(108 days)
Good Biotech Corp. CRPex-HS C-reactive protein LIT assay is intended to be used for quantitative determination of C-reactive protein in serum. The measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. For in vitro diagnostic use.
CRPex-HS C-reactive protein LIT assay is the ready-to-use reagent suitable for quantification of C-reactive protein by latex particle enhanced immunoturbidimetry (LIT). Duck anti-CRP IgY (△Fc) is coupled to polystyrene microparticles, which greatly increased the analytical sensitivity. CRPex-HS C-reactive protein LIT assay is a hs-CRP assay for CRP quantification in the lower range.
Here's a breakdown of the acceptance criteria and study findings for the CRPex-HS C-reactive protein LIT Assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device, Wako CRP-UL. The primary performance metric presented is correlation.
| Performance Metric | Acceptance Criteria (Implied - based on predicate device performance) | Reported Device Performance (CRPex-HS C-reactive protein LIT assay) |
|---|---|---|
| Correlation | High correlation (R² close to 1) with Wako CRP-UL | y = 0.9293x + 0.169 (where x = Wako CRP-UL, y = CRPex-HS) |
| R² = 0.991 | ||
| Assay Range | Similar to Wako CRP-UL | 0.05 - 20 mg/L |
| Interference | Tolerable levels of common interferences | Bilirubin: up to 45 mg/dlHemolysis: up to 800 mg/dlLipemia: up to 10 g/L |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: N = 141 (for the correlation study).
- Data Provenance: Not explicitly stated (e.g., country of origin). Likely retrospective, as it involves comparing results to an existing predicate device using collected samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is an in vitro diagnostic (IVD) assay for quantitative measurement. The "ground truth" for the test set is established by the measured values from the predicate device (Wako CRP-UL) and the CRPex-HS assay itself, as well as the known concentrations of calibrators. There are no human experts "establishing ground truth" in the diagnostic interpretation sense for this type of device.
4. Adjudication Method for the Test Set
Not applicable. As described above, the study involves quantitative measurement and comparison to a predicate device, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or other tests that rely on human interpretation to assess reader performance with and without AI assistance. This device is an automated in vitro diagnostic assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study primarily demonstrates standalone performance of the CRPex-HS C-reactive protein LIT assay. It measures the assay's output directly and compares it to a predicate device. "Human-in-the-loop" is relevant for clinical interpretation, but the assay itself, as an IVD, functions as a standalone measurement tool.
7. The Type of Ground Truth Used
The ground truth for the correlation study is the quantitative result obtained from the predicate device, Wako CRP-UL. For the assay range and interference studies, the "ground truth" refers to known concentrations of CRP in control samples and known concentrations of interfering substances added to samples. Essentially, it's a reference measurement or established reference material.
8. The Sample Size for the Training Set
Not applicable. This device is a reagent-based assay system, not an AI/machine learning algorithm requiring a "training set" in the conventional sense. The "training" of the device involves the development and optimization of the chemical reagents and protocols, which is an iterative laboratory process, not a data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no specific "training set" for an AI algorithm. The development of the assay's performance characteristics (like sensitivity, specificity of the antibodies, reagent concentrations, etc.) is based on standard laboratory practices and experimentation to achieve optimal performance, utilizing calibrated reference materials and internal standards.
{0}------------------------------------------------
JUN 13 2002
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 807.922
| CRPex-HS C-Reactive Protein LIT Assay | |
|---|---|
| Submitter | |
| Name, | Good Biotech Corp. |
| Address, | 38 34th Rd. Taichung Industrial Park Taichung City 407 Taiwan |
| R.O.C. | |
| Telephone number, | +886-4-23596873 |
| Contact person, | Victor Chiou |
| Preparation date | Feburary 21, 2002 |
| Device | |
| Trade name, | CRPex-HS C-reactive protein LIT assay |
| Common name, | CRP immunological diagnostic assay |
| Classification name | C-reactive protein immunological test system (21CFR 866.5270) |
| Predicate Device | |
| Trade name, | Wako CRP-UL |
| 510(k) number | K003342 |
| Description | |
| CRPex-HS C-reactive protein LIT assay is the ready-to-use reagent | |
| suitable for quantification of C-reactive protein by latex particle | |
| enhanced immunoturbidimetry (LIT). Duck anti-CRP IgY (△Fc) is | |
| coupled to polystyrene microparticles, which greatly increased the |
hs-CRP assay for CRP quantification in the lower range.
analytical sensitivity. CRPex-HS C-reactive protein LIT assay is a
{1}------------------------------------------------
Intended Use
Good Biotech Corp. CRPex-HS C-reactive protein LIT assay is intended to be used for quantitative determination of C-reactive protein in serum. The measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. For in vitro diagnostic use.
