The SYNCHRON® Systems C-Reactive Protein (CRP) Reagent , in conjunction with the SYNCHRON CX® CRP Calibrator Set, is intended for the quantitative determination of C-reactive protein concentration in serum or plasma.

Device Description

The SYNCHRON Systems C-Reactive Protein (CRP) Reagent is designed for optimal performance on Beckman's SYNCHRON® Systems. It is intended for use in the quantitative determination of human C-reactive protein by rate nephelometry.

AI/ML Overview

The SYNCHRON® Systems C-Reactive Protein (CRP) Reagent is a device for the quantitative determination of C-reactive protein in serum or plasma. The device was submitted for 510(k) clearance and found substantially equivalent to the IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent (K963061).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" for each performance metric, but it does present performance data that would have been evaluated against internal or regulatory thresholds for substantial equivalence. The "Reported Device Performance" column reflects the results provided.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Method Comparison (vs. IMMAGE System CRP Reagent)	The regression analysis of SYNCHRON CRP vs. IMMAGE CRP should demonstrate good correlation and agreement, ideally close to a regression line of Y = 1.0X + 0.0 with a high correlation coefficient (r).	Not explicitly stated, but the summary states "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution." No specific regression equation or correlation coefficient is provided for the method comparison directly.
Serum vs. Plasma Correlation	Strong correlation (high 'r' value) and close agreement (slope near 1, intercept near 0) between serum and plasma samples with various anticoagulants.	Lithium Heparin: Y = 1.042X - 0.45; r = 0.977 Sodium Heparin: Y = 0.994X - 0.07; r = 0.989 EDTA: Y = 0.992X - 0.20; r = 0.967
Within-Run Imprecision (Low Level)	Low Coefficient of Variation (%CV)	Level 1 (1.03 IU/mL): 4.46% CV
Within-Run Imprecision (Medium Level)	Low Coefficient of Variation (%CV)	Level 2 (4.06 IU/mL): 1.58% CV
Within-Run Imprecision (High Level)	Low Coefficient of Variation (%CV)	Level 3 (7.09 IU/mL): 1.14% CV
Total Imprecision (Low Level)	Low Coefficient of Variation (%CV)	Level 1 (1.03 IU/mL): 5.49% CV
Total Imprecision (Medium Level)	Low Coefficient of Variation (%CV)	Level 2 (4.06 IU/mL): 4.49% CV
Total Imprecision (High Level)	Low Coefficient of Variation (%CV)	Level 3 (7.09 IU/mL): 3.56% CV

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

Sample Size for Method Comparison: The document states "145 SUSSAFE SERVACETRY SERVED SERIE CONFECT STARE", but this appears to be garbled text. The table header "Method Comparison for CRP Reagent" suggests a comparison was performed, but the specific number of samples for this comparison is not clearly legible.
Sample Size for Serum vs Plasma Study: The regression data provided for serum vs. plasma does not explicitly state the number of samples used for each anticoagulant study.
Sample Size for Imprecision Study:
- Within-Run Imprecision: 80 replicates (N=80) for each of the three levels tested.
- Total Imprecision: 80 replicates (N=80) for each of the three levels tested.
Data Provenance: Not explicitly stated. Given that Beckman Instruments, Inc. is located in Brea, California, USA, and the submission is to the FDA, it is highly probable that the data was generated in the USA. The studies are prospective as they were conducted to support the 510(k) submission for the device.

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

This device is a quantitative clinical chemistry reagent. The "ground truth" for such devices is typically established through a reference method or a predicate device, rather than expert human interpretation in the same way an imaging device might use radiologists. For the method comparison, the predicate device (IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent) served as the reference for comparison.

Therefore, the concept of "number of experts" and "qualifications of experts" for establishing ground truth in this context is not applicable. The "ground truth" is based on the analytical results of established laboratory methods.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies where human readers or interpreters make subjective assessments, such as interpreting medical images or clinical observations. Since this is an in-vitro diagnostic device providing a quantitative measurement, and the ground truth is established by a reference method or predicate device performance, an adjudication method for the test set is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is primarily for devices that assist human interpretation (e.g., AI for radiology), where the effect of the AI on human reader performance is measured. The SYNCHRON Systems C-Reactive Protein (CRP) Reagent is an automated in-vitro diagnostic assay for direct quantitative measurement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done

Yes, the performance data presented (Method Comparison, Serum vs. Plasma Study, and Imprecision) represents the standalone performance of the SYNCHRON® Systems C-Reactive Protein (CRP) Reagent without human-in-the-loop assistance for interpretation. The device itself performs the measurement.

