The SYNCHRON® Systems Lipid Calibrator, used in conjunction with SYNCHRON® HDL Cholesterol reagent, is intended for use on Beckman's SYNCHRON Systems for the calibration of HDL Cholesterol test systems.

Device Description

The SYNCHRON Systems Lipid Calibrator Set is a two level ready-to-use human serum-based liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 3 X 2 mL bottles of a specific level of calibrator (identified as Level 1 and Level 2). Once opened, the calibrators are stable for 65 days when stored at +2℃ to +8℃.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, accuracy, and associated statistical analyses characteristic of AI/diagnostic device studies).

The document is a "Summary of Safety & Effectiveness" for a Lipid Calibrator (SYNCHRON® Systems Lipid Calibrator), which is a and a reagent used to calibrate other diagnostic devices, not a diagnostic device itself with typical performance metrics.

The "Summary of Performance Data" section only mentions:

"The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution."
"Stress stability and open bottle stability studies of the lipid calibrator support the Beckman stability claim of 24 months and 65 days for open bottles."

This indicates that the performance evaluation was focused on stability and establishing substantial equivalence to a predicate device, as required for a 510(k) submission for a calibrator. It does not contain information on the performance metrics or study designs typically used for AI or diagnostic devices, such as those that would involve ground truth determination by experts, sample sizes for test/training sets, or MRMC studies.

Therefore, most of the requested fields cannot be answered from the provided text.

Here's an attempt to answer the parts that can be inferred or directly stated:

A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., accuracy, precision) in the provided text. The primary acceptance criterion for a calibrator, based on the document, appears to be demonstrating substantial equivalence to a predicate device and meeting stability claims.

Reported Device Performance:

Performance Aspect	Reported Finding
Stability (Stress)	Supports Beckman's claim of 24 months.
Stability (Open)	Supports Beckman's claim of 65 days when stored at +2℃ to +8℃.
Equivalence	Substantial equivalence to predicate device (Beckman™ VIGIL LipidControl) confirmed.

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
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)
- Not applicable. The device is a calibrator, not a diagnostic tool that requires expert interpretation of results for ground truth establishment in this context. The "ground truth" for a calibrator would typically be its assigned values based on reference methods, not expert consensus on diagnostic images or clinical outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This product is a physical calibrator.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable as typically defined for diagnostic tests. For a calibrator, "ground truth" would relate to the accuracy of its assigned analyte concentrations, typically established through rigorous analytical methods (e.g., gravimetric measurements, reference methods, certified reference materials). The document states "Value Assignment Methodology" is a characteristic, implying this process was performed, but details are not provided.
The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.

Summary

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DEC 2 1 1998

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Summary of Safety & Effectiveness SYNCHRON® Systems Lipid Calibrator

1.0 Submitted By:

Lucinda Stockert Staff Requlatory Specialist, Product Submissions 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:

October 15, 1998

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems Lipid Calibrator

3.2 Classification Name

Calibrator, (21 CFR §862.1150)

4.0 Predicate Device(s):

SYNCHRON SystemsReagent	Predicate	Manufacturer	DocketNumber
SYNCHRON® SystemsLipid Calibrator	Beckman™ VIGIL LipidControl	Beckman Coulter, Inc.	K974452

5.0 Description:

The SYNCHRON Systems Lipid Calibrator Set is a two level ready-to-use human serumbased liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 3 X 2 mL bottles of a specific level of calibrator (identified as Level 1 and Level 2). Once opened, the calibrators are stable for 65 days when stored at +2℃ to +8℃.

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Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Lipid Calibrator Summary of Safety & Effectiveness

5.0 Intended Use:

The SYNCHRON® Systems Lipid Calibrator is intended for use with the SYNCHRON Systems for the calibration of direct HDL Cholesterol reagent.

7.0 Comparison to Predicate(s):

Reagent	Aspect/Characteristic	Comments
SYNCHRONSystems LipidCalibrator	Source Material: Defibrinated human plasmaspiked with human lipids and stabilized byfreezing.	Same as Beckman™VIGIL Lipid Control
	Storage Temperature (-15°C to -20°C)
	Liquid, ready-to-use form
	Value Assignment Methodology

Reagent	Aspect/Characteristic	Comments
SYNCHRONSystems LipidCalibrator	Intended Use:	SYNCHRON Systems Lipid Calibrator isintended for use in calibration ofSYNCHRON Systems HDL CholesterolReagent.
		Beckman™ VIGIL Lipid Control isintended for use in monitoring thereliability of automated in vitro diagnosticassays of HDL Cholesterol.
	Analytes	SYNCHRON Systems Lipid Calibratorcontains HDL Cholesterol.
		Beckman™ VIGIL Lipid Control containscholesterol, HDL cholesterol,triglycerides, apolipoprotein A-1,apolipoprotein B.
	Levels of Analyte	SYNCHRON Systems Lipid Calibrator:2 levels
		Beckman™ VIGIL Lipid Control: 4 levels

Differences from the Predicate

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution. Stress stability and open bottle stability studies of the lipid calibrator support the Beckman stability claim of 24 months and 65 days for open bottles.

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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DEC 2 1 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lucinda Stockert Staff Regulatory Specialist, Product Submissions Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, CA 92822-8000

Re: K983640 Trade Name: SYNCHRON® Systems Lipid Calibrator Regulatory Class: II Product Code: 75 JIS October 15, 1998 Dated: October 16, 1998 Received:

Dear Ms. Stockert:

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 Requlations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. this response to your premarket notification Please note: 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

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 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/dsma/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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page of

510(k) Number (if known): K 9836 40

Device Name: SYNCHRON® Systems Lipid Calibrator

Indications for Use:

Clinical Significance:

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

(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

vision of Clinical Laboratory Devices 510(k) Number

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.