SeptiCyte RAPID

K232095 · Immunexpress, Inc. · PRE · Dec 15, 2023 · Microbiology

Device Facts

• Record ID: K232095
• Device Name: SeptiCyte RAPID
• Applicant: Immunexpress, Inc.
• Product Code: PRE · Microbiology
• Decision Date: Dec 15, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3215
• Device Class: Class 2

Indications for Use

The SeptiCyte RAPID test is a gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood collected in the PAXgene Blood RNA Tubes, K2-EDTA blood tubes, or K3-EDTA blood tubes. The SeptiCyte RAPID test is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis on their first day of ICU admission. The SeptiCyte RAPID test generates a score (SeptiScore) that falls within one of four discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte RAPID is intended for in-vitro diagnostic use on the Biocartis Idylla System.

Device Story

SeptiCyte RAPID is an in-vitro diagnostic gene expression assay; utilizes reverse transcription polymerase chain reaction (RT-PCR) to quantify host response gene expression levels from whole blood samples (PAXgene, K2-EDTA, or K3-EDTA tubes). Operates on the Biocartis Idylla System; processes samples to generate a 'SeptiScore'. Output consists of a score categorized into four discrete interpretation bands representing increasing likelihood of infection-positive systemic inflammation. Used in ICU settings; operated by laboratory personnel. Healthcare providers integrate the SeptiScore with clinical assessments and other laboratory findings to aid in sepsis diagnosis. Benefits include improved differentiation between sepsis and non-infectious systemic inflammation, supporting timely clinical decision-making.

Clinical Evidence

Bench testing only. Matrix comparison study (n=60) compared matched EDTA and PAXgene samples from patients suspected of sepsis or SIRS; linear regression analysis supported agreement between matrices. Precision/reproducibility studies (lot-to-lot and intermediate precision) and interference testing (17 substances) met acceptance criteria. Limit of detection/quantitation established at 400 cells/μL. K2-EDTA vs K3-EDTA comparison (n=7 donors) showed equivalent performance.

Technological Characteristics

Quantitative reverse transcription polymerase chain reaction (qRT-PCR) assay. Analyzes mRNA transcripts of PLA2G7 and PLAC8. Integrated sample processing control (inactivated MS2 bacteriophage). Form factor: single-use cartridge for Biocartis Idylla System. Automated extraction and amplification. Connectivity: Idylla System platform.

Indications for Use

Indicated for patients suspected of sepsis on their first day of ICU admission to differentiate infection-positive (sepsis) from infection-negative systemic inflammation.

Regulatory Classification

Identification

A device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis is identified as an in vitro device intended for the detection and qualitative and/or quantitative measurement of one or more non-microbial analytes in human clinical specimens to aid in the assessment of patients with suspected sepsis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.

Special Controls

A device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis must comply with the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the device's detailed Indications for Use statement describing what the device detects and measures, the results provided to the user, whether the measure is qualitative and/or quantitative, the clinical indications for which the test is to be used, and the specific population(s) for which the device use is intended. (2) Premarket notification submissions must include detailed documentation of the device description, including (as applicable), all device components, software, ancillary reagents required but not provided, explanation of the device principle and methodology, and for molecular devices include detailed documentation of the primer/probe sequence, design, and rationale for sequence selection. (3) Premarket notification submissions must include detailed documentation of applicable analytical studies, such as, analytical sensitivity (Limit of Detection, Limit of Blank, and Limit of Quantitation), precision, reproducibility, analytical measuring range, interference, cross-reactivity, and specimen stability. (4) Premarket notification submissions must include detailed documentation of a prospective clinical study or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information: (i) Results must demonstrate adequate device performance relative to a well-accepted comparator. (ii) Clinical sample results must demonstrate consistency of device output throughout the device measuring range likely to be encountered in the Intended Use population. (iii) Clinical study documentation must include the original study protocol (including predefined statistical analysis plan), study report documenting support for the Indications for Use(s), and results of all statistical analyses. (5) Premarket notification submissions must include evaluation of the level of the non-microbial analyte in asymptomatic patients with demographic characteristics ( *e.g.,* age, racial, ethnic, and gender distribution) similar to the Intended Use population.(6) As part of the risk management activities performed under 21 CFR 820.10(c) design and development, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument. (7) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling, and a detailed explanation of the interpretation of the limitations of the samples ( *e.g.,* collected on day of diagnosis) must be included in the device's 21 CFR 809.10(b)(10) compliant labeling.

