The Ethyl Alcohol Clinical Standard Solutions are intended for use in the calibration and standardization of instruments and methods for the determination of ethyl alcohol in whole blood or serum. The Standard Solutions may also be used for validation of the laboratory's routine standards and/or control materials.

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 NHzDPH. These reactions, catalyzed by glutamate dehydrogenase (GLDH), produce glutamate and NH2DP*. The oxidation of NHxDPH produces a decrease in absorbance at 340 nm which is directly proportional to the concentration of ammonia in the sample.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the Ammonia assay (K981926):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (from predicate)	Reported Device Performance (Ammonia assay)
Method Comparison	Correlation with predicate device	Correlation coefficient = 0.9957
	Slope relative to predicate	Slope = 0.971
	Y-intercept relative to predicate	Y-intercept = -2.083 umol/L
Precision	%CV (Within-run, Between-run, Between-day)	Level 1/Panel 103: 11.7% total %CV
		Level 2/Panel 104: 4.0% total %CV
		Level 3/Panel 105: 5.5% total %CV
Linearity	Maximum quantifiable range	Linear up to 1,574.9 umol/L
Limit of Quantitation (Sensitivity)	Minimum quantifiable concentration	20.6 umol/L

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

The document does not specify the exact sample size used for the method comparison or precision studies. It mentions "Comparative performance studies were conducted" and "Precision studies were conducted using three levels of control material," but no specific number of patient samples or replicates are given.

The data provenance is not explicitly stated (e.g., country of origin). Since it's a 510(k) submission to the FDA, it is highly likely the studies were conducted in the US, but this is not confirmed in the text. The studies appear to be prospective as performance characteristics were "conducted" using the new device and compared to a predicate.

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

This information is not applicable to this type of in vitro diagnostic device (IVD) study. The ground truth for quantitative assays like ammonia is established by the reference method (the predicate device in this case) or by well-characterized control materials, not by expert consensus on interpretations.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical imaging or diagnostic studies where human interpretation of results is involved, and there's a need to resolve discrepancies. For this quantitative IVD, the comparison is direct numerical measurement against a predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This is not applicable. MRMC studies are used for assessing the performance of human readers, often aided by AI, in interpreting diagnostic images or data. The Ammonia assay is a fully automated quantitative measurement, not requiring human interpretation of visual or complex data in the same way.

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

Yes, the studies described are standalone performance studies for the Ammonia assay. The device directly measures ammonia concentrations without human intervention in the interpretive process. The "performance characteristics" outlined (method comparison, precision, linearity, sensitivity) all evaluate the algorithmic and analytical performance of the device itself.

7. The Type of Ground Truth Used

The primary ground truth used is the performance of the predicate device, the A-GENT® Ammonia assay on the ABBOTT SPECTRUM® Series II™ System. For precision, well-characterized control materials at three different levels were used as ground truth.

8. The Sample Size for the Training Set

The document does not provide information on a separate training set. For in vitro diagnostic assays of this nature, especially those based on established chemical reactions, there isn't typically a "training set" in the machine learning sense. The assay is developed and validated based on the underlying chemical principles and established analytical performance characteristics.

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

As no "training set" is described for this IVD, this information is not applicable. The development of such an assay relies on well-understood chemical principles and rigorous analytical validation rather than data-driven machine learning training.

Summary

{0}------------------------------------------------

510(k) Summary

K98 1926

Submitter's Name/Address

Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038 Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-6062 Fax (972) 753-3367

Date of Preparation of this Summary:	May 29, 1998
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 A-GENT® Ammonia assay (K870787) on the ABBOTT SPECTRUM® Series II™ System.

Ammonia 510(k) May 29, 1998 Ammf.lwp

Section II Page 1

0000012

{1}------------------------------------------------

Both assays yield 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. .

Intended Use:

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

Performance Characteristics:

Comparative performance studies were conducted using the AEROSET™ System. The Ammonia assay method comparison vielded acceptable correlation with the A-GENT Ammonia assay on the ABBOTT SPECTRUM Series II System. The correlation coefficient = 0.9957, slope = 0.971, and Y-intercept = -2.083 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 103 is 11.7%, 4.0% for Level 2/Panel 104, and 5.5% for Level 3/Panel 105. The Ammonia assay is linear up to 1.574.9 umol/L. The limit of quantitation (sensitivity) of the Ammonia assay is 20.6 umol/L. These data demonstrate that the performance of the Ammonia assay is substantially equivalent to the performance of the A-GENT Ammonia assay on the ABBOTT SPECTRUM Series II System.

Conclusion:

The Ammonia assay is substantially equivalent to the A-GENT Ammonia assay on the ABBOTT SPECTRUM Series II System as demonstrated by results obtained in the studies.

Ammonia 510(k) May 29, 1998 Ammf.lwp

Section II Page 2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's role in protecting and promoting the health and well-being of the nation.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 22 1998

Anna G. Bentley Director, Regulatory and Quality Affairs EM Science 480 S. Democrat Road Gibbstown, New Jersey 08027

Re : K981926 Ethyl Alcohol Calibrators Requlatory Class: II Product Code: DLJ Dated: June 1, 1998 Received: June 2, 1998

Dear Ms. Bentley:

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 requlations affecting your device can be found in the Code of Federal Requlations, 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 regulations.

{3}------------------------------------------------

Page 2

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 Gutman

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

{4}------------------------------------------------

Page 1 of 1

0(k) Number (if Known): _ K 98 1926

Device Name: Ethyl Alcohol Clinical Standard Solutions

Indications for Use:

(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)

(Division Sign-Off)
Division of Clinical Laboratory Devices,
510(k) Number k 981426

Regulation Number and Section

§ 862.3200 Clinical toxicology calibrator.

(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.