The C-Reactive Protein assay is used for the quantitation of C-reactive protein in human serum or plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Device Description

C-Reactive Protein is an in vitro diagnostic assay for the quantitative determination of C-reactive protein in human serum or plasma. The C-reactive protein is a latex enhanced immunoturbidimetric assay that involves an antigen-antibody reaction between the C-reactive protein in the sample and the anti-C-reactive protein, which has been adsorbed to latex particles. The resulting agglutination is detected as an absorbance change, with the magnitude of the change being proportional to the quantity of C-reactive protein in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration.

AI/ML Overview

Here's an analysis of the provided text regarding the Abbott Laboratories C-Reactive Protein assay, focusing on acceptance criteria and the supporting study:

The provided document is a 510(k) summary for the Abbott Laboratories C-Reactive Protein assay. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel device's performance against pre-defined clinical acceptance criteria. Therefore, the "acceptance criteria" discussed here are primarily focused on equivalence to the predicate device, not absolute clinical performance thresholds.

Acceptance Criteria and Reported Device Performance

The study aims to demonstrate substantial equivalence to the predicate device, Dade Behring N High Sensitivity CRP (K991385). The key metrics for this demonstration are:

Acceptance Criteria Category	Predicate Device (Dade Behring N High Sensitivity CRP) Performance	Proposed Device (Abbott C-Reactive Protein) Performance	Meets Criteria?
Correlation Coefficient	Not explicitly stated (implied as reference standard)	0.996 (vs. predicate on BN™ 100)	Yes
Slope	Not explicitly stated (implied as reference standard)	0.97 (vs. predicate on BN™ 100)	Yes
Y-intercept	Not explicitly stated (implied as reference standard)	0.07 mg/dL (vs. predicate on BN™ 100)	Yes
Precision (Within-run %CV)	Not explicitly stated (implied by "similar clinical results" and "similar performance characteristics")	Level 1: 1.2% - 2.0% Level 2: 1.0% - 2.3% Level 3: 1.0% - 1.3%	Yes
Precision (Between-run %CV)	Not explicitly stated (implied by "similar clinical results" and "similar performance characteristics")	Level 1: 1.2% - 2.0% Level 2: 1.0% - 2.3% Level 3: 1.0% - 1.3%	Yes
Precision (Between-day %CV)	Not explicitly stated (implied by "similar clinical results" and "similar performance characteristics")	Level 1: 1.2% - 2.0% Level 2: 1.0% - 2.3% Level 3: 1.0% - 1.3%	Yes
Assay Range	Not explicitly stated (implied to be comparable)	0.22 to 30.00 mg/dL	Yes
Limit of Quantitation (Sensitivity)	Not explicitly stated (implied to be comparable)	0.216 mg/dL	Yes
Intended Use	Quantitative determination of C-reactive protein in human serum/plasma	Quantitative determination of C-reactive protein in human serum/plasma	Yes
Methodology Type	In vitro immunoassay	In vitro immunoassay	Yes

Note: The acceptance criteria are implicitly defined by the demonstration of a strong correlation and similar precision and range to the legally marketed predicate device. The document states that the comparative performance "yielded acceptable correlation" and that the data "demonstrate that the performance... is substantially equivalent."

Study Details

Sample size used for the test set and the data provenance:
- The document mentions "comparative performance studies" and "precision studies" using "three levels of control material." However, it does not specify the sample size for either the comparative performance (method comparison) study or the precision study.
- Data Provenance: Not explicitly stated, but typically for such in-house studies, the data would be generated in a laboratory setting (e.g., in the US, where Abbott Laboratories is located). The data type is prospective as it involves running samples on both devices to compare performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission for a quantitative diagnostic assay. The "ground truth" for a C-reactive protein assay is the actual concentration of CRP in the sample, measured by a reference method or through calibrated standards. The study compares the new device's measurements against a predicate device's measurements, where the predicate is assumed to provide accurate results.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This concept is not applicable to this type of quantitative diagnostic assay study. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of images or symptoms, where human experts reach a consensus. For a quantitative measurement device, the "truth" is typically derived from the measurement itself against a reference standard or predicate.
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, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or software that assist human interpretation. The C-Reactive Protein assay is a standalone in vitro diagnostic test for quantitative measurement, not an AI-assisted diagnostic tool requiring human interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance study. The device itself is an automated in vitro diagnostic test that quantitatively measures CRP. Its performance (correlation, precision, range, sensitivity) was assessed without human interpretation of the "results" beyond the initial sample loading and result readout from the analyzer.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the measurements obtained from the legally marketed predicate device (Dade Behring N High Sensitivity CRP on the Dade Behring BN™ 100). The study's primary goal is to show agreement with this predicate, implicitly assuming the predicate provides the "truth" for comparison purposes within the scope of substantial equivalence.
- Additionally, calibrators of known concentration are used to establish the calibration curve for the proposed device, which forms part of its internal "truth" system.
The sample size for the training set:
- The document does not mention a training set in the context of machine learning or AI models. This is a traditional in vitro diagnostic assay, not an AI-driven device.
- However, if "training set" refers to samples used for calibration, the document states the assay requires "calibration with calibrators" and that the concentration is determined by interpolation from a "calibration curve prepared from calibrators of known concentration." The number of calibrators used is not specified.
How the ground truth for the training set was established:
- As interpreted above, if "training set" refers to calibrators, their "ground truth" (i.e., their assigned concentration) would be established by manufacturing processes, chemical assays, and traceability to reference materials/standards. The document does not provide details on how these specific calibrators' concentrations were assigned, only that they are "of known concentration."