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K232095

B Applicant

Immunexpress, Inc

C Proprietary and Established Names

SeptiCyte RAPID

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PRE | Class II | 21 CFR 866.3215 - Device To Detect And Measure Non-Microbial Analyte(S) In Human Clinical Specimens To Aid In Assessment Of Patients With Suspected Sepsis | MI - Microbiology |

## II Submission/Device Overview:

A Purpose for Submission:

To obtain a substantial equivalence determination for addition of EDTA venous whole blood as a sample type for the previously cleared SeptiCyte RAPID test (K203748).

B Measurand:

mRNA transcripts of host response genes PLA2G7 and PLAC8.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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C Type of Test:

The SeptiCyte RAPID test is a quantitative reverse transcription polymerase chain reaction-based test (qRT-PCR).

III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

The SeptiCyte RAPID test is a gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood collected in the PAXgene Blood RNA Tubes, K2-EDTA blood tubes, or K3-EDTA blood tubes. The SeptiCyte RAPID test is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis on their first day of ICU admission. The SeptiCyte RAPID test generates a score (SeptiScore) that falls within one of four discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte RAPID is intended for in-vitro diagnostic use on the Biocartis Idylla System.

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

D Special Instrument Requirements:

For use on the Biocartis Idylla System.

IV Device/System Characteristics:

A Device Description:

The SeptiCyte RAPID test was cleared previously for use with venous blood samples collected in PAXgene Blood RNA tubes (K203748) on the Biocartis Idylla System (K163628). The purpose of this submission is to validate use of venous whole blood samples collected in K2-EDTA and K3-EDTA tubes for use with the device.

The SeptiCyte RAPID test uses quantitative reverse transcription - polymerase chain reaction (qRT-PCR) to measure the expression levels of the host response genes PLA2G7 and PLAC8. Each SeptiCyte RAPID test kit includes six cartridges. Cartridges are individually packaged in sealed pouches. Each cartridge contains the necessary reagents to perform a single test.

B Principle of Operation:

Amplicons generated by qRT-PCR are detected and quantitated by fluorescence generated upon exonucleolytic release of dyes from oligonucleotide probes that specifically bind to the amplicons. The Idylla Cartridge contains all reagent components needed by the SeptiCyte RAPID test to generate patient results and automates all SeptiCyte RAPID test steps, including

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sample extraction/purification and qRT-PCR for the detection and relative quantification of the two human mRNA targets PLAC8 and PLA2G7. These values are combined to produce a SeptiScore which is interpreted by means of four discrete bands which reflect a monotonically increasing likelihood of sepsis as shown in the following figure:


# Sample Type

PAXgene blood sample: Whole blood $(2.5\mathrm{mL})$ is collected into a PAXgene Blood RNA tube (US FDA 510(k) number K042613) containing $6.9~\mathrm{mL}$ stabilizing solution. A $0.9\mathrm{mL}$ volume of the resultant PAXgene-stabilized blood sample is then used as input for the SeptiCyte RAPID test.

EDTA blood sample: Whole blood is collected into either a K3-EDTA or K2-EDTA lavender top vacutainer, according to manufacturer's instructions. After mixing thoroughly by gentle inversion $10\mathrm{x}$ , a volume of $240~\mu \mathrm{L}$ EDTA blood sample is run fresh on the SeptiCyte RAPID test. Freeze/thawing of EDTA blood samples is not recommended and samples should be run fresh.

# V Substantial Equivalence Information:

A Predicate Device Name(s):

SeptiCyte RAPID

B Predicate 510(k) Number(s):

K203748

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K232095 | K203748 |
| --- | --- | --- |
| Device Trade Name | SeptiCyte RAPID | SeptiCyte RAPID |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The SeptiCyte RAPID test is a gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood collected in the PAXgene Blood RNA Tubes, K2-EDTA blood tubes, or K3-EDTA blood tubes. The SeptiCyte RAPID | The SeptiCyte RAPID test is a gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood collected in the PAXgene Blood RNA Tube. The SeptiCyte RAPID test is used in conjunction with clinical assessments and |

