The SYNCHRON® Systems Ammonia (AMM) Reagent, in conjunction with SYNCHRON® Systems Ammonia Calibrators, is intended for the quantitative determination of ammonia concentration in plasma on SYNCHRON® Systems.

Device Description

The SYNCHRON System Ammonia Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. It is intended for use in the quantitative determination of ammonia in plasma.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SYNCHRON® Systems Ammonia (AMM) Reagent, intending to demonstrate substantial equivalence to a predicate device. The information focuses on method comparison and imprecision studies for this in vitro diagnostic device.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for precision or method comparison in the format of pass/fail thresholds. Instead, it presents observed performance data and implicitly assumes these results demonstrate substantial equivalence.

Based on the "Summary of Performance Data" section, we can infer the performance metrics reported:

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (SYNCHRON® CX System)	Reported Device Performance (SYNCHRON® LX System)
Method Comparison (vs. Predicate: Dade aca®)	No explicit criteria stated, but values close to 1.0 for slope and close to 0 for intercept, with high 'r' value, are indicative of good agreement.	Slope: 1.018 Intercept: -5.3 µmol/L r: 0.9991	Slope: 1.003 Intercept: -2.2 µmol/L r: 0.9986
Within-Run Imprecision (C.V.%)	No explicit criteria stated, but low C.V.% values indicate good precision. Industry standards typically expect low single-digit C.V.% for chemistry assays.	Level 1: 4.2% Level 2: 2.3% Level 3: 0.8%	Level 1: 4.9% Level 2: 2.2% Level 3: 0.8%

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Method Comparison Test Set Sample Size: 82 plasma samples ("n = 82").
Imprecision Test Set Sample Size: For each of the three levels tested on both CX and LX systems, there were 15 replicates ("N = 15"). So, 3 levels * 15 replicates * 2 systems = 90 total imprecision measurements.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. 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)

This is an in vitro diagnostic device (reagent for chemical analysis). The "ground truth" for method comparison is established by the predicate device's measurement, not by human expert opinion or interpretation in the way it would be for an imaging AI device. Therefore, this question is not directly applicable to this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 refer to consensus processes among human experts, typically used in imaging or clinical evaluation studies to establish ground truth. Since this is an in vitro diagnostic device where the reference standard is another device (the predicate) and standard laboratory methods, there is no human adjudication process involved.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers (e.g., radiologists interpreting images). The SYNCHRON® Systems Ammonia (AMM) Reagent is a laboratory reagent for quantitative chemical analysis, not an AI-assisted diagnostic tool that involves human "readers."

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

Yes, the performance data presented (method comparison and imprecision) represents the standalone performance of the SYNCHRON® Systems Ammonia (AMM) Reagent when used on the specified SYNCHRON® CX and LX Systems. There is no "human-in-the-loop" aspect to the fundamental measurement process of this chemical reagent. The device itself performs the measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" or reference standard for the method comparison study was the measurement result from the predicate device, the Dade aca®* clinical analyzer, using its ammonia reagent.

8. The sample size for the training set

The document does not describe a "training set" in the context of machine learning. This device is a chemical reagent and an associated analytical system, not an AI algorithm that requires training data in the typical sense. The development of such a system involves chemical formulation and analytical optimization, not an AI model training process.

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

As there is no "training set" for an AI algorithm in this context, this question is not applicable.

Summary

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JAN 29 1999

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Summary of Safety & Effectiveness SYNCHRON® Systems Ammonia (AMM) Reagent

1.0 Submitted By:
Lucinda Stockert Staff Regulatory 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:

December 7, 1998

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems Ammonia (AMM) Reagent

3.2 Classification Name

Ammonia (21CFR §862.1065)

4.0 Predicate Device(s):

SYNCHRON SystemsReagent	Predicate	Manufacturer	DocketNumber
SYNCHRON®Systems Ammonia(AMM)	Ammonia reagent on theDade aca®* clinicalanalyzer	Dade Behring, Inc	K770363

*Trademark of Dade Behring Inc. - formerly DuPont

5.0 Description:

The SYNCHRON System Ammonia Reagent is designed for optimal performance on the SYNCHRON CX and LX Systems. It is intended for use in the quantitative determination of ammonia in plasma.

Beckman Coulter, Inc. 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

Telephone: (714) 993-5321 (714) 961-4165 Facsimile: Internet: www.beckmancoulter.com

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Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Ammonia (AMM) Reagent Summary of Safety & Effectiveness

6.0 Intended Use:

7.0 Comparison to Predicate(s):

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

	SIMILARITIES
SYNCHRON®SystemsAmmonia	SYNCHRON assay uses GLDHenzymatic method for measuringammonia at 37°C.	Same as Dada aca Reagent
	GLDH source is beef liver
	The reagent is ready to load onto theinstrument (requires no user preparation).
	Reagent measures ammonia in humanplasma.
	DIFFERENCES
	Reagent components	All components of the SYNCHRONAmmonia reagent are liquidSome components of the Dade acaAmmonia reagent are in tablets andothers are liquid.
	Sample Volume	SYNCHRON Ammonia assayrequires 25 µL of sample.aca assay requires 500 µL ofsample.
	Type of measurement	SYNCHRON Ammonia is a timedendpoint assay.Dade aca is a rate assay.

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, and imprecision experiments.

SYNCHRONDIGN Reagent	SampleType	Slope	Intercept(μmol/L)	r	n	PredicateMethod
SYNCHRONCX System	Plasma	1.018	-5.3	0.9991	82	Dade aca
SYNCHRON LXSystem	Plasma	1.003	-2.2	0.9986	82	Dade aca

Method Comparison Study Results SYNCHRON® Systems Digoxin (DIGN) Reagent

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SYNCHRON System	Sample	Mean (µmol/L)	S.D. (µmol/L)	%C.V.	N
CX	Level 1	48	2.6	4.2	15
	Level 2	128	3.0	2.3	15
	Level 3	644	5.3	0.8	15
LX	Level 1	48	2.3	4.9	15
	Level 2	128	2.8	2.2	15
	Level 3	644	4.9	0.8	15

Estimated Within-Run Imprecision

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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Public Health Service

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JAN 29 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Lucinda Stockert Staff Regulatory Specialist, Product Submissions BECKMAN COULTER, INC. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000

K984402 Re: Trade Name: SYNCHRON® Systems Ammonia (AMM) Reagent Regulatory Class: I Product Code: JIF December 7, 1998 Dated: December 9, 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 Regulations, 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 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 requlations.

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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 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 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/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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K984402 510(k) Number (if known):

Device Name: SYNCHRON® Systems

Ammonia (AMM) Reagent

Indications for Use:

The SYNCHRQN® Systems Ammonia (AMM) Reagent, in conjunction with SYNCHRON® Systems Ammonia Calibrators, is intended for the quantitative determination of ammonia concentration in plasma on SYNCHRON® Systems.

Clinical Significance:

An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984402

(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)

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

(

Regulation Number and Section

§ 862.1065 Ammonia test system.

(a)
Identification. An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.(b)
Classification. Class I.