(22 days)
Not Found
No
The summary describes a standard immunoassay for measuring C-Reactive protein using a chemiluminescent method on an automated analyzer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The predicate devices are also older immunoassay systems.
No
The device is an immunoassay intended for in vitro diagnostic use to measure C-Reactive Protein, aiding in the detection and evaluation of certain conditions, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use."
No
The device description explicitly states it is a "solid-phase, two-site, chemiluminescent immunometric assay for use with the IMMULITE 2500 Automated Analyzer," indicating it is a physical assay kit used with a hardware analyzer, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use with the IMMULITE 2500 Analyzer". This is the primary indicator that the device is intended for diagnostic testing performed outside of the body (in vitro).
N/A
Intended Use / Indications for Use
The IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay is intended for use as follows:
For in vitro diagnostic use with the IMMULITE 2500 Analyzer -- for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and 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 noronary syndrome, may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.
Product codes (comma separated list FDA assigned to the subject device)
NQD
Device Description
The IMMULITE 2500 High Sensitivity C-Reactive Protein Immunoassav is a solid-phase, two-site, chemiluminescent immunometric assay for use with the IMMULITE 2500 Automated Analyzer,
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)
Not Found
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.
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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Section 14 - 510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
Establishment Name:
Siemens Medical Solutions Diagnostics 5700 West 96th Street Los Angeles, CA 90045-5597
MAY - 2 2007
Siemens Medical Solutions Diagnostics 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900
Telephone Number: (310) 645-8200
Facsimile Number: (310) 645-9999
- Deborah L. Morris Contact Person: Director, Clinical Affairs & Regulatory Submissions
Date of Preparation: April 6, 2007
Device Trade Name: IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay
Catalog Number: L5KCRP
21 CFR 862.1377: 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.
| Device Common Name: | Reagent system for the determination of C-reactive protein in plasma or serum. |
|---|---|
| Classification: | Class II device; Product Code: NQD (21 CFR 866.5270) |
| Panel: | Immunology |
| CLIA Complexity | |
| Category: | We believe the category to be moderate based on previous |
| classification of analogous tests. | |
| Manufacturer: | Siemens Medical Solutions Diagnostics |
| 5700 West 96th Street | |
| Los Angeles, CA 90045-5597 |
Siemens Medical Solutions Diagnostics
5210 Pacific Concourse Drive
Los Angeles, CA 90045-6900 |
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Establishment Registration Number:
Siemens Medical Solutions Diagnostics 5700 West 96th Street Los Angeles, CA 90045-5597 Registration #: 2017183
Siemens Medical Solutions Diagnostics 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900 Registration #: 3005250747
Substantially Equivalent Predicate Device:
IMMULITE 2000 High Sensitivity C-Reactive Protein Immunoassay (K063057, K003372)
Description of Device:
The IMMULITE 2500 High Sensitivity C-Reactive Protein Immunoassav is a solid-phase, two-site, chemiluminescent immunometric assay for use with the IMMULITE 2500 Automated Analyzer,
Intended Use of the Device:
The IMMULITE 2500 High Sensitivity C-Reactive Protein Immunoassay is intended for in vitro diagnostic use with the IMMULITE 2500 analyzer for the quantitative measurement of C-reactive protein (CRP) in human serum or plasma, as an aid in 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 measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome, may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.
- Conclusion: The information presented in this Special 510(k) is that which the Food and Drug Administration used in granting Siemens Medical Solutions Diagnostics substantial equivalence for the IMMULITE 2500 High Sensitivity C-Reactive Protein Immunoassay.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, with its wings forming a protective shape.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Medical Solutions Diagnostics c/o Ms. Deborah L. Morris. Director of Clinical Affairs & Regulatory Submissions 5210 Pacific Concourse Drive Los Angeles, CA 90045-6900
રિક: K071017
Trade/Device Name: IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay Regulation Number: 21 CFR§ 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: NOD Dated: April 6, 2007 Received: April 10, 2007
MAY - 2 2007
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 logally marketed predicate device results in a classification for your device and thus, perroits 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 vours.
Jean M. Cooper, M.S., D.V.M.
Sean 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
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Indications for Use
4071017 510(k) Number (if known):
Device Name: IMMULITE® 2500 High Sensitivity C-Reactive Protein
Indications For Use:
The IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay is intended for use as follows:
For in vitro diagnostic use with the IMMULITE 2500 Analyzer -- for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and 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 noronary syndrome, may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
K07 1017
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