The Bayer ADVIA IMS Ammonia (NH3) assay is an in vitro diagnostic device intended to measure Ammonia in human plasma (K3EDTA). Measurements of ammonia are used as an aid in the diagnosis and treatment of several hepatic diseases such as cirrhosis, hepatic failure, hepatitis and Reye's syndrome.

The Bayer ADVIA IMS Ammonia method is an in vitro diagnostic device intended to measure ammonia levels in human plasma. Such measurements are used in the diagnosis and treatment of several hepatic diseases such as cirrhosis, hepatic failure, hepatitis and Reye's syndrome.

Device Description

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AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Ammonia method for ADVIA® IMS™, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device (Sigma Ammonia) and the determination that the ADVIA IMS Ammonia Assay's performance is "equivalent" and "within proposed manufacturing specifications." The provided data serves as the basis for demonstrating this equivalency.

Characteristic	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (ADVIA IMS)
Imprecision (Total CV%)	Comparable to Sigma Ammonia's CV% at similar levels (e.g., 4.2% at 52.9 umol/L, 1.7% at 323 umol/L, 1.8% at 490 umol/L)	15.8% at 21.4 umol/L, 3.5% at 112 umol/L, 4.3% at 234 umol/L
Correlation (to predicate)	High correlation (R ~0.998), low Syx (9.7 umol/L), and regression equation (Y=0.93X+14.8) indicating close agreement.	Y=0.93X+14.8, Syx = 9.7 umol/L, R = 0.998
Interfering Substances	Acceptable effect on ammonia concentration (e.g., small % change for specified interfering substances at given concentrations).	Bilirubin (unconjugated) 18.8 mg/dL: -8.0%Bilirubin (conjugated) 25 mg/dL: +3.0%Hemoglobin 500 mg/dL: +11.0%Lipids (Triglycerides) 500 mg/dL: -12.0%
Analytical Range	Comparable to clinically relevant range.	5 - 500 umol/L

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 51 specimens for the correlation study.
- Data Provenance: Not explicitly stated whether retrospective or prospective, or country of origin. The specimens are "human plasma (K3EDTA)".
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This device is a quantitative assay, and the "ground truth" for the test set is established by the comparative system (predicate device), not expert consensus.
Adjudication method for the test set:
- Not applicable. As a quantitative assay compared to a predicate device, adjudication methods by experts are not relevant here.
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 study was not done. This is a submission for an in vitro diagnostic device, not an AI-assisted diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone device performance study. The "algorithm" here refers to the chemical assay method performed by the ADVIA IMS system. The performance metrics (imprecision, correlation, interference, analytical range) reflect the device's capability without human interpretation or intervention in the results beyond standard laboratory operation.
The type of ground truth used:
- Comparative Reference Method: The predicate device, Sigma Ammonia, run on a Fara II system, served as the comparative reference for establishing the performance characteristics, particularly for correlation. The performance is deemed "equivalent" to this predicate.
The sample size for the training set:
- Not applicable/Not provided. This is a conventional chemical assay, not a machine learning or AI-based device that would typically have a separate "training set" in the computational sense. The development of the assay would involve various experimental and optimization phases, but these are not referred to as a "training set" in this context.
How the ground truth for the training set was established:
- Not applicable. See point 7. The development of the assay would rely on established biochemical principles and analytical chemistry methodologies.

Summary

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'JUL 1 3 2002

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Ammonia method for ADVIA® IMSTM

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

1. Intended Use

2. Predicate Device

Product Name	Reagent Part #	Calibrator Part #
Sigma Ammonia	171-C	171-C

3. Device / Method

Product Name	Reagent BAN	Calibrator BAN
Bayer ADVIA® IMS™ Ammonia	04454764	08648547

Imprecision

ADVIA IMS		Sigma
Level(umol/L)	TotalCV(%)	Level(umol/L)	TotalCV(%)
21.4	15.8	52.9	4.2
112	3.5	323	1.7
234	4.3	490	1.8

Correlation (Y=ADVIA IMS, X=comparison system)

Specimen type	Comparison System (X)	N	Regression Equation	Syx (umol/L)	R	Sample Range (umol/L)
Plasma (K3EDTA)	Sigma/Fara II	51	Y=0.93X+14.8	9.7	0.998	13.0 to 500

Interfering Substances

Interfering	Interfering Sub.	Ammonia Conc	Effect
Substance	Conc. (mg/dL)	(umol/L)	(% change)
Bilirubin (unconjugated)	18.8	100	-8.0
Bilirubin (conjugated)	25	100	+3.0
Hemoglobin	500	100	+11.0
Lipids (Triglycerides)	500	100	-12.0

Analytical Range

Plasma: 5 - 500 umol/L

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4. Conclusion

Performance for the ADVIA IMS Ammonia Assay on the Bayer ADVIA® IMS™ is equivalent to the performance of the Ammonia Assay on the predicate device (Sigma, K760332) and is within proposed manufacturing specifications. No safety and effectiveness issues have been raised.

Semuel Halls

4/8/02
Date

Date

Kenneth T. Edds Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with three profiles.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

IJUL 1 3 2002

Kenneth T. Edds, Ph.D. Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: K021151

Trade/Device Name: Ammonia Assay for the ADVIA® IMS™ Regulation Number: 21 CFR 862.1065 Regulation Name: Ammonia test system Regulatory Class: Class I, reserved Product Code: JIF Dated: June 26, 2002 Received: June 27, 2002

Dear Dr. Edds:

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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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" (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/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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Page 1 of 1

510(k) Number: K021151

Device Name: Ammonia Assay for the ADVIA® IMSTM

Indications for Use:

(Division Sign-Off)

Cooper
Division of Clinical Laboratory Dévices
510(k) Number K021151

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-CounterUse

(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.