(100 days)
Not Found
No
The device description details a standard immunoturbidimetric assay based on antigen-antibody reactions and absorbance changes, with results determined by interpolation from a calibration curve. There is no mention of AI or ML in the description, intended use, or performance studies.
No
The device is described as an "in vitro diagnostic assay" used for the "quantitation of C-reactive protein in human serum or plasma" to "aid in evaluation of the amount of injury to body tissues." It is designed for diagnosis and assessment, not for treating or alleviating a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the assay is "used for the quantitation of C-reactive protein in human serum or plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues." This clearly indicates its role in diagnosis. Furthermore, the "Device Description" explicitly calls it an "in vitro diagnostic assay".
No
The device description clearly states it is an "in vitro diagnostic assay" that involves a "latex enhanced immunoturbidimetric assay" and detects "agglutination" as an "absorbance change." This indicates a physical, chemical, and optical process requiring hardware components, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the quantitation of C-reactive protein in human serum or plasma. This indicates that the test is performed on samples taken from the human body.
- Device Description: The "Device Description" further clarifies that it is an in vitro diagnostic assay for the quantitative determination of C-reactive protein in human serum or plasma. The description of the method (latex enhanced immunoturbidimetric assay) also aligns with typical in vitro diagnostic procedures.
- Performance Studies: The performance studies describe testing conducted on the assay itself, comparing its results to a predicate device using biological samples (implied by the mention of control material and correlation with another CRP assay).
All these points confirm that the device is designed to be used outside of the body to examine specimens obtained from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The C-Reactive Protein assay is used for the quantitative analysis of C-reactive protein in human serum and plasma.
The C-Reactive Protein assay is used for the quantitation of C-reactive protein in human serum or plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
Product codes (comma separated list FDA assigned to the subject device)
DCN
Device Description
C-Reactive Protein is an in vitro diagnostic assay for the quantitative determination of C-reactive protein in human serum or plasma. The C-reactive protein is a latex enhanced immunoturbidimetric assay that involves an antigen-antibody reaction between the C-reactive protein in the sample and the anti-C-reactive protein, which has been adsorbed to latex particles. The resulting agglutination is detected as an absorbance change, with the magnitude of the change being proportional to the quantity of C-reactive protein in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum or plasma
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 were conducted using the AEROSET® System. The C-Reactive Protein assay method comparison vielded acceptable correlation with the Dade Behring N High Sensitivity CRP on the Dade Behring BN 100. On the AEROSET System, the correlation coefficient = 0.996, slope = 0.97, and the Y-intercept = 0.07 mg/dL. Precision studies were conducted using the C-Reactive Protein assay. Within-run, between-run, and between-day studies were performed using three levels of control material. On the AEROSET System, the total %CV for Level 1 ranged from 1.2 to 2.0%, Level 2 ranged from 1.0 to 2.3%, and Level 3 ranged from 1.0 to 1.3%. The C-Reactive Protein assay range is 0.22 to 30.00 mg/dL. The limit of quantitation (sensitivity) of the C-Reactive Protein assay is 0.216 mg/dL on the AEROSET System. These data demonstrate that the performance of the C-Reactive Protein assay is substantially equivalent to the performance of the Dade Behring N High Sensitivity CRP on the Dade Behring BN 100.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The limit of quantitation (sensitivity) of the C-Reactive Protein assay is 0.216 mg/dL on the AEROSET System.
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
JUL 2 2003
510(k) Summary
Submitter's Name/Address
Abbott Laboratories 1920 Hurd Drive Irving, TX 75038
Contact Person Linda Morris Senior Regulatory Specialist MS 1-8 Regulatory Affairs (972) 518-6711 Fax (972) 753-3367
| Date of Preparation of this Summary: | March 20, 2003 |
|---|---|
| Device Trade or Proprietary Name: | C-Reactive Protein |
| Device Common/Usual Name or Classification Name: | C-Reactive Protein |
| Classification Number/Class: | DCN, Class II |
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.
The assigned 510(k) number is:
Test Description:
C-Reactive Protein is an in vitro diagnostic assay for the quantitative determination of C-reactive protein in human serum or plasma. The C-reactive protein is a latex enhanced immunoturbidimetric assay that involves an antigen-antibody reaction between the C-reactive protein in the sample and the anti-C-reactive protein, which has been adsorbed to latex particles. The resulting agglutination is detected as an absorbance change, with the magnitude of the change being proportional to the quantity of C-reactive protein in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration.
Section II Page I
Image /page/0/Picture/13 description: The image shows the number 00012 in a bold, slightly distressed font. The numbers are black against a white background. The digits are evenly spaced and easily readable.
1
Substantial Equivalence:
The C-Reactive Protein assay is substantially equivalent to the Dade Behring N High Sensitivity CRP (K991385) on the Dade Behring BN™ 100.
Both assays yield similar Performance Characteristics.
Similarities:
- . Both assays are in vitro immunoassays.
- Both assays can be used for the quantitative determination of C-reactive protein in . human serum or plasma.
- Both assays yield similar clinical results. .
- . Both assays require calibration with calibrators.
- Both assays are based on the measurement of the agglutination following . antigen-antibody reaction.
Differences:
- . There is a difference between the assay ranges.
- . The C-Reactive Protein assay measures the intensity of transmitted light. The Dade Behring N High Sensitivity assay measures the intensity of scattered light.
Intended Use:
The C-Reactive Protein assay is used for the quantitative analysis of C-reactive protein in human serum and plasma.
C-Reactive Protein 510(k) 3/20/2003 CRP_S_RI.doc
Section II Page 2
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2
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET® System. The C-Reactive Protein assay method comparison vielded acceptable correlation with the Dade Behring N High Sensitivity CRP on the Dade Behring BN 100. On the AEROSET System, the correlation coefficient = 0.996, slope = 0.97, and the Y-intercept = 0.07 mg/dL. Precision studies were conducted using the C-Reactive Protein assay. Within-run, between-run, and between-day studies were performed using three levels of control material. On the AEROSET System, the total %CV for Level 1 ranged from 1.2 to 2.0%, Level 2 ranged from 1.0 to 2.3%, and Level 3 ranged from 1.0 to 1.3%. The C-Reactive Protein assay range is 0.22 to 30.00 mg/dL. The limit of quantitation (sensitivity) of the C-Reactive Protein assay is 0.216 mg/dL on the AEROSET System. These data demonstrate that the performance of the C-Reactive Protein assay is substantially equivalent to the performance of the Dade Behring N High Sensitivity CRP on the Dade Behring BN 100.
Conclusion:
The C-Reactive Protein assay is substantially equivalent to the Dade Behring N High Sensitivity CRP on the Dade Behring BN 100 as demonstrated by results obtained in the studies.
Section II Page 3
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3
Image /page/3/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 an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 2003
Ms. Linda Morris Senior Regulatory Specialist Abbott Laboratories ADD Regulatory Affairs 1920 Hurd Drive Irving, TX 75038
K030899 Re:
Trade/Device Name: C-Reactive Protein Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: June 12, 2003 Received: June 16, 2003
Dear Ms. Morris:
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): $03089 g
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The C-Reactive Protein assay is used for the quantitation of C-reactive protein in human serum or plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | ✓ |
| (Per 21 CFR 801.109) | |
| OR | Over-The-Counter Use ______ |
| (Optional Format 1-2-96) | |
| Division Sign-Off | |
| Office of In Vitro Diagnostic Device | |
| Evaluation and Safety | |
| 510(k) | K030899 |
C-Reactive Protein 510(k) 3/20/2003 CRP_5_R1.doc