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

Device Description

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

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: SYNCHRON® Systems Alcohol (ALC) Reagent

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values for the SYNCHRON® Systems Alcohol (ALC) Reagent. Instead, it presents performance data (Method Comparison and Imprecision) and states that this data supports substantial equivalence to predicate devices already in commercial distribution. The implicit acceptance criteria are that the device performs comparably or better than the predicate device.

Given this, the table below reports the performance metrics directly from the study:

Performance Metric	Acceptance Criteria (Implicit: Comparable to Predicate)	Reported Device Performance (SYNCHRON ALC Reagent)
Method Comparison (vs. DCL Ethanol Assay)
Slope	Close to 1.0	1.037
Intercept (mg/dL)	Close to 0.0	0.34
r (correlation coefficient)	Close to 1.0	0.9986

Within-Run Imprecision (Default Range)
Level 1 (51.4 mg/dL): %C.V.	Low and acceptable for clinical use	1.73%
Level 2 (102.2 mg/dL): %C.V.	Low and acceptable for clinical use	1.53%
Level 3 (239.7 mg/dL): %C.V.	Low and acceptable for clinical use	1.33%

Within-Run Imprecision (Extended Range)
Level 1 (287.55 mg/dL): %C.V.	Low and acceptable for clinical use	1.24%
Level 2 (488.63 mg/dL): %C.V.	Low and acceptable for clinical use	1.24%

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

Method Comparison Study:
- Sample Size: n = 78
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This type of study (comparing a new assay to a predicate) is typically prospective, but the document doesn't specify.
Imprecision Study:
- Sample Size (Default Range): n = 80 for each of the three levels (Level 1, Level 2, Level 3)
- Sample Size (Extended Range): n = 20 for each of the two levels (Level 1, Level 2)
- Data Provenance: Not explicitly stated. These are laboratory-based studies.

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

For the SYNCHRON® Systems Alcohol (ALC) Reagent, the "ground truth" for the method comparison study was established by the predicate method: DCL Ethanol Assay Kit on the SYNCHRON CX Systems. This is a comparative study against an existing, legally marketed device, not a study requiring human expert interpretation for ground truth. Therefore, there were no human experts used to establish ground truth in the traditional sense.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or adjudication for the test set. The comparison is between two quantitative analytical methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document describes the validation of a laboratory reagent for quantitative measurement of alcohol. MRMC studies are typically used for imaging or diagnostic algorithms that require interpretation by human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies presented are standalone performance evaluations of the SYNCHRON® Systems Alcohol (ALC) Reagent. The method comparison and imprecision studies assess the analytical performance of the reagent system itself, without human intervention in the result determination process beyond standard laboratory procedures for running the assay.

7. Type of Ground Truth Used

The ground truth for the method comparison study was the results obtained from the predicate method (DCL Ethanol Assay Kit). For the imprecision studies, the "ground truth" is the true concentration of alcohol in the control samples used, which is typically established by reference methods or gravimetric preparation.

8. Sample Size for the Training Set

Not applicable. This is an in vitro diagnostic (IVD) reagent, and the validation described involves analytical performance studies rather than machine learning model training. The reagent itself does not have a "training set" in the context of an AI/ML algorithm.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this device.

Summary

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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems Alcohol (ALC) Reagent Summary of Safety & Effectiveness

K971506

JUN - 3 1997

Summary of Safety & Effectiveness SYNCHRON® Systems Alcohol (ALC) Reagent

Submitted By: 1.0

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 Alcohol (ALC) Reagent

3.2 Classification Names

Alcohol Test system (21 CFR 862.3040)

4.0 Predicate Device(s):

SYNCHRONReagent	Predicate	Predicate Company	DocketNumber
SYNCHRONSystems Alcohol(ALC) Reagent	DCL EthanolAssay	Diagnostic ChemicalsLimited (DCL),Charlottetown, PEI,Canada	K923783 K924733

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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems Alcohol (ALC) Reagent Summary of Safety & Effectiveness

Description: 5.0

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

Intended Use: 6.0

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

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 Alcohol(ALC) Reagent	Intended use	Same as DCL Ethanol Assay Kit;determination of alcoholconcentration in serum or plasma
	Chemical reaction	Same as DCL Ethanol Assay Kit;enzymatic, AlcoholDehydrogenase (ADH) reaction
	Formulation	Same as DCL Ethanol Assay Kit
	Measurementmethod	Same as DCL Ethanol Assay Kit;endpoint measurement at 340 nm
	Packaging	Same as DCL Ethanol Assay Kit;a multi reagent kit that requirespreparation.
	Calibration	Same as DCL Ethanol Assay Kit;single level aqueous calibrator

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SUNE INFE

Reagent	Aspect/Characteristic	Comments
DIFFERENCES
SYNCHRONSystemsAlcohol (ALC)Reagent	Range expansion	The DCL Ethanol Assay Kitmeasures alcohol concentrations atthe initial range of 5 -250 mg/dL;while the SYNCHRON SystemsALC reagent measures alcoholconcentrations at the initial range of5 - 250 mg/dL and expanded rangeof 200 - 500 mg/dL

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 Alcohol Reagent.

Method Comparison Study Results SYNCHRON Systems Alcohol (ALC) Reagent

Reagent(Analyte)	Slope	Intercept(mg/dL)	r	n	PredicateMethod
SYNCHRONSystemsAlcohol (ALC)Reagent	1.037	0.34	0.9986	78	DCL EthanolAssay Kit ontheSYNCHRONCX Systems

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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems Alcohol (ALC) Reagent Summary of Safety & Effectiveness

Sample	Mean(mg/dL)	S.D.(mg/dL)	%C.V.	N
Within-Run Imprecision Default Range
Level 1	51.4	0.89	1.73	80
Level 2	102.2	1.57	1.53	80
Level 3	239.7	3.19	1.33	80
Within-Run Imprecision Extended Range
Level 1	287.55	3.58	1.24	20
Level 2	488.63	6.08	1.24	20

Estimated Within-Run Imprecision Alcohol Reagent

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 logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 3 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

K971506 Re : SYNCHRON® Systems Alcohol (ALC) Reagent Requlatory Class: II Product Code: DIC, DMT 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 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 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 atlow you to begin marketing your device as i 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 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 (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 Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: SYNCHRON® Systems Alcohol (ALC) Reagent

Indications for Use:

21 CFR 862.3040 Alcohol test system

(a) Identification. An alcohol test system is a device intended to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.

(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-on)
Division of Clinical Laboratory Devices

510(k) Number
K971506

Prescription Use (per 21 CFR 801.109)

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

Regulation Number and Section

§ 862.3040 Alcohol test system.

(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.