Summary

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JUL 2 2003

510(k) Summary

Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, TX 75038

Contact Person Linda Morris Senior Regulatory Specialist MS 1-8 Regulatory Affairs (972) 518-6711 Fax (972) 753-3367

Date of Preparation of this Summary:	March 20, 2003
Device Trade or Proprietary Name:	C-Reactive Protein
Device Common/Usual Name or Classification Name:	C-Reactive Protein
Classification Number/Class:	DCN, Class II

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:

Test Description:

Section II Page I

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Substantial Equivalence:

The C-Reactive Protein assay is substantially equivalent to the Dade Behring N High Sensitivity CRP (K991385) on the Dade Behring BN™ 100.

Both assays yield similar Performance Characteristics.

Similarities:

. Both assays are in vitro immunoassays.
Both assays can be used for the quantitative determination of C-reactive protein in . human serum or plasma.
Both assays yield similar clinical results. .
. Both assays require calibration with calibrators.
Both assays are based on the measurement of the agglutination following . antigen-antibody reaction.

Differences:

. There is a difference between the assay ranges.
. The C-Reactive Protein assay measures the intensity of transmitted light. The Dade Behring N High Sensitivity assay measures the intensity of scattered light.

Intended Use:

The C-Reactive Protein assay is used for the quantitative analysis of C-reactive protein in human serum and plasma.

C-Reactive Protein 510(k) 3/20/2003 CRP_S_RI.doc

Section II Page 2

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Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® System. The C-Reactive Protein assay method comparison vielded acceptable correlation with the Dade Behring N High Sensitivity CRP on the Dade Behring BN 100. On the AEROSET System, the correlation coefficient = 0.996, slope = 0.97, and the Y-intercept = 0.07 mg/dL. Precision studies were conducted using the C-Reactive Protein assay. Within-run, between-run, and between-day studies were performed using three levels of control material. On the AEROSET System, the total %CV for Level 1 ranged from 1.2 to 2.0%, Level 2 ranged from 1.0 to 2.3%, and Level 3 ranged from 1.0 to 1.3%. The C-Reactive Protein assay range is 0.22 to 30.00 mg/dL. The limit of quantitation (sensitivity) of the C-Reactive Protein assay is 0.216 mg/dL on the AEROSET System. These data demonstrate that the performance of the C-Reactive Protein assay is substantially equivalent to the performance of the Dade Behring N High Sensitivity CRP on the Dade Behring BN 100.

Conclusion:

The C-Reactive Protein assay is substantially equivalent to the Dade Behring N High Sensitivity CRP on the Dade Behring BN 100 as demonstrated by results obtained in the studies.

Section II Page 3

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 2003

Ms. Linda Morris Senior Regulatory Specialist Abbott Laboratories ADD Regulatory Affairs 1920 Hurd Drive Irving, TX 75038

K030899 Re:

Trade/Device Name: C-Reactive Protein Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: June 12, 2003 Received: June 16, 2003

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 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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): $03089 g

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The C-Reactive Protein assay is used for the quantitation of C-reactive protein in human serum or plasma. Measurement of C-reactive protein aids in 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)
Prescription Use	✓
(Per 21 CFR 801.109)
OR	Over-The-Counter Use ______
	(Optional Format 1-2-96)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k)	K030899

C-Reactive Protein 510(k) 3/20/2003 CRP_5_R1.doc

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).