(112 days)
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No
The device description details an enzymatic method for quantitative measurement, and there are no mentions of AI, ML, or related concepts in the provided text.
No
This device is an in vitro diagnostic test used for the quantitative measurement of ammonia, which aids in diagnosis and treatment monitoring, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma... Ammonia measurements are used in the diagnosis and treatment of severe liver disorders..." This directly indicates its role in diagnosing and treating medical conditions.
No
The device description clearly states it is an "in vitro diagnostic test" and an "enzymatic method" that uses chemical reagents and is performed on a "Dimension® clinical chemistry system," indicating it is a hardware-based laboratory assay, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma.
- Device Description: The description details a chemical reaction performed on a biological sample (human plasma) to measure a specific analyte (ammonia). This is characteristic of an in vitro diagnostic test.
- Performance Studies: The document includes various performance studies (Method Comparison, Plasma Comparison, Precision, Linearity, Analytical Specificity/Interferences, etc.) which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K863840) indicates that this device is being compared to a previously cleared IVD device, a common practice in the regulatory pathway for IVDs.
All of these elements strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma (heparin or EDTA) on the Dimension® clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome.
Product codes
JIF
Device Description
The Dimension® Ammonia assay (AMM) is an enzymatic method that uses glutamate dehydrogenase (GLDH) and a stabilized NADPH analog. Ammonia reacts with a-ketoglutarate and reduced cofactor to form L-glutamate and the cofactor. The reaction is catalyzed by glutamate dehydrogenase. The decrease in absorbance due to the oxidation of the reduced cofactor is monitored at 340/700 nm and is proportional to the ammonia concentration.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: Split sample comparison between the Dimension® Ammonia (AMM) assay and the Dimension® Ammonia (AMON) assay gave the following correlation statistics, when tested with patient samples: Slope 0.98, Intercept 9 [5] µg/dL[µmol/L], Correlation Coefficient (r) 1.00, n 127.
Plasma Comparison: Comparison testing of 50 matched lithium heparin and EDTA plasma samples were tested on the Dimension® System and gave the following linear regression statistics: Slope 0.96, Intercept 1.6 [1.0] µg/dL[µmol/L], Correlation Coefficient (r) 1.00, n 50.
Reference Interval (Expected Values): The predicate Dimension® Ammonia (AMON) therapeutic range of 19 – 54 µg/dL [11 – 32 umol/L] was validated for use with the Dimension® Ammonia (AMM) method by transference following CLSI C28-A3 Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory - Approved Guideline - Third Edition. Samples were collected from 30 healthy adults (17 men and 13 women) and analyzed with the Dimension® AMM method versus the predicate, Dimension® AMON method. Expected Values: 11 - 32 umol/L [19 - 54 ug/dL].
Precision: Precision testing was performed over 20 days, two separate runs with two test samples for each test material. Analysis of variance (ANOVA) was used to evaluate the data. For Liquichek™ Ethanol/Ammonia control:
Level 1: Mean 40 [23] µg/dL [µmol/L], Repeatability Standard Deviation (%CV) 2.1 [1.2] (5.2), Within-Lab Standard Deviation (%CV) 3.7 [2.2] (9.3).
Level 2: Mean 187 [110] µg/dL [µmol/L], Repeatability Standard Deviation (%CV) 2.6 [1.5] (1.4), Within-Lab Standard Deviation (%CV) 3.7 [2.2] (2.0).
Level 3: Mean 565 [332] µg/dL [µmol/L], Repeatability Standard Deviation (%CV) 3.3 [1.9] (0.6), Within-Lab Standard Deviation (%CV) 7.3 [4.4] (1.3).
Linearity: The linear range was determined to be 17 – 1277 µg/dL [10 - 750 µmol/L].
Analytical Specificity/Interferences: Bias exceeding 10% is considered interference. Hemoglobin (hemolysate) at 75 mg/dL [0.05 mmol/L] showed +11% bias at 85 [50] µg/dL [µmol/L] ammonia. Lipemia (Intralipid®) at 400 mg/dL [4.52 mmol/L] and above tripped a test report message; interference could not be determined. Studies for exogenous substances found inaccuracies (biases) less than 10%. For endogenous interferents which exceeded 10 % bias (Albumin, Bilirubin (unconjugated), Dextran 40, Cholesterol, Creatinine, Hemoglobin, Immunoglobulin G, Uric Acid), no significant interference was observed based on recovery within 10% of expected value when mixed with a plasma pool containing ammonia.
