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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the Dimension® Ammonia Flex® reagent cartridge (AMM), based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for the Dimension® Ammonia Flex® reagent cartridge (AMM) are not explicitly stated as pass/fail thresholds in the provided document. Instead, the document describes the performance characteristics that were "evaluated" or "determined" and compares them to the predicate device or established guidelines. The device demonstrates substantial equivalence based on these performance characteristics.

Here is a table summarizing the reported device performance for key characteristics:

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Dimension® AMM)
Measuring Range (Linearity)	Comparable to predicate, determined according to CLSI EP-6A.	17-1277 µg/dL [10 – 750 µmol/L]
Sample Size	Optimized for the new device.	44 µL
Sample Type	Plasma (Lithium Heparin and EDTA).	Plasma (Lithium Heparin and EDTA)
Reagent Form	Liquid formulation for the new device.	Liquid
Method Comparison (vs. Predicate)	High correlation (r ≥ 0.975), low bias (slope near 1, intercept near 0) when compared to predicate AMON.	Slope: 0.98, Intercept: 9 [5] µg/dL[µmol/L], Correlation Coefficient (r): 1.00 (with Dimension® AMON)
Plasma Comparison (Lithium Heparin vs. EDTA)	High correlation (r ≥ 0.975), low bias (slope near 1, intercept near 0) between sample types on the Dimension® System.	Slope: 0.96, Intercept: 1.6 [1.0] µg/dL[µmol/L], Correlation Coefficient (r): 1.00
Reference Interval (Expected Values)	Validation of predicate's therapeutic range by transference following CLSI C28-A3.	Validated therapeutic range: 11 - 32 umol/L [19 - 54 ug/dL]
Precision	Demonstrated repeatability and within-lab standard deviation according to CLSI EP5-A2.	Level 1 (Mean 40 [23]): Repeatability SD (CV) 2.1 [1.2] (5.2); Within-Lab SD (CV) 3.7 [2.2] (9.3) Level 2 (Mean 187 [110]): Repeatability SD (CV) 2.6 [1.5] (1.4); Within-Lab SD (CV) 3.7 [2.2] (2.0) Level 3 (Mean 565 [332]): Repeatability SD (CV) 3.3 [1.9] (0.6); Within-Lab SD (CV) 7.3 [4.4] (1.3)
Analytical Specificity/Interferences	Bias exceeding 10% is considered interference. Inaccuracies (biases) less than 10% for common endogenous and exogenous substances at tested concentrations.	Hemoglobin: +11% at 75 mg/dL (85 μg/dL ammonia), <10% otherwise. Bilirubin (unconjugated/conjugated): <10%. Lipemia (Intralipid®): <10% at relevant concentrations; 400 mg/dL tripped test message. Specific interferents listed in table (Albumin, Bilirubin (unconjugated), Dextran 40, Cholesterol, Creatinine, Hemoglobin, Immunoglobulin G, Uric Acid) show biases >10% at certain concentrations, but subsequent recovery studies indicated no significant interference (within 10% of expected value) for certain endogenous interferents.
Limit of Blank (LoB)	Determined according to CLSI EP17-A.	5 µg/dL [3 µmol/L]
Limit of Detection (LoD)	Determined according to CLSI EP17-A.	11 µg/dL [7 µmol/L]
Limit of Quantitation (LoQ)	Determined according to CLSI EP17-A.	17 µg/dL [10 µmol/L]

