(543 days)
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No
The summary describes a standard immunoassay and analyzer for measuring drug levels, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is an immunoassay designed to measure adalimumab levels in patient serum, which is used as an aid in the management of patients undergoing adalimumab therapy. It does not directly treat or prevent a disease; rather, it provides diagnostic information.
Yes
The "Intended Use / Indications for Use" section states: "Measurements obtained by this assay can be used to detect adalimumab as an aid in the management of patients with inflammatory bowel diseases (IBD)..." This indicates that the device provides information used to diagnose, treat, or prevent disease, which is the definition of a diagnostic device.
No
The device description clearly states that the Procise ADL assay kit includes physical components such as reagent cartridges, buffer bulbs, and assay controls. It also requires the use of the ProciseDx Analyzer, which is a hardware device designed to detect fluorescent signals. Therefore, it is not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the assay is for the "quantitative determination of adalimumab (ADL) levels in venous serum in patients undergoing adalimumab therapy." This involves testing a sample taken from the human body (venous serum) to provide information about a medical condition or physiological state (adalimumab levels in patients with inflammatory bowel diseases).
- Sample Type: The assay uses "venous serum," which is a biological specimen derived from the human body.
- Purpose: The measurements obtained are used "as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with adalimumab." This indicates the test is used for medical purposes to inform clinical decisions.
- Setting: The test is intended for use in a "clinical laboratory," which is a typical setting for IVD testing.
- Device Description: The description details reagents and controls used to perform the test on a biological sample.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Procise ADL assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of adalimumab (ADL) levels in venous serum in patients undergoing adalimumab therapy, using the ProciseDx Analyzer.
Measurements obtained by this assay can be used to detect adalimumab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with adalimumab. The test is intended for use in a clinical laboratory.
Product codes (comma separated list FDA assigned to the subject device)
QYD
Device Description
Each Procise ADL assay kit includes Procise ADL reagent cartridges, buffer bulbs, and Procise ADL low and high assay controls as follows:
-. Twenty pouched Procise ADL cartridges each containing a lyophilized test-specific reagent bead located in the cartridge cap comprised of test-specific conjugates (monoclonal Fab anti-ADL/TNFa complex labeled with acceptor fluorophore and TNFa protein labeled with donor fluorophore)
- Twenty 1.5 mL buffer bulbs .
-. Two pouched assay ADL Low controls
-. Two pouched assay ADL High controls - Product Insert .
-. Quick Reference Guide
The Procise ADL assay requires the ProciseDx Analyzer. The ProciseDx Analyzer is designed to detect time-resolved fluorescent signal from both the donor and FRET acceptor emission within the Procise ADL assay.
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)
Precision/Reproducibility:
- Precision studies were conducted following CLSI EP05-A3 guideline using five pools of native ADL serum samples with targeted ADL concentrations (2.8, 6, 10, 14, and 45 ug/mL). Three lots of reagents were used with three instruments, tested in replicates of two, twice daily for twenty days.
- A reproducibility study was performed at three external sites using five serum samples (three pools of native serum ~5, 10, 40 ug/mL and two quality control samples 3.2 and 22.8 ug/mL). The same reagent lot was used, tested in replicates of three, twice daily for five days by two operators using two instruments.
Linearity:
- A linearity study was conducted following CLSI EP06 2nd edition guideline using serum samples with 13 different ADL levels ranging from 0.5 to 74.9 ug/mL. The linearity test supported a claimed measuring range of 1.0 to 50 ug/mL.
- A second linearity study used native samples, mixing a negative serum pool with a positive ADL serum sample to create eleven serum levels.
Analytical Specificity/Interference:
- Interference studies were conducted following CLSI EP37 guideline. Potentially interfering substances were prepared at twice the CLSI recommended level and combined with native ADL serum samples at 5 and 25 ug/mL. None of the listed substances showed significant interference (bias ≤10%).
