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

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.

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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k063766

B. Purpose for Submission:
New device

C. Measurand:
Transferrin

D. Type of Test:
Turbidimetric immunoassay (TIA)

E. Applicant:
Good Biotech Corp.

F. Proprietary and Established Names:
Good Biotech Corp. Transferrin TIA, Transferrin Calibrator Set and Transferrin Control-L, Control-M, and Control-H

G. Regulatory Information:

1. Regulation sections:
21 CFR 866.5880 Transferrin immunological test system
21 CFR 862.1150 Calibrator
21 CFR 862.1660 Quality control material (assayed and unassayed)

2. Classifications:
Class II (Device and calibrator set)
Class I (Controls)

3. Product codes:
DDG Transferrin, antigen, antiserum, control
JIT Calibrator, secondary
JJX Single (specified) analyte controls (assayed and unassayed)

4. Panel:
Immunology (82) (Device)
Chemistry (75) (Calibrator and control)

H. Intended Use:

1. Intended use(s):
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.

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2. Indication(s) for use:
Same as the Intended Use

3. Special conditions for use statement(s):
Prescription use

4. Special instrument requirements:
The GBC Transferrin TIA assay is a ready to use reagent kit for chemistry analyzers capable of running an immunoturbidimetric assay. Performance was established by testing the reagents on the Hitachi 917 chemistry analyzer.

I. Device Description:
The GBC Transferrin reagent assay consists of Reagent 1 (R1), Reactive Tris Buffer solution and Reagent 2 (R2), a solution of duck anti-transferrin antibody. The assay is to be run in conjunction with the 6 levels of calibrators: 0, 50, 100, 200, 400 and 700 mg/dL, and 3 levels of controls: low, moderate, and high.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Roche Diagnostics Tina-quant Transferrin ver. 2; C.f.a.s. (Calibrators for automated systems) Protein Calibrators; and controls: Precinorm Protein and Precipath Protein

2. Predicate 510(k) number(s):
k012393

3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | New Device | Predicate |
| | GBC Transferrin | Roche Tina-quant V. 2 Transferrin |
| Indications for use | Aid in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia | Same |
| Methodology | Immunoturbidimetric | Same |
| Reference Interval | 200-360 mg/dL | Same |
| | GBC Transferrin | Roche Tina-quant v. 2 Transferrin |
| Calibrators | Six levels: 0, 50, 100, 200, 400, 700 mg/dL traceable to CRM-470 | Six levels [concentration factors based on lot assigned values] traceable to CRM-470 |

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| Differences | | |
| --- | --- | --- |
| Item | New Device | Predicate |
| Reagents | GBC Transferrin
Reagent 1 (Tris buffer)
Reagent 2 (duck anti-transferrin) | Roche Tina-quant v. 2 Transferrin
Reagent 1 (phosphate buffer, Reagent 2 (rabbit anti-transferrin) |
| Reagents | Low, medium and high | Normal and abnormal |
| Reagents | 10-700 mg/dL | 10-520 mg/dL |
| Reagent Stability | Unopened: 12 months (2°C - 10°C), Opened: 30 days (2°C - 10°C) | Unopened: up to the stated expiration (2°C - 8°C), Opened: 84 days refrigerated on the analyzer |
| Sample type | Serum | Serum and plasma |
| Sample volume | 2 μL/test | 3 μL/test |

K. Standard/Guidance Document Referenced (if applicable):
Replacement Reagent and Instrument Family Policy; Abbreviated 510(k)
Submissions for In Vitro Diagnostic Calibrators; Shelf Life of Medical Devices, FOD Number 415; CLSI EP14-A Evaluation of Matrix Effects, Approved Guideline.

L. Test Principle:
When a sample containing transferrin is mixed with the duck anti-transferrin antibodies, the resulting agglutination based on the antigen-antibody reaction increases the turbidity of the sample. The value of the absorbance change at 505nm is proportional to the transferrin concentration of the sample and is recorded by the instrument. The transferrin concentration of the serum sample is determined by comparison to a standard curve. The calibration curve is generated by running 6 standards with known concentrations.

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Three samples with three different levels of transferrin were prepared. For within run precision, each level was assayed 10 times.

| Within-run | | | |
| --- | --- | --- | --- |
| Replicates | 10 | 10 | 10 |
| Mean (mg/dL) | 65.1 | 143 | 377.2 |
| SD | 0.57 | 2.87 | 6.53 |
| CV % | 0.87 | 2.01 | 1.73 |

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Three samples measured in duplicate for 14 days were used to determine total precision.

| Total | | | |
| --- | --- | --- | --- |
| Replicates | 14 | 14 | 14 |
| Mean (mg/dL) | 107.5 | 210.91 | 452.07 |
| SD | 4.48 | 13.70 | 13.91 |
| CV % | 4.17 | 6.49 | 3.08 |

b. Linearity/assay reportable range:

Linearity: To cover the low and high ends of the measuring range, dilutions were made of the 100 and the $700\mathrm{mg / dL}$ calibrators. Linear regression analyses yielded $\mathbb{R}^2$ values of 0.9995 and 0.9982 for the low range and the high range respectively.



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Prozone Effect: Diluted samples were prepared from the transferrin standard (2,000 mg/dL). No hook effect was observed for the tested specimens up to 2,000 mg/dL compared to the upper limit of the measuring range of 700 mg/dL.

The assay reportable range is from 10 to 700 mg/dL.

c. Traceability, Stability, Expected values (controls, calibrators, or methods): The recommended calibrators are standardized against the Certified Reference Material, CRM 470. The calibrators are assigned values of 0, 50, 100, 200, 400 and 700 mg/dL. The zero calibrator is stable for 19 months and calibrators 50 – 700 mg/mL are stable for 4 years unopened and at the recommended storage conditions of 2°C - 10°C.

d. Detection Limit:

The detection limit was calculated as 2 SD above the mean response for the zero calibrator when assayed 20 times and was 0.4 mg/dL. The detection limit claim is 10 mg/dL.

e. Analytical specificity:

Interference testing was performed by spiking different levels of each interferant into low and high transferrin serum samples. Percent recoveries ranged from 94.4 to 106.6%. The following concentrations of potential interferants were tested.

| Potential interferant | Concentration |
| --- | --- |
| Bilirubin F | 60 mg/dL |
| Bilirubin C | 60 mg/dL |
| Chyle | 2,940 FTU |
| RF | 500 IU/mL |
| Hemoglobin | 1,000 mg/dL |

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

Serum samples from 82 patients were tested with the new device and the predicate. Transferrin values for the samples ranged from 33.0 to 648.5 mg/dL. Linear Regression Analysis showed: y = 0.927x + 19.784 mg/dL with a correlation coefficient of R² = 0.992.

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b. Matrix comparison: Both assays use serum as the recommended matrix.

3. Clinical studies:

a. Clinical Sensitivity: Not determined
b. Clinical specificity: Not determined
c. Other clinical supportive data (when a. and b. are not applicable): Not applicable

4. Clinical cut-off: Not applicable

5. Expected values/Reference range: The recommended reference interval is $200 - 360\mathrm{mg / dL}$ $(2.0 - 3.6\mathrm{g / L})$ . The interval may vary with the populations studied and individual laboratories should establish their own. The reference range is based on the published article, Dati F, et al. Consensus of a group of professional societies and diagnostic companies on guidelines for interim reference ranges for 14 proteins in serum based on the standardization against the IFCC/BCR/CAP reference material (CRM 470). Eur J Clin Chem Clin Biochem 1996; 34(6): 517-20.

N. Proposed Labeling: The labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10.

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O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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