Salicylate (SALY) Reagent, when used in conjunction with SYNCHRON® Systems Salicylate Calibrator, is intended for the quantitative determination of salicylate in serum and plasma on Beckman Coulter's SYNCHRON Systems by a colorimetric timed-endpoint method. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.

Device Description

The SYNCHRON System Salicylate (SALY) Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. The assay is intended for use in the quantitative determination of salicylate concentration in serum or plasma by a colorimetric timed-endpoint method. The reagent kit contains two 45-test cartridges and is packaged with the single-level calibrator.

AI/ML Overview

The document provided is a 510(k) summary for the SYNCHRON® Systems Salicylate Reagent, an in vitro diagnostic device used for quantitative determination of salicylate concentration in serum or plasma. It is not an AI/ML device, and therefore, many of the requested criteria (like sample size for test/training set, expert ground truth, adjudication methods, MRMC studies, standalone performance for AI, etc.) are not applicable.

However, based on the information available in the document, here's a description related to its performance validation:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance in terms of Method Comparison and Imprecision. While explicit acceptance criteria (e.g., "slope must be between X and Y") are not detailed as such, the results presented demonstrate performance compared to a predicate device and show reproducibility.

Performance Metric	Acceptance Criteria (Implied / Not Explicitly Stated)	Reported Device Performance (SYNCHRON® Salicylate Assay)
Method Comparison	Close agreement with predicate device (High 'r', slope close to 1, intercept close to 0)
N (Samples)	--	75
Slope	--	1.096
Intercept	--	-0.14
Correlation Coefficient (r)	--	0.989
Predicate Method	--	Abbott TDx Salicylate Assay
Within-Run Imprecision	(Low %C.V. for reproducibility)
Level 1 (9.7 mg/dL)	--	3.8% C.V.
Level 2 (31.7 mg/dL)	--	2.0% C.V.
Level 3 (82.7 mg/dL)	--	1.0% C.V.
Total Imprecision	(Low %C.V. for reproducibility)
Level 1 (9.7 mg/dL)	--	6.7% C.V.
Level 2 (31.7 mg/dL)	--	2.7% C.V.
Level 3 (82.7 mg/dL)	--	2.3% C.V.

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

Sample Size (Method Comparison): 75 serum patient specimens.
Data Provenance: The specimens were "serum patient specimens." The country of origin is not specified, but the submission is from Beckman Coulter in Brea, CA, suggesting US-based data is likely. The study appears to be retrospective, using existing patient specimens.

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 (IVD) device, not an AI/ML device that requires human expert review for image interpretation or similar. The "gold standard" or "ground truth" for the method comparison is the predicate device, the Abbott TDx Salicylate Assay. For imprecision, the ground truth is statistical reliability based on repeat measurements of control samples.

4. Adjudication Method for the Test Set:

Not applicable. This concept relates to reconciling discrepancies between human readers or between AI and human readers, which is not relevant for an IVD device measuring analyte concentrations.

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. MRMC studies are for AI/ML devices involving human readers. This device is an automated reagent system.

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

Yes, in spirit. The performance data presented (Method Comparison and Imprecision) are for the SYNCHRON® Systems Salicylate Reagent and system stand-alone, meaning its performance is evaluated based on its own measurements compared to a predicate or its own reproducibility, independent of human interpretive intervention. The device's output is a quantitative value, not an interpretation requiring human review. User input for sample loading and initiating tests is implied, but the core measurement and result generation are automated.

7. The type of ground truth used:

For Method Comparison: A legally marketed predicate device (Abbott TDx Salicylate Assay) was used as the comparative "ground truth" to establish substantial equivalence.
For Imprecision: Statistical measures of variability (Standard Deviation and % Coefficient of Variation) across repeated measurements of control samples served as the basis for assessing precision.

8. The sample size for the training set:

Not applicable. This device is a reagent for a colorimetric timed-endpoint method, not an AI/ML algorithm that requires a training set. Its development would involve chemical and analytical optimization, not machine learning training.

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

Not applicable. As stated above, there is no AI/ML training set for this type of IVD device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized black oval shape with two curved lines running through it. To the right of the oval is the company name, "BECKMAN COULTER," with "BECKMAN" on the top line and "COULTER" on the bottom line. The text is in a bold, sans-serif font.

