System reagent for the quantitative determination of Cholinesterase activity (E.C. 3.1.1.8) in human serum and plasma on Beckman Coulter Synchron CX® Pro System(s), Synchron LX® Pro System(s) and UniCel® DxC 600/800 System(s).

Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

Device Description

A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

The method is based on the recommendations of the German Society for Clinical Chemisty (Deutsche Gesellschaft für Klinische Chemie, DGKCh).

Cholinesterase catalyses the hydrolysis of butyrytthiocholine to butyrate and thiocholine. Thiocholine reduces yellow hexacyanoferrate (III) to colorless hexacvanoferrate (II). The decrease in absorbance at 410 nm is directly proportional to the cholinesterase activity in the sample.

AI/ML Overview

The provided document is a 510(k) summary for the SYNCHRON® Systems Cholinesterase (CHEX) Reagent, which is a device for measuring cholinesterase activity in human serum and plasma. This is an in vitro diagnostic device (IVD) and not an AI/ML powered medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

Here's the relevant information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The summary states that "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, stability, linearity, and imprecision experiments." However, specific quantitative acceptance criteria or detailed performance metrics are not explicitly presented as a table in this summary. The summary highlights that key analytical characteristics are "same" as the predicate device (Olympus Cholinesterase (CHE) Assay).

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (SYNCHRON CHEX Reagent)
Intended Use	Same as Olympus Cholinesterase (CHE) Assay	Same (as predicate)
Methodology	Same as Olympus Cholinesterase (CHE) Assay	Same (as predicate)
Reagent Constituents	Same as Olympus Cholinesterase (CHE) Assay	Same (as predicate)
Fundamental Technology	Same as Olympus Cholinesterase (CHE) Assay	Same (as predicate)
Analytic Interval	Same as Olympus Cholinesterase (CHE) Assay	Same (as predicate)
Expected Values	Same as Olympus Cholinesterase (CHE) Assay	Same (as predicate)
Sensitivity	Same as Olympus Cholinesterase (CHE) Assay	Same (as predicate)
Within run precision	Same as Olympus Cholinesterase (CHE) Assay	Same (as predicate)
Total precision	Same as Olympus Cholinesterase (CHE) Assay	Same (as predicate)
LIQUID stable reagents	Same as Olympus Cholinesterase (CHE) Assay	Same (as predicate)
On board, open reagent stability	Same as Olympus Cholinesterase (CHE) Assay	Same (as predicate)
Interfering Substances
- Hemoglobin	500 mg/dL (Predicate)	1000 mg/dL (Improved from Predicate)
- Bilirubin	40 mg/dL (Predicate)	60 mg/dL (Improved from Predicate)
- Lipemia	≤ 1000 mg/dL (Intralipid) (Predicate)	2000 mg/dL (triglyceride) (Improved from Predicate)
- Ascorbic Acid	20 mg/dL (Predicate)	30 mg/dL (Improved from Predicate)

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The experiments mentioned are "method comparison, stability, linearity, and imprecision experiments," which are typical for IVD devices, but the specifics are not provided in this summary.

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

This is not applicable as the device is an IVD for quantitative measurement of an enzyme. "Ground truth" in the context of expert consensus for image interpretation or diagnosis is not relevant here. The ground truth for such a device is typically established through reference methods or highly accurate analytical techniques, not expert review.

4. Adjudication Method for the Test Set

Not applicable for an IVD device measuring a quantitative biomarker.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. This is an in vitro diagnostic reagent, not an AI/ML-powered device that assists human readers in interpreting medical cases.

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

Not applicable. This is an in vitro diagnostic reagent that produces a quantitative result. Its performance is evaluated through analytical studies, not typically against human interpretation.

7. The Type of Ground Truth Used

For an IVD device like this, the "ground truth" for evaluating its performance would typically involve:

Reference methods: Using highly accurate and established analytical methods to determine the true concentration or activity of cholinesterase in samples.
Known concentrations: Using samples with known, spiked concentrations of cholinesterase for linearity and accuracy studies.
Comparative methods: Comparison against a legally marketed predicate device (as indicated by the "Comparison to Predicate(s)" section). The predicate device itself serves as a standard for comparison.

8. The Sample Size for the Training Set

Not applicable. This is an IVD device, not an AI/ML device that requires a training set. Its functionality is based on biochemical reactions.

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

Not applicable.

Summary

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K103373
FEB -7 2011

Summary of Safety & Effectiveness SYNCHRON® Systems Cholinesterase (CHEX) 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.

