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.

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,

AI/ML Overview

The provided text is a 510(k) summary for the IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study information needed to fill out all requested sections about acceptance criteria, device performance, ground truth establishment, or sample sizes for testing and training.

Therefore, I can only provide limited information based on the text provided.

Acceptance Criteria and Device Performance

The provided document does not explicitly state specific acceptance criteria in terms of precision, accuracy, or correlation coefficients, nor does it present detailed study results proving the device meets particular thresholds. It asserts substantial equivalence to a predicate device, which inherently means its performance should align with the predicate's established performance for the intended uses. Without specific study data from the document, I cannot create a table of acceptance criteria and reported device performance.

Study Information Based on Provided Text:

Here's what can be inferred or explicitly stated from the given text:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the provided document. The 510(k) process relies on demonstrating substantial equivalence to a legally marketed predicate device rather than meeting specific performance thresholds presented in the summary.
- Reported Device Performance: Not detailed in the provided document. The document describes the device and its intended use but does not present the results of performance studies (e.g., accuracy, precision, linearity).
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts: Not applicable or specified. This device is an in vitro diagnostic (IVD) immunoassay. The "ground truth" for such devices typically refers to a reference method or validated standard, not expert consensus as in imaging studies.
- Qualifications of Experts: Not applicable or specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable or specified. This is relevant for studies involving human interpretation (e.g., radiology), not typically for automated immunoassay performance evaluation.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Comparative Effectiveness Study: Not applicable. This device is an automated immunoassay for quantitative measurement of C-reactive protein, not an AI-assisted diagnostic tool for human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The IMMULITE® 2500 High Sensitivity C-Reactive Protein Immunoassay is an automated, standalone diagnostic test. Its performance is evaluated intrinsically through analytical studies (e.g., precision, accuracy, linearity) against reference methods, rather than in conjunction with human-in-the-loop scenarios. The summary does not provide details of these studies or their results.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For an immunoassay, the "ground truth" for performance studies would typically be established using a reference method, a comparative method deemed accurate, or certified reference materials/calibrators with known concentrations of C-reactive protein. The specific method used is not detailed in this summary.
The sample size for the training set:
- Sample Size for Training Set: Not applicable or specified. This device is a traditional immunoassay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. Its reagents and calibration curves are developed and optimized through laboratory procedures, not by training on a dataset.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As explained above, this is not an AI/ML device that uses a training set with established ground truth labels in the typical sense. Reagent and assay development involves standard chemical and biological validation processes.

Summary

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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 ComplexityCategory:	We believe the category to be moderate based on previousclassification of analogous tests.
Manufacturer:	Siemens Medical Solutions Diagnostics5700 West 96th StreetLos Angeles, CA 90045-5597Siemens Medical Solutions Diagnostics5210 Pacific Concourse DriveLos 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

Page 1 of 1

0000015

Regulation Number and Section

§ 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).