DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511

K050713 · Good Biotech Corp. · DCN · Jun 6, 2005 · Immunology

Device Facts

• Record ID: K050713
• Device Name: DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511
• Applicant: Good Biotech Corp.
• Product Code: DCN · Immunology
• Decision Date: Jun 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

Good Biotech Corp. Duet hs-CRP LIT Assay is intended to be used as a high sensitive assay for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). Highly sensitive measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Good Biotech Corp. Duet hs-CRP Calibrator Set is intended to be used with Duet hs-CRP LIT Assay for the quantitative determination of C-reactive protein in serum samples. For in vitro diagnostic use.

Device Story

Duet hs-CRP LIT Assay uses latex particle enhanced immunoturbidimetry to quantify C-reactive protein (CRP) in serum samples. Reagents include a buffer and latex particles coated with duck anti-CRP IgY monoclonal antibodies. When sample CRP binds to sensitized latex particles, agglutination occurs, increasing absorbance at 570 nm. The assay is performed on the Roche Diagnostic Hitachi 911 Analyzer. The analyzer measures absorbance changes, which are proportional to CRP concentration, and calculates results via interpolation of a calibration curve. The device is intended for clinical laboratory use by trained personnel. Results assist clinicians in detecting and evaluating inflammatory conditions, tissue injury, and infection. The system includes a six-level calibrator set derived from human serum.

Clinical Evidence

Bench testing only. Performance validated via precision studies (CV < 10%), linearity (R^2=0.9997, range 0-200 mg/L), and detection limit (0.041 mg/L). Method comparison with predicate (n=93) showed high correlation (r=0.998). No prozone effect observed up to 800 mg/L. Specificity testing confirmed no interference from hemoglobin, bilirubin, or lipemia.

Technological Characteristics

Latex particle enhanced immunoturbidimetry (LIT). Reagents: buffer and latex particles coated with duck anti-CRP IgY monoclonal antibodies. Energy source: optical absorbance at 570 nm via Roche Hitachi 911 Analyzer. Calibrators: six-level stabilized human serum. Matrix: serum. Sterilization: not specified.

Indications for Use

Indicated for quantitative determination of C-reactive protein (CRP) in serum to aid in detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases in patients requiring high-sensitivity CRP measurement.

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 (3) and K-Assay CRP Multi-Calibrator D (k023828)

Submission Summary (Full Text)

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K050713

JUN 6 - 2005

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."

| <b>Submitter</b> | |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name, | Good Biotech Corp. |
| Address, | 38 34th Rd. Taichung Industrial Park Taichung 407 Taiwan |
| Telephone number, | [phone] |
| Contact person, | Victor Chiou |
| Preparation date | March 18, 2005 |
| <b>Device</b> | |
| Trade name, | Duet hs-CRP LIT Assay<br>Duet hs-CRP calibrator set |
| Common name, | CRP immunological diagnostic assay<br>CRP calibrator |
| Classification name | C-reactive protein immunological test system (21CFR 866.5270)<br>Calibrator (21CFR 862.1150) |
| <b>Predicate Device</b> | |
| Trade name, | K-ASSAY CRP (3)<br>K-ASSAY Multi-Calibrator D |
| 510(k) number | K023828 |
| <b>Description</b> | |
| | Duet hs-CRP LIT kit is the ready-to-use reagent suitable for<br>quantification of C-reactive protein by latex particle enhanced<br>immunoturbidimetry (LIT). Duck anti-CRP IgY (ΔFc) is |

# Duet hs-CRP LIT Assay/ Duet hs-CRP Calibrator Set

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coupled to polystyrene microparticles, which greatly increased the analytical sensitivity. When CRP of the sample encounters with the latex microparticles sensitized with duck anti-CRP IgY (ΔFc), agglutination among the latex microparticles occurs based on the antigen-antibody reaction. The agglutination increases the turbidity of the sample and the degree of agglutination is detected by the absorbance change at 570 nm. The value of the absorbance change is proportional to the CRP concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual CRP concentration of the sample is determined by interpolation of the calibration curve obtained by standard samples with known CRP concentrations.

#### Intended Use

Good Biotech Corp. Duet hs-CRP LIT Assay is intended to be used as a high sensitive assay for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). Highly sensitive measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Good Biotech Corp. Duet hs-CRP Calibrator Set is intended to be used with Duet hs-CRP LIT Assay for the quantitative determination of C-reactive protein in serum samples. For in vitro diagnostic use.

Duet hs-CRP LIT kit is a "ready to use" reagent kit for clinical Special chemistry auto-analyzers. Duet hs-CRP LIT kit has been tested on the Instrument Hitachi 911 Clinical Chemistry analyzer. Requirements Duet hs-CRP LIT kit was compared with Kamiya Biomedical Substantial Company's K-ASSAY CRP (3) to demonstrate the substantial Equivalence equivalence. Testing was performed on the Roche Diagnostics Hitachi

911 analyzer.

