(80 days)
Not Found
No
The device description details a standard immunoturbidimetry assay and data analysis based on a calibration curve, with no mention of AI or ML techniques.
No
Explanation: The device is an in vitro diagnostic assay used for the quantitative determination of C-reactive protein in serum, which is a diagnostic function, not a therapeutic one (treatment or cure).
Yes
The device is an assay intended for the quantitative determination of C-reactive protein in serum, which is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. This information is used to aid in the diagnosis and monitoring of medical conditions.
No
The device is an in vitro diagnostic (IVD) assay kit, which is a physical reagent and calibrator set used with a chemistry autoanalyzer. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use."
- Nature of the Test: The device is a "high sensitive assay for the quantitative determination of C-reactive protein in serum." This involves testing biological samples (serum) outside of the body to provide diagnostic information.
- Methodology: The description details a laboratory-based method (latex particle enhanced immunoturbidimetry) for analyzing a biological marker (CRP).
- Purpose: The intended use is for "detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases," which are all diagnostic purposes.
- Calibrator Set: The inclusion of a calibrator set specifically for use with the assay further indicates its role in quantitative diagnostic testing.
N/A
Intended Use / Indications for Use
Good Biotech Corp. Duet hs-CRP LIT Assay is intended to be used as a high sensitive assay for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). Highly sensitive measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Good Biotech Corp. Duet hs-CRP Calibrator Set is intended to be used with Duet hs-CRP LIT Assay for the quantitative determination of C-reactive protein in serum samples. For in vitro diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
DCN, JIT
Device Description
Duet hs-CRP LIT kit is the ready-to-use reagent suitable for quantification of C-reactive protein by latex particle enhanced immunoturbidimetry (LIT). Duck anti-CRP IgY (ΔFc) is coupled to polystyrene microparticles, which greatly increased the analytical sensitivity. When CRP of the sample encounters with the latex microparticles sensitized with duck anti-CRP IgY (ΔFc), 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 CRP concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual CRP concentration of the sample is determined by interpolation of the calibration curve obtained by standard samples with known CRP concentrations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Correlation study performed for Duet hs-CRP LIT Assay against K-ASSAY CRP (3).
Correlation 1: y = 0.955 x + 0.938 mg/L, x = K-ASSAY CRP (3), y = Duet hs-CRP LIT Assay, R2 = 0.998, N = 93 (CRP conc.: 0~ 200 mg/L)
Correlation 2: y = 1.075 x + 0.226 mg/L, x = K-ASSAY CRP (3), y = Duet hs-CRP LIT Assay, R2 = 0.996, N = 64 (CRP conc.: 0~ 10 mg/L)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).
0
JUN 6 - 2005
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."
| Submitter | |
|---|---|
| Name, | Good Biotech Corp. |
| Address, | 38 34th Rd. Taichung Industrial Park Taichung 407 Taiwan |
| Telephone number, | +886-4-23596873 |
| Contact person, | Victor Chiou |
| Preparation date | March 18, 2005 |
| Device | |
| Trade name, | Duet hs-CRP LIT Assay |
| Duet hs-CRP calibrator set | |
| Common name, | CRP immunological diagnostic assay |
| CRP calibrator | |
| Classification name | C-reactive protein immunological test system (21CFR 866.5270) |
| Calibrator (21CFR 862.1150) | |
| Predicate Device | |
| Trade name, | K-ASSAY CRP (3) |
| K-ASSAY Multi-Calibrator D | |
| 510(k) number | K023828 |
| Description | |
| Duet hs-CRP LIT kit is the ready-to-use reagent suitable for | |
| quantification of C-reactive protein by latex particle enhanced | |
| immunoturbidimetry (LIT). Duck anti-CRP IgY (ΔFc) is |
Duet hs-CRP LIT Assay/ Duet hs-CRP Calibrator Set
1
coupled to polystyrene microparticles, which greatly increased the analytical sensitivity. When CRP of the sample encounters with the latex microparticles sensitized with duck anti-CRP IgY (ΔFc), 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 CRP concentration of the sample and is recorded by a general chemistry autoanalyzer. Then, the actual CRP concentration of the sample is determined by interpolation of the calibration curve obtained by standard samples with known CRP concentrations.
Intended Use
Good Biotech Corp. Duet hs-CRP LIT Assay is intended to be used as a high sensitive assay for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). Highly sensitive measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Good Biotech Corp. Duet hs-CRP Calibrator Set is intended to be used with Duet hs-CRP LIT Assay for the quantitative determination of C-reactive protein in serum samples. For in vitro diagnostic use.
