(51 days)
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.
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 NHxDP+ The oxidation of NHxDPH produces a decrease in absorbance at 340 nm which is directly proportional to the concentration of ammonia in the sample.
The provided document K981920 describes the Abbott Laboratories Ammonia (Amm) assay. This is an in vitro diagnostic assay for the quantitative determination of ammonia in human plasma, used in the diagnosis and treatment of severe liver disorders. This device is not an AI/ML powered device, therefore, some of the requested information (e.g. effect size of human readers with vs without AI assistance) is not applicable.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Ammonia assay are implicitly stated by its substantial equivalence to the predicate device, the A-GENT® Ammonia assay (K870787) on the ABBOTT SPECTRUM® Series II™ System. The performance characteristics of the Ammonia assay are presented and deemed "acceptable" and "substantially equivalent" when compared to the predicate.
| Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Method Comparison | Acceptable correlation with predicate device | Correlation Coefficient = 0.9957 |
| Slope = 0.971 | ||
| Y-intercept = -2.083 umol/L | ||
| Precision | Acceptable within-run, between-run, and between-day precision | 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 | Acceptable linearity up to a specified concentration | Linear up to 1,574.9 umol/L |
| Limit of Quantitation (Sensitivity) | Acceptable sensitivity | 20.6 umol/L |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in terms of the number of patient samples. It mentions "Comparative performance studies were conducted using the AEROSET™ System" and "Precision studies were conducted using the Ammonia assay... using three levels of control material."
- Sample Size: Not explicitly stated for patient equivalence studies. For precision studies, it mentions "three levels of control material." The number of replicates or runs for these controls is not specified.
- Data Provenance: Not explicitly stated. There is no information regarding 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 Qualifications of Those Experts
Not applicable. This device is a quantitative diagnostic assay. The "ground truth" for method comparison and precision is typically established by the reference method (predicate device) and analytical standards, respectively, rather than by human expert consensus or adjudication.
4. Adjudication Method for the Test Set
Not applicable. As a quantitative assay, adjudication by experts for ground truth is not relevant.
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 in vitro diagnostic assay, not an AI/ML powered device that would involve human readers interpreting results with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in essence, the described performance characteristics (method comparison, precision, linearity, sensitivity) represent the standalone performance of the Ammonia assay without human intervention influencing the measurement itself. The output is a quantitative value.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the comparative performance studies, the "ground truth" was established by the predicate device, the A-GENT® Ammonia assay on the ABBOTT SPECTRUM® Series II™ System. The goal was to show similarity in results.
For precision, linearity, and sensitivity, the ground truth is based on analytical standards and control materials with known concentrations.
8. The Sample Size for the Training Set
Not applicable. This diagnostic assay is not an AI/ML model that requires a "training set." It is a chemical-based assay.
9. How the Ground Truth for the Training Set was Established
Not applicable. As this is not an AI/ML model, there is no training set or ground truth in that context.
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JUL 22 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) 518-6062 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:
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 NHxDP+ The oxidation of NHxDPH produces a decrease in absorbance at 340 nm which is directly proportional to the concentration of ammonia in the sample.
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
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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 vield 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 yielded 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 Jwp
Section II Page 2
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Jul 22 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 : K981920 AMM Regulatory Class: I Product Code: JIF Dated: May 29, 1998 Received: June 1, 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 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 In addition, FDA may publish further announcements action. 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 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):
Device Name:
Indications For Use:
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.
(Division Sign-Off)
Division of Cized Laboratory Levices
510(k) Number K9811928
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
______________________________________________________________________________________________________________________________________________________________________________ Concycrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use OR (Per 21 CFR 801.109) (Optional Format 1-2-96)
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§ 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.