High-Dose Hook Effect:
- Evaluated potential high dose hook effect at ADL concentrations of 25, 50, 100, 200, and 300 ug/mL. The device displayed >50 ug/mL for results above the upper limit of quantification. No hook effect was observed up to 300 ug/mL.
Assay Reportable Range:
- 1.0 to 50.0 ug/mL.
Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
-
Traceability: Calibration standards are traceable to the ADL WHO International Standard (NIBSC code: 17/236).
-
Procise ADL Assay Recovery Study: Assessed functional accuracy of calibration and control methodology, showing good linearity and bias when testing dilutions of the WHO IS Standard.
-
Sample Stability:
- Room Temperature and Refrigerated: Supported 3 days of stability for serum specimens at room temperature or 4°C.
- Frozen Serum Stability: Supported stability up to 142 weeks for serum samples stored at -80°C.
- Freeze-Thaw Serum Stability: Supported stability for up to five freeze-thaw cycles for serum samples stored at -80°C.
Detection Limit:
- LoB: 0.08 ug/mL
- LoD: 0.25 ug/mL
- LoQ: 0.96 ug/mL (at which
N/A
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine. The text is written in a clear, sans-serif font, with "FDA" in a blue square and the rest of the text in blue.
EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR Procise ADL DECISION SUMMARY
I Background Information:
A De Novo Number
B Applicant
ProciseDx Inc.
C Proprietary and Established Names
Procise ADL
D Regulatory Information
| Product
Code(s) | Classification | Regulation
Section | Panel |
|--------------------|----------------|----------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| QYD | Class II | 21 CFR 862.3115 - Anti-tumor
necrosis factor alpha monoclonal
antibody test system for
inflammatory bowel disease | TX - Clinical
Toxicology |
II Submission/Device Overview:
A Purpose for Submission:
De Novo request for evaluation of automatic class III designation for Procise ADL
B Measurand:
Adalimumab (ADL)
C Type of Test:
Quantitative, Time-resolved fluorescence energy transfer immunoassay
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III Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
The Procise ADL assay is a time-resolved fluorescence energy transfer immunoassay for the quantitative determination of adalimumab (ADL) levels in venous serum in patients undergoing adalimumab therapy, using the ProciseDx Analyzer.
Measurements obtained by this assay can be used to detect adalimumab as an aid in the management of patients with inflammatory bowel diseases (IBD): Crohn's disease and ulcerative colitis being treated with adalimumab. The test is intended for use in a clinical laboratory.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
For in vitro diagnostics use only
D Special Instrument Requirements:
ProciseDx Analyzer
IV Device/System Characteristics:
A Device Description:
Each Procise ADL assay kit includes Procise ADL reagent cartridges, buffer bulbs, and Procise ADL low and high assay controls as follows:
- . Twenty pouched Procise ADL cartridges each containing a lyophilized test-specific reagent bead located in the cartridge cap comprised of test-specific conjugates (monoclonal Fab anti-ADL/TNFa complex labeled with acceptor fluorophore and TNFa protein labeled with donor fluorophore)
- Twenty 1.5 mL buffer bulbs .
- . Two pouched assay ADL Low controls
- . Two pouched assay ADL High controls
- Product Insert .
- . Quick Reference Guide
The Procise ADL assay requires the ProciseDx Analyzer. The ProciseDx Analyzer is designed to detect time-resolved fluorescent signal from both the donor and FRET acceptor emission within the Procise ADL assay.
B Principle of Operation
The Procise ADL assay is a sandwich immunoassay that uses time-resolved fluorescence to detect the presence and quantity of ADL in patient serum specimens. It is a homogenous assay
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that uses an energy transfer between a terbium cryptate acceptor fluorophore labeled anti-ADL/TNFa complex Fab' antibody and a terbium cryptate donor fluorophore labeled to TNFa protein. When ADL is present in a sample and tested with the Procise ADL assay, it binds to the donor labeled TNFa protein allowing the anti-ADL/TNFa Fab' antibody bound to an acceptor to bind.
