The Bayer ADVIA 1650 Ammonia method and calibrator is an in vitro diagnostic device intended to quantitatively measure ammonia levels in human plasma (heparin or EDTA). Such measurements are used in assessing hepatic function and diagnosis of Reye's syndrome.

Device Description

The Bayer ADVIA 1650 Ammonia assay is an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA).

AI/ML Overview

The provided document describes the safety and effectiveness summary for the Bayer ADVIA® 1650™ Ammonia assay. This device is an in vitro diagnostic device used to quantitatively measure ammonia levels in human plasma. The information pertains to an analytical performance study rather than an AI/ML medical device. Therefore, several sections of the requested output (2, 3, 4, 5, 6, 7, 8, and 9) related to AI/ML and human experts are not applicable.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" but presents performance data for imprecision, correlation, and interfering substances, comparing the ADVIA 1650 to a predicate device (Roche Ammonia on Hitachi). The acceptance is implied by the presentation of the data itself against the predicate device's performance.

Performance Metric	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (ADVIA 1650)
Imprecision	CV(%) comparable to Roche Ammonia (e.g., 3.9%, 0.7%, 7.33%)	CV(%) at various levels: - 3.8% (at 69.7 ug/dL) - 1.7% (at 150.6 ug/dL) - 0.7% (at 387.9 ug/dL)
Correlation	Strong linear correlation (r value close to 1) and low Syx compared to Roche (On Hitachi)	$Y = 1.05x + 7.19$ (where Y = ADVIA 1650, X = Roche) Syx = 62.18 r = 0.98
Interfering Substances Recovery	Recovery % should be within an acceptable range (typically 90-110% or similar) despite interferents	Hemoglobin: 105.18% Bilirubin conj: 95.30% Bilirubin unconj: 100.48% Intralipid: 91.06% TRIG Concentrate: 108.98%
Analytical Range	25 to 1300 ug/dL (This is the stated range, implying it meets internal criteria)	25 to 1300 ug/dL (Serum/Plasma(Lithium heparin))

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

Sample Size for Correlation Test: 94 plasma specimens (N=94).
Data Provenance: The document does not specify the country of origin of the data or whether it was 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)

Not applicable. This is an analytical performance study of an in vitro diagnostic device, not an AI/ML medical device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" (or reference method) for comparison is the predicate device's measurement.

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

Not applicable. This is an analytical performance study of an in vitro diagnostic device. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical trials with human readers.

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. This is an analytical performance study of an in vitro diagnostic device, not an AI/ML assisted diagnostic tool.

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

Yes, the study describes the standalone analytical performance of the ADVIA 1650 Ammonia assay. The performance metrics (imprecision, correlation, interference) are inherent to the device's measurement capabilities.

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

The "ground truth" or reference for comparison in this analytical study is the measurements obtained from the predicate device, the Roche Ammonia assay (on Hitachi).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning. The device is a chemical analyzer.

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

Not applicable. Refer to point 8.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Ammonia method for ADVIA® 1650TM

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: K 0 2 3 8 4/

1. Intended Use

The Bayer ADVIA 1650 Ammonia assay is an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA).

2. Predicate Device

Product Name	Reagent Part #	Calibrator Part #
Roche Ammonia	1877984	166570

3. Device / Method

Product Name	Reagent Part #	Calibrator Part #
Bayer ADVIA® 1650™ Ammonia	B01-4822-01	B03-4827-01

Imprecision

ADVIA 1650		Roche
Level(ug/dL)	Within-runCV(%)	Level(ug/dL)	Within-runCV(%)
69.7	3.8	67.5	3.9
150.6	1.7	496.8	0.7
387.9	0.7	574.8	7.33

Correlation (Y=ADVIA 1650, X=comparison system)

SpecimenType	ComparisonSystem (x)	N	RegressionEquation	Syx	r	Sample Rangeµg/dL
Plasma	Roche(On Hitachi)	94	$Y = 1.05x + 7.19$	62.18	0.98	26 - 1174

Interfering Substances

METHOD	SampleConcentration	Interferent	InterferentConcentration(mg/dL)	Sample+InterferentConcentration	Recovery%
Ammonia	179.28	hemoglobin	250	188.57	105.18%
	176.71	bilirubin conj	18.75	168.4	95.30%
	168.25	bilirubin unconj	25	169.05	100.48%
	214.24	Intralipid	62.5	195.08	91.06%
	187.56	TRIG Concentrate	62.5	204.4	108.98%

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Analytical Range Serum/Plasma(Lithium heparin):

。

25 to 1300 ug/dL

Sa Si Parc, Andres Holle

11-/15-02

Date

Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

DEC 24 2002

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Mr. Andres Holle Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

Re:

K023841 Trade/Device Name: Ammonia Assay and Calibrator for the ADVIA® 1650 Regulation Number: 21 CFR 862.1065 Regulation Name: Ammonia test system Regulatory Class: Class II Product Code: JIF; JIT Dated: November 15, 2002 Received: November 18, 2002

Dear Mr. Holle:

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. Iisting 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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.

If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 Autman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page

K023841 510(k) Number:

Device Name: Ammonia Assay and Calibrator for the ADVIA® 1650™

Indications for Use:

tean

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023841

(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) OR

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.