:
Substantial
Equivalence
CRPex-HS C-reactive protein LIT assay is compared with Wako CRP-UL to demonstrate the substantial equivalence.
2008年07月15日 日本 2004年 10月 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 10時 1
| Item Device | CRPex-HSC-reactive LIT assay | Wako CRP-UL |
|---|---|---|
| Intended Use | Measurement ofC-reactive protein isuseful for the detectionand evaluation ofinfection, tissue injury,inflammatory disordersand associated diseases. | Measurement ofC-reactive protein isuseful for the detectionand evaluation ofinfection, tissue injury,inflammatory disordersand associated diseases. |
| Methodology | Latex particle enhancedimmunoturbidimetry | Latex particle enhancedimmunoturbidimetry |
| Test Objective | C-reactive protein | C-reactive protein |
| Test Principle | Latex microparticleagglutination based onantigen-antibody reaction. | Latex microparticleagglutination based onantigen-antibody reaction. |
| Type of Test | Quantitative | Quantitative |
| Product Type | Reagent 1 (R 1):Reactive buffer solutionReagent 2 (R 2):Latex suspension | Buffer:Reactive buffer solutionLatex reagent:Latex suspensionDiluent:Sample diluent |
• ﺷ
{2}------------------------------------------------
| Antibody(Source) | Duck anti-CRP IgY(AFc)(Egg Yolk) | Goat anti-CRP antibodiesSerum |
|---|---|---|
| Sterility | N.A. | N.A. |
| Stability | 2-10 °COpened: 1 month | 2-10 °COpened: 1 month |
| Specimen | Human serum | Human serum |
| OperatingRequirement | For professional use only | For professional use only |
| Calibration Mode | Spline | Spline |
| Calibrator | Wako CRP-UL Calibrator | Wako CRP-UL Calibrator |
| Set (5 concentrations) | Set (5 concentrations) | |
| Sample Volume | 8 ul/test | 3 (6) ul/test |
| Reagent Volume | R1:120 µl/test | R1:270 ul/test |
| R2:120 ul/test | R2:60 µl/test | |
| WavelengthSelection | Main-wavelength:570 nmSub-wavelength: 800 nm | Main-wavelength:700 nm |
| Assav Code【Hitachi 717 (7150)】 | 2 point:(27)-(33) | 2 point:(28)-(50) |
| Assay Range | 0.05-20 mg/L | 0.1-10 mg/L (samplevolume= 3 ul)0.05-5 mg/L (samplevolume= 6 ul) |
| Calibration Curve | Nearly linear | Nearly linear |
| Interference | Bilirubin:up to 45 mg/dlunconjugated bilirubinHemolysis:up to 800-mg/dlhemoglobinLipemia:up to 10 g/L Liposyn®(fat emulsion) | Ascorbic acid:up to 50 mg/LFree bilirubin:up to 50 mg/dlHemoglobin:up to 500 mg/dlIntrafat:up to 5.0 % |
:
E-3
i
ﺘﺮ
{3}------------------------------------------------
Correlation
y=0.9293x + 0.169 x=Wako CRP-UL y= CRPex-HS C-reactive protein LIT assay R2=0.991 N=141
Conclusion
Good Biotech Corp.'s CRPex-HS C-reactive protein LIT assay is substantially equivalent to the predicate device Wako CRP-UL.
ﺷ
{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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, possibly representing human profiles or a stylized bird.
JUN 1 3 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Victor Chiou President Good Biotech Corp. 38 34th Road Taichung Industrial Park Taichung 407 Taiwan R. O. C.
K020603 Trade/Device Name: CRPex-HS C-reactive protein LIT assay Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: May 9, 2002 Received: May 9, 2002
Dear Mr. Chiou:
Re:
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 forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{5}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): KO:λΟζΟζΟ
Device Name: CRPex-HS C-reactive protein LIT assay
Indications For Use:
Good Biotech Corp. CRPex-HS C-reactive protein LIT assay is intended to be used for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). Measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. For In Vitro Diagnostic Use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sean Cooper
(Division Sign-Off)
sion of Clinica 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
OR
§ 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).