AMI™ Plasma Cartridge, AMI™
Device Facts
| Record ID | K260613 |
|---|---|
| Device Name | AMI™ Plasma Cartridge, AMI™ |
| Applicant | Sequitur Health Corp. |
| Product Code | JID · Clinical Chemistry |
| Decision Date | Sep 1, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1065 |
| Device Class | Class 1 |
Indications for Use
The AMI™ Plasma Cartridge is a photometric in vitro test for the quantitative determination of ammonia in human plasma on the AMI™ analyzer. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome. The AMI™ is an analyzer for in vitro diagnostic use in clinical laboratories, utilizing photometric technology for analyte detection.
Device Story
AMI™ system measures ammonia in human K2-EDTA plasma; utilizes single-use AMI™ Plasma Cartridge. Sample applied to cartridge; capillary action moves plasma through cell-trapping, buffer, gas-permeable, and reagent layers. Chemical reaction converts ammonium to ammonia gas, reacting with bromophenol blue to produce blue dye. Analyzer measures 604nm reflected light; calculates ammonia concentration via software-resident equation using lot-specific calibration data from QR code. Used in clinical laboratories by trained personnel. Output provides quantitative ammonia concentration (μmol/L) to assist clinicians in diagnosing/treating severe liver disorders. System includes cartridge reader, computerized display, and QR code reader.
Clinical Evidence
Bench testing only. Precision (CLSI EP05-A3), linearity (CLSI EP06-Ed2), interference (CLSI EP07-A3), and detection limits (CLSI EP17-A2) were evaluated. Method comparison study (CLSI EP09c-A3) using 99 human K2-EDTA plasma samples (range 23-488 μmol/L) showed high correlation (r=0.995) with the predicate device. No clinical trials were required.
Technological Characteristics
Photometric analyzer; dry chemical cartridge technology. Cartridge contains bromophenol blue (≥ 2.3 μg/cm²) and buffer. Sensing principle: reflectance photometry at 604nm. Connectivity: QR code scanning for calibration. Electrical safety: IEC 61010-1. Software: embedded, rule-based calculation.
Indications for Use
Indicated for quantitative determination of ammonia in human plasma for patients suspected of or being treated for severe liver disorders, including cirrhosis, hepatitis, and Reye's syndrome. For prescription use only in clinical laboratory settings; not for point-of-care testing.
Regulatory Classification
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.
Predicate Devices
Submission Summary (Full Text)
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[LOGO]
FDA
U.S. FOOD & DRUG
ADMINISTRATION
### 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
### DECISION SUMMARY
### ASSAY AND INSTRUMENT
### I Background Information:
### A 510(k) Number
K260613
### B Applicant
Sequitur Health Corp.
### C Proprietary and Established Names
AMI™
AMI™ Plasma Cartridge
### D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JID | Class I, reserved | 21 CFR 862.1065, Ammonia test system | Chemistry (75) |
| JJE | Class I | 21 CFR 862. 2160 - Discrete photometric chemistry analyzer for clinical use | CH - Clinical Chemistry |
### II Submission/Device Overview:
### A Purpose for Submission:
New device
### B Measurand:
Ammonia
### C Type of Test:
Quantitative photometric
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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### III Intended Use/Indications for Use:
#### A Intended Use(s):
See Indications for Use below.
#### B Indication(s) for Use:
The AMI™ Plasma Cartridge is a photometric in vitro test for the quantitative determination of ammonia in human plasma on the AMI™ analyzer. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.
The AMI™ is an analyzer for in vitro diagnostic use in clinical laboratories, utilizing photometric technology for analyte detection.
#### C Special Conditions for Use Statement(s):
Rx - For prescription use only
This device is intended for clinical laboratory use only and not for point-of-care (near-patient) testing.
#### D Special Instrument Requirements:
AMI™
### IV Device/System Characteristics:
#### A Device Description:
The AMI™ is an instrument which consists of a cartridge reader and computerized display with a QR code reader. The AMI™ measures color changes in a dry chemical AMI™ Cartridge through reflected light when you apply a fixed volume of sample to an AMI™ Cartridge.
