CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET

K021757 · Good Biotech Corp. · DCN · Jul 29, 2002 · Immunology

Device Facts

• Record ID: K021757
• Device Name: CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET
• Applicant: Good Biotech Corp.
• Product Code: DCN · Immunology
• Decision Date: Jul 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended 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.

Device Story

CRPex-BR is an in vitro diagnostic assay for quantitative measurement of C-reactive protein (CRP) in human serum. It utilizes latex particle enhanced immunoturbidimetry (LIT); duck anti-CRP IgY (ΔFc) antibodies are coupled to polystyrene microparticles. When mixed with patient serum, CRP antigen-antibody reactions cause agglutination, increasing turbidity. The device is intended for professional use in clinical laboratories. It is used on automated clinical chemistry analyzers (e.g., Hitachi 717/7150). The analyzer measures absorbance at 570 nm and 800 nm; results are calculated via a spline calibration curve. Healthcare providers use the resulting CRP concentration to assess the extent of tissue injury. The assay provides a quantitative range of 1-300 mg/L.

Clinical Evidence

Bench testing only. Correlation study performed comparing CRPex-BR to the predicate device using 94 human serum samples, yielding a regression equation of y = 0.976x + 1.179 and R2 = 0.998. Interference testing evaluated bilirubin, hemolysis, and lipemia.

Technological Characteristics

Latex particle enhanced immunoturbidimetry. Reagents: R1 (buffer), R2 (polystyrene microparticles coated with duck anti-CRP IgY). Wavelengths: 570 nm (main), 800 nm (sub). Calibration: Spline mode. Assay range: 1-300 mg/L. Sample volume: 3 µl. Automated analyzer compatibility.

Indications for Use

Indicated for quantitative determination of C-reactive protein in human serum to aid in evaluating tissue injury. For professional in vitro diagnostic use.

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

• K-ASSAY CRP (1) (K992311)

Submission Summary (Full Text)

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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 Taiwan<br>R.O.C. |
| Telephone number, | [phone] |
| Contact person, | Victor Chiou |
| Preparation date | May 24, 2002 |
| Device | |
| Trade name, | CRPex-BR C-reactive protein LIT assay<br>CRPex-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)<br>K-ASSAY multi-calibrator.C |
| 510(k) number | K992311 |
| Description | |
| | CRPex-BR C-reactive protein LIT Kit is the ready-to-use reagent<br>suitable for quantification of C-reactive protein by latex particle<br>enhanced 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-BR<br>CRP LIT Kit | K-ASSAY<br>CRP (1) |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Measurement of<br>C-reactive protein aids in<br>evaluation of the amount<br>of injury to body tissues. | |
| Methodology | Latex particle enhanced<br>immunoturbidimetry | Latex particle enhanced<br>immunoturbidimetry |
| Test Objective | C-reactive protein | C-reactive protein |
| Test Principle | Latex microparticle<br>agglutination based on<br>antigen-antibody reaction | Latex microparticle<br>agglutination based on<br>antigen-antibody reaction |
| Type of Test | Quantitative | Quantitative |
| Product Type | Reagent 1 (R 1):<br>Reactive buffer solution<br>Reagent 2 (R 2):<br>Latex suspension | |
| Antibody<br>【Source】 | Duck anti-CRP IgY(ΔFc)<br>【Egg Yolk】 | Rabbit anti-CRP antibodies<br>【Serum】 |
| Sterility | N.A. | N.A. |
| Specimen | Human serum | Human serum |
| Operating<br>Requirement | For professional use only | For professional use only |
| Calibration Mode | Spline | Spline |
| Calibrator | CRPex-BR Calibrator Set | K-ASSAY CRP<br>Multi-Calibrator Set C<br>(standard protocol);<br>K-ASSAY CRP<br>Multi-Calibrator Set A<br>(high sensitivity protocol) |
| Sample Volume | 3 µl/test | 3 (15) µl/test |
| Reagent<br>Volume | R1 : 150 µl/test<br>R2 : 150 µl/test | R1 : 150 µl/test<br>R2 : 150 µl/test |
| Wavelength<br>Selection | Main-wavelength:570 nm<br>Sub-wavelength: 800 nm | Main-wavelength:570 nm<br>Sub-wavelength: 800 nm |
| Assay Code<br>【Hitachi 717 (7150)】 | 2 point:<br>(27)-(40) | 2 point:<br>(28)-(42) |
| Assay Range | 1-300 mg/L | 1-300 mg/L (standard<br>protocol)<br>0.1-20 mg/L (high<br>sensitivity protocol) |
| Calibration Curve | Nearly linear | Nearly Curved |
| Interference | Bilirubin C:<br>up to 60 mg/dl<br>Bilirubin F:<br>up to 60 mg/dl<br>Hemolysis:<br>up to 500-mg/dl<br>hemoglobin<br>Lipemia:<br>up to 10 g/L Liposyn®<br>(fat emulsion) | Bilirubin C:<br>up to 60 mg/dl<br>Bilirubin F:<br>up to 60 mg/dl<br>Hemoglobin:<br>up to 500 mg/dl<br>Lipid:<br>up to 1500 mg/dl<br>triglyceride |

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#### Correlation

ం

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 [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/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)