(124 days)
Not Found
No
The device description details a standard turbidimetric immunoassay method using antigen-antibody reactions and absorbance measurements. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis relies on a calibration curve and interpolation, which are not AI/ML techniques.
No
The device is an in vitro diagnostic (IVD) test system for measuring transferrin levels, which aids in diagnosis but does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device aids in the diagnosis of various conditions, such as malnutrition, acute inflammation, infection, and red blood cell disorders.
No
The device description clearly indicates it is a reagent kit for a turbidimetric immunoassay, which is a chemical-based test requiring laboratory equipment (a general chemistry autoanalyzer) to measure absorbance. This involves physical components and chemical reactions, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For In Vitro Diagnostic Use" in the "Intended Use / Indications for Use" section.
- Intended Use: The intended use is for the "quantitative determination of transferrin in human serum," which is a biological sample taken from the body.
- Diagnostic Purpose: The measurement of transferrin levels is stated to "aid in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia." This clearly indicates a diagnostic purpose.
- Device Description: The device description details a method for analyzing a biological sample (serum) using a chemical reaction (turbidimetric immunoassay) to obtain a quantitative result.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DDG, JIT, JJX
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative performance studies conducted on 82 serum samples yielded high correlation coefficients upon comparison of the GBC Transferrin TIA system and the predicate devices, Roche Tina-quant Transferrin ver.2.
Summary:
Comparative Method: Roche Tina-quant Transferrin ver.2
Slope: 0.927
Intercept (mg/dL): 19.784
Correlation Coefficient: 0.992
n: 82
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient: 0.992
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.5880 Transferrin immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).
0
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, | +886-4-23596873 |
| Contact person, | Victor Chiou |
| Preparation date | 12/15/2006 |
| Device | |
| Trade name, | Transferrin TIA |
| Transferrin Calibrator Set | |
| Transferrin Control-L, Control M, Control-H | |
| Common name, | Serum Transferrin immunological diagnostic assay |
| Transferrin calibrator | |
| Transferrin control | |
| Classification name | Transferrin immunological test system (21 CFR § 866.5880) |
| Calibrator (21 CFR § 862.1150) | |
| 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,
2
Roche Tina-quant Transferrin ver.2. The results are summarized below:
| Comparative Method | Slope | Intercept
(mg/dL) | Correlation
Coefficient | n |
|---------------------------------------|-------|----------------------|----------------------------|----|
| Roche Tina-quant
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.
3
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 (240) 276-0450. 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 (800) 638-2041 or (240) 276-3150 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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