1.0 Submitted By:

Yvette Lloyd, JD Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 250 S. Kraemer Blvd Mail Stop: E2.SE.08 Brea, CA 92821 Phone: (714) 961-3626 FAX: (714) 961-4234 email: vrlloyd@beckman.com

2.0 Date Submitted:

November 16, 2010

3.0 Device Name(s):

3.1 Proprietary Names SYNCHRON® Systems Cholinesterase (CHEX) Reagent

3.2 Classification Name

-- Cholinesterase test system, (Product Code -- DIH; 21 CFR & 862.3240) --

4.0 Predicate Device:

····

Candidate(s)	Predicate	Manufacturer	DocketNumber
SYNCHRON® SystemsCholinesterase (CHEX)Reagent	Cholinesterase (CHE)	OLYMPUSAMERICA,INC.	K030045

5.0 Description:

System reagent for the quantitative determination of Cholinesterase activity (E.C. 3.1.1.8)1 in human serum and plasma on Beckman Coulter Synchron CX® Pro System(s), Synchron LX® Pro System(s) and UniCel® DxC 600/800 System(s).

۔ ﻧﮧ ﺑﮩﺖ ۔۔۔۔ ﺏ ، Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Cholinesterase (CHEX) Reagent SYN CHEX 510K Summary_02022011.doc____________________________________________________________________________________________________________________________________________ 2010

. . . . . . . . . . . . . . . . . . . . . . . .

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The method is based on the recommendations of the German Society for Clinical Chemisty (Deutsche Gesellschaft für Klinische Chemie, DGKCh).

6.0 Intended Use:

Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

7.0 Comparison to Predicate(s):

The following table shows similarities and differences between the predicate identified in Section 4.0 of this summary.

Predicate Device: Olympus Cholinesterase""(CHE) Assay	Current device: SYNCHRON® SystemsCholinesterase (CHEX) Reagent
Intended Use	same
Methodology	same
Reagent Constituents'	same
Fundamental Technology: chromogenic coloredchange measured by spectrophotometer	same
Analytic Interval	same
Expected Values	same
Sensitivity	same
Within run precision	same
Total precision	same
LIQUID stable reagents (ready to use)	same
On board, open reagent stability	same

List of design inputs that are similar between the two devices
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16-Nov-

Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Cholinesterase (CHEX) Reagent SYN CHEX 510K Summary_02022011.doc____________________________________________________________________________________________________________________________________________ 2010

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	List of design inputs that are different between the two devices
	Predicate Device: Olympus Cholinesterase(CHE) Assay	Current device: SYNCHRON® SystemsCholinesterase (CHEX) Reagent
System use	AU400/400e/480, AU600/640/640e andAU2700/5400	CX5 PRO, CX9 PRO, LX20 PRO, DxC600,DxC 800
Sample type	Serum, Plasma (Li Heparin, Na Heparin,EDTA)	Serum, Plasma (Li Heparin, Na Heparin)
Interferingsubstances	Hemoglobin: 500 mg/dL	Hemoglobin: 1000 mg/dL
	Bilirubin: 40 mg/dL	Bilirubin: 60 mg/dL
	Lipemia: ≤ 1000 mg/dL (Intralipid)	Lipemia: 2000 mg/dL (triglyceride)
	Ascorbic Acid: 20 mg/dL	Ascorbic Acid: 30 mg/dL

List of design inputs that are different between the two devices

... .. . . . . . . . . . . . . . . .

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. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments. ,

Image /page/2/Figure/4 description: The image shows a document with some text and markings. The text includes "Beckman Coulter, Inc., Section 510(k) Notification". There are also some lines and symbols scattered throughout the document. The image appears to be a scan or photocopy of an original document.

SYNCHRON® Systems Cholinesterase (CHEX) Reagent SYN CHEX 510K Summary_02022011.doc ___________________________________________________________________________________________________________________________________________ 2010

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

FEB 07 2011

Beckman Coulter, Inc. C/O Ms. Y vette Lloyd 250 S. Kraemer Blvd. Brea, CA 92821

Re: K103373

Trade/Device Name: SYNCHRON Systems Cholinesterase (CHEX) assay Regulation Number: 21 CFR 862.3240 Regulation Name: Cholinesterase test system Regulatory Class: Class I Reserved Product Code: DIH Dated: November 16, 2010 Received: November 17, 2010

Dear Ms. Lloyd:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.

Comments of Children

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premy aket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-fire mober (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.

Sincerely yours,

G.C.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K103373

Device Name: _________________________________________________________________________________________________________________________________________________________________

CHEX (Cholinesterase)

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Indications for Use: of and specificance the result on your compression in the count

Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

Prescription Use	X
(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use
		(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Division Sign-Off of course and Unit of " raxCha Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103373

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- BCDRH, Office of In Varo Dinghostic Dessee (40)(VD

. . . . . . . . . .

Regulation Number and Section

§ 862.3240 Cholinesterase test system.

(a)
Identification. A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).(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 the limitations in § 862.9.