(124 days)
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.
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.
Here's an analysis of the acceptance criteria and study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state pre-defined acceptance criteria in terms of specific numeric thresholds for slope, intercept, and correlation coefficient. Instead, it relies on a "high correlation coefficient" as an indicator of substantial equivalence. The predicate device's performance characteristics (slope, intercept, correlation coefficient) likely serve as an implicit benchmark for "high correlation."
| Metric | Acceptance Criteria (Implicit from Predicate/General Expectation for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Slope | Close to 1.0 (indicating similar proportionality) | 0.927 |
| Intercept (mg/dL) | Close to 0.0 (indicating similar baseline/bias) | 19.784 |
| Correlation Coefficient | High (e.g., >0.95 or >0.90, indicating strong linear relationship) | 0.992 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 82 serum samples
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "serum samples."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to this kind of diagnostic device (immunoassay). The "truth" for the test set is established by the measurements obtained from the predicate device, which is an already legally marketed and validated assay. No human experts are used to interpret the results or establish "ground truth" in the way they would for imaging or clinical diagnosis.
4. Adjudication Method for the Test Set
Not applicable. The comparison is between two quantitative assays, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation, such as imaging AI, where the impact of AI assistance on human reader performance is evaluated. This submission is for a quantitative immunoassay.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, a standalone study was performed. The device's performance was compared directly against the predicate device without human intervention or interpretation as part of the primary measurement. The "algorithm" here refers to the immunoassay's ability to quantitatively determine transferrin levels.
7. Type of Ground Truth Used
The "ground truth" in this context is the quantitative determination of transferrin levels by the predicate device (Roche Tina-quant Transferrin ver.2). This is a common approach for establishing substantial equivalence for new diagnostic assays, where a well-established and legally marketed device serves as the reference standard.
8. Sample Size for the Training Set
The document does not specify a training set. This is a pre-market submission for an immunoassay, not a machine learning algorithm that typically requires a distinct training and test set in the same way. The development and optimization of the immunoassay reagents and methodology would have been an iterative process by the manufacturer, but the term "training set" as commonly applied to AI/ML is not relevant here. The studies described are for validation/testing.
9. How the Ground Truth for the Training Set Was Established
As no training set (in the AI/ML sense) is explicitly mentioned, this question is not directly applicable. The "ground truth" for the comparative performance study was established by the predicate device's measurements.
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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 TIATransferrin Calibrator SetTransferrin Control-L, Control M, Control-H |
| Common name, | Serum Transferrin immunological diagnostic assayTransferrin calibratorTransferrin 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,
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Roche Tina-quant Transferrin ver.2. The results are summarized below:
| Comparative Method | Slope | Intercept(mg/dL) | CorrelationCoefficient | n |
|---|---|---|---|---|
| Roche Tina-quantTransferrin 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 (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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§ 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).