Once the labeled TNFa protein and anti-ADL/TNFa Fab' antibody are bound together within a complex, their close proximity allows for fluorescence resonance energy transfer (FRET) to occur. The acceptor fluorophore emission created from FRET is measured along with the donor signal. The ratio of the two emissions is used by the ProciseDx Analyzer to determine the concentration of ADL within the sample. The acceptor to donor ratio is proportional to the amount of ADL in the sample.
V Standards/Guidance Documents Referenced:
CLSI EP05-A3, 3rd Edition, 2015, Evaluation of Precision of Quantitative Measurement Procedures, Approved Guideline
CLSI EP06 2nd Edition, 2021, Evaluation of the Linearity of Quantitative Measurement Procedures
CLSI EP07 3rd Edition, 2018, Interference Testing in Clinical Chemistry
CLSI EP09c 3rd Edition, 2020, Measurement Procedure Comparison and Bias Estimation Using Patient Samples
CLSI EP17-A2, 2013, Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline
CLSI EP25-A, 2013, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
CLSI EP37 1st Edition, 2018, Supplemental Tables for Interference Testing in Clinical Chemistry
CLSI EP32-R, 2014, Metrological Traceability and Its Implementation; A Report
VI Performance Characteristics:
A Analytical Performance:
-
- Precision/Reproducibility:
Precision studies were conducted following the recommendations in CLSI EP05-A3 guideline.
- Precision/Reproducibility:
Precision studies were performed using five pools of native ADL serum samples with targeted ADL concentrations at approximately 2.8, 6, 10, 14, and 45 ug/mL. Three lots of Procise ADL assay reagents were paired with three lots of buffer bulbs using three different
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instruments. The paired assay lot and instruments were changed from the first daily run compared to the second. Samples were tested in replicates of two, two times per day, for twenty days. The precision results characterize the precision of the Procise ADL assay across the measurement range and are summarized below for all lots.
| Sample | N | Mean
($\mu$g/mL) | Between
Lot | | Between
Analyzer | | Between
Day | | Between Run | | Within
Run | | Total | |
|--------|-----|-----------------------|----------------|------|---------------------|------|----------------|------|-------------|------|---------------|------|-------|-------|
| | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| 1 | 240 | 2.47 | 0.12 | 4.8% | 0.12 | 4.9% | 0.05 | 2.2% | 0.01 | 0.6% | 0.19 | 7.8% | 0.26 | 10.6% |
| 2 | 240 | 5.79 | 0.26 | 4.6% | 0.11 | 1.9% | 0.07 | 1.2% | 0.02 | 0.3% | 0.26 | 4.5% | 0.40 | 6.8% |
| 3 | 240 | 10.22 | 0.26 | 2.6% | 0.21 | 2.0% | 0.10 | 0.9% | 0.04 | 0.4% | 0.51 | 5.0% | 0.62 | 6.1% |
| 4 | 240 | 12.71 | 0.29 | 2.3% | 0.17 | 1.3% | 0.14 | 1.1% | 0.06 | 0.5% | 0.85 | 6.7% | 0.93 | 7.3% |
| 5 | 240 | 45.79 | 0.49 | 1.1% | 0.25 | 0.5% | 0.18 | 0.4% | 0.17 | 0.4% | 2.31 | 5.0% | 2.39 | 5.2% |
Procise ADL Assay Precision (20-Day) for All Reagent Lots and Analyzers
A reproducibility study was performed at three external sites. Reproducibility studies were performed using five serum samples consisting of three pools of native serum samples with ADL concentrations approximately 5, 10, and 40 ug/mL and two serum quality control samples with ADL concentrations of 3.2 and 22.8 ug/mL. The same Procise ADL assay lot was used at all three sites. At each site, samples were tested in replicates of three, two times per day, for five days by two operators using two instruments. The reproducibility results characterize the precision of the Procise IFX assay across the measurement range and are summarized below for all lots.