Each single-use AMI™ Plasma Cartridge contains:
Reactive Ingredients per cm2 - Bromophenol blue ≥ 2.3 μg
Other ingredients: buffer
#### B Principle of Operation:
The AMI™ measures ammonia by detecting color changes in a single-use AMI™ Plasma Cartridge using reflected light. Capillary action moves the applied plasma through four layers: a cell-trapping layer, a buffer layer that converts ammonium to ammonia gas, a gas-permeable barrier layer that blocks liquids, and a reagent layer with color-changing dye. The system measures the resulting color change, which is proportional to ammonia concentration.
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The chemical reactions that occur in an AMI™ Cartridge are:
(1) Plasma + buffer → NH3
(2) NH3 + bromophenol blue (ammonia indicator) → blue dye
The AMI™ measures 604nm light reflected from the Cartridge window every second. To calculate the amount of ammonia in an unknown sample, the AMI™ solves the software-resident equation for the unknown value using the Cartridge lot-specific calibration information. The AMI™ calculates the concentration of ammonia in μmol/L.
### C Instrument Description Information:
1. Instrument Name:
AMI™
2. Specimen Identification:
The AMI™ allows manual entry of a sample identifier on the touchscreen.
3. Specimen Sampling and Handling:
Specimen sampling and handling procedures are documented in the AMI™ Plasma Cartridge Instructions for Use.
4. Calibration:
The AMI™ Plasma Cartridges are pre-calibrated during manufacturing and automatically transferred via QR code scanning of the reagent cartridge for each test.
5. Quality Control:
The sponsor recommends AMI™ Quality control solutions for use with the AMI™. The labeling also recommends that quality control testing should be performed in accordance with state, local, and federal regulations.
### V Substantial Equivalence Information:
### A Predicate Device Name(s):
KODAK EKTACHEM Clinical Chemistry Slides (NH₃); KODAK EKTACHEM 400 Analyzer
### B Predicate 510(k) Number(s):
K820723
K811919
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# C Comparison with Predicate(s):
| Device & Predicate Device(s): | K260613 | K820723 |
| --- | --- | --- |
| Device Trade Name | AMI™ Plasma Cartridges | KODAK EKTACHEM Clinical Chemistry Slides (NH₃) |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Quantitative measurement of ammonia | Same |
| General Device Characteristic Differences | | |
| Instrument Platform | AMI™ | KODAK EKTACHEM 400 Analyzer |
# VI Standards/Guidance Documents Referenced:
- Clinical and Laboratory Standards Institute (CLSI) EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition.
- CLSI EP06-Ed2: Evaluation of the Linearity of Quantitative Measurement Procedures; Approved Guideline.
- CLSI EP07-Ed3: Interference Testing in Clinical Chemistry.
- CLSI EP09c-A3: Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Third Edition.
- CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline – Second Edition.
- IEC 61010-1 Edition 3.1 2017-01 consolidated version: Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General Requirements (including: Corrigendum 1).