7. The Type of Ground Truth Used

The ground truth used for the performance studies is based on:

Comparison to a Predicate Device: For method comparison, the results generated by the predicate IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent would serve as the comparative ground truth.
Analytical Measurement: For imprecision, the ground truth is the inherent analytical measurement of the C-reactive protein in the samples by the device itself.
Reference Standards: While not explicitly mentioned, it is typical for such studies to use quality control materials and calibrators traceable to international reference standards to ensure accuracy.

8. The Sample Size for the Training Set

This submission describes an in-vitro diagnostic reagent, not a machine learning or AI algorithm in the modern sense that typically involves "training sets." Therefore, the concept of a "training set" does not apply to this device. The development of such a reagent involves chemical formulation, optimization, and characterization, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

As stated above, the concept of a "training set" does not apply here, so the establishment of ground truth for a training set is not applicable.

Summary

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K974050

BECKMAN

NOV 2 4 1997

Summary of Safety & Effectiveness SYNCHRON® Systems C-Reactive Protein (CRP) Reagent

1.0 Submitted By:

Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4457

2.0 Date Submitted:

October 23, 1997

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems C-Reactive Protein (CRP) Reagent

3.2 Classification Names

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

4.0 Predicate Device(s):

IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent K963061

5.0 Description:

ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

6.0 Intended Use:

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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.

Reagent	Aspect/Characteristic	Comments
SIMILARITIES
SYNCHRONSystems CRPReagent	Sample types(serum/plasma)	Same as IMMAGE System CRP Reagent
SYNCHRONSystems CRPReagent	Shelf-life of 24 months(stored at 2-8°C)	Same as IMMAGE System CRP Reagent
SYNCHRONSystems CRPReagent	Antibody	Same as IMMAGE System CRP Reagent
DIFFERENCES
SYNCHRONSystems CRPReagent	Calibrator	The SYNCHRON uses a five level systemcalibration while the IMMAGE uses a singlecal point update.
SYNCHRONSystems CRPReagent	Methodology	The SYNCHRON Systems CRP utilizes aturbidimetric method while the IMMAGESystem CRP utilizes a nephelometricmethod.

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.

Method Comparison for CRP Reagent

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Serum vs Plasma Study Summary

Anticoagulant	Level of Anticoagulant Tested	Deming Regression Analysis (mg/dL)
Lithium Heparin	14 Units/mL	$Y = 1.042X - 0.45; r = 0.977$
Sodium Heparin	14 Units/mL	$Y = 0.994X - 0.07; r = 0.989$
EDTA	1.5 mg/mL	$Y = 0.992X - 0.20; r = 0.967$

Estimated SYNCHRON CRP Reagent Imprecision

Sample	Mean (IU/mL)	S.D. (IU/mL)	%C.V.	N
Within-Run Imprecision
Level 1	1.03	0.05	4.46	80
Level 2	4.06	0.06	1.58	80
Level 3	7.09	0.08	1.14	80
Total Imprecision
Level 1	1.03	0.06	5.49	80
Level 2	4.06	0.18	4.49	80
Level 3	7.09	0.25	3.56	80

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Annette Hellie Senior Regulatory Specialist, Product Submissions NOV 2 4 1997 Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-337 Brea, California 92822-8000

Re: K974050 SYNCHRON® System C-Reactive Protein (CRP) Reagent Trade Name: Requlatorv Class: II Product Code: DCK Dated: October 23, 1997 Received: October 24, 1997

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 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 requirement, as set forth in the Quality System Requlation (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 Reqister. 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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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

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): K974050

Device Name: SYNCHRON® Systems C-Reactive Protein (CRP) Reagent

Indications for Use:

The SYNCHRON® Systems C-Reactive Protein (CRP) Roagent, In conjunction with the SYNCHRON CX® CRP Calibrator Set. Is intended for the quantitative determination of C-reactive protein concentration in serum or plaema.

21 CFR 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. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. . . . - - --- ---- -----------------------------------------------------------------------------------------------------------------------------------. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(b) Classification. Class II (performance standards)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off

beratory Devices 5100c) Nowel

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).