K Number
K060369
Device Name
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
Manufacturer
Date Cleared
2006-05-04

(80 days)

Product Code
Regulation Number
866.5270
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Stratus® CS Acute Care™ CardioPhase® hsCRP TestPak: The Stratus® CS Acute Care™ CardioPhase® hsCRP assay is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. 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. Stratus® CS Acute Care™ CardioPhase® hsCRP CalPak: The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP Calibrator, is an in vitro diagnostic product intended to be used for calibration of the Acute Care™ CardioPhase® method on the Stratus® CS analyzer. Stratus® CS Acute Care™ CardioPhase® hsCRP DilPak: The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP Dilution Pak, is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ CardioPhase® TestPak, for the measurement of samples with elevated levels of C-reactive protein.
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.
More Information

Not Found

No
The description focuses on a standard immunoassay technology (RPIA) for quantitative determination of CRP. There is no mention of AI or ML in the intended use, device description, or performance studies.

No
The device is an in vitro diagnostic reagent used to measure C-reactive protein levels, which helps in the detection and evaluation of certain conditions rather than directly treating them.

Yes
The "Intended Use / Indications for Use" section explicitly states that the Stratus® CS Acute Care™ CardioPhase® hsCRP TestPak is an "in vitro diagnostic reagent." It also describes its use for the "quantitative determination of C-reactive protein (CRP)" which is useful for the "detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases," and as a "risk marker for the identification of individuals at risk for future cardiovascular disease." These are all diagnostic purposes.

No

The device description explicitly states it is a "two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology," which is a laboratory-based hardware and reagent system, not software only.

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 assay is an in vitro diagnostic reagent..."
  • "The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP Calibrator, is an in vitro diagnostic product..."
  • "The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP Dilution Pak, is an in vitro diagnostic product..."

This clearly indicates that the device and its associated components are intended for use in vitro (outside of the body) to diagnose or aid in the diagnosis of conditions.

N/A

Intended Use / Indications for Use

The Stratus® CS Acute Care™ CardioPhase® hsCRP assay is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. 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 (comma separated list FDA assigned to the subject device)

NQD, JIT

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

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)

Method Comparison Study: The Stratus® CS Acute Care™ CardioPhase "hsCRP assay was compared to the Dade Behring CardioPhase® hsCRP assay by evaluating 154 plasma samples with concentrations ranging from 0.20 to 48.05 mg/L. Regression analysis of the results yielded the following equations:
Range of Sample values: 0 – 50 mg/L, Slope: 0.952, Intercept: 0.098, Correlation Coefficient: 0.999, N: 154
Range of Sample values: 0 – 10 mg/L, Slope: 0.997, Intercept: 0.047, Correlation Coefficient: 0.995, N: 123
Range of Sample values: 0 – 5 mg/L, Slope: 1.002, Intercept: 0.042, Correlation Coefficient: 0.994, N: 107

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.

K033908

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

MAY - 4 2005

510(k) Summary for Stratus® CS Acute™ Care CardioPhase® hsCRP

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: K0600369

  • Manufacturer's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
    Manufacturer:

Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714

  • Dade Behring Inc. Contact Information: Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Kathleen Dray-Lyons Tel: 781-826-4551 Fax: 781-826-2497
    Preparation date: February 10, 2006

  • Stratus® CS Acute Care™ CardioPhase® hsCRP TestPak
    Stratus® CS Acute Care™ CardioPhase® hsCRP CarPak
    Stratus® CS Acute Care™ CardioPhase® hsCRP DilPak 2. Device Name: Classification: Class II
    21 CFR 866.5270; 862.1150 Panel: Immunology (81) Product Code: NQD; JIT

3. Identification of the Legally Marketed Device:

Dade Behring CardioPhase hsCRP- K033908

000112

1

Dade Behring Inc. Stratus® CS Acute Care™ CardioPhase® hsCRP 510(k) Notification

4. 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.

ર. Device Intended Use:

Stratus® CS Acute Care™ CardioPhase® hsCRP TestPak:

The Stratus® CS Acute Care™ CardioPhase® hsCRP assay is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. 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.

Stratus® CS Acute Care™ CardioPhase® hsCRP CalPak:

The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP Calibrator, is an in vitro diagnostic product intended to be used for calibration of the Acute Care™ CardioPhase® method on the Stratus® CS analyzer.

Stratus® CS Acute Care™ CardioPhase® hsCRP DilPak:

The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP Dilution Pak, is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ CardioPhase® TestPak, for the measurement of samples with elevated levels of Creactive protein.

6. Medical device to which equivalence is claimed and comparison information:

The Stratus® CS Acute Care™ CardioPhase® hsCRP assay is substantially equivalent to the Dade Behring CardioPhase hsCRP assay (K033908). The Stratus® CS Acute Care™ CardioPhase® hsCRP assay, like the Dade Behring CardioPhase® hsCRP assay is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP).

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7. Device Performance Characteristics:

The Stratus® CS Acute Care™ CardioPhase "hsCRP assay was compared to the Dade
Behring CardioPhase® hsCRP assay by evaluating 154 plasma samples with concentrations ranging from 0.20 to 48.05 mg/L. Regression analysis of the results yielded the following equations:

| Comparative Method | Range of
Sample values | Slope | Intercept | Correlation
Coefficient | N |
|-------------------------------------------------------------------------------|---------------------------|-------|-----------|----------------------------|-----|
| Dade Behring
CardioPhase ® hsCRP,
performed on the BN™
System | 0 – 50 mg/L | 0.952 | 0.098 | 0.999 | 154 |
| | 0 – 10 mg/L | 0.997 | 0.047 | 0.995 | 123 |
| | 0 – 5 mg/L | 1.002 | 0.042 | 0.994 | 107 |

Method Comparison Study

3

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three ribbon-like shapes extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen Dray-Lyons Manager, Regulatory Affairs and Compliance Dade Behring Inc. Glasgow Building 500 PO Box 6101, M/S 514 Newark DE 19714

IV - 4 222

Re: K060369

Trade/Device Name: Stratus® CS Acute Cute™ CardioPhase® hsCRP TestPak Stratus® CS Acute Cute™ CardioPhase® hsCRP CalPak Stratus® CS Acute Cute™ CardioPhase® hsCRP DilPak Regulation Number: 21 CFR& 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: NQD, JIT Dated: February 10, 2006 Received: February 13, 2006

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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Alberto Gutt

Alberto Gutierrez, Ph.D. 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

Stratus® CS Acute Care™ CardioPhase® hsCRP Device Name:

Indications for Use:

Stratus® CS Acute Care™ CardioPhase® hsCRP TestPak:

The Stratus® CS Acute Care™ CardioPhase® hsCRP assay is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma. 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.

Stratus CS Acute Care™ CardioPhase® hsCRP CalPak:

The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP Calibrator, is an in vitro diagnostic product intended to be used for calibration of the Acute Care™ CardioPhase® method on the Stratus® CS analyzer.

Stratus® CS Acute Care™ CardioPhase® hsCRP DilPak:

The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP Dilution Pak, is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ CardioPhase® hsCRP TestPak, for the measurement of samples with elevated levels of C- reactive protein.

Prescription Use (Per 21 CFR 801 Subpart D)

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)

Carol C. Benner

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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