(34 days)
No
The document describes a calibrator set for a C-reactive protein assay, which is a standard laboratory reagent and does not involve AI/ML technology. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is a calibrator set used for quantitative determination of C-reactive protein in serum samples, making it an in vitro diagnostic device, not a therapeutic device.
No
This device is a calibrator set, which is used to calibrate an assay, not to diagnose a condition itself. The intended use states it's for "quantitative determination of C-reactive protein (CRP) in serum samples" when used with a specific assay, indicating it's a tool for measurement within a diagnostic process, not the diagnostic device itself.
No
The device is a calibrator set, which is a physical component used in an in vitro diagnostic assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use."
This is the primary indicator that the device is intended for use in testing samples taken from the human body (in this case, serum) outside of the body to diagnose or monitor a medical condition.
N/A
Intended Use / Indications for Use
The calibrators contain certain quantities of human C-reactive protein (CRP). CRPex-HS CRP Calibrator Set is intended to be used with CRPex-HS C-Reactive Protein LIT Assay for the quantitative determination of CRP in serum samples. The measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. For in vitro diagnostic use.
Good Biotech Corp. CRPex-HS CRP Calibrator Set is intended to be used with CRPex-HS C-Reactive Protein LIT Assay for the quantitative determination of C-reactive protein (CRP) in serum samples. For In Vitro Diagnostic Use.
Product codes
DCN
Device Description
The calibrators contain certain quantities of human C-reactive protein (CRP). CRPex-HS CRP Calibrator Set. Matrix / Biological Sources: Liquid human serum. Preparation: Ready for use. Expected CRP Concentration (mg/L): 0.00, 0.50, 1.50, 5.00, 10.00, 20.00. Traceability: CAP/BCR/IFCC RPPHS, lot 91/0619.
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
Correlation: y = 1.045 x - 0.141 x = Wako CRP-UL y = CRPex-BR CRP LIT Kit R2 = 0.998 N = 67
Key Metrics
R2 = 0.998
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
'JUL 11 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-HS CRP Calibrator Set | |
|---|---|
| Submitter | |
| Name, | Good Biotech Corp. |
| Address, | 38 34th Road Taichung Industrial Park Taichung City 407 Taiwan |
| R.O.C. | |
| Telephone number, | +886-4-23596873 |
| Contact person, | Victor Chiou |
| Preparation date | June 5, 2002 |
| Device | |
| Trade name, | CRPex-HS CRP Calibrator Set |
| Common name, | CRP Calibrators |
| Classification name | C-reactive protein immunological test system (21CFR 866.5270) |
| Predicate Device | |
| Trade name, | Wako CRP-UL Calibrator Set |
| 510(k) number | K003342 |
| Description / | |
| Intended Use | The calibrators contain certain quantities of human C-reactive protein |
| (CRP). CRPex-HS CRP Calibrator Set is intended to be used with | |
| CRPex-HS C-Reactive Protein LIT Assay for the quantitative | |
| determination of CRP in serum samples. |
1
The measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
For in vitro diagnostic use.
Substantial Equivalence
| Item\Device | CRPex-HS CRP
Calibrator Set | Wako CRP-UL
Calibrator Set |
|--------------------------------------|------------------------------------|------------------------------------|
| Matrix / Biological Sources | Liquid human serum | Liquid human serum |
| Preparation | Ready for use | Ready for use |
| Expected CRP
Concentration (mg/L) | 0.00 | 0.00 |
| | 0.50 | 1.25 |
| | 1.50 | 2.50 |
| | 5.00 | 5.00 |
| | 10.00 | 9.00 |
| | 20.00 | |
| Traceability | CAP/BCR/IFCC
RPPHS, lot 91/0619 | CAP/BCR/IFCC
RPPHS, lot 91/0619 |
Correlation
y = 1.045 x - 0.141 x = Wako CRP-UL y = CRPex-BR CRP LIT Kit R2 = 0.998 N = 67
Conclusion
Good Biotech Corp.'s CRPex-BR CRP Calibrator Set is substantially equivalent to the predicate device Wako CRP-UL calibrator set.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized image of a caduceus. The caduceus is a symbol often associated with healthcare and medicine. The seal is in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 11 2002
Mr. Victor Chiou President Good Biotech Corporation 38 34th Road Taichung Industrial Park Taichung City, Taiwan R.O.C.
K021882 Re:
Trade/Device Name: CRPex-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 Dated: June 5, 2002 Received: June 7, 2002
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 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 (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.
3
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 1 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
4
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K O2 | 8 8 8 8 8 --
Device Name: CRPex-HS CRP Calibrator Set
Indications For Use:
Good Biotech Corp. CRPex-HS CRP Calibrator Set is intended to be used with CRPex-HS C-Reactive Protein LIT Assay for the quantitative determination of C-reactive protein (CRP) 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)
Prescription Use _
OR
Over-The-Counter Use _________
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
JP Reeves for S. Altaie