| Sample | Mean
(µg/mL) | | Within
Run | | Between
Run | | Between
Day | | Between
Instrument | | Between
Operator | | Between
Site | | Total |
|---------|-----------------|------|---------------|------|----------------|------|----------------|------|-----------------------|------|---------------------|------|-----------------|------|--------|
| | | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) | SD | CV (%) |
| QC Low | 3.20 | 0.20 | 6.2 | 0.04 | 1.3 | 0.08 | 0.3 | 0.03 | 1.0 | 0.06 | 1.9 | 0.07 | 2.1 | 0.22 | 7.0 |
| QC High | 22.77 | 1.34 | 5.9 | 0.49 | 2.1 | 0.35 | 1.5 | 0.25 | 1.1 | 0.52 | 2.3 | 0.41 | 1.8 | 1.63 | 7.2 |
| 1 | 5.18 | 0.24 | 4.6 | 0.06 | 1.2 | 0.06 | 1.2 | 0.09 | 1.6 | 0.13 | 2.5 | 0.12 | 2.3 | 0.32 | 6.2 |
| 2 | 9.77 | 0.53 | 5.4 | 0.10 | 1.0 | 0.11 | 1.1 | 0.11 | 1.1 | 0.16 | 1.6 | 0.15 | 1.5 | 0.60 | 6.1 |
| 3 | 44.32 | 3.27 | 7.3 | 0.80 | 1.8 | 0.76 | 1.7 | 0.58 | 1.3 | 1.05 | 2.4 | 1.50 | 3.4 | 3.95 | 8.9 |
Procise ADL Assay Reproducibility for All Sites
2. Linearity:
Linearity studies were conducted following the recommendations in CLSI EP06 2nd edition guideline.
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A linearity study was conducted to evaluate linearity across the measuring range of the Procise ADL assay. Serum samples with 13 different ADL levels were evaluated: 0.5, 0.8, 1.4. 2.1. 3.1. 4.6. 6.9. 10.2. 15.9. 23.0. 34.3. 51.6 and 74.9 ug/mL. A native serum sample with ADL concentrations of 18.1 ug/mL was spiked with ADL Intermediate Dilution (PN4707) ug/mL) to obtain a concentration of 84.0 ug/mL. This was mixed with a native serum pool with no ADL to achieve the 13 different levels of ADL tested. The linear regression results are shown below. The percent deviation from linearity was within ±5% across the reportable range of the assay.
| Claimed Measuring
Range | Sample Range
Tested | Slope | Intercept | R2 |
|----------------------------|------------------------|-------|-----------|--------|
| 1.0-50 µg/mL | 0.5-74.9
µg/mL | 0.98 | 0.28 | 0.9995 |
These results support the claimed measuring range of 1.0 to 50 ug/mL for ADL.
A second linearity study was conducted with native samples. A pool of negative native serum was mixed in known ratios with a single ADL native serum sample with an ADL concentration of 28.1 ug/mL measured by the Procise ADL assay to create eleven serum levels known relative to one another. The percent deviation from linearity was within ±5% across the range of the assay tested.
3. Analytical Specificity/Interference:
Interference studies were conducted following the recommendations in CLSI EP37 guideline.
Each potentially interfering substance was prepared at twice the CLSI recommended level in pooled ADL negative serum which was then combined at a 1:1 ratio with native ADL serum sample pools to obtain ADL serum concentrations at approximately 5 and 25 ug/mL plus the interferent. The control samples without interferent were made by combining the native ADL serum at each level with ADL negative serum at a 1:1 ratio. None of the substances in the tables below showed significant interference, defined as bias ≤10% for each potential interferent and concentration level tested when compared to the nominal condition.