Duet hs-CRP LIT kit is a "ready to use" reagent kit for clinical Special chemistry auto-analyzers. Duet hs-CRP LIT kit has been tested on the Instrument Hitachi 911 Clinical Chemistry analyzer. Requirements Duet hs-CRP LIT kit was compared with Kamiya Biomedical Substantial Company's K-ASSAY CRP (3) to demonstrate the substantial Equivalence equivalence. Testing was performed on the Roche Diagnostics Hitachi
911 analyzer.
2
| | | | Wavelength
Selection | Main-wavelength:570 nm
Sub-wavelength: 800 nm | Main-wavelength:570 nm
Sub-wavelength: 800 nm |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------------------------------|--------------------------------------------------|
| Item | Device | Predicate | Assay Range | 0.3-200 mg/L | 0.1-320 mg/L (standard protocol) |
| Reagent | | | Interference | Bilirubin C:
up to 45 mg/dl | Bilirubin C:
up to 30 mg/dl |
| Name | Duet hs-CRP LIT Assay | K-ASSAY CRP (3) | | Bilirubin F:
up to 45 mg/dl | Bilirubin F:
up to 30 mg/dl |
| | Good Biotech Corp. Duet
hs-CRP LIT Assay is
intended to be used as a high
sensitive assay for the
quantitative determination of
C-reactive protein in serum
by latex particle enhanced
immunoturbidimetry (LIT).
Highly sensitive
measurement of C-reactive
protein is useful for the
detection and evaluation of
infection, tissue injury,
inflammatory disorders and
associated diseases. | The K-ASSAY CRP (3) is
intended to be used as a
high-sensitive assay for
the quantitative
determination of CRP in
serum and plasma by
immunoturbidimetric
assay. Measurement of
C-Reactive Protein aids in
the detection and
evaluation of tissue injury,
inflammatory disorders,
and related diseases. | | Hemoglobin:
up to 805-mg/dl
hemoglobin | Hemoglobin:
up to 500 mg/dl |
| Intended Use | | | | Lipemia:
up to 10 g/L Liposyn®
(fat emulsion) | Lipid:
up to 3000 mg/dl Interfa |
| Methodology | Latex particle enhanced
immunoturbidimetry | Latex particle enhanced
immunoturbidimetry | | Calibrator | |
| Test Objective | C-reactive protein | C-reactive protein | | Name | Duet hs-CRP Calibrator Set |
| Type of Test | Quantitative | Quantitative | | Target Analyte | C-reactive protein |
| | Reagent 1 (R 1):
Reactive buffer solution | Reagent 1 (R 1):
Reactive buffer solution | | Matrix | Human serum |
| Product Type | Reagent 2 (R 2):
Latex suspension | Reagent 2 (R 2):
Latex suspension | Traceability | Traceable to IFCC
CRM470 | Traceable to IFCC
CRM470 |
| Antibody | Duck anti-CRP IgY(ΔFc) | Rabbit anti-CRP antibodies | Preservative | Sodium Azide | Sodium Azide |
| Source | □Egg Yolk□ | □Serum□ | Preparation | Liquid (ready-to-use) | Liquid (ready-to-use) |
| Calibration
Mode | Spline | Spline | | | |
| Sample
Volume | 2 µl/test | 3 µl/test | | | |
| Reagent
Volume | R1 150 µl/test
R2 150 µl/test | R1 150 µl/test
R2 150 µl/test | | | |
E-3
.
3
Correlation
| y = 0.955 x + 0.938 mg/L | y = 1.075 x + 0.226 mg/L |
|---|---|
| x = K-ASSAY CRP (3) | x = K-ASSAY CRP (3) |
| y = Duet hs-CRP LIT Assay | y = Duet hs-CRP LIT Assay |
| R2 = 0.998 | R2 = 0.996 |
| N = 93 (CRP conc.: 0~ 200 mg/L) | N = 64 (CRP conc.: 0~ 10 mg/L) |
Conclusion
Good Biotech Corp. Duet hs-CRP LIT assay and calibrator set are substantially equivalent to the predicate devices based on their intended purposes, design and the comparison performance results.
mg/L)
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes extending upwards and to the right.
JUN 6 - 2005
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Victor Chiou President Good Biotech Corp. 38 34th Road Taichung Industrial Park Taichung City, 407 Taiwan
Re: K050713
Trade/Device Name: Duet hs-CRP LIT Assay Duet hs-CRP Calibrator Set Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN, JIT Dated: May 10, 2005 Received: May 11, 2005
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
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) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Carol C. Benson
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K050713
Device Name: Duet hs-CRP LIT Assay ; Duet hs-CRP Calibrator Set
Indications For Use:
Good Biotech Corp. Duet hs-CRP LIT Assay is intended to be used as a high sensitive assay for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). Highly sensitive measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Good Biotech Corp. Duet hs-CRP Calibrator Set is intended to be used with Duet hs-CRP LIT Assay for the quantitative determination of C-reactive protein in serum samples.
For In Vitro Diagnostic Use.
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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)
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