C-RP reagent, when used in conjunction with SYNCHRON CAL 5 Plus on SYNCHRON LX Systems and CX C-RP Calibrator on SYNCHRON CX Systems, is intended for use in the quantitative determination of human C-reactive protein in human serum and plasma samples on SYNCHRON Systems by rate turbidimetry. CX C-RP Calibrator, when used in conjunction with SYNCHRON Systems C-RP Reagent, is intended for the calibration of C-reactive protein test systems on SYNCHRON CX Systems.

Device Description

The SYNCHRON Systems C-RP reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4/4PRO, CX5/5CE/54/5PRO, CX7/7RTS/7/2/7PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems. The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrators.

AI/ML Overview

The provided text describes the 510(k) summary for the SYNCHRON® Systems C-Reactive Protein (C-RP) Reagent and Calibrator. It outlines the device's intended use, comparison to a predicate device, and performance data to demonstrate substantial equivalence.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" for the studies, but it presents performance data for method comparison and imprecision. The implicit acceptance criteria are that the device performs comparably to the predicate device and demonstrates acceptable linearity and imprecision.

Table of Performance Results:

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (CX Platform)	Reported Device Performance (LX Platform)
Method Comparison	Substantial equivalence to predicate
Slope	Close to 1.0	1.007	1.033
Intercept	Close to 0.0	0.05	0.01
R (Correlation Coefficient)	Close to 1.0	0.996	0.998
Imprecision	Biologically/clinically acceptable variability
Within-Run Imprecision (C.V. %)
Level 1 (0.49 mg/dL)		2.77%	(Not specified as different from 'Total')
Level 2 (5.40 mg/dL)		1.17%	(Not specified as different from 'Total')
Level 3 (13.45 mg/dL)		1.56%	(Not specified as different from 'Total')
Level 4 (23.99 mg/dL)		2.49%	(Not specified as different from 'Total')
Total Imprecision (C.V. %)
Level 1 (0.49 mg/dL)		3.45%	(Not specified as different from 'Total')
Level 2 (5.40 mg/dL)		1.60%	(Not specified as different from 'Total')
Level 3 (13.45 mg/dL)		2.13%	(Not specified as different from 'Total')
Level 4 (23.99 mg/dL)		2.60%	(Not specified as different from 'Total')

Note: The imprecision data presented is under the "SYNCHRON LX System C-RP Estimated Imprecision" heading. It's not explicitly stated if both CX and LX platforms showed similar imprecision, but the method comparison includes both platforms.

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

Method Comparison Test Set Sample Sizes:
- CX Platform: 132 samples (n=132)
- LX Platform: 143 samples (n=143)
Imprecision Test Set Sample Sizes:
- For each of the 4 levels tested: 80 samples (N=80) for both within-run and total imprecision.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). The study is described as "SYNCHRON Systems C-RP Method Comparison Study Results" and "SYNCHRON LX System C-RP Estimated Imprecision," which indicates internal testing by the manufacturer, Beckman Coulter, Inc.

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) reagent and calibrator used for quantitative determination of C-reactive protein. The "ground truth" for such devices is typically established through reference methods or predicate devices, rather than expert consensus in the same way it would be for an imaging AI device.

Ground Truth Establishment: For the method comparison study, the predicate device (SYNCHRON LX Systems CRPH Assay) served as the reference for comparative measurements. For imprecision and linearity, the "ground truth" is based on the known concentrations of quality control materials or spiked samples.
Number of Experts/Qualifications: The document does not mention the involvement of experts (e.g., laboratory specialists, clinical chemists) for reviewing or establishing the ground truth beyond the use of the predicate device and standard laboratory practices.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation where multiple experts might disagree). For objective quantitative laboratory measurements like C-RP, adjudication in this sense is not employed. The performance is assessed by comparing quantitative results against a reference method or expected values.

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 device is a diagnostic reagent and calibrator kit, not an AI or imaging device that would involve human readers or MRMC studies. Its purpose is to quantitatively measure C-reactive protein in serum and plasma samples, not to assist human interpretation of complex data like images.

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

Yes, the performance presented is a standalone performance of the reagent and calibrator system on the SYNCHRON CX and LX platforms. The device itself performs the quantitative measurement without human interpretation or intervention in the measurement process. The results are then reported for clinical interpretation by healthcare professionals.

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

Method Comparison: The predicate device, SYNCHRON LX Systems CRPH Assay, served as the reference standard for comparison. This is a form of comparative ground truth against an established, legally marketed device.
Imprecision and Linearity: The ground truth for these studies relies on known concentrations of prepared samples (e.g., quality control materials, spiked samples) to assess the device's accuracy and reproducibility across its measuring range. This implicitly uses defined analytical ground truth.

