Good Biotech Corp. (GBC) Ferritin LIT Assay is intended to be used for the quantitative determination of ferritin in human serum by latex particle enhanced immunoturbidimetry (LIT). Measurement of ferritin aids in the diagnosis of diseases affecting iron metabolism.

GBC Ferritin Calibrator Set is intended to be used with GBC Ferritin LIT Assay for the quantitative determination of ferritin in serum samples.

GBC ferritin Controls are intended to be used as the assayed quality control material for ferritin analysis.

For In Vitro Diagnostic Use.

For Prescription Use Only

Device Description

Good Biotech Corp. Ferritin LIT Assay is a ready to use reagent for the quantitative determination of ferritin by latex particle enhanced immunoturbidimetry (LIT). Duck anti-ferritin IgY(ΔFc) is coupled to polystyrene microparticles, which greatly increase the analytical sensitivity. When ferritin of the sample encounters with the latex microparticles sensitized with duck anti-ferritin IgY(AFc), 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 ferritin concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual ferritin concentration of the sample is determined by interpolation of the calibration curve obtained by standard samples with known ferritin concentrations.

AI/ML Overview

This 510(k) submission describes the Ferritin LIT Assay, Ferritin Calibrator Set, and Ferritin Controls (Level-L & Level-H) developed by Good Biotech Corp. The purpose of the study was to demonstrate substantial equivalence to a predicate device, the Biokit quantex Ferritin system.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Comparative Study)
High correlation coefficient with predicate device	Slope: 1.07
	Intercept: -17.73 ng/ml
	Correlation Coefficient: 0.9808

Note: The document does not explicitly state numerical acceptance criteria for slope, intercept, or correlation coefficient. However, a "high correlation coefficient" is an implicit acceptance criterion for demonstrating substantial equivalence based on comparative performance studies.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 50 serum samples
Data Provenance: Retrospective (clinical samples for comparative study). The country of origin is not specified but given the submitter is in Taiwan, it is likely the samples were sourced there.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is an in vitro diagnostic (IVD) device for quantifying ferritin in human serum. The "ground truth" for comparative studies in IVD typically refers to the results obtained from a reference method (the predicate device in this case) rather than expert interpretation of images or other subjective data. No human experts were involved in establishing the "ground truth" in the way described for medical imaging devices.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used when subjective interpretations are involved, such as in clinical trials or medical imaging studies to resolve discrepancies among experts. This study involves quantitative measurements, where the "ground truth" is established by the predicate device's numerical output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess improvements in reader performance. This device is an automated IVD assay, not a device requiring human interpretation of complex data.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance study conducted was a standalone performance of the device. The Ferritin LIT Assay directly measures ferritin concentration in serum samples without human intervention in the measurement process (beyond sample handling and initiation of the automated analyzer). The comparison was between the new assay and the predicate device's measurements.

7. The Type of Ground Truth Used

The "ground truth" used for the comparative study was the results obtained from the predicate device (Biokit quantex Ferritin). This is a common practice in IVD substantial equivalence demonstrations, where the new device's performance is compared against an already legally marketed and accepted device.

8. The Sample Size for the Training Set

The document does not report a separate training set size. For IVD assays, development often involves internal optimization and calibration using various samples, but a formally defined "training set" in the context of machine learning or AI is not typically described in these types of 510(k) summaries unless the device incorporates such algorithms. The 50 serum samples mentioned were for the comparative performance study (test set).

9. How the Ground Truth for the Training Set Was Established

Since a distinct "training set" (as typically defined in AI/ML contexts) is not described, the method for establishing its "ground truth" is not provided. For IVD assay development, calibration is typically performed using calibrators with known concentrations, and controls are used to verify performance within established ranges. The "GBC Ferritin Calibrator Set" and "GBC ferritin Controls" are mentioned as being used with the assay to establish the calibration curve and for quality control, respectively. These materials would have their "ground truth" concentrations established through rigorous analytical methods by the manufacturer.

