Good Biotech Corp. CRPex-BR C-reactive protein LIT assay is intended to be used for quantitative determination of C-reactive protein in serum. The measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. For in vitro diagnostic use.

Good Biotech Corp. CRPex-BR CRP calibrator set is intended to be used with CRPex-BR C-reactive protein LIT assay for the quantitative determination of C-reactive protein in serum samples.

For In Vitro Diagnostic Use.

Device Description

CRPex-BR C-reactive protein LIT Kit is the ready-to-use reagent suitable for quantification of C-reactive protein by latex particle enhanced immunoturbidimetry (LIT). Duck anti-CRP IgY (△Fc) is coupled to polystyrene microparticles, which greatly increased the analytical sensitivity.

AI/ML Overview

This document describes the CRPex-BR C-reactive protein LIT assay, a device for the quantitative determination of C-reactive protein in serum. The submission aims to demonstrate its substantial equivalence to the predicate device, K-ASSAY CRP (1).

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

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail format. However, substantial equivalence is claimed based on a correlation study comparing the CRPex-BR C-reactive protein LIT kit with the predicate device, K-ASSAY CRP (1). The performance is reported as a regression analysis and correlation coefficient:

Performance Metric	Acceptance Criteria (Implicit from Predicate Equivalence)	Reported Device Performance (CRPex-BR C-reactive protein LIT kit vs. K-ASSAY CRP (1))
Linear Regression	Not explicitly defined, but close to y=x	y = 0.976 x + 1.179 mg/L
Correlation (R²)	Not explicitly defined, but very high (close to 1)	R² = 0.998

Additional characteristics for substantial equivalence were presented, indicating the CRPex-BR device aims to match the predicate device in aspects such as intended use, methodology, test objective, test principle, type of test, specimen type, operating requirement, calibrator, sample volume, reagent volume, wavelength selection, and assay range. The interference results are also presented for comparison.

2. Sample size used for the test set and the data provenance

Sample size for the test set: N = 94
Data provenance: The document does not specify the country of origin of the data. It's also not explicitly stated whether the study was retrospective or prospective, but given it's a correlation study with patient samples, it's likely retrospective or a cross-sectional prospective study comparing results from the two devices on collected samples.

3. 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 document. For an in vitro diagnostic device like this, "ground truth" is typically established by comparative measurement to a gold standard or a well-established predicate device, rather than expert review of images or clinical cases. The predicate device (K-ASSAY CRP (1)) served as the reference for comparison, and its measurements were presumably used as the 'truth' for evaluating the new device.

4. Adjudication method for the test set

This information is not applicable/not provided for this type of in vitro diagnostic device study. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or clinical outcomes, where human experts might disagree. For an assay comparing quantitative measurements, the comparison is directly between the numerical results of the two devices.

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

This is not applicable to this submission. MRMC studies are relevant for medical imaging AI devices where human readers interpret cases with and without AI assistance. This device is an in vitro diagnostic assay for C-reactive protein measurement, not an imaging interpretation tool. There is no human-in-the-loop interpretation intended for this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This concept is fundamentally applicable to this device, though the wording "algorithm only" is more typical for AI software. This device is an automated in vitro diagnostic assay. Its performance, as reported by the y = 0.976 x + 1.179 mg/L and R² = 0.998 correlation with the predicate device, represents its "standalone" performance. There is no human interpretation or intervention in the measurement process of the CRPex-BR assay itself, beyond operating the instrument and preparing samples.

7. The type of ground truth used

The ground truth for evaluating the CRPex-BR device was established by comparison to the results obtained from the predicate device, K-ASSAY CRP (1). This is a common method for demonstrating substantial equivalence for in vitro diagnostic devices, where the predicate is considered the established method.

8. The sample size for the training set

This information is not provided and is generally not applicable in the context of traditional in vitro diagnostic assays like this. "Training set" is a concept primarily used in machine learning or AI where an algorithm learns from data. This device relies on chemical and immunoturbidimetric principles, not machine learning, so there is no "training set" in the AI sense.

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

As there is no "training set" in the AI sense for this device, this question is not applicable.

Summary

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KC21757

JUL 2 9 2002

510(k) Summary Safety and Effectiveness

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

CRPex-BR C-Reactive Protein LIT Assay
Submitter
Name,	Good Biotech Corp.
Address,	38 34 th Rd. Taichung Industrial Park Taichung City 407 TaiwanR.O.C.
Telephone number,	+886-4-23596873
Contact person,	Victor Chiou
Preparation date	May 24, 2002
Device
Trade name,	CRPex-BR C-reactive protein LIT assayCRPex-BR CRP calibrator set
Common name,	CRP immunological diagnostic assay
Classification name	C-reactive protein immunological test system (21CFR 866.5270)
Predicate Device
Trade name,	K-ASSAY CRP (1)K-ASSAY multi-calibrator.C
510(k) number	K992311
Description
	CRPex-BR C-reactive protein LIT Kit is the ready-to-use reagentsuitable for quantification of C-reactive protein by latex particleenhanced immunoturbidimetry (LIT). Duck anti-CRP IgY (△Fc) is

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coupled to polystyrene microparticles, which greatly increased the analytical sensitivity.

