Good Biotech Corp. CRPex-HS CRP Calibrator Set is intended to be used with CRPex-HS C-Reactive Protein LIT Assay for the quantitative determination of C-reactive protein (CRP) in serum samples. For In Vitro Diagnostic Use.

Device Description

The calibrators contain certain quantities of human C-reactive protein (CRP). CRPex-HS CRP Calibrator Set is intended to be used with CRPex-HS C-Reactive Protein LIT Assay for the quantitative determination of CRP in serum samples.

AI/ML Overview

Here's an analysis of the provided text regarding the CRPex-HS CRP Calibrator Set, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the CRPex-HS CRP Calibrator Set is a 510(k) premarket notification for a device that is substantially equivalent to a predicate. As such, explicit "acceptance criteria" for performance are not typically presented in the same way they would be for a de novo device. Instead, the primary "acceptance criterion" is generally "substantial equivalence" to the predicate device.

For calibration devices, this usually involves demonstrating comparable performance characteristics, particularly in terms of correlation with the predicate device across a range of expected concentrations.

Acceptance Criterion (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Device (Wako CRP-UL Calibrator Set)	Correlation Equation: y = 1.045 x - 0.141 (where x = Wako CRP-UL, y = CRPex-BR CRP LIT Kit) R-squared (R²): 0.998
Comparable Matrix/Biological Sources	Both use Liquid human serum
Comparable Preparation	Both are Ready for use
Comparable Expected CRP Concentration Range	CRPex-HS: 0.00, 0.50, 1.50, 5.00, 10.00, 20.00 mg/L Wako CRP-UL: 0.00, 1.25, 2.50, 5.00, 9.00 mg/L (Ranges overlap, though specific intermediate values differ slightly)
Comparable Traceability	Both are traceable to CAP/BCR/IFCC RPPHS, lot 91/0619

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: N = 67 (This refers to the number of data points used in the correlation study between the CRPex-BR CRP LIT Kit and the Wako CRP-UL predicate.)
Data Provenance: Not specified in the provided document. It does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is a calibration device used with an immunoassay for measuring C-reactive protein. The "ground truth" for such a device is typically established through reference materials and methodologies, rather than expert consensus on diagnostic images or clinical outcomes.
The document states that both the CRPex-HS CRP Calibrator Set and the predicate device are traceable to CAP/BCR/IFCC RPPHS, lot 91/0619. This implies that the 'ground truth' or accuracy of the calibrators is linked to this internationally recognized reference material, which would have been characterized by expert committees in the field of clinical chemistry/immunology. The number and specific qualifications of the experts involved in establishing this reference material are not provided within this 510(k) summary, as it's an external, established reference.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense. The test set involves quantitative comparison of CRP concentrations, not subjective interpretations requiring adjudication. The correlation study directly compares measurements from the test device's associated assay (CRPex-BR CRP LIT Kit) when calibrated by the test calibrator, against measurements given by the predicate calibrator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and the study assesses the impact of AI assistance on their performance. This device is a calibrator for an in vitro diagnostic assay, where direct human interpretation of the calibrator itself is not the primary function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not directly applicable in the typical sense for a calibrator. A calibrator is a physical substance used to set the measurement scale for an assay that then quantifies an analyte (CRP). It's not an "algorithm" in the way an AI diagnostic tool would be. However, the performance data provided (correlation, R²) effectively represents the "standalone" performance of the new calibrator in conjunction with its intended assay, compared to the predicate. The "human-in-the-loop" for this type of device would be the lab technician performing the assay, which is external to the calibrator's function itself.

7. The Type of Ground Truth Used

The ground truth used for the CRP concentrations in the calibrators themselves is based on traceability to a recognized international reference material: CAP/BCR/IFCC RPPHS, lot 91/0619. This ensures the measured values of CRP in the calibrator are accurate and standardized.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/machine learning algorithm. This device is a calibrator, not an AI system that learns from data.
The reported "N = 67" likely refers to the number of samples or measurements in the correlation study (test set), not a training set.

9. How the Ground Truth for the Training Set Was Established

As a "training set" for an AI algorithm is not applicable here, this question is not relevant. The CRP concentrations in the calibrators are established through the manufacturing process and verified against the aforementioned international reference standard.

Summary

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K021882

'JUL 11 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-HS CRP Calibrator Set
Submitter
Name,	Good Biotech Corp.
Address,	38 34th Road Taichung Industrial Park Taichung City 407 TaiwanR.O.C.
Telephone number,	+886-4-23596873
Contact person,	Victor Chiou
Preparation date	June 5, 2002
Device
Trade name,	CRPex-HS CRP Calibrator Set
Common name,	CRP Calibrators
Classification name	C-reactive protein immunological test system (21CFR 866.5270)
Predicate Device
Trade name,	Wako CRP-UL Calibrator Set
510(k) number	K003342
Description /Intended Use	The calibrators contain certain quantities of human C-reactive protein(CRP). CRPex-HS CRP Calibrator Set is intended to be used withCRPex-HS C-Reactive Protein LIT Assay for the quantitativedetermination of CRP in serum samples.

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The measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

For in vitro diagnostic use.

Substantial Equivalence

Item\Device	CRPex-HS CRPCalibrator Set	Wako CRP-ULCalibrator Set
Matrix / Biological Sources	Liquid human serum	Liquid human serum
Preparation	Ready for use	Ready for use
Expected CRPConcentration (mg/L)	0.00	0.00
	0.50	1.25
	1.50	2.50
	5.00	5.00
	10.00	9.00
	20.00
Traceability	CAP/BCR/IFCCRPPHS, lot 91/0619	CAP/BCR/IFCCRPPHS, lot 91/0619

Correlation

y = 1.045 x - 0.141 x = Wako CRP-UL y = CRPex-BR CRP LIT Kit R2 = 0.998 N = 67

Conclusion

Good Biotech Corp.'s CRPex-BR CRP Calibrator Set is substantially equivalent to the predicate device Wako CRP-UL calibrator set.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized image of a caduceus. The caduceus is a symbol often associated with healthcare and medicine. The seal is in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 11 2002

Mr. Victor Chiou President Good Biotech Corporation 38 34th Road Taichung Industrial Park Taichung City, Taiwan R.O.C.

K021882 Re:

Trade/Device Name: CRPex-HS 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: June 5, 2002 Received: June 7, 2002

Dear Mr. Chiou:

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 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: registration 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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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 (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/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

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): K O2 | 8 8 8 8 8 --

Device Name: CRPex-HS CRP Calibrator Set

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 _

Over-The-Counter Use _________

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

JP Reeves for S. Altaie

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).