8. The sample size for the training set

Not applicable. This device is a chemical reagent and calibrator, not a machine learning or AI model that requires a "training set" in the computational sense. Its performance is based on chemical reactions and optical measurement principles.

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

Not applicable, as there is no "training set" for this type of medical device as understood in AI/ML contexts.

Summary

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16021572

JUL 1 9 2002

510(k) Summary SYNCHRON® Systems C-Reactive Protein (C-RP) Reagent and Calibrator

1.0 Submitted By:

Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123

2.0 Date Submitted:

May 13, 2002

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems C-Reactive Protein (C-RP) Reagent SYNCHRON Systems CX® C-RP Calibrator

3.2 Classification Name

C-Reactive Protein immunological test system (21 CFR § 866.5270) Primary Calibrator (21 CFR § 862.1150)

4.0 Predicate Device:

Candidate(s)	Predicate	Manufacturer	DocketNumber
SYNCHRON® SystemsC-RP Reagent	SYNCHRON LX®Systems CRPH Reagent	Beckman Coulter,Inc.*	K010597
SYNCHRON SystemsCX® C-RP Calibrator	SYNCHRON SystemsCRP Calibrator	Beckman Coulter, Inc.	K910535

*Beckman Coulter, Inc., Brea, CA

5.0 Description:

6.0 Intended Use:

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7.0 Comparison to Predicate(s):

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

		Similarities
C-RP Reagent	Intended Use	Same as Beckman CoulterSYNCHRON LX Systems HighSensitivity CRPH Reagent
	Use of Latex particle technology
	Sample Type
	Antibody source (mouse, goat)
	Liquid-stable reagents
	Differences
	Detection Wavelength	C-RP: 600 nmCRPH: 910 nm
	Platform	C-RP: All CX and LX modelsCRPH: LX PRO models only
	Initial Measuring Range	C-RP: 0.20 to 25 mg/dL (CX)0.10 to 25 mg/dL (LX)CRPH: 0.02 to 8 mg/dL
	Extended Measuring Range	C-RP: up to 50 mg/dLCRPH: up to 38 mg/dL
	Sensitivity	C-RP: 0.20 mg/dL (CX),0.10 mg/dL (LX)CRPH: 0.02 mg/dL

8.0 Summary of Performance Data:

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.

SYNCHRON Systems C-RP Method Comparison Study Results

Candidate Method	Platform	Slope	Intercept	R	n	Predicate Method
SYNCHRONSystems C-RP	CX	1.007	0.05	0.996	132	Beckman Coulter
Reagent	LX	1.033	0.01	0.998	143	SYNCHRON LX SystemsCRPH Assay

Sample	Mean (mg/dL)	S.D. (mg/dL)	%C.V.	N
Within-Run Imprecision
Level 1	0.49	0.014	2.77	80
Level 2	5.40	0.063	1.17	80
Level 3	13.45	0.210	1.56	80
Level 4	23.99	0.598	2.49	80
Total Imprecision
Level 1	0.49	0.017	3.45	80
Level 2	5.40	0.086	1.60	80
Level 3	13.45	0.287	2.13	80
Level 4	23.99	0.624	2.60	80

SYNCHRON LX System C-RP 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.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and the background is white. There is a logo to the left of the text.

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top and left side. Inside the circle is a stylized image of an eagle with three lines forming the body and head, and two curved lines forming the legs and feet.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard, W-104 P.O. Box 8000 Brea, California 92822-8000

JUL 1 9 2002

K021572 Re:

Trade/Device Name: SYNCHRON® Systems C-Reactive Protein (C-RP) Reagent and Calibrator Regulation Number: 21 CFR § 866.5270 and 21 CFR § 862.1150 Regulation Name: C-Reactive Protein Immunological Test System and Primary Calibrator Regulatory Class: II Product Code: DCN, JIS Dated: May 13, 2002 Received: May 14, 2002

Dear Ms. Tang:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set

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Page 2

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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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510(k) Number (if known):

Device Name:

SYNCHRON® Systems C-Reactive Protein (C-RP) Reagent and Calibrator

Indications for Use:

C-RP reagent, when used in conjunction with SYNCHRON CAL 5 Plus on SYNCHRON LX® Systems and CX® C-RP Calibrator on SYNCHRON CX® Systems, is intended for use in the quantitative determination of human C-reactive protein in human serum and plasma samples by rate turbidimetry. Measurement of C-reactive protein aids in evaluation of stress, trauma, infection, inflammation, and surgery.

KO21572

CX C-RP Calibrator, when used in conjunction with SYNCHRON Systems C-Reactive Protein (C-RP) Reagent, is intended for the calibration of C-reactive protein test systems on SYNCHRON CX Systems.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1/Reeve for E. Altaie

(Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number _

Prescription Use
(per 21 CFR 801.109)

. '

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).