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| | | | Wavelength<br>Selection | Main-wavelength:570 nm<br>Sub-wavelength: 800 nm | Main-wavelength:570 nm<br>Sub-wavelength: 800 nm |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------------------------------|--------------------------------------------------|
| Item | Device | Predicate | Assay Range | 0.3-200 mg/L | 0.1-320 mg/L (standard protocol) |
| Reagent | | | Interference | Bilirubin C:<br>up to 45 mg/dl | Bilirubin C:<br>up to 30 mg/dl |
| Name | Duet hs-CRP LIT Assay | K-ASSAY CRP (3) | | Bilirubin F:<br>up to 45 mg/dl | Bilirubin F:<br>up to 30 mg/dl |
| | Good Biotech Corp. Duet<br>hs-CRP LIT Assay is<br>intended to be used as a high<br>sensitive assay for the<br>quantitative determination of<br>C-reactive protein in serum<br>by latex particle enhanced<br>immunoturbidimetry (LIT).<br>Highly sensitive<br>measurement of C-reactive<br>protein is useful for the<br>detection and evaluation of<br>infection, tissue injury,<br>inflammatory disorders and<br>associated diseases. | The K-ASSAY CRP (3) is<br>intended to be used as a<br>high-sensitive assay for<br>the quantitative<br>determination of CRP in<br>serum and plasma by<br>immunoturbidimetric<br>assay. Measurement of<br>C-Reactive Protein aids in<br>the detection and<br>evaluation of tissue injury,<br>inflammatory disorders,<br>and related diseases. | | Hemoglobin:<br>up to 805-mg/dl<br>hemoglobin | Hemoglobin:<br>up to 500 mg/dl |
| Intended Use | | | | Lipemia:<br>up to 10 g/L Liposyn®<br>(fat emulsion) | Lipid:<br>up to 3000 mg/dl Interfa |
| Methodology | Latex particle enhanced<br>immunoturbidimetry | Latex particle enhanced<br>immunoturbidimetry | | Calibrator | |
| Test Objective | C-reactive protein | C-reactive protein | | Name | Duet hs-CRP Calibrator Set |
| Type of Test | Quantitative | Quantitative | | Target Analyte | C-reactive protein |
| | Reagent 1 (R 1):<br>Reactive buffer solution | Reagent 1 (R 1):<br>Reactive buffer solution | | Matrix | Human serum |
| Product Type | Reagent 2 (R 2):<br>Latex suspension | Reagent 2 (R 2):<br>Latex suspension | Traceability | Traceable to IFCC<br>CRM470 | Traceable to IFCC<br>CRM470 |
| Antibody | Duck anti-CRP IgY(ΔFc) | Rabbit anti-CRP antibodies | Preservative | Sodium Azide | Sodium Azide |
| Source | □Egg Yolk□ | □Serum□ | Preparation | Liquid (ready-to-use) | Liquid (ready-to-use) |
| Calibration<br>Mode | Spline | Spline | | | |
| Sample<br>Volume | 2 µl/test | 3 µl/test | | | |
| Reagent<br>Volume | R1 150 µl/test<br>R2 150 µl/test | R1 150 µl/test<br>R2 150 µl/test | | | |

E-3

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## Correlation

| y = 0.955 x + 0.938 mg/L | y = 1.075 x + 0.226 mg/L |
|---------------------------------|--------------------------------|
| x = K-ASSAY CRP (3) | x = K-ASSAY CRP (3) |
| y = Duet hs-CRP LIT Assay | y = Duet hs-CRP LIT Assay |
| R2 = 0.998 | R2 = 0.996 |
| N = 93 (CRP conc.: 0~ 200 mg/L) | N = 64 (CRP conc.: 0~ 10 mg/L) |

## Conclusion

Good Biotech Corp. Duet hs-CRP LIT assay and calibrator set are substantially equivalent to the predicate devices based on their intended purposes, design and the comparison performance results.

mg/L)

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes extending upwards and to the right.

JUN 6 - 2005

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Victor Chiou President Good Biotech Corp. 38 34th Road Taichung Industrial Park Taichung City, 407 Taiwan

Re: k050713

> Trade/Device Name: Duet hs-CRP LIT Assay Duet 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, JIT Dated: May 10, 2005 Received: May 11, 2005

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 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).

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#### Page 2 -

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.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Carol C. Benson

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K050713

Device Name: Duet hs-CRP LIT Assay ; Duet hs-CRP Calibrator Set

Indications For Use:

Good Biotech Corp. Duet hs-CRP LIT Assay is intended to be used as a high sensitive assay for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). Highly sensitive measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

Good Biotech Corp. Duet hs-CRP Calibrator Set is intended to be used with Duet hs-CRP LIT Assay for the quantitative determination of C-reactive protein in serum samples.

For In Vitro Diagnostic Use.

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Rute cineler

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