(89 days)
Not Found
No
The description focuses on a traditional immunoassay method (Radial Partition Immunoassay) and does not mention any AI or ML components. The performance studies described are standard method comparison and precision analyses, not AI/ML model validation.
No
The device is described as an in vitro diagnostic reagent for quantitative determination of C-reactive protein, which is used for detection and evaluation of conditions, not for treatment.
Yes
The device is described as an "in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP)" and its measurements are stated to be "useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases," clearly indicating its diagnostic purpose.
No
The device is described as an in vitro diagnostic reagent and a two-site sandwich assay based on solid phase Radial Partition Immunoassay (RPIA) technology, indicating it is a physical reagent and not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"The Stratus® CS Acute Care™ CardioPhase® hsCRP method is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma."
This statement clearly identifies the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The Stratus® CS Acute Care™ CardioPhase® hsCRP method is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
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. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, 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
NQD
Device Description
The Stratus® CS Acute Care™ CardioPhase® hsCRP method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology.
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
trained health care professionals in the clinical laboratory and point of care (POC) settings.
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)
Precision and accuracy data were generated by "non-laboratory" personnel and compared to data generated by "laboratory" personnel. Method comparison and precision analyses were performed at three different locations: clinical laboratory (LAB), Emergency Department (ED), and Cardiac Care Unit (CCU) within one external evaluation site. The data supports the use of these products by trained health care professionals in clinical laboratory and point of care (POC) settings.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
DEC 26 2006
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K062924
Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation
Manufacturer:
Contact Information:
Dade Behring Inc. P.O. Box 6101 Newark, DE 19714
Dade Behring Inc. P.O. Box 6101 Newark, DE 19714 Attn: Pamela A. Jurga Tel: 302-631-8891
Date of Preparation:
September 27, 2006
2. Device Name / Classification
- . Stratus® CS Acute Care™ CardioPhase® hsCRP TestPak / Class II
3. Identification of the Predicate Device
- . Dade Behring Stratus® CS Acute Care™ CardioPhase® hsCRP TestPak K060369
4. Device Description(s):
The Stratus® CS Acute Care™ CardioPhase® hsCRP method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology.
1
5. Device Intended Use:
The Stratus® CS Acute CardioPhase® hsCRP method is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
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. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, imay be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
6. Medical device to which equivalence is claimed:
Substantial Equivalence:
The product is substantially equivalent to the commercial Dade Behring Stratus® CS CardioPhase® hsCRP TestPak: K060369
The Stratus® CS Acute Care™ CardioPhase® hsCRP Test Pak is substantially equivalent in the principle of operation and performance to the current Dade Behring Stratus® CS CardioPhase® hsCRP TestPak (K060369). Both assays are in vitro diagnostic tests for the quantitative measurement of the C-reactive protein (CRP) in lithium and sodium heparin plasma and are useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
There are no formulation or design changes associated with the Stratus® CS CardioPhase® hsCRP TestPak indications for use change. The two products are identical and use the same manufacturing processes. Labeling changes reflect the new indications for use and include supporting data.
Precision and accuracy data generated by "non-laboratory" personnel is comparable to precision and accuracy data generated by "laboratory" personnel supporting the addition of point of care to the intended use.
Comparison to Predicate Device:
The modification of this method by adding point of care to the indications for use is supported by data included in Section 18.
Method comparison and precision analyses were performed at three different locations (clinical laboratory (LAB), Emergency Department (ED) and Cardiac Care Unit (CCU) within one external evaluation site. This data and a summary of information on the operators and their training, from either the ED or CCU, i.e. "non-lab" operators, are also included in Section 18.
This data supports use of these products by trained health care professionals in the clinical laboratory and point of care (POC) settings.
2
Conclusion:
The product listed in the following table is substantially equivalent based on its indications for use and performance characteristics. Precision and accuracy data generated by "non-laboratory" personnel is comparable to precision and accuracy data generated by "laboratory" personnel supporting the addition of point of care to the intended use.
| Predicate Device | New Device |
|---|---|
| Dade Behring Stratus® CS CardioPhase® | |
| hsCRP TestPak (K060369) | Stratus® CS Acute Care™ CardioPhase® |
| hsCRP TestPak |
Regulatory Affairs and Compliance Manager September 27, 2006
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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Pamela A. Jurga Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714
DEC 26 2006
Re: K062924 Trade/Device Name: Stratus CS Acute Care CardioPhase hsCRP TestPak Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Product Code: NQD Dated: September 27, 2006 Received: September 28, 2006
Dear Ms. Jurga:
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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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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., 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
5
Indications for Use
510(k) Number (if known): K062924
Device Name:
Stratus® CS Acute Care™ CardioPhase® hsCRP TestPak
Indications For Use:
The Stratus® CS Acute Care™ CardioPhase® hsCRP method is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings.
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. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, 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.
Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Olan Cooper, M.S., DVM
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety