The SYNCHRON Systems Cholesterol (CHOL) Reagent, when used in conjunction with SYNCHRON Systems Multi Calibrator, is intended for the quantitative determination of human cholesterol in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.

Device Description

The SYNCHRON Systems Cholesterol (CHOL) Reagent in conjunction with SYNCHRON Systems Multi Calibrator, is intended for use on Beckman's SYNCHRON Systems Clinical Systems.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the SYNCHRON® Systems Cholesterol (CHOL) Reagent:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for performance. Instead, it presents performance data (method comparison and imprecision) which is presumably used to demonstrate substantial equivalence to the predicate device. The implied acceptance criteria are that the new device's performance should be comparable to or better than the predicate's and generally accepted clinical standards for cholesterol measurement.

Performance Metric	Implied Acceptance Criteria (Based on general clinical standards for cholesterol)	Reported Device Performance
Method Comparison (vs. Predicate)	Close to 1.0 (slope), close to 0 (intercept), high correlation (r > 0.99)	Slope: 0.983 Intercept: 2.41 mg/dL r (correlation coefficient): 0.9996 (Compared to SYNCHRON Systems Cholesterol (CHOL) Reagent predicate)
Method Comparison (vs. Reference Method)	Close to 1.0 (slope), close to 0 (intercept), high correlation (r > 0.99)	Slope: 1.002 Intercept: -2.07 mg/dL r (correlation coefficient): 0.9961 (Compared to Abell-Kendall Reference Method)
Within-Run Imprecision (Default Range)	Typical CVs for cholesterol assays are generally < 5-10%, often striving for < 2-3%	Level 1 (98.7 mg/dL): 1.09 %CV Level 2 (155.4 mg/dL): 1.06 %CV Level 3 (213.2 mg/dL): 0.98 %CV
Within-Run Imprecision (Extended Range)	Similar to default range, potentially slightly higher at extreme concentrations	Level 1 (716.2 mg/dL): 2.28 %CV Level 2 (876.25 mg/dL): 1.74 %CV

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

Sample Sizes:
- Method Comparison (vs. Predicate): 79 samples (n=79)
- Method Comparison (vs. Abell-Kendall Reference Method): 39 samples (n=39)
- Within-Run Imprecision (Default Range): 80 samples for each of the three levels (Level 1, Level 2, Level 3).
- Within-Run Imprecision (Extended Range): 20 samples for each of the two levels (Level 1, Level 2).
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It implies the studies were conducted by Beckman Instruments, Inc.

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

This information is not applicable and not provided in the document. The device is a diagnostic reagent for quantitative measurement of a biochemical analyte (cholesterol). The "ground truth" for method comparison studies in this context is established by a reference method (Abell-Kendall) or a predicate device. It does not involve expert interpretation of images or clinical cases requiring multiple expert opinions.

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

Not applicable. This is a quantitative chemical assay, not a device requiring human adjudication of results in a diagnostic context like imaging or pathology. The "adjudication" is inherent in the comparison against a reference method or predicate.

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 an AI-assisted diagnostic device, nor is it a device that requires human readers. It is a chemical reagent used on automated clinical systems.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The performance data presented (method comparison, imprecision) represents the "standalone" performance of the reagent and the SYNCHRON Systems when performing the cholesterol assay. "Human-in-the-loop" for this type of device typically refers to a lab technician operating the analyzer, but the performance metrics provided are for the analytical system itself.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for method comparison studies was:

The results obtained from the SYNCHRON Systems Cholesterol (CHOL) Reagent (predicate device).
The results obtained from the Abell-Kendall Reference Method, which is a recognized gold standard for cholesterol measurement.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of device development. This is a chemical reagent, not a machine learning or AI algorithm that typically requires a large training dataset. The development process for such a reagent would involve analytical optimization and validation, rather than machine learning training.

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

Not applicable, as there is no mention of a "training set" for an AI or machine learning model.

Summary

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Kanisos

June 11, 1997

Summary of Safety & Effectiveness SYNCHRON® Systems Cholesterol (CHOL) Reagent

1.0 Submitted By:

Maria Zeballos Scientist II, Chemistry Development Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-150 Brea, California 92822-8000 Telephone: (714) 961-4435 FAX: (714) 961-3740

2.0 Date Submitted:

18 April 1997

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems Cholesterol (CHOL) Reagent

3.2 Classification Names

Cholesterol (Total) Test system (21 CFR 862.1175)

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Predicate Device(s): 4.0

SYNCHRONReagent	Predicate	PredicateCompany	DocketNumber
SYNCHRON SystemsCholesterol (CHOL)Reagent	SYNCHRON CXSystems Cholesterol(CHOL) Reagent	BeckmanInstruments, Inc.	K934046
SYNCHRONCX4/CX5 Systems	ASTRA &SYNCHRON CX3	BeckmanInstruments, Inc	K881498 K881495
SYNCHRON CX5CESystem	SYNCHRONCX4/CX5 Systems	BeckmanInstruments, Inc	K926060
SYNCHRONCX4CE/CX7 System	SYNCHRONCX4/CX5 Systems	BeckmanInstruments, Inc	K904220 K904219
SYNCHRON SystemsCX4/CX5 Systems	SYNCHRON SystemsCX4/CX5 Systems	BeckmanInstruments, Inc	K950958
SYNCHRON LX 20System	SYNCHRON CX7DELTA System	BeckmanInstruments, Inc.	K965240

5.0 Description:

The SYNCHRON Systems Cholesterol (CHOL) Reagent in conjunction with SYNCHRON Systems Multi Calibrator, is intended for use on Beckman's SYNCHRON Systems Clinical Systems.

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.

Reagent	Aspect/Characteristic	Comments
SIMILARITIES
SYNCHRONSystemsCholesterol(CHOL)Reagent	Intended use	Same; determination ofcholesterol concentration inserum or plasma
	Chemical reaction	Same; enzymatic, CholesterolOxidase reaction
	Measurementmethod	Same; endpoint measurement at520 nm
	Packaging	Same; a two cartridge reagent kit
	Reaction time	Same; 32 seconds
	Calibration	Same; single level serum basecalibrator

Reagent	Aspect/Characteristic	Comments
DIFFERENCES
SYNCHRONSystemsCholesterol(CHOL)Reagent	Range expansion	The SYNCHRON CX Systemsmeasures cholesterolconcentrations at the initial rangeof 5 -750 mg/dL; while theSYNCHRON LX Systemsmeasures cholesterolconcentrations at the initial rangeof 5-750 mg/dL and expandedrange of 600 - 1000 mg/dL

10_sse, 04/97

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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 studies and imprecision experiments that relate results obtained from SYNCHRON Systems Cholesterol Reagent.

Reagent(Analyte)	Slope	Intercept(mg/dL)	r	n	Predicate Method
SYNCHRONSystemsCholesterol(CHOL)Reagent	0.983	2.41	0.9996	79	SYNCHRONSystemsCholesterol(CHOL)Reagent
SYNCHRONSystemsCholesterol(CHOL)Reagent	1.002	-2.07	0.9961	39	Abell-KendallReferenceMethod

Method Comparison Study Results SYNCHRON Systems Cholesterol (CHOL) Reagent

Estimated Within-Run Imprecision Cholesterol Reagent

Sample	Mean(mg/dL)	S.D.(mg/dL)	%C.V.	N
Within-Run Imprecision Default Range
Level 1	98.7	1.08	1.09	80
Level 2	155.4	1.65	1.06	80
Level 3	213.2	20.8	0.98	80
Within-Run Imprecision Extended Range
Level 1	716.2	12.53	2.28	20
Level 2	876.25	19.94	1.74	20

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/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 1 1997

Sheri Hall Manager, Premarket Regulatory Beckman_Instruments _ Inc ... . 200 S. Kraemer Boulevard, M/S W-337 P.O. Box 8000 Brea, California 92822-8000 48 Re : K971505 SYNCHRON® Systems Cholesterol (CHOL) Reagent Regulatory Class: I Product Code: CHH Dated: April 18, 1997 Received: April 25, 1997

Dear Ms. Hall:

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 reqistration, 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. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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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Page 2

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 requlation (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 requlation 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/dsmamain.html".

sincerely yours,
Steven Gutman

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

Enclosure

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of page -

510(k) Number (if known):

Device Name:

Indications for Use:

The SYNCHRON Systems Cholesterol (CHOL) Reagent, when used in conjunction with SYNCHRON Systems Multi Calibrator, is intended for the quantitative determination of human cholesterol in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.

21 CFR 862.1175 Cholesterol (total) test system

(a) Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorder involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

(b) Classification. Class II.

(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
K947555

510(k) Number

Prescription Use
(per 21 CFR 801.109)

Over-the-Counter Use Optional Format 1-2-96

Regulation Number and Section

§ 862.1175 Cholesterol (total) test system.

(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.