(36 days)
No
The device description details a standard immunonephelometry method based on particle agglutination and light scattering, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic reagent used to measure C-reactive protein for detection and evaluation of various conditions, not to treat them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "N High Sensitivity CRP is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma". It further details that "Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases", indicating its use in diagnosing medical conditions.
No
The device description clearly describes a physical in vitro diagnostic reagent and its interaction with a nephelometer system, indicating it is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "N High Sensitivity CRP is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma..."
This clearly indicates that the device is intended for use outside of the body to examine specimens (serum, plasma) from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
N High Sensitivity CRP is an in vitro diagnostic reagent for the quantitative r + right of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using BN™ Systems. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
Product codes (comma separated list FDA assigned to the subject device)
81 NQD
Device Description
Polystyrene particles coated with monoclonal antibodies to CRP are agglutinated when mixed with samples containing CRP. The intensity of the scattered light in the nephelometer depends on the CRP content of the sample and therefore the CRP concentration can be determined versus dilutions of a standard of a known concentration. The method is standardized against the IFCC/BCR/CAP reference preparation (Lot No.91/0619 = CRM 470 = RPPHS 91/0619 [Lot 5]).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All performance characteristics were previously established under 510(k) Premarket Notification K991385.
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.
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 for N High Sensitivity CRP
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: K033908
Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation: Dade Behring Marburg GmbH Manufacturer: Emil-von-Behring Str. 76 Marburg/Germany Dade Behring Inc. Contact Information: Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781.826.4551 January 20, 2004 Preparation date:
Device Name/ Classification: 2.
| N High Sensitivity CRP: | C-reactive protein (CRP) immunological test
system, Class II (866.5270) |
|-------------------------|----------------------------------------------------------------------------|
| Product Code: | 81 NQD |
ldentification of the Legally Marketed Device: 3.
N High Sensitivity CRP - K991385
Device Description: 4.
Polystyrene particles coated with monoclonal antibodies to CRP are agglutinated when mixed with samples containing CRP. The intensity of the scattered light in the nephelometer depends on the CRP content of the sample and therefore the CRP concentration can be determined versus dilutions of a standard of a known concentration. The method is standardized against the IFCC/BCR/CAP reference preparation (Lot No.91/0619 = CRM 470 = RPPHS 91/0619 [Lot 5]).
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Device Intended Use: 5.
N High Sensitivity CRP is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using BN™ Systems. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
Medical device to which equivalence is claimed and comparison information: હ.
The current N High Sensitivity CRP assay is an in vitro diagnostic test for the quantitative determination of C-reactive protein (CRP) in human serum and heparin and EDTA plasma by means of particle enhanced immunonephelometry using BN™ Systems, which was cleared by FDA under 510(k) Premarket Notifications K962523 and K991385. Dade Behring is currently modifying the intended use statement and indications for use statements to include the use of CRP measurements as an aid in the identification of individuals at risk from cardiovascular disease. Patients with stable coronary disease or acute coronary syndromes, high sensitivity CRP (hsCRP) measurements may be useful as an independent marker of prognosis for recurrent events. This revision was accomplished without changing the current operating principle or reagent composition. The modified N High Sensitivity CRP assay is substantially equivalent in intended use and results obtained to the currently marketed N High Sensitivity CRP assay (K991385).
Device Performance Characteristics: 7.
All performance characteristics were previously established under 510(k) Premarket Notification K991385.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Public Health Service
JAN 2 2 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kathleen A. Dray-Lyons Regulatory Affairs and Compliance Manager Dade Behring, Inc. Glasgow Business Community P.O. Box 6101 - M.S. 514 Newark, DE 19714
Re: K033908
Trade/Device Name: N High Sensitivity CRP Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: NQD Dated: December 15, 2003 Received: December 17, 2003
Dear Ms. Dray-Lyons:
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,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications Statement
Device Name:
N High Sensitivity CRP
Indications for Use:
N High Sensitivity CRP is an in vitro diagnostic reagent for the quantitative r + right of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using BN™ Systems. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
Jean Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033908
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
Over-The-Counter-Use_ (Optional Format 1-2-96)