Study Details

Sample size used for the test set and the data provenance:
- Method Comparison: 127 patient samples for comparison between AMM and predicate AMON.
- Plasma Comparison: 50 matched lithium heparin and EDTA plasma samples.
- Reference Interval: 30 healthy adults (17 men and 13 women) for validation of reference interval.
- Precision: Not explicitly stated as "sample size" but involved multiple runs (20 days, two runs per day, two test samples for each of 3 control levels).
- Linearity: Not explicitly stated as number of samples, but determined according to CLSI EP-6A which involves multiple dilutions/levels.
- Analytical Specificity/Interferences: Various concentrations of interferents tested at two ammonia levels (85 µg/dL and 426 µg/dL), and for certain endogenous interferents, patient samples containing the interferent were mixed with a plasma pool. The exact number of samples for each interferent test is not specified, but the methodology follows CLSI EP7-A2.
- LoB, LoD, LoQ:
  - LoB: 4 samples of calibrator (zero level) over 3 days (1 run/day, 2 replicates/run).
  - LoD: 4 low level samples over 3 days (1 run/day, 2 replicates/run).
  - LoQ: 3 ammonia standards diluted to 17 µg/dL [10 µmol/L] over 3 days (1 run/day, 3 replicates/run).
- Data Provenance: The document does not explicitly state the country of origin for the patient or control samples. Given Siemens Healthcare Diagnostics, Inc. is based in Newark, DE (USA), it is likely the data were collected in the United States. The studies are described as typically performed by Siemens, indicating prospective collection in a laboratory setting for regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is an in vitro diagnostic (IVD) device for quantitative measurement. The "ground truth" for the test samples is their measured ammonia concentration, determined by established laboratory methods, specifically the predicate device and the new device itself. There are no human expert adjudicators involved in determining the "truth" of an ammonia level.
- The reference interval (expected values) was validated using the predicate device's established therapeutic range and a literature reference (Textbook of Clinical Chemistry by NW Tietz).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in image-based AI studies where human readers might disagree on a diagnosis and a consensus mechanism is needed. For an IVD device, the "truth" value for a sample is its chemical concentration, determined by the measurement system rather than human interpretation or consensus.
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 not an AI-assisted diagnostic imaging device or a device involving human interpretation of results in a clinical read environment. It is an automated in vitro diagnostic test for quantitative chemical measurement.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is essentially a standalone device performance study. The Dimension® Ammonia Flex® reagent cartridge (AMM) is an automated system for quantitative measurement. Its performance characteristics (linearity, precision, interference, LoB/LoD/LoQ, and comparison to a predicate device) are evaluated intrinsically, without human-in-the-loop performance influencing the measurement results themselves. Human involvement would be in operating the instrument and interpreting the numerical output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is established by direct chemical measurement.
  - For Method Comparison, the predicate device (Dimension® Ammonia (AMON)) served as the reference method for comparison.
  - For Precision, commercially available control materials (Liquichek™ Ethanol/Ammonia control) with known target values were used.
  - For Linearity, LoB, LoD, LoQ, studies were performed using calibrators and diluted standards/samples, with the "truth" being the calculated or theoretical concentration values.
  - For Interference studies, the "truth" for bias calculation was the measurement of control samples without the interferent, which then established the baseline against which the interferent's effect was measured.
  - For Reference Interval, the established therapeutic range of the predicate (Dimension® AMON) and a textbook reference (NW Tietz) provided the basis for the expected values.
The sample size for the training set:
- Not applicable in the conventional sense of machine learning/AI models. This is a chemical assay, and thus there is no "training set" like in deep learning for image recognition. The "development" or "optimization" of such an assay involves chemical formulation and engineering, not data-driven model training.
How the ground truth for the training set was established:
- Not applicable for the reason stated above. The "ground truth" for chemical assays is based on established analytical chemistry principles, reference methods, and certified calibrators/controls, rather than a labeled training set.

Summary

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K123320

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

1. 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:

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

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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:

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® reagentcartridge (AMM)	Predicate: Dimension®Ammonia Flex® reagentcartridge (AMON) K863840
Intended Use	The AMM method is an in vitrodiagnostic test for the quantitativemeasurement of ammonia inhuman plasma on the Dimension®clinical chemistry system.Ammonia measurements are usedin the diagnosis and treatment ofsevere liver disorders such ascirrhosis, hepatitis and Reye'ssyndrome.	The AMON method used on theDimension® clinical chemistrysystem is an in vitro diagnostictest intended for the quantitativedetermination of ammonia inhuman plasma.
Format	Prepackaged for use on anautomated system	Prepackaged for use on anautomated system
Measurement	Bichromatic Rate	Bichromatic Rate

Similarities for Dimension® AMM assay:

Differences for Dimension® AMM assay:

Feature	New Device: Dimension®Ammonia Flex® reagentcartridge (AMM)	Predicate: Dimension®Ammonia Flex® reagentcartridge (AMON) K863840
MeasuringRange	17-1277 µg/dL [10 – 750 µmol/L]	0 - 1000 µmol/L
Sample Size	44 µL	53 µL
Sample Type	Plasma (Lithium Heparin andEDTA)	Plasma (EDTA, Lithium Heparin,Sodium Fluoride)
ReagentForm	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	Interceptµg/dL[µmol/L]	CorrelationCoefficient (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
LithiumHeparin vs.	Slope	Interceptµg/dL[µmol/L]	CorrelationCoefficient (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	Meanµg/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	Ammoniaµg/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<10
Bilirubin(unconjugated)	60 mg/dL [1026 µmol/L]80 mg/dL [1368 µmol/L]	85 [50]426 [50]	<10<10
Bilirubin(conjugated)	80 mg/dL [1368 µmol/L]	85 [50]426 [250]	<10<10
Lipemia(Intralipid®)	400 mg/dL [4.52 mmol/L]200 mg/dL [2.26 mmol/L]	85 [50]426 [250]85 [50]426 [250]	<10<10

*Lipemia (Intralipid®) at 400 mg/dL [4.52 mmol/L] and above tripped a test report message; interference could not be determined.