# VII Performance Characteristics (if/when applicable):
# A Analytical Performance:
# 1. Precision/Reproducibility:
A precision study to assess repeatability and within-laboratory precision was conducted according to CLSI EP05-A3. Three native K₂ EDTA plasma samples and two controls were run in replicates of two per run, with two runs per day, over 20 days at one site. The results are summarized in the tables below:
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| Sample | Mean (μmol/L) | Repeatability | | Within Laboratory | |
| --- | --- | --- | --- | --- | --- |
| | | SD | CV(%) | SD | CV(%) |
| Plasma 1 | 53.9 | 3.7 | 6.9% | 4.4 | 8.1% |
| Plasma 2 | 150 | 6.6 | 4.4% | 6.8 | 4.6% |
| Plasma 3 | 443 | 11.8 | 2.7% | 12.7 | 2.9% |
| Control 1 | 58.2 | 1.8 | 3.2% | 2.2 | 3.8% |
| Control 2 | 215 | 3.4 | 1.6% | 3.7 | 1.7% |
A reproducibility study was conducted to assess instrument-to-instrument variability. Five human \( K_{2} \) EDTA plasma samples with different analyte concentrations were run on three analyzers (i.e., AMI \( ^{TM} \) ). The samples were tested across three reagent lots (i.e., AMI \( ^{TM} \) Plasma Cartridge) at each site on each instrument with three replicates per run and two runs per day over five days. The between-lot, between-instrument, and reproducibility was calculated for each reagent lot. The results are summarized in the tables below:
| Sample | Mean (μmol/L) | Between-Lot | | Between-Instrument | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | SD | CV(%) | SD | CV(%) | SD | CV(%) |
| Plasma 1 | 23.7 | 0.46 | 1.9% | 1.24 | 5.2% | 3.57 | 15.1% |
| Plasma 2 | 47.7 | 0 | 0.0% | 1.08 | 2.3% | 4.14 | 8.7% |
| Plasma 3 | 120 | 3.11 | 2.6% | 0.61 | 0.5% | 7.3 | 6.1% |
| Plasma 4 | 446 | 2.51 | 0.6% | 0 | 0.0% | 15.1 | 3.4% |
| Plasma 5 | 546 | 8.29 | 1.5% | 1.13 | 0.2% | 19.5 | 3.6% |
#### 2. Linearity:
Linearity was evaluated in accordance with the CLSI Guideline EP06-Ed2. 11 levels were prepared using a human \(\mathrm{K}_2\) EDTA plasma sample pool with ammonia concentration above the upper measuring range. Testing for each sample type was completed with two AMI™ Plasma Cartridge lots in one run each, 4 replicates per sample. The deviation from linearity did not exceed \(2.8\mu \mathrm{mol} / \mathrm{L}\) for values \(\leq 10~\mu \mathrm{mol} / \mathrm{L}\) or \(-3.8\%\) for values \(>10~\mu \mathrm{mol} / \mathrm{L}\). The results of the linearity study support the claimed measuring range of \(13.2 - 567~\mu \mathrm{mol} / \mathrm{L}\).
#### 3. Analytical Specificity/Interference:
Interference was evaluated according to the CLSI EP07-A3 guideline. Testing was performed using human \( K_{2} \) EDTA plasma samples with two ammonia levels ( \( \sim \) 39 and 229 \( \mu \) mol/L). The samples were assayed, and the ammonia concentrations of the spiked samples were compared to control samples without interferent. The tables below summarize the results indicating the highest interferent level at which bias between the samples with and without interferent is \( \leq \) 10 \( \mu \) mol/L at ammonia concentrations < 100 \( \mu \) mol/L and \( \leq \) 9.7% at ammonia concentrations \( \geq \) 100 \( \mu \) mol/L.
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Endogenous Interferences
| Substance | Highest concentration at which no significant interference was observed |
| --- | --- |
| Albumin | 5425 mg/dL |
| Bilirubin (conjugated) | 40 mg/dL |
| Bilirubin (unconjugated) | 21 mg/dL |
| Glucose | 600 mg/dL |
| Hemoglobin | 100 mg/dL |
| Intralipid | 1000 mg/dL |
| Total Protein | 8520 mg/dL |
| Urea | 135 mg/dL |
Exogenous Interferences
| Substance | Highest concentration at which no significant interference was observed |
| --- | --- |
| Acetaminophen | 7.8 mg/dL |
| Ascorbic acid | 5.25 mg/dL |
| Ethanol | 600 mg/dL |
| Eltrombopag | 3 mg/dL |
The sponsor included the following limitation statements in the package insert:
Eltrombopag at therapeutic doses can be present in plasma at concentrations up to 4 mg/dL. Eltrombopag in plasma above 3 mg/dL can lead to positive bias of up to 25 \( \mu \) mol/L in ammonia measurement. Do not use this test on patients taking Eltrombopag. For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings.
