(153 days)
Not Found
No
The device description details a standard immunoturbidimetry assay based on antigen-antibody reactions and absorbance measurements, which are interpreted using a calibration curve. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No.
Explanation: This device is an in vitro diagnostic assay used for quantitative determination of ferritin in human serum and aids in diagnosis, not directly treating a disease or condition.
Yes
Explanation: The "Intended Use" section explicitly states that the device "aids in the diagnosis of diseases affecting iron metabolism." This indicates its role in obtaining information for diagnostic purposes.
No
The device description clearly states it is a "ready to use reagent" and describes a chemical reaction (latex particle enhanced immunoturbidimetry) detected by an "autoanalyzer," indicating it is a physical in vitro diagnostic (IVD) assay kit, not 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 to "quantitatively determine ferritin in human serum," which is a biological sample taken from the body.
- Method: The method used is "latex particle enhanced immunoturbidimetry (LIT)," which is a laboratory-based assay performed on the sample outside of the body.
- Purpose: The measurement of ferritin "aids in the diagnosis of diseases affecting iron metabolism," indicating a diagnostic purpose.
- Components: The description includes reagents (assay, calibrator set, controls) specifically designed for use in a laboratory setting to perform the test.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
DBF, JIT, JJX
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.
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 50 serum samples yielded high correlation coefficient upon comparison of the GBC Ferritin LIT system and the predicate devices, Biokit quantex Ferritin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient: 0.9808
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
§ 866.5340 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).
0
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 Assay | ||
| Ferritin Calibrator Set | |||
| Ferritin Controls, Level-L & Level-H | |||
| Common name, | Ferritin immunological diagnostic assay | ||
| Ferritin calibrator | |||
| Ferritin 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 Ferritin | ||
| Biokit quantex FERRITIN standard multipoint |
510(k) number
Biokit quantex FERRITIN / MYOGLOBIN / IgE control I/II
1
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.
Intended Use
Reagent:
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.
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
2
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) | Correlation
Coefficient | 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.
3
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
5
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
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Office of In Vito Device Evaluation of
510(k) K052617