Summary

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K052617

FEB 2 3 2006

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 866.5340"

Ferritin LIT Assay / Ferritin Calibrator Set / Ferritin Control-L, Control-H
Submitter
Name,	Good Biotech Corp.
Address,	38 34th Road, Taichung Industrial Park Taichung 407 Taiwan
Telephone number,	+886-4-23596873
Contact person,	Victor Chiou
Preparation date	September 20, 2005
Device
Trade name,	Ferritin LIT AssayFerritin Calibrator SetFerritin Controls, Level-L & Level-H
Common name,	Ferritin immunological diagnostic assayFerritin calibratorFerritin control
Classification name	Ferritin immunological test system (21 CFR § 866.5340)Calibrator (21 CFR § 862.1150)Quality control material (assayed and unassayed) (21 CFR § 862.1660)
Predicate Device
Trade name,	Biokit quantex FerritinBiokit quantex FERRITIN standard multipoint

K040879

510(k) number

Biokit quantex FERRITIN / MYOGLOBIN / IgE control I/II

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Description

Intended Use

Reagent:

Calibrator:

GBC Ferritin Calibrator Set is intended to be used with GBC Ferritin LIT Assay for the quantitative determination of ferritin in serum samples.

Control:

GBC ferritin Controls are intended to be used as the assayed quality control material for ferritin analysis.

For In Vitro Diagnostic Use.

For Prescription Use Only

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Substantial Equivalence

Comparative performance studies conducted on 50 serum samples yielded high correlation coefficient upon comparison of the GBC Ferritin LIT system and the predicate devices, Biokit quantex Ferritin. The result is summarized below:

Comparative Method	Slope	Intercept(ng/ml)	CorrelationCoefficient	n
Biokit quantex Ferritin	1.07	-17.73	0.9808	50

Conclusion

Good Biotech Corp. Ferritin LIT assay, 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 3 2006

Good Biotech Corp. c/o Mr Victor Chiou President 38, 34" Rd Taichung Industrial Park Taichung, TW 407.

Re: K052617

KU2017
Trade/Device Name: Ferritin LIT Assay, Ferritin Calibrator Set and Ferritin Controls, Level L and Level H Regulation Number: 21 CFR 866.5340

Regulation Name: Ferritin immunological test system Regulatory Class: Class II Product Code: DBF, JIT, JJX Dated: September 20, 2005 Received: September 23, 2005

Dear Mr. Chiou:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave it viewed your beetion 970(t) procession is substantially equivalent (for the indications for referenced above and have to legally marketed predicate devices marketed in interstate commerce use suned in the enactment date of the Medical Device Amendments, or to devices that provision in the First, and cordance with the provisions of the Federal Food, Drug, and Cosmetic nave been roetassified in are approval of a premarket approval application (PMA). You may, Act (fiel) market the device, subject to the general controls provisions of the Act. The general therefore, mained 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 n your device to such additional controls. Existing major regulations affecting your device can be may be subject to sam adam 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 thus 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); an the Fee L FFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will allow you to begin marketing your avvalence of your devenits any devenits any prematication. The PDA miding of subscanal veryour device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device of variable please note the regulation entitied, contact the Office of Comphance at (210) 21 C + + + + + + + + + + + + + + + + + + + + + " Misoranding of reference to premailer the Act from the Division of Small
general information on your responsibilities under the Act from the Division of Small general information on your responsionner Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consailer Pissions: Passwords of Carly/industry/support/index.html.

Sincerely yours,

Robert Becker/

Robert L. Becker, Jr., M.B., 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_052617___

Ferritin LIT Assay Ferritin Calibrator Set Ferritin Controls, Level-L & Control-H Device Name:

Indications For Use:

Good Biotech Corp. (GBC) Ferritin LIT Assay system is intended to be used for the Sood Droben of ferritin in human serum by latex particle enhanced qualitial. 7 - 80.00 millions .
immunoturbidimetry (LIT). Measurement of ferritin aids in the diagnosis of diseases affecting iron metabolism.

GBC Ferritin Calibrator Set is intended to be used with GBC Ferritin LIT Assay for the quantitative determination of ferritin in serum samples.

GBC Ferritin Controls are intended to be used as the assayed quality control material for ferritin analysis.

For In Vitro Diagnostic Use.

For Prescription Use Only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 Chan
Division Sign-Off

Division Sign-Off

Page 1 of 1

Office of In Vito Device Evaluation of

510(k) K052617

Regulation Number and Section

§ 866.5340 Ferritin immunological test system.

(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).