IMMULITE® C-Reactive Protein is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Analyzer and designed for the quantitative measurement of Creactive protein (CRP) in serum or plasma. It is intended strictly for in vitro use as an aid in the evaluation of the amount of injury to body tissues.

Device Description

IMMULITE® C-Reactive Protein is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Analyzer

AI/ML Overview

The provided document is a 510(k) summary for the IMMULITE® C-Reactive Protein device. It describes the device, its intended use, and states that the data presented led to substantial equivalence. However, it does not include details about specific acceptance criteria, study methodologies, sample sizes for test or training sets, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not provided in the document.	Not provided in the document.
(Typically involves precision, accuracy, linearity, detection limits, etc. for IVD devices)	(Specific numerical results like %CV, bias, correlation coefficients, etc.)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for the test set: Not provided in the document.
Data provenance: Not provided in the document.

3. 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)

This device is an In Vitro Diagnostic (IVD) for quantitative measurement of C-reactive protein. "Experts" in the sense of radiologists interpreting images are not relevant here. Ground truth would typically be established by reference methods or validated assays. The document does not specify how C-reactive protein levels were confirmed for study samples.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. Adjudication methods are typically used in image interpretation studies where multiple readers' opinions need to be reconciled. For a quantitative IVD, the "ground truth" is a measured value rather than an interpretation.

5. 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

No. This is an In Vitro Diagnostic device for measuring C-reactive protein. It is not an AI-assisted diagnostic tool that humans would "read" or interpret in the same way as an imaging device. Therefore, an MRMC study and human reader improvement with AI assistance are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, implicitly. As an automated immunoassay system, the IMMULITE® C-Reactive Protein system operates as a standalone device to produce quantitative results. The stated "performance" (though not detailed in this summary) would be the algorithm/device's performance without human intervention in the CRP measurement process itself. Human involvement would be in sample collection and result interpretation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not explicitly stated, but for a quantitative IVD, ground truth would typically be established by:
- Reference methods: A highly accurate and precise method for measuring CRP, often a gold standard.
- Validated comparative methods: Comparison against another legally marketed and accepted CRP assay.
  The document mentions substantial equivalence to another IMMULITE® C-Reactive Protein device (K984132), implying comparison to a known standard.

8. The sample size for the training set

Not provided in the document.

9. How the ground truth for the training set was established

Not provided in the document. (Similar to point 7, it would likely involve reference or validated comparative methods).

**Summary of what is available: **

Device Name: IMMULITE® C-Reactive Protein
Intended Use: Quantitative measurement of C-reactive protein (CRP) in serum or plasma, as an aid in evaluating tissue injury.
Predicate Device: IMMULITE® C-Reactive Protein (K984132)
Conclusion: The FDA granted substantial equivalence based on the data presented (though the data itself is not detailed in this summary).

Summary

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4-6-99

990886

510 (k) Summary 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.

Name: Address:

Telephone Number: Facsimile_Number:

Contact Person:

Date of Preparation:

Catalog Number:

Device Name Trade:

Common:

Classification:

Manufacturer:

Establishment Registration #:

Substantially Equivalent Predicate Device:

Description of Device:

Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597

(310) 645-8200 (310) 645-9999

Edward M. Levine, Ph.D. Director of Clinical Affairs

March 15, 1999

LKCR1, LKCR5

IMMULITE® C-Reactive Protein

Reagent system for the determination of C-reactive protein (CRP) in serum or plasma.

Class II device, 82-DCK (21 CFR 866.5270)

Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597

DPC Registration number is 2017183

IMMULITE® C-Reactive Protein (K984132)

IMMULITE® C-Reactive Protein is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE® Automated Analyzer

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Intended Use of the Device:

Conclusion:

The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE® C-Reactive Protein.

Edward M. Lewis, Ph.D.

Edward M. Levine, Ph.D Director of Clinical Affairs

3/15/89
Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/10 description: The image shows a partial view of a logo or emblem, featuring a stylized graphic element consisting of three curved, parallel lines. These lines are thick and black, creating a bold visual impact. To the left of the graphic, a portion of text is visible, oriented vertically and reading 'DEPARTMENT O'. The overall impression is that of a formal, official symbol, likely associated with a government department or organization.

APR 6 1399

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Edward M. Levine, Ph.D. Director, Clinical Affairs DIAGNOSTIC PRODUCTS CORPORATION 5700 West 96th Street Los Angeles, CA 90045

Re: K990886 Trade Name: IMMULITE® C-Reactive Protein Regulatory Class: II Product Code: DCK March 15, 1999 Dated: Received: March 17, 1999

Dear Dr. Levine:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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.

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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990886 510(k) Number (if known): Device Name: IMMULITE® C-Reactive Protein

Indications For Use:

IMMULITE® C-Reactive Protein is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of Creactive protein (CRP) in serum or plasma. It is intended strictly for in vitro use as an aid in the evaluation of the amount of injury to body tissues.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arthur E. Makin

sion Sign-Off) sion of Clinical Laboratory Devices 990886 (k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-

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).