CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510

K021882 · Good Biotech Corp. · DCN · Jul 11, 2002 · Immunology

Device Facts

• Record ID: K021882
• Device Name: CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510
• Applicant: Good Biotech Corp.
• Product Code: DCN · Immunology
• Decision Date: Jul 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

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 Story

The CRPex-HS CRP Calibrator Set consists of liquid human serum containing specific quantities of C-reactive protein (CRP). It is used as a calibration tool in conjunction with the CRPex-HS C-Reactive Protein LIT Assay. The device is intended for in vitro diagnostic use in clinical laboratory settings. By providing known concentrations of CRP, the calibrator allows the assay to establish a standard curve for the quantitative measurement of CRP in patient serum samples. Healthcare providers use the resulting CRP concentration values to assist in the detection and clinical evaluation of inflammatory conditions, infections, and tissue injury. The device is ready for use and traceable to international standards (CAP/BCR/IFCC RPPHS).

Clinical Evidence

No clinical trials were performed. Substantial equivalence was established via bench testing, specifically a correlation study comparing the subject device to the predicate (Wako CRP-UL). The study included 67 samples and yielded a correlation coefficient (R2) of 0.998, with a regression equation of y = 1.045x - 0.141.

Technological Characteristics

Liquid human serum matrix; ready-to-use form factor. Traceable to CAP/BCR/IFCC RPPHS (lot 91/0619). Quantitative calibrator set for immunological test systems (21 CFR 866.5270).

Indications for Use

Indicated for use in the quantitative determination of C-reactive protein (CRP) in human serum samples to aid in the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases.

Regulatory Classification

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.

Predicate Devices

• Wako CRP-UL Calibrator Set (K003342)

Submission Summary (Full Text)

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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 Taiwan<br>R.O.C. |
| Telephone number, | [phone] |
| 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 /<br>Intended Use | The calibrators contain certain quantities of human C-reactive protein<br>(CRP). CRPex-HS CRP Calibrator Set is intended to be used with<br>CRPex-HS C-Reactive Protein LIT Assay for the quantitative<br>determination 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 CRP<br>Calibrator Set | Wako CRP-UL<br>Calibrator Set |
|--------------------------------------|------------------------------------|------------------------------------|
| Matrix / Biological Sources | Liquid human serum | Liquid human serum |
| Preparation | Ready for use | Ready for use |
| Expected CRP<br>Concentration (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/IFCC<br>RPPHS, lot 91/0619 | CAP/BCR/IFCC<br>RPPHS, 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 [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/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:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _

OR

Over-The-Counter Use _________

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

JP Reeves for S. Altaie