FEB 1 5 2002

K014173

510(k) Summary SYNCHRON® Systems Salicylate Reagent

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:

December 19, 2001

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems Salicylate Reagent

3.2 Classification Name

Salicylate test system (21 CFR § 862.3830) Clinical toxicology calibrator (21 CFR § 862.3200)

4.0 Predicate Device(s):

Beckman Coulter	Predicate	Manufacturer	DocketNumber
SYNCHRON® SystemsSalicylate (SALY) Reagent	TDx® Salicylate Assay	Abbott Laboratories, Inc.*	K844070

*Abbott Laboratories, Inc., Abbott Park, IL

5.0 Description:

6.0 Intended Use:

Salicylate (SALY) Reagent, when used in conjunction with the SYNCHRON Systems Salicylate Calibrator, is intended for the quantitative determination of salicylate concentration in serum or plasma on SYNCHRON Systems.

Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

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Comparison to Predicate(s): 7.0

Assay	Aspect/Characteristic	Comments
SIMILARITIES
SYNCHRON®Systems SALYReagent	Intended use	Same as predicate
	Sample Type
	Liquid-stable reagents and calibrators
	Storage conditions (+2°C to +8°C)
DIFFERENCES
	Methodology	SYNCHRON: Enzymatic,colorimetricTDx: Fluorescence PolarizationImmunoassay (FPIA)
	Formulation	Specific to methodology
	Reportable Range	SYNCHRON: 4.0 - 100 mg/dLTDx: 0.0 - 80 mg/dL
	Sensitivity	SYNCHRON: 4.0 mg/dLTDx: 0.5 mg/dL
	Sample Size	SYNCHRON: 4 µLTDx: 3 µL

Summary of Performance Data: 8.0

Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of The data in the Premarket Notincation on Salesy and enrocks in commercial distribution.
substantial equivalence to chemistry test systems and imperising experiments that substantial equivalence to chemistry test systems and imprecision experiments that
Equivalence is demonstrated Equivalence is demonstrated through methou companson and inforcessor of any and Salicylate assay.

Method Comparison Study Results*

Analyte	N	Slope	Intercept	r	Predicate Method
SYNCHRONSalicylate Assay	75	1.096	-0.14	0.989	Abbott TDx SalicylateAssay

Salicylate Assay
*Serum patient specimens were analyzed in the range of 5.1 to 9.52 mg/d. salicylate. Data shown *Serum patient specimens were analyzed in the large of 3.1 to occ. mg of saily.
was collected using SYNCHRON LX Systems. Equivalency between SYNCHRON CX has been
Shas collec was collected using of NON DN DN ON DV Cystems.

Sample	Mean (mg/dL)	S.D. (mg/dL)	%C.V.	N
Within-Run Imprecision
Level 1	9.7	0.36	3.8	80
Level 2	31.7	0.63	2.0	80
Level 3	82.7	0.83	1.0	80
Total Imprecision
Level 1	9.7	0.65	6.7	80
Level 2	31.7	0.86	2.7	80
Level 3	82.7	1.93	2.3	80

Estimated SYNCHRON LX Salicylate Assay Imprecision

The Summary of Safety and Effectiveness information for the SYNCHRON Systems The Summary of Saley and Ellectively and are being submitted in accordance Salicylate Reagent is found in TAB T of this notes and are beling cability of the requirementing regulation 21 CFR 807.92.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. M/S W-104 Box 8000 Brea, CA 92822-8000

Re: K014173

Trade/Device Name: SYNCHRON® Systems Salicylate Reagent Regulation Number: 21 CFR 862.3830; 21 CFR 862.1150 Regulation Name: Salicylate test system; Calibrator Regulatory Class: Class II; Class II Product Code: DKJ; JIS Dated: December 19, 2001 Received: December 20, 2001

FEB 1 5 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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/odrb/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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K014173

page 1 of 1

510(k) Number (if known): Not yet assigned

Device Name: SYNCHRON® Systems Salicylate Reagent

Indications for Use:

Jan
(Division Sign-Off)
Division of Clinical
510(k) Number K014173

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(per 21 CFR 801.109)

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

Regulation Number and Section

§ 862.3830 Salicylate test system.

(a)
Identification. A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.(b)
Classification. Class II.