C-Reactive Protein (CRPME) Reagent, when used in conjunction with Beckman Coulter's Array® 360 System and Calibrator 5 Plus, is intended for the quantitative determination of human C-reactive protein in serum or plasma by rate nephelometry.

Device Description

The Array 360 System (CRPMPE) reagent, in conjunction with Calibrator 5 Plus, is intended for use in the quantitative determination of human C-reactive protein concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with Beckman Coulter's Array 360 System.

AI/ML Overview

The provided document describes a 510(k) submission for the Array® 360 System C-Reactive Protein (CRPMPE) Reagent. This is an in vitro diagnostic device, and the acceptance criteria and study details are focused on analytical performance rather than clinical diagnostic performance based on image analysis or similar AI applications.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of device and submission. The provided information centers on demonstrating substantial equivalence to a predicate device through analytical performance studies.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values (e.g., "slope must be between X and Y"). Instead, it presents the results of method comparison and imprecision studies, implying that these results met internal acceptance thresholds for demonstrating substantial equivalence. The predicate device's performance would serve as the implicit benchmark.

Performance Characteristic	Acceptance Criteria (Implicit from Predicate)	Reported Device Performance (Array® 360 CRPMPE)
Method Comparison	Close agreement with predicate device
Slope	Near 1.0	0.983
Intercept	Near 0.0	0.072
Correlation Coefficient (r)	High correlation (near 1.0)	0.995
Imprecision	Low variability
Within-Run Imprecision	Low %C.V.	Level 1: 10.1% C.V.
		Level 2: 2.1% C.V.
		Level 3: 3.4% C.V.
Total Imprecision	Low %C.V.	Level 1: 13.9% C.V.
		Level 2: 3.6% C.V.
		Level 3: 4.8% C.V.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- Method Comparison: 180 samples (referred to as "n=180" for the method comparison study).
- Imprecision Study: 80 measurements per level (N=80) for both within-run and total imprecision, across 3 levels.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be conducted internally by Beckman Coulter, Inc. The document refers to "human serum and plasma samples," implying human-derived biological samples. The studies are retrospective in the sense that they are conducted on collected samples to evaluate the device performance before market release, but not in the context of analyzing previously collected patient data for diagnostic outcomes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not Applicable. This is an in vitro diagnostic reagent evaluating analytical performance (e.g., concentration of a biomarker). Ground truth is established by the reference method (the predicate device for method comparison) or by repeated measurements for imprecision, not by expert interpretation like in imaging studies.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not Applicable. See point 3.

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

Not Applicable. This is not a diagnostic imaging or AI-based device that humans would interpret.

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

Yes, in essence. The performance studies (method comparison and imprecision) evaluate the Array® 360 System CRPMPE Reagent as a standalone analytical device, comparing its output to a known predicate and assessing its internal variability. The device is designed for automated quantitative determination, so human "interpretation" is minimal beyond loading samples and reviewing numerical results.

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

Method Comparison: The "ground truth" or reference standard for comparison was the IMMAGE System C-Reactive Protein (CRP) Reagent (the predicate device), which is an existing, legally marketed diagnostic system. The output of the new device was compared to the output of the predicate device for the same samples.
Imprecision: The "ground truth" for imprecision is the true concentration of CRP in the control samples, with the study assessing the variability around this true concentration.

8. The sample size for the training set

Not Applicable. This device is a reagent for an in vitro diagnostic system, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such systems involves rigorous assay development, calibration, and optimization using control materials and sometimes characterized clinical samples, but not a "training set" like an AI model.

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

Not Applicable. See point 8.

Summary

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5/3/99

90704

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Summary of Safety & Effectiveness Array® 360 System C-Reactive Protein (CRPMPE) Reagent

1.0 Submitted By:

Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123

2.0 Date Submitted:

March 3, 1999

3.0 Device Name(s):

3.1 Proprietary Names

Array® 360 System C-Reactive Protein (CRPMPE) Reagent

3.2 Classification Name

C-Reactive Protein immunological test system (21 CFR § 866.5270)

4.0 Predicate Device(s):

	Predicate	Manufacturer	DocketNumber
Array® 360 System C-Reactive Protein(CRPMPE) Reagent	IMMAGE System C-Reactive Protein (CRP)Reagent	Beckman Coulter, Inc.	K981638

5.0 Description:

6.0 Intended Use:

Beckman Coulter, Inc. 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

Telephone: (714) 993-5321 Facsimile: (714) 961-4165 Internet: www.beckmancoulter.com

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Comparison to Predicate(s): 7.0

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

	SIMILARITIES
Array 360 SystemCRPMPE Reagent	Intended use	Same as IMMAGE System CRPReagent
	Nephelometric principle
	Latex coated particles
	Shelf-life of 24 months(stored at 2-8°C)
	Calibrator(Calibrator 5 Plus)
	DIFFERENCES
Array 360 SystemCRPMPE Reagent	Angle of measurement	The Array 360 System measures at a70° angle while the IMMAGE Systemmeasures at a 90° angle
	Initial analytic range	The initial analytic range for the Array360 is 0.1 - 12.0 mg/dL while theIMMAGE System is 0.1 - 8.0 mg/dL.
	Reaction temperature	The Array 360 System measure at26.7°C while the IMMAGE Systemmeasures at 37°C.

Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, linearity, and imprecision experiments.

Method Comparison Study Results

Test Method	Sample Type	Slope	Intercept	r	n	Predicate Method
Array 360CRPMPE	serum	0.983	0.072	0.995	180	IMMAGE CRP

Estimated Imprecision
Sample	Mean (mg/dL)	S.D. (mg/dL)	%C.V.	N
Within-Run Imprecision
Level 1	0.27	0.027	10.1	80
Level 2	6.92	0.143	2.1	80
Level 3	10.9	0.37	3.4	80
Total Imprecision
Level 1	0.27	0.038	13.9	80
Level 2	6.92	0.248	3.6	80
Level 3	10.9	0.52	4.8	80

Estimated Imprecision

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

Beckman Coulter, Inc., Section 510(k) Notification Array® 360 System C-Reactive Protein (CRPMPE) Reagent Summary of Safety & Effectiveness file: crpmpe510k.sse

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3 1959 MAY

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Annette Hellie Senior Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 South Kraemer Boulevard, W-104 Brea, California 92822-8000

K990704 Re:

Trade Name: Array® 360 System C-Reactive Protein (CRPMPE) Reagent Regulatory Class: II Product Code: DCK Dated: March 3, 1999 Received: March 4, 1999

Dear Ms. Hellie:

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 Regulations, 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 regulatory 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 regulations.

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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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page ___ of __________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K 990704

Device Name: Array® 360 System C-Reactive Protein (CRPMPE) Reagent

Indications for Use:

Clinical Significance:

Measurement of C-reactive protein aids in evaluation of stress, trauma, infection, inflammation, and surgery.

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

Concurrence of CDRH/Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K990704

Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
Optional Format 1-2-96

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).