List of interferents at their concentration up to which no interference was observed.
| Compound | Tested concentration |
|---|---|
| 5-aminosalicylate | 2.04 mg/dL |
| 6-mercaptopurine | 0.148 mg/dL |
| Acetaminophen | 15.6 mg/dL |
| Acetylsalicylic Acid | 3 mg/dL |
| Antidrug antibodies to ADL | 200 ng/mL |
| Ascorbic Acid | 5.25 mg/dL |
| Azathioprine | 0.258 mg/dL |
| Bilirubin Conjugated | 20 mg/dL |
| Bilirubin Unconjugated | 40 mg/dL |
| Budesonide | 0.0146 µmol/L |
| Ciprofloxacin | 1.2 mg/dL |
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| Compound | Tested concentration |
|---|---|
| Hemolysate | 800 mg/dL |
| Human Anti-Mouse Antibody | 200x |
| Infliximab | 20 ug/mL |
| Methotrexate | 2000 umol/L |
| Metronidazole | 12.3 mg/dL |
| Prednisone | 0.276 umol/L |
| Rheumatoid Factors | 1285 IU/mL |
| Sulfasalazine | 7.5 mg/dL |
| Total Protein | 15 g/dL |
| Triglycerides | 1500 mg/dL |
| Vitamin D | 300 ng/mL |
The sponsor included the following limitation in the labeling:
Note: Due to possibility of introducing error, highly hemolyzed (>800 mg/dL hemolysate) or highly icteric (>20 mg/dL conjugated bilirubin) samples should not be tested in the Procise ADL assay.
High-Dose Hook Effect
To evaluate the potential for a high dose hook effect in the Procise ADL assay, serum samples were tested at ADL concentrations of approximately 25, 50, 100, 200 and 300 ug/mL. The samples were tested in replicates of five using three assay lots and three buffer bulb lots. For results above the Procise ADL assay upper limit of quantification (50 ug/mL), the ProciseDx Analyzer displayed >50 ug/mL as a result. Device results are unimpacted by a hook effect at ADL concentrations of up to 300 ug/mL.
-
- Assay Reportable Range:
The assay reportable range is from 1.0 to 50.0 ug/mL
- Assay Reportable Range:
-
- Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Traceability
The Procise ADL assay calibration standards are traceable to the ADL WHO International Standard: 1st International Standard for Adalimumab (NIBSC code: 17/236).
Procise ADL Assay Recovery Study
A study was performed to assess the functional accuracy of the Procise ADL assay calibration and control methodology. 50 ug of the WHO IS Standard for ADL was reconstituted using 1.0 mL of pooled native negative serum to achieve a known starting concentration of 50 ug/mL. Native ADL negative serum was used to dilute the starting sample to create a total of 11 samples, each one-third less than the previous. These 11 dilutions were tested in triplicates using one lot of the Procise ADL assay components in singlicate. The results are summarized below individually for three replicates.
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| Analyte | Replicate | Slope | Y-Intercept | R2 |
|---|---|---|---|---|
| ADL | 1 | 1.03 | 0.11 | 1.00 |
| 2 | 0.99 | 0.29 | 1.00 | |
| 3 | 1.03 | 0.05 | 1.00 |
Procise ADL Result vs. WHO IS Standard for ADL Linear Regression Results
Procise ADL Result Summary When Testing the WHO IS Standard for ADL
| WHO IS
[ADL]
(µg/mL) | Replicate | Procise
[ADL]
(µg/mL) | % Bias | %CV |
|----------------------------|-----------|-----------------------------|--------|-----|
| 50.0 | 1 | 51.3 | 3% | 3% |
| | 2 | 48.6 | -3% | |
| | 3 | 50.7 | 1% | |
| 33.3 | 1 | 35.0 | 5% | 1% |
| | 2 | 34.5 | 4% | |
| | 3 | 35.4 | 6% | |
| 22.2 | 1 | 22.6 | 2% | 2% |
| | 2 | 23.4 | 5% | |
| | 3 | 22.6 | 2% | |
| 14.8 | 1 | 15.5 | 5% | 2% |
| | 2 | 14.9 | 1% | |
| | 3 | 14.8 | 0% | |
| 9.9 | 1 | 9.4 | -4% | 4% |
| | 2 | 10.0 | 1% | |
| | 3 | 10.3 | 4% | |
| 6.6 | 1 | 6.7 | 1% | 3% |
| | 2 | 6.9 | 4% | |
| | 3 | 6.5 | -2% | |
| 4.4 | 1 | 5.0 | 13% | 6% |
| | 2 | 4.4 | 1% | |
| | 3 | 4.5 | 2% | |
| 2.9 | 1 | 3.0 | 4% | 2% |
| | 2 | 3.1 | 7% | |
| | 3 | 3.0 | 4% | |
| 2.0 | 1 | 2.2 | 14% | 8% |
| | 2 | 2.0 | 4% | |
| | 3 | 1.9 | -3% | |
| 1.3 | 1 | 1.6 | 21% | 11% |
| | 2 | 1.3 | 3% | |
| | 3 | 1.3 | 0% | |
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Sample Stability
Room Temperature and Refrigerated
To test the stability of serum specimens at room temperature or at 4℃, the sponsor performed a stability study using freshly drawn serum from three patients (targeting low, mid, and high range ADL concentrations) receiving ADL therapy. Refrigerated (~4°C) and room temperature (~22°C) specimens were tested in duplicate at Baseline, defined as 2-4 hours after draw (Day 0). Day 3. Day 5. and Day 7 using three different lots of Procise ADL reagents. The results support the labeling claim of three days of stability at room temperature or refrigerated (4℃).