Intended Use

Good Biotech Corp. CRPex-BR C-reactive protein LIT kit is intended to be used for quantitative determination of C-reactive protein in serum. The measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. For in vitro diagnostic use.

Substantial

Equivalence

CRPex-BR C-reactive protein LIT kit is compared with Kamiya Biomedical Company's K-ASSAY CRP (1) to demonstrate the substantial equivalence.

。

Item\Device	CRPex-BRCRP LIT Kit	K-ASSAYCRP (1)
Intended Use	Measurement ofC-reactive protein aids inevaluation of the amountof injury to body tissues.
Methodology	Latex particle enhancedimmunoturbidimetry	Latex particle enhancedimmunoturbidimetry
Test Objective	C-reactive protein	C-reactive protein
Test Principle	Latex microparticleagglutination based onantigen-antibody reaction	Latex microparticleagglutination based onantigen-antibody reaction
Type of Test	Quantitative	Quantitative
Product Type	Reagent 1 (R 1):Reactive buffer solutionReagent 2 (R 2):Latex suspension
Antibody【Source】	Duck anti-CRP IgY(ΔFc)【Egg Yolk】	Rabbit anti-CRP antibodies【Serum】
Sterility	N.A.	N.A.
Specimen	Human serum	Human serum
OperatingRequirement	For professional use only	For professional use only
Calibration Mode	Spline	Spline
Calibrator	CRPex-BR Calibrator Set	K-ASSAY CRPMulti-Calibrator Set C(standard protocol);K-ASSAY CRPMulti-Calibrator Set A(high sensitivity protocol)
Sample Volume	3 µl/test	3 (15) µl/test
ReagentVolume	R1 : 150 µl/testR2 : 150 µl/test	R1 : 150 µl/testR2 : 150 µl/test
WavelengthSelection	Main-wavelength:570 nmSub-wavelength: 800 nm	Main-wavelength:570 nmSub-wavelength: 800 nm
Assay Code【Hitachi 717 (7150)】	2 point:(27)-(40)	2 point:(28)-(42)
Assay Range	1-300 mg/L	1-300 mg/L (standardprotocol)0.1-20 mg/L (highsensitivity protocol)
Calibration Curve	Nearly linear	Nearly Curved
Interference	Bilirubin C:up to 60 mg/dlBilirubin F:up to 60 mg/dlHemolysis:up to 500-mg/dlhemoglobinLipemia:up to 10 g/L Liposyn®(fat emulsion)	Bilirubin C:up to 60 mg/dlBilirubin F:up to 60 mg/dlHemoglobin:up to 500 mg/dlLipid:up to 1500 mg/dltriglyceride

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Correlation

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y = 0.976 x + 1.179 mg/L x = K-ASSAY CRP (1) y = CRPex-BR C-reactive protein LIT kit R2 = 0.998 N = 94

Conclusion

Good Biotech Corp.'s CRPex-BR C-reactive protein LIT kit is substantially equivalent to the predicate device K-ASSAY CRP (1).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted with flowing lines, giving a sense of movement. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Victor Choiu President Good Biotech Corp. 38 34th Raod - Taichung Industrial Park 407 Taichung City, Taiwan Taiwan R.O.C.

Re: K021757

Trade/Device Name: CRPex-BR C-reactive protein LIT assay CRPex-BR CRP calibrator set Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: May 24, 2002 Received: May 29, 2002

Dear Mr. Choiu:

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.

JUL 2 9 2002

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 the Code of Federal 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 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: recistration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact.the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely vours.

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

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): KO21757

CRPex-BR C-reactive protein LIT assay Device Name: CRPex-BR CRP calibrator set

Indications For Use:

Good Biotech Corp. CRPex-BR C-reactive protein LIT assay is intended to be used for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry. The measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Good Biotech Corp. CRPex-BR CRP calibrator set is intended to be used with CRPex-BR C-reactive protein LIT assay for the quantitative determination of C-reactive protein in serum samples.

For In Vitro Diagnostic Use.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

J P Reeves for 6. Altare

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021757

Prescription Use / OR Over-The-Counter Use __

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

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).