Do not use hemolyzed samples.
### 4. Detection Limit and Assay Reportable Range:
Determination of the Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) were conducted in accordance with the CLSI guideline EP17-A2.
#### Limit of Blank (LoB)
For determination of LoB, four analyte-free samples were measured in replicates of 5 using two AMI \( ^{TM} \) Plasma Cartridge lots over 3 days on one AMI \( ^{TM} \). In total 60 measured values of analyte free samples were obtained per lot. Data analysis was based on determination of the 95th percentile of the 60 measured values.
#### Limit of Detection (LoD)
For determination of LoD, four human \( K_{2} \) EDTA plasma samples with low-analyte concentrations were measured in replicates of 5 using two AMI \( ^{TM} \) Plasma Cartridge lots over 3 days on one AMI \( ^{TM} \) . In total 60 measured values of samples with low analyte
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concentrations were obtained per lot. The LoD was calculated non-parametrically. The higher LoD of the 2 lots was chosen as the assay's LoD.
### Limit of Quantitation (LoQ)
For the determination of LoQ, five human \( K_{2} \) EDTA plasma samples with low-analyte concentrations were measured in replicates of 5 across two AMI \( ^{TM} \) Plasma Cartridge lots over 3 days for a total of 75 replicates per lot on one AMI \( ^{TM} \) . The LoQ was defined as the concentration of analyte which has imprecision less than 20% CV.
The LoB, LoD and LoQ results are summarized below:
| LoB | LoD | LoQ |
| --- | --- | --- |
| 6.2 μmol/L | 10.8 μmol/L | 13.2 μmol/L |
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The AMI \( ^{™} \) assay is traceable to NIST-certified ammonium chloride.
Sample Stability: Sample stability studies validating K2-EDTA plasma storage conditions were reviewed and found acceptable to support 2 hours at 2-8 °C, 3 days at -20 °C ± 5 °C, and 20 days at -80 °C ± 5 °C.
6. Assay Cut-Off:
Not applicable.
## B Comparison Studies:
1. Method Comparison with Predicate Device:
A method comparison study was performed comparing the ammonia assay on the AMI \( ^{TM} \) using AMI \( ^{TM} \) Plasma Cartridge to the predicate device, using a protocol based on CLSI EP09c-A3. A total of 99 human K \( _{2} \) -EDTA plasma samples (95 native and 4 contrived) with ammonia concentrations ranging from 23 to 488 \( \mu \) mol/L were evaluated with the candidate and comparator devices in singlicate. The linear regression analysis results between the candidate device (dependent variable, y) and the comparator device (x, comparator), are shown below:
| N | Concentration Range (μmol/L) | Slope | Intercept | Correlation Coefficient (r) |
| --- | --- | --- | --- | --- |
| 99 | 23 to 488 | 1.003 | 0.04772 | 0.995 |
2. Matrix Comparison:
Not applicable.
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### C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
2. Clinical Specificity:
Not applicable.
3. Clinical Cut-Off
Not applicable.
4. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
### D Expected Values:
K2 EDTA plasma: <13.2 - 30 μmol/L (22.5 - 86.9 μg/dL)
The central 95% reference interval from apparently healthy adults was verified consistent with CLSI EP28-A3C. The sponsor includes the following information in the package insert:
It is the responsibility of each laboratory to confirm the validity of these intervals for the population it serves.
### E Other Supportive Instrument Performance Characteristics Data:
1. Environmental Conditions: The sponsor provided adequate information to support the AMI™ and AMI™ Plasma Cartridge would work as intended in the environmental operating conditions claimed in the labeling.
2. Electrical safety and electromagnetic compatibility (EMC) testing were performed, and the system was found to be acceptable.
3. Software and cybersecurity documentation was reviewed and found to be acceptable.
### VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
### IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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