Studies were also performed following CLSI EP7-A2 for Interference Testing of exogenous substances at an ammonia concentration of 85 and 426 µg/dL and were found not to interfere with the AMM method when present in plasma. Inaccuracies (biases) were all less than 10%. See Dimension® AMM Instructions for Use for a full list of substances tested.

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Interfering Substances

The AMM assay was evaluated for interference according to CLSI/NCCLS EP7-A2. 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. Testing was performed at two levels of analyte concentration.

Analyte Test Level	85 µg/dL[50 mmol/L]
Interferent	[Test]mg/dL	[Test] SIUnits	Bias(%)
Albumin	6 g/dL	60 g/L	61
Bilirubin(unconjugated)	80mg/dL	136.8 µmol/L	-25
Dextran 40	500 mg/dL	125 µmol/L	20
Cholesterol	503 mg/dL	13 mmol/L	73
Creatinine	30 mg/dL	2.65 mmol/L	40
Hemoglobin	75 mg/dL	0.05 mmol/L(monomer)	11
Immunoglobulin G	5 g/dL	50 g/L	32
Uric Acid	20 mg/dL	1.2 mmol/L	56

Analyte Test Level	426 µg/dL[250 mol/L]
Interferent	[Test]mg/dL	[Test] S.I.Units	Bias(%)
Albumin	6 g/dL	60 g/L	15
Dextran 40	3000 mg/dL	750 µmol/L	16
Cholesterol	503 mg/dL	13 mmol/L	34
Uric Acid	20 mg/dL	1.2 mmol/L	16

For certain endogenous interferents which exceeded 10 % bias, an aliquot of patient sample containing the potential interferent (test) was mixed with equal parts of a plasma pool containing approximately 85 µg/dL [50 µmo//L] ammonia (control). Test samples and control samples were processed and percent recovery calculated from expected and observed values. No significant interference was observed based on recovery within 10% of expected value.

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SubstanceTested	Test Concentration		AMM concentration
	conventional	SI unit	µg/dL	[µmol/L]
Albumin	5.4 g/dL	54 g/L	170	[100]
Cholesterol	489 mg/dL	13 mmol/L	341	[200]
Creatinine	21.1 mg/dL	1.87 mmol/L	230	[135]
Triglyceride	1102 mg/dL	12.5 mmol/L	363	[213]
Uric Acid	9.3 mg/dL	0.6 mmol/L	145	[85]

Limit of Blank, Limit of Determination and Limit of Quantitation

The Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) was evaluated in accordance with CLSI EP17-A Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. Studies were performed on the Dimension® clinical chemistry analyzer with the following results:

Dimension® Ammonia (AMM)
Limit	Protocol	Value
LoB	4 samples of calibrator (zerolevel) were tested for 3 days,one run per day, 2 replicatesper run, 2 reagent lots, 1instrument	5 µg/dL [3 µmol/L]
LoD	4 low level samples weretested for 3 days, one run perday, 2 replicates per run, 2reagent lots, 1 instrument	11 µg/dL [7 µmol/L]
LoQ	3 ammonia standards eachdiluted to 17 µg/dL [10 µmol/L]with purified water were testedfor 3 days, one run per day, 3replicates per run, 2 reagentlots, 1 instrument	17 µg/dL [10 µmol/L]

Conclusion: Based on the data presented, the Dimension® Ammonia (AMM) Flex® reagent cartridge is substantially equivalent in principle and performance to the Dimension® Ammonia (AMON) assay,

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract human figure or a flame-like design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Public Health Service

February 15, 2013

Siemens Healthcare Diagnostics. Inc. c/o Rose T. Marinelli P.O. Box 6101/MS 514 Newark, DE 19714-6101

Re: K123320

Trade/Device Name: Dimension Ammonia Flex reagent cartridge (AMM) Regulation Number: 21 CFR 862.1065 Regulation Name: Ammonia test system Regulatory Class: I, reserved Product Code: JIF Dated: February 05, 2013 Received: February 07, 2013

Dear Ms. Marinelli:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fdaggov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for

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Page 2-Ms. Marinelli

the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. Benson for

Courtney H. Lias, Ph.D.

. Director

Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics

and Radiological Health

Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123320

Device Name: Dimension® Ammonia Flex® reagent cartridge (AMM)

Indications for Use:

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Denise Johnson-lyles -S 2013.02.15 10:04:32 -05'00'

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K123320 510(k)

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.