(61 days)
Not Found
No
The summary describes a standard in vitro diagnostic assay using immunoturbidimetry and does not mention any AI or ML components.
No
Explanation: This device is an in vitro diagnostic assay used to quantify C-reactive protein in serum, which aids in evaluating body tissue injury. It is not used for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" states that the assay is for "quantitative determination of C-reactive protein in serum" and "aids in evaluation of the amount of injury to body tissues," which are diagnostic purposes. It also explicitly states "For in vitro diagnostic use."
No
The device description clearly states it is a "ready-to-use reagent suitable for quantification of C-reactive protein by latex particle enhanced immunoturbidimetry (LIT)." This describes a physical kit containing reagents, 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." and "For In Vitro Diagnostic Use."
- Nature of the Test: The device is designed to measure C-reactive protein in serum, which is a biological sample taken from the body. This is a classic example of an in vitro test (performed outside the living organism).
- Purpose: The purpose is for the "quantitative determination of C-reactive protein in serum," which is used to "aid in evaluation of the amount of injury to body tissues." This is a diagnostic purpose.
- Device Description: The description details a "ready-to-use reagent suitable for quantification of C-reactive protein by latex particle enhanced immunoturbidimetry (LIT)," which is a laboratory technique used for in vitro testing.
All these factors strongly indicate that this device is intended for use in a laboratory setting to diagnose or aid in the diagnosis of a condition based on the analysis of a biological sample.
N/A
Intended Use / Indications for Use
Good Biotech Corp. CRPex-BR C-reactive protein LIT kit is intended to be used for quantitative determination of C-reactive protein in serum. The measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. For in vitro diagnostic use.
Good Biotech Corp. CRPex-BR 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. The measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
Good Biotech Corp. CRPex-BR CRP calibrator set is intended to be used with CRPex-BR C-reactive protein 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
Device Description
CRPex-BR C-reactive protein 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.
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
For professional use only
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
y = 0.976 x + 1.179 mg/L x = K-ASSAY CRP (1) y = CRPex-BR C-reactive protein LIT kit R2 = 0.998 N = 94
Conclusion
Good Biotech Corp.'s CRPex-BR C-reactive protein LIT kit is substantially equivalent to the predicate device K-ASSAY CRP (1).
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
KC21757
JUL 2 9 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 807.92."
| CRPex-BR C-Reactive Protein LIT Assay | |
|---|---|
| Submitter | |
| Name, | Good Biotech Corp. |
| Address, | 38 34 th Rd. Taichung Industrial Park Taichung City 407 Taiwan |
| R.O.C. | |
| Telephone number, | +886-4-23596873 |
| Contact person, | Victor Chiou |
| Preparation date | May 24, 2002 |
| Device | |
| Trade name, | CRPex-BR C-reactive protein LIT assay |
| CRPex-BR CRP calibrator set | |
| Common name, | CRP immunological diagnostic assay |
| Classification name | C-reactive protein immunological test system (21CFR 866.5270) |
| Predicate Device | |
| Trade name, | K-ASSAY CRP (1) |
| K-ASSAY multi-calibrator.C | |
| 510(k) number | K992311 |
| Description | |
| CRPex-BR C-reactive protein 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 (△Fc) is |
1
coupled to polystyrene microparticles, which greatly increased the analytical sensitivity.
Intended Use
Good Biotech Corp. CRPex-BR C-reactive protein LIT kit is intended to be used for quantitative determination of C-reactive protein in serum. The measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. For in vitro diagnostic use.
Substantial
Equivalence
CRPex-BR C-reactive protein LIT kit is compared with Kamiya Biomedical Company's K-ASSAY CRP (1) to demonstrate the substantial equivalence.
。
| Item\Device | CRPex-BR
CRP LIT Kit | K-ASSAY
CRP (1) |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Measurement of
C-reactive protein aids in
evaluation of the amount
of injury to body tissues. | |
| Methodology | Latex particle enhanced
immunoturbidimetry | Latex particle enhanced
immunoturbidimetry |
| Test Objective | C-reactive protein | C-reactive protein |
| Test Principle | Latex microparticle
agglutination based on
antigen-antibody reaction | Latex microparticle
agglutination based on
antigen-antibody reaction |
| Type of Test | Quantitative | Quantitative |
| Product Type | Reagent 1 (R 1):
Reactive buffer solution
Reagent 2 (R 2):
Latex suspension | |
| Antibody
【Source】 | Duck anti-CRP IgY(ΔFc)
【Egg Yolk】 | Rabbit anti-CRP antibodies
【Serum】 |
| Sterility | N.A. | N.A. |
| Specimen | Human serum | Human serum |
| Operating
Requirement | For professional use only | For professional use only |
| Calibration Mode | Spline | Spline |
| Calibrator | CRPex-BR Calibrator Set | K-ASSAY CRP
Multi-Calibrator Set C
(standard protocol);
K-ASSAY CRP
Multi-Calibrator Set A
(high sensitivity protocol) |
| Sample Volume | 3 µl/test | 3 (15) µl/test |
| Reagent
Volume | R1 : 150 µl/test
R2 : 150 µl/test | R1 : 150 µl/test
R2 : 150 µl/test |
| Wavelength
Selection | Main-wavelength:570 nm
Sub-wavelength: 800 nm | Main-wavelength:570 nm
Sub-wavelength: 800 nm |
| Assay Code
【Hitachi 717 (7150)】 | 2 point:
(27)-(40) | 2 point:
(28)-(42) |
| Assay Range | 1-300 mg/L | 1-300 mg/L (standard
protocol)
0.1-20 mg/L (high
sensitivity protocol) |
| Calibration Curve | Nearly linear | Nearly Curved |
| Interference | Bilirubin C:
up to 60 mg/dl
Bilirubin F:
up to 60 mg/dl
Hemolysis:
up to 500-mg/dl
hemoglobin
Lipemia:
up to 10 g/L Liposyn®
(fat emulsion) | Bilirubin C:
up to 60 mg/dl
Bilirubin F:
up to 60 mg/dl
Hemoglobin:
up to 500 mg/dl
Lipid:
up to 1500 mg/dl
triglyceride |
2
3
Correlation
ం
y = 0.976 x + 1.179 mg/L x = K-ASSAY CRP (1) y = CRPex-BR C-reactive protein LIT kit R2 = 0.998 N = 94
Conclusion
Good Biotech Corp.'s CRPex-BR C-reactive protein LIT kit is substantially equivalent to the predicate device K-ASSAY CRP (1).
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 stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted with flowing lines, giving a sense of movement. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Victor Choiu President Good Biotech Corp. 38 34th Raod - Taichung Industrial Park 407 Taichung City, Taiwan Taiwan R.O.C.
Re: K021757
Trade/Device Name: CRPex-BR C-reactive protein LIT assay CRPex-BR CRP calibrator set Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: May 24, 2002 Received: May 29, 2002
Dear Mr. Choiu:
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.
JUL 2 9 2002
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: recistration and listing (21 CFR Part 807); labeling (21 CFR 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.
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/dsmaldsmamain.html".
Sincerely vours.
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): KO21757
CRPex-BR C-reactive protein LIT assay Device Name: CRPex-BR CRP calibrator set
Indications For Use:
Good Biotech Corp. CRPex-BR 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. The measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
Good Biotech Corp. CRPex-BR CRP calibrator set is intended to be used with CRPex-BR C-reactive protein LIT assay for the quantitative determination of C-reactive protein in serum samples.
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)
J P Reeves for 6. Altare
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021757
Prescription Use / OR Over-The-Counter Use __
(Per 21 CFR 801.109) (Optional Format 1-2-96)