The Ammonia assay is used for the quantitation of ammonia in human plasma. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

Device Description

Ammonia is an in vitro diagnostic assay for the quantitative determination of ammonia in human plasma. The Ammonia assay is a clinical chemistry assay which utilizes the amination of x-ketoglutarate by ammonia (NH3) along with the concomitant oxidation of NH2DPH. These reactions, catalyzed by glutamate dehydrogenase (GLDH), produce glutamate and NHzDP*. The oxidation of NHzDPH produces a decrease in absorbance at 340 nm which is directly proportional to the concentration of ammonia in the sample.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria (implied by predicate)	Reported Device Performance (Ammonia assay)
Correlation with Predicate	"Similar Performance Characteristics" to Roche Cobas Mira Plus	Correlation coefficient = 0.9969
Slope (Method Comparison)	Close to 1.0	1.044
Y-intercept (Method Comparison)	Close to 0 (or within acceptable clinical limits)	12.020 umol/L
Precision (Total %CV - Level 1)	Acceptable for clinical use (implied by predicate)	13.8%
Precision (Total %CV - Level 2)	Acceptable for clinical use (implied by predicate)	5.2%
Precision (Total %CV - Level 3)	Acceptable for clinical use (implied by predicate)	3.0%
Linearity	Up to the predicate's range (implied by predicate)	Up to 630 µmol/L
Limit of Quantitation (Sensitivity)	Comparable to predicate (implied by predicate)	19 µmol/L
Assay Range	Similar to predicate	"minor difference" from predicate

Note: The acceptance criteria are largely implied by the claim of substantial equivalence to the Roche Cobas Mira Plus Automated Chemistry System Ammonia assay (K914750). The FDA's clearance of K914750 would have established acceptable performance limits. The Ammonia assay demonstrates comparable and statistically similar performance to that predicate.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the sample size used for the comparative performance studies (method comparison and precision studies). It mentions "three levels of control material" for precision studies. For the method comparison, it refers to "comparative performance studies" which likely involved patient samples, but the number is not specified.
- Data Provenance: Not explicitly stated, but clinical chemistry assays typically use human plasma. The document does not specify the country of origin, or if the study was retrospective or prospective.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This information is not applicable to this submission. The Ammonia assay is an in vitro diagnostic (IVD) clinical chemistry assay where the "ground truth" is established by a reference method (the predicate device) or by measuring known concentrations in control materials. It does not involve human interpretation of images or other subjective data that would require expert consensus.
Adjudication Method for the Test Set:
- This information is not applicable. As an IVD clinical chemistry assay, there is no need for an adjudication method for a test set in the way it's used for image-based diagnostics. The performance is assessed by direct comparison of numerical results.
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:
- This information is not applicable. This is an in vitro diagnostic assay and does not involve human readers interpreting images or data, nor does it incorporate AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a standalone device in the sense that the assay measures ammonia in a sample without direct human intervention in the result generation once the sample is loaded and the assay begins on the ALCYON™ Analyzer. The performance characteristics described (correlation, precision, linearity, sensitivity) are all "algorithm only" or "device only" performance.
The Type of Ground Truth Used:
- The primary "ground truth" for the comparative performance studies was the Roche Cobas Mira Plus Automated Chemistry System Ammonia assay (K914750), which served as the legally marketed predicate device. For precision, the ground truth was implied by the known concentrations in the three levels of control material.
The Sample Size for the Training Set:
- This information is not applicable for this type of device. The Ammonia assay is a chemical reaction-based in vitro diagnostic assay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The assay's parameters are derived from scientific principles and optimized through experimental design, not statistical training on a large dataset.
How the Ground Truth for the Training Set was Established:
- This information is not applicable for the reasons stated above (point 8). There is no "training set" for this chemical assay.

Summary

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K981467

JUN 222 1998

510(k) Summary

Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-7861 Fax (972) 753-3367

April 22, 1998 Date of Preparation of this Summary: Device Trade or Proprietary Name: Amm Device Common/Usual Name or Classification Name: Ammonia Classification Number/Class: 75JIX/Class I

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

The assigned 510(k) number is:

Test Description:

Substantial Equivalence:

The Ammonia assay is substantially equivalent to the Roche® Cobas Mira® Plus Automated Chemistry System Ammonia assay (K914750).

Ammonia 510(k) April 22, 1998 Ammf.lwp

Section II Page 1

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Both assays vield similar Performance Characteristics.

Similarities:

Both assays are in vitro clinical chemistry methods. .
Both assays can be used for the quantitative determination of ammonia. .
Both assays yield similar clinical results. .

Differences:

There is a minor difference between assay range. .

Intended Use:

The Ammonia assay is used for the quantitation of ammonia in human plasma.

Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Ammonia assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Ammonia assay. The correlation coefficient = 0.9969, slope = 1.044, and Y-intercept = 12.020 umol/L. Precision studies were conducted using the Ammonia assay. Within-run, between-run, and between-day studies were performed using three levels of control material. The total %CV for Level 1/Panel 121 is 13.8%, 5.2% for Level 2/Panel 122, and 3.0% for Level 3/Panel 123. The Ammonia assay is linear up to 630 µmol/L. The limit of quantitation (sensitivity) of the Ammonia assay is 19 umol/L. These data demonstrate that the performance of the Ammonia assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Ammonia assay.

Conclusion:

The Ammonia assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Ammonia assay as demonstrated by results obtained in the studies.

Ammonia 510(k) April 22, 1998 Ammf.lwp

Section II Page 2

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JUN 2 2 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Re: K981467 AMM Requlatory Class: I Product Code: JIF Dated: April 22, 1998 Received: April 23, 1998

Dear Mr. Littlefield:

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 The general controls provisions of the Act 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. ಗಿ 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 requlation (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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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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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/dsmamain.html".

Sincerely yours,
Steven Litman

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):

Ammonia ______________________________________________________________________________________________________________________________________________________________________ Device Name:

Indications For Use:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Nurnber `K981467

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

Concurpence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109)

(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.