reactive protein in human serum and lithium heparin or EDTA plasma samples by immunoturbidimetry. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.

Device Description

The CRP-Latex (II)X2 SEIKEN Assay Kit is a latex in vitro diagnostic immunoassay for the quantitative determination of C-reactive protein in human serum and in heparinized and EDTA-plasma. Antigen in the sample bonds to the specific anti-CRP antibody, which has been adsorbed to latex particles, and agglutinates. The agglutination is detected as an absorbance change when read on an automated chemistry analyzer (the Hitachi 917 was used for these studies), with the magnitude of the change being proportional to the quantity of CRP in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the CRP-Latex (II)X2 SEIKEN Assay Kit, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study to Demonstrate Performance
Comparative Performance	High correlation coefficient with predicate device.	r = 0.999 (Least squares)	Comparative performance study on 451 donor samples
	Slope (Least squares) approaching 1.0.	Slope = 1.012 (Least squares)	Comparative performance study on 451 donor samples
	Y-intercept (Least squares) approaching 0.0.	Y-intercept = 0.005 (Least squares)	Comparative performance study on 451 donor samples
	Slope (Passing/Bablock) approaching 1.0.	Slope = 1.053 (Passing/Bablock)	Comparative performance study on 451 donor samples
	Y-intercept (Passing/Bablock) approaching 0.0.	Y-intercept = -0.004 (Passing/Bablock)	Comparative performance study on 451 donor samples
Precision (Within Run)	% CV for Level 1 not exceeding 7.0%.	% CV for Level 1 did not exceed 7.0%	Precision studies using three levels of control material
	% CV for Level 2 not exceeding 3.4%.	% CV for Level 2 did not exceed 3.4%	Precision studies using three levels of control material
	% CV for Level 3 not exceeding 1.3%.	% CV for Level 3 did not exceed 1.3%	Precision studies using three levels of control material
Precision (Between Day)	% CV for Level 1 not exceeding 7.0%.	% CV for Level 1 did not exceed 7.0%	Precision studies using three levels of control material
	% CV for Level 2 not exceeding 3.4%.	% CV for Level 2 did not exceed 3.4%	Precision studies using three levels of control material
	% CV for Level 3 not exceeding 1.3%.	% CV for Level 3 did not exceed 1.3%	Precision studies using three levels of control material

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 451 donor samples were used for the comparative performance studies.
- Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text. The "ground truth" for the comparative study was the measurement given by the predicate device (N High Sensitivity CRP Assay).
Adjudication method for the test set:
- This information is not applicable as the "ground truth" was established by a predicate device's measurements, not by human expert assessment requiring adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic immunoassay, not an AI-powered diagnostic imaging tool that would typically involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance reported is a standalone (algorithm only) performance, comparing the output of the CRP-Latex (II)X2 SEIKEN Assay Kit to a legally marketed predicate device. The device itself is an automated immunoassay, not one that typically involves a human-in-the-loop for its basic measurement function.
The type of ground truth used:
- The "ground truth" for the comparative performance study was the measurements obtained from the legally marketed predicate device, the N High Sensitivity CRP Assay (Dade Behring Inc.).
The sample size for the training set:
- This information is not provided in the text. The study describes performance testing against a predicate device, not the development or training of an algorithm that would typically require a separate training set.
How the ground truth for the training set was established:
- This information is not provided as a separate training set and its ground truth establishment are not discussed in the context of this 510(k) submission.

Summary

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DENKA SEIKEN CO.,LTD. 3-4-2, Nihonbashi kayabacho, Chuo-ku, Tokyo, Japan 103-0025

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: K 030545

(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 telephone number: (03) 3669-9421

Mr. Toshimi Matsunaga Contact Person: Manager Regulatory & Pharmaceutical Affairs

Date Summary Prepared: February 17, 2003

(2) Trade or proprietary device name: CRP-Latex (II)X2 SEIKEN Assay Kit

Common or usual name: Latex-enhanced turbidimetric in vitro immunoassay for determination of C-reactive protein

Classification Name: C-reactive protein immunological test system Panel: Immunology Class: II

(3) Legally marketed predicate device: N High Sensitivity CRP Assay Dade Behring Inc. .

(4) Subject device description:

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3-4-2, Nihonbashi kayabacho, Chuo-ku, Tokyo, Japan 103-0025

(5) Subject device intended use:

(6) Performance data:

The CRP-Latex (II)X2 SEIKEN Assay and the predicate device, N High Sensitivity CRP Assay have only minor difference that do not affect the performance, safety or effectiveness of the measurement.

Comparative performance studies conducted on 451 donor samples yielded a high correlation coefficient upon comparison of the CRP-Latex (II)X2 SEIKEN and the predicate device, N High Sensitivity CRP. The correlation coefficient r = 0.999; slope = 1.012, y intercept = 0.005 (Least squares); slope = 1.053, y intercept = - 0.004 (Passing/Bablock).

Precision studies, both within run and between day studies, were performed using three levels of control material. % CV for Level 1 did not exceed 7.0%; for Level 2, % CV did not exceed 3.4%; and for Level 3, % CV did not exceed 1.3%.

These findings serve to demonstrate that the performance of the CRP-Latex (II)X2 SEIKEN Assay kit is substantially equivalent to the predicate device, N High Sensitivity CRP (Dade Behring).

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three overlapping profiles, suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol, emphasizing the organization's name and national affiliation.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

JUN - 2 2003

Re: K030545 Trade/Device Name: CRP-Latex (II)X2 SEIKEN Assay Kit Regulation Number: 21 CFR § 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: II Product Code: DKC Dated: April 30, 2003 Received: May 5, 2003

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). 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.

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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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director 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 CRP-Latex (II) SEIKEN X2 Assay Kit

C. Indications for use of the Device

Page 1 of 1

510(k) Number): ______________________________________________________________________________________________________________________________________________________________

CRP-Latex (II)X2 SEIKEN Assay Kit Device Name:

Indications for Use:

(Please do not write below this line-continue on another page if needed)

- - - - * * *

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Over-the-Counter Use

J. Prews for S.B. Bautista

of Clinical Laboratory Devices 100 00045

510(k) Number-

Regulation Number and Section

§ 866.5270 C-reactive protein immunological test system.

(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).