Limit of Blank, Limit of Detection and Limit of Quantitation:
LoB: 5 µg/dL [3 µmol/L].
LoD: 11 µg/dL [7 µmol/L].
LoQ: 17 µg/dL [10 µmol/L].
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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510k Summarv
FEB 1 5 2013
Dimension® Ammonia Flex® reagent cartridge (AMM)
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. 510(k) Number
-
- Applicant: Rose T. Marinelli Siemens Healthcare Diagnostics, Inc. P.O. Box 6101, Newark, DE 19714-6101 Office Number: 302-631-8805; Fax Number: 302-631-6299
3. Date: October 25, 2012
4. Proprietary and Established Names:
Dimension® Ammonia Flex® reagent cartridge, (AMM)
5. Regulatory Information:
Ammonia (AMM) Flex® reagent cartridge
Requlation section: 21 CFR 862,1065 Enzvmatic Method, Ammonia Classification: Class I Product Code: JIF Panel: Clinical Chemistry
6. Predicate Devices:
The predicate device used to demonstrate substantial equivalence to the Dimension® Ammonia (AMM) Flex® reagent cartridge is the Dimension® Ammonia (AMON) previously cleared under K863840.
7. Device Description:
The Dimension® Ammonia assay (AMM) is an enzymatic method that uses glutamate dehydrogenase (GLDH) and a stabilized NADPH analog. Ammonia reacts with a-ketoglutarate and reduced cofactor to form L-glutamate and the cofactor. The reaction is catalyzed by glutamate dehydrogenase. The decrease in absorbance due to the oxidation of the reduced cofactor is monitored at 340/700 nm and is proportional to the ammonia concentration.
GLDH
α-ketoglutarate + NH4* + reduced cofactor ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------L-glutamate + cofactor + H2O
8. Intended Use:
The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma (heparin or EDTA) on the Dimension® clinical chemistry system. Ammonia
1
measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reve's syndrome.
9. Indication(s) for Use:
The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma (heparin or EDTA) on the Dimension® clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye's syndrome.
10. Substantial Equivalence Information:
Both the Dimension® Ammonia Flex® reagent cartridge (AMM) assay and the predicate Dimension® Ammonia Flex® reagent cartridge (AMON) assay employ prepackaged reagents for use on automated clinical chemistry test systems. A comparison of the similarities and differences between the devices is provided in the following tables:
| Feature | New Device : Dimension®
Ammonia Flex® reagent
cartridge (AMM) | Predicate: Dimension®
Ammonia Flex® reagent
cartridge (AMON) K863840 |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The AMM method is an in vitro
diagnostic test for the quantitative
measurement of ammonia in
human plasma on the Dimension®
clinical chemistry system.
Ammonia measurements are used
in the diagnosis and treatment of
severe liver disorders such as
cirrhosis, hepatitis and Reye's
syndrome. | The AMON method used on the
Dimension® clinical chemistry
system is an in vitro diagnostic
test intended for the quantitative
determination of ammonia in
human plasma. |
| Format | Prepackaged for use on an
automated system | Prepackaged for use on an
automated system |
| Measurement | Bichromatic Rate | Bichromatic Rate |
Similarities for Dimension® AMM assay:
Differences for Dimension® AMM assay:
| Feature | New Device: Dimension®
Ammonia Flex® reagent
cartridge (AMM) | Predicate: Dimension®
Ammonia Flex® reagent
cartridge (AMON) K863840 |
|--------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------|
| Measuring
Range | 17-1277 µg/dL [10 – 750 µmol/L] | 0 - 1000 µmol/L |
| Sample Size | 44 µL | 53 µL |
| Sample Type | Plasma (Lithium Heparin and
EDTA) | Plasma (EDTA, Lithium Heparin,
Sodium Fluoride) |
| Reagent
Form | Liquid | Tablet |
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Note: Siemens has decided to offer our customers both conventional units and Systéme International d'Unites (Sl units) in the Instructions for Use (IFU). The predicate, Dimension® Ammonia (AMON) assay results are reported in SI Units only. All data supplied in Appendix C will include both conventional units and SI Units for ease of review. Raw data was collected from the instruments in SI units and the conventional units were calculated using the following equation: ug/dL x 0.587 = [umol/L].
