(42 days)
Not Found
No
The description focuses on a standard in vitro diagnostic assay based on turbidimetry and does not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for the quantitative determination of C-reactive protein to aid in the evaluation of body tissue injury, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the assay "aids in evaluation of the amount of injury to body tissues," and the "Device Description" states it is an "in vitro diagnostic assay." Both indicate its use for diagnosis or aiding in diagnosis.
No
The device description clearly states it is an "in vitro diagnostic assay" that measures turbidity using light at specific wavelengths, indicating it is a physical assay requiring reagents and instrumentation, not software alone.
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 and plasma." This indicates that the device is intended to be used in vitro (outside of the body) to analyze biological samples (serum and plasma).
- Device Description: The "Device Description" further clarifies that it is an "in vitro diagnostic assay" and describes the process of analyzing the sample to determine the concentration of C-reactive protein.
- Predicate Device: The mention of a "Predicate Device" (K930621 Boehringer Mannheim® C-Reactive Protein assay) which is also an IVD, strongly suggests that this device falls under the same regulatory category.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of transfused blood, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The C-Reactive Protein assay is used for the quantitation of C-reactive protein in human serum and 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 and plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 340 nm and 700 nm, which correlates with the concentration of C-reactive protein in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum and 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 yielded acceptable correlation with the Boehringer Mannheim C-Reactive Protein assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9963, slope = 1.093, and the Y-intercept = 0.203 mg/dL. Precision studies were conducted using the C-Reactive Protein assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 401 control is 4.5% and Level 2/Panel 402 is 2.8%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The limit of quantitation (sensitivity) of the C-Reactive Protein assay is 0.263 mg/dL.
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).
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510(k) Summary
Contact Person Submitter's Name/Address Linda Morris Abbott Laboratories Senior Regulatory Specialist MS 1-8 1920 Hurd Drive Regulatory Affairs Irving, Texas 75038 (972) 518-6711 Fax (972) 753-3367
| Date of Preparation of this Summary: | April 19, 1999 |
|---|---|
| Device Trade or Proprietary Name: | CRP |
| Device Common/Usual Name or Classification Name: | C-Reactive Protein |
| Classification Number/Class: | 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: K991372-
Test Description:
C-Reactive Protein is an in vitro diagnostic assay for the quantitative determination of C-reactive protein in human serum and plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 340 nm and 700 nm, which correlates with the concentration of C-reactive protein in the sample.
Substantial Equivalence:
The C-Reactive Protein assay is substantially equivalent to the Boehringer Mannheim® C-Reactive Protein assay (K930621) on the Hitachi® 717 Analyzer.
C-Reactive Protein 510(k) April 19, 1999 Сгр
Section II Page l
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These assays yield similar Performance Characteristics.
Similarities:
- Both assays are in vitro immunoturbidimetric methods. .
- Both assays can be used for the quantitative determination of C-reactive . protein.
- Both assays yield similar clinical results. .
- Both assays are based on the light scattering properties of antigen-antibody . complexes.
Differences:
- There is a difference in the assay range. .
Intended Use:
The C-Reactive Protein assay is used for the quantitation of C-reactive protein in human serum and plasma.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System.. The C-Reactive Protein assay method comparison yielded acceptable correlation with the Boehringer Mannheim C-Reactive Protein assay on the Hitachi 717 Analyzer. The correlation coefficient = 0.9963, slope = 1.093, and the Y-intercept = 0.203 mg/dL. Precision studies were conducted using the C-Reactive Protein assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 401 control is 4.5% and Level 2/Panel 402 is 2.8%. The C-Reactive Protein assay range is up to 12.68 mg/dL. The limit of quantitation (sensitivity) of the C-Reactive Protein assay is 0.263 mg/dL. These data demonstrate that the performance of the C-Reactive Protein assay is substantially equivalent to the performance of the Boehringer Mannheim C-Reactive Protein assay on the Hitachi 717 Analyzer.
C-Reactive Protein 510(k) April 19, 1999 Стр
Section II Page 2 0000012
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Conclusion:
The C-Reactive Protein assay is substantially equivalent to the Boehringer Mannheim C-Reactive Protein assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
C-Reactive Protein 510(k) April 19, 1999
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Section II
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
| |099 JUN
Ms. Linda Morris Senior Regulatory Specialist Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Re: K991372 Trade Name: C-Reactive Protein (CRP) Regulatory Class: II Product Code: DCN Dated: April 19, 1999 Received: April 20, 1999
Dear Ms. Morris:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Putman
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
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510(k) Number (if known): H99 |372-
C-Reactive Protein Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The C-Reactive Protein assay is used for the quantitation of C-reactive protein in human serum and plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
Peter E. Mdeum
(Division Sign-Off)
linical Laboratory Devices
(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)
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