Frozen Serum Stability
The sponsor performed a frozen serum stability study to demonstrate that serum samples stored at -80% that contain ADL are stable when measured with the Procise ADL assay. The sponsor performed the stability study using freshly drawn serum from 33 patients, tested by using the Procise ADL assay within a day of draw. Samples were stored frozen at -80℃ then thawed and retested in duplicate using one lot of Procise ADL assay reagents. The results show that serum samples with ADL stored at -80°C are stable up to 142 weeks.
Freeze-Thaw Serum Stability
The sponsor performed a freeze-thaw study to test the stability of frozen clinical serum specimens stored at -80°C that contain ADL when the samples undergo multiple freeze-thaw cycles. The sponsor tested five frozen serum samples with ADL concentrations of ~3, 5, 7, 20, and 40 ug/mL, previously measured using the Procise ADL assay when freshly collected. Each sample was tested after 1, 2, 3, and 5 freeze-thaw cycles and the ADL results were compared back to the original pre-frozen value. The results show that ADL is stable in serum samples frozen at -80°C that have undergone up to five freeze-thaw cycles.
6. Detection Limit:
Detection limits were assessed following the recommendations in CLSI EP17-A2 guideline.
The limit of blank (LoB) was determined using four native serum specimens containing no ADL. Each of the four serum samples were tested in replicates of five over three days using two Procise ADL assay lots for a total of 60 measurements per reagent lot. The 95th percentile from each reagent lot was calculated, multiplied by the standard deviation of the blank and the result was added to the mean of the blank to calculate the LoB for each lot. The sponsor determined the LoB to be 0.08 ug/mL which was the highest LoB calculation between the two Procise ADL assay lots.
The limit of detection (LoD) was determined using four different ADL serum samples with the concentrations: 0.1. 0.2, 0.4 and 0.5 ug/mL. Each of the four serum samples were tested in replicates of five across three days using two Procise ADL assay reagent lots for a total of 60 measurements per lot. Two operators performed the testing. A one-sided 95% confidence t-distribution table (with a sample size of 60) was used to calculate a multiplier. To calculate the LoD, this multiplier was multiplied by the pooled standard deviations for 60 data points for each assay lot then the result was added to the LoB. The sponsor determined the LoD to be 0.25 ug/mL using the assay lot with the highest LoD determination.
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The limit of quantitation (LoQ) was determined using four to five (depending on the Procise ADL assay reagent lot) samples above the LoD with ADL concentrations at: 0.7, 0.9, 1.1 and 1.4 ug/mL (Lot 1) and 0.4, 0.5, 0.7, 0.9 and 1.1 ug/mL (Lot 2). Each of the four serum samples were tested in replicates of five across three days using two Procise ADL assay reagent lots for a total of 60-75 measurements per lot. Two operators performed the testing. The LoQ was determined to be 0.96 ug/mL at which they observed