11. Standard/Guidance Document Reference:
- · Evaluation of Precision Performance of Quantitative Measurement in Methods; Approved Guideline (EP5-A2)
- · Evaluation of the Linearity of Quantitative Measurement Procedures; A Statistical Approach; Approved Guideline (EP6-A)
- · Interference Testing in Clinical Chemistry; Approved Guideline (EP7-A2)
- · Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP9-A2)
- Protocols for Determination of Limits of Detection and Quantitation; Approved Guideline (EP17-A)
- · Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline (C28-A3)
12. Performance Characteristics
The following data represent typical performance for the Dimension® clinical chemistry system and were collected on a Dimension® RxL Max.
Method Comparison
Split sample comparison between the Dimension® Ammonia (AMM) assay and the Dimension® Ammonia (AMON) assay gave the following correlation statistics, when tested with patient samples:
| Dimension® | Predicate | Slope | Intercept
µg/dL[µmol/L] | Correlation
Coefficient (r) | n |
|------------|--------------------|-------|----------------------------|--------------------------------|-----|
| AMM | Dimension®
AMON | 0.98 | 9 [5] | 1.00 | 127 |
Dimension® Ammonia (AMM) vs. Predicate
Plasma Comparison
To demonstrate equivalency between lithium heparin plasma for Dimension® AMM, comparison testing of 50 matched lithium heparin and EDTA plasma samples were tested on the Dimension® System and gave the following linear regression statistics:
| Serum vs. Plasma Comparison Data | ||||
|---|---|---|---|---|
| Lithium | ||||
| Heparin vs. | Slope | Intercept | ||
| µg/dL[µmol/L] | Correlation | |||
| Coefficient (r) | n | |||
| EDTA | 0.96 | 1.6 [1.0] | 1.00 | 50 |
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Reference Interval (Expected Values)
The predicate Dimension® Ammonia (AMON) therapeutic range of 19 – 54 µg/dL [11 – 32 umol/L1 was validated for use with the Dimension® Ammonia (AMM) method by transference following CLSI C28-A3 Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory - Approved Guideline - Third Edition. The Dimension® AMM assay is based on the same intended use and measuring principle as the predicate, Dimension® AMON. The literature reference used was the Textbook of Clinical Chemistry by NW Tietz; WB Saunders Co., Philadelphia, PA; pages 1487-1488.
Samples were collected from 30 healthy adults (17 men and 13 women) and analyzed with the Dimension® AMM method versus the predicate, Dimension® AMON method.
Expected Values: 11 - 32 umol/L [19 - 54 ug/dL] '
Precision
Precision testing was performed in accordance with CLSI EPS-A2 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition. Samples consisted of three levels of Liquichek™ Ethanol/Ammonia control. Testing was performed over 20 days, two separate runs with two test samples for each test material. Analysis of variance (ANOVA) was used to evaluate the data consistent with the recommendations of EP5-A2. The data are summarized in the following Dimension® Ammonia (AMM) Summary Table:
| Material | Mean
µg/dL [µmol/L] | | Standard Deviation (%CV)
Repeatability Within-Lab | |
|------------------------------------|------------------------|-------|------------------------------------------------------|-----------------|
| Liquichek™ Ethanol/Ammonia control | | | | |
| Level 1 | 40 | [23] | 2.1 [1.2] (5.2) | 3.7 [2.2] (9.3) |
| Level 2 | 187 | [110] | 2.6 [1.5] (1.4) | 3.7 [2.2] (2.0) |
| Level 3 | 565 | [332] | 3.3 [1.9] (0.6) | 7.3 [4.4] (1.3) |
Linearitv
The linear range was determined according to CLSI EP-6A. Evaluation of the Linearity of Quantitative Measurement Procedures; A Statistical Approach; Approved Guideline. Based on the results of this testing and the Limit of Detection testing, the analytical measurement range was determined to be 17 – 1277 µg/dL [10 - 750 µmol/L].
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Image /page/4/Figure/0 description: The image shows a graph with a straight line and several data points plotted along it. The line appears to be a linear regression or a line of best fit for the data points. The data points are closely aligned with the line, indicating a strong positive correlation between the variables represented on the x and y axes. There is also a rectangular box in the lower right quadrant of the graph.
Analytical Specificity/Interferences
The AMM method was evaluated for interference according to CLSI EP7-A2 Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition. Bias is the difference in the results between the control sample (without the interferent) and the test sample (contains the interferent) expressed in percent. Bias exceeding 10% is considered interference.
| Substance Tested | Substance Concentration | Ammonia
µg/dL [µmol/L] | Bias % |
|-----------------------------|-----------------------------------------------------|----------------------------------------------|----------------------|
| Hemoglobin
(hemolysate) | 75 mg/dL [0.05 mmol/L]
500 mg/dL [0.3105 mmol/L] | 85 [50]
426 [250] | +11