TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C

K063766 · Good Biotech Corp. · DDG · Apr 23, 2007 · Immunology

Device Facts

• Record ID: K063766
• Device Name: TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C
• Applicant: Good Biotech Corp.
• Product Code: DDG · Immunology
• Decision Date: Apr 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5880
• Device Class: Class 2

Intended Use

Good Biotech, Corp. Transferrin test system is intended to be used for the quantitative determination of transferrin in human serum by turbidimetric immunoassay (TIA). Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia. Good Biotech, Corp. Transferrin Calibrator Set is intended to be used with Transferrin TIA for the quantitative determination of transferrin in serum samples. Good Biotech, Corp. Transferrin Controls are intended to be used as the assayed quality control material for transferrin analysis.

Device Story

The device is an in vitro diagnostic reagent system for quantitative transferrin measurement in human serum. It utilizes a turbidimetric immunoassay (TIA) where serum transferrin reacts with duck anti-transferrin antibodies to form agglutination, increasing sample turbidity. A general chemistry autoanalyzer measures absorbance change at 505 nm; the concentration is determined by interpolating against a calibration curve generated from known standards. The system includes reagents, calibrators, and assayed controls. It is intended for use by clinical laboratory professionals to assist in diagnosing malnutrition, inflammation, infection, and anemia. Results are used by clinicians to inform patient management and diagnostic decisions.

Clinical Evidence

No clinical studies performed. Analytical performance established via bench testing. Precision: within-run CV 0.87-2.01%, total CV 3.08-6.49%. Linearity: R² 0.9982-0.9995 over 10-700 mg/dL range. Method comparison: 82 serum samples tested against predicate yielded y = 0.927x + 19.784, R² = 0.992. Interference testing showed 94.4-106.6% recovery for bilirubin, chyle, RF, and hemoglobin.

Technological Characteristics

Turbidimetric immunoassay. Reagents: Tris buffer (R1) and duck anti-transferrin antibody (R2). Calibrators: 6 levels (0-700 mg/dL) traceable to CRM-470. Analytical range: 10-700 mg/dL. Detection limit: 0.4 mg/dL. Compatible with automated chemistry analyzers (e.g., Hitachi 917). Storage: 2°C - 10°C.

Indications for Use

Indicated for quantitative determination of transferrin in human serum to aid in diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders (e.g., iron deficiency anemia).

Regulatory Classification

Identification

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Predicate Devices

• Roche Tina-quant Transferrin ver.2 (K012393)

Submission Summary (Full Text)

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K063766

APR 2 3 2007

# 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."

| | Transferrin TIA/ Transferrin Calibrator Set / |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Transferrin Control-L, Control M, Control-H |
| Submitter | |
| Name, | Good Biotech Corp. |
| Address, | 38 34th Rd. Taichung Industrial Park Taichung City 407 Taiwan |
| Telephone number, | [phone] |
| Contact person, | Victor Chiou |
| Preparation date | 12/15/2006 |
| Device | |
| Trade name, | Transferrin TIA<br>Transferrin Calibrator Set<br>Transferrin Control-L, Control M, Control-H |
| Common name, | Serum Transferrin immunological diagnostic assay<br>Transferrin calibrator<br>Transferrin control |
| Classification name | Transferrin immunological test system (21 CFR § 866.5880)<br>Calibrator (21 CFR § 862.1150)<br>Quality control material (assayed and unassayed) (21 CFR § 862.1660) |
| Predicate Device | |
| Trade name, | Roche Tina-quant Transferrin ver.2 |
| 510(k) number | K012393 |

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#### Description

Good Biotech Corp. Transferrin TIA is a ready to use reagent for the quantitative determination of transferrin in human serum by turbidimetric immunoassay (TIA). When transferrin of the serum sample encounters with duck anti-transferrin antibody, the aqqlutination based on the antigen-antibody reaction increases the turbidity of the sample. The value of the absorbance change at 505 nm is proportional to the transferrin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual transferrin concentration of the serum sample is determined by interpolation of the calibration curve obtained by standard samples with known transferrin concentrations.

#### Intended Use

#### Reagent:

Good Biotech Corp. Transferrin test system is intended to be used for the quantitative determination of transferrin in human serum by turbidimetric immunoassay (TIA). Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

#### Calibrator:

Good Biotech Corp. Transferrin Calibrator Set is intended to be used with Transferrin TIA for the quantitative determination of transferrin in serum samples.

#### Control:

Good Biotech Corp. Transferrin Controls are intended to be used as the assayed quality control material for transferrin analysis.

For In Vitro Diagnostic Use.

#### Substantial Equivalence

Comparative performance studies conducted on 82 serum samples yielded high correlation coefficients upon comparison of the GBC Transferrin TIA system and the predicate devices,

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Roche Tina-quant Transferrin ver.2. The results are summarized below:

| Comparative Method | Slope | Intercept<br>(mg/dL) | Correlation<br>Coefficient | n |
|---------------------------------------|-------|----------------------|----------------------------|----|
| Roche Tina-quant<br>Transferrin ver.2 | 0.927 | 19.784 | 0.992 | 82 |

### Conclusion

Good Biotech Corp. Transferrin TIA system, calibrator set and controls are substantially equivalent to the predicate devices based on their intended purposes, design and the comparison performance results.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Good Biotech Corporation c/o Mr. Victor Chiou President 38 34th Road Taichung Industrial Park Taichung 407 Taiwan

APR 2 3 2007

Re: k063766

Trade/Device Name: Good Biotech Corp. Transferrin TIA Good Biotech Corp. Transferrin Calibrator Set Good Biotech Corp. Transferrin Control-L. Control-M, Control-H Regulation Number: 21 CFR 866.5880 Regulation Name: Transferrin Immunological Test System Regulatory Class: Class II Product Code: DDG, JIT, JJX Dated: March 26, 2007 Received: March 26, 2007

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

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forth in the quality systems (QS) regulation (21 CFR Part 820). 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" (21 CFR 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.

Robert H. Barker/

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

### 510(k) Number (if known): K Ob37(oCo

#### Transferrin TIA Transferrin Calibrator Set Transferrin Control-L, Control-M, Control-H Device Name:

#### Indications For Use:

Good Biotech Corp. Transferrin test system is intended to be used for the quantitative determination of transferrin in human serum by turbidimetric immunoassay (TIA). Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia

Good Biotech Corp. Transferrin Calibrator Set is intended to be used with Transferrin TIA for the quantitative determination of transferrin in serum samples.

Good Biotech Corp. Transferrin Controls are intended to be used as the assayed quality control material for transferrin analysis.

For In Vitro Diagnostic Use.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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)

Mana

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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K063766