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| | test is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis on their first day of ICU admission. The SeptiCyte RAPID test generates a score (SeptiScore) that falls within one of four discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte RAPID is intended for in-vitro diagnostic use on the Biocartis Idylla System. | other laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis on their first day of ICU admission. The SeptiCyte RAPID test generates a score (SeptiScore) that falls within one of four discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte RAPID is intended for in-vitro diagnostic use on the Biocartis Idylla System. |
| --- | --- | --- |
| Intended Use Population | Same | Patients suspected of sepsis on their first day of Intensive Care Unit admission |
| Assay Principle | Same | qRT-PCR amplification and quantification of host mRNA transcripts |
| Analytes | Same | Two mRNA transcript immune biomarkers: PLA2G7, PLAC8 |
| Result Output | Same | SeptiScore, calculated from the expression levels of the two mRNA analytes PLA2G7, PLAC8. The SeptiScore is placed into four discrete bands that describe a monotonically increasing likelihood of sepsis vs. Systemic Inflammatory Response Syndrome (SIRS). |
| Controls | Same | MS2 bacteriophage particles, serving as sample processing control (SPC), i.e., as within-cartridge positive control for both the sample extraction |

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| | | step and the coupled qRT-PCR step.
External controls not provided with the assay but are described in labeling with protocols available from sponsor. |
| --- | --- | --- |
| Specimen Processing | Same | Automated extraction of material using the Idylla System |
| Instrument Platform | Same | Biocartis Idylla System |
| General Device Characteristic Differences | | |
| Specimen Type | Whole blood collected in a PAXgene Blood RNA Tube, K2-EDTA, or a K3-EDTA tube | Whole blood collected in a PAXgene Blood RNA Tube |
| Sample Volume | EDTA blood (240μL/cartridge) and PAXgene blood RNA Samples (900μL/cartridge) | PAXgene blood RNA Samples (900μL/cartridge) |

VI Standards/Guidance Documents Referenced:
- CLSI. Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st ed. CLSI guidelines EP35. Wayne, PA: Clinical and Laboratory Standards Institute; 2019.
- CLSI. Interference Testing in Clinical Chemistry, 3st ed. CLSI guidelines EP07. Wayne, PA: Clinical and Laboratory Standards Institute; 2018.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Lot-to-Lot Reproducibility

Lot-to-lot reproducibility of the SeptiCyte RAPID was assessed at a single site with three test lots using replicate EDTA whole blood samples from two healthy donors (Table 1). Replicate samples of EDTA whole blood from each donor were prepared. Control samples were prepared by mixing EDTA whole blood with PAXgene stabilizing solution to replicate PAXgene Blood RNA collection. Replicate samples of EDTA whole blood and PAXgene-stabilized blood were tested across three lots of the SeptiCyte RAPID. Acceptance criteria for this study included:

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1. $< 1.0$ -unit difference in mean SeptiScore between the control PAXgene-stabilized samples and the corresponding EDTA blood samples from the same donor for each of the tested cartridge lots.
2. $< 1.0$ -unit difference in mean SeptiScore between the PAXgene-stabilized controls from the same donor tested with the three cartridge lots.
3. $< 1.0$ -unit difference in mean SeptiScore between the EDTA blood samples from the same donor tested with the three cartridge lots.

Table 1. Summary of Lot-to-Lot Reproducibility Data

| | Subject 1 | | | Subject 2 | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Lot Number | | | Lot Number | | |
| | | 1 | 2 | 3 | 1 | 2 | 3 |
| EDTA blood | Mean | 4.60 | 4.88 | 4.83 | 5.13 | 5.43 | 5.30 |
| | SD | 0.22 | 0.21 | 0.15 | 0.17 | 0.17 | 0.24 |
| | %CV | 4.70% | 4.23% | 3.11% | 3.33% | 3.15% | 4.62% |
| PAXgene blood | Mean | 4.55 | 4.90 | 4.65 | 5.40 | 5.50 | 5.40 |
| | SD | 0.07 | 0.28 | 0.21 | 0.14 | 0.00 | 0.42 |
| | %CV | 1.55% | 5.77% | 4.56% | 2.62% | 0.00% | 7.86% |
| | Delta Mean | 0.05 | 0.02 | 0.18 | 0.27 | 0.07 | 0.10 |

For each subject, the change in SeptiScore among the sample matrices and test lots was less than 1.0 and met the study acceptance criteria. These data are acceptable.

Additional estimates of assay precision were determined by analyzing data generated during specimen stability testing of EDTA whole blood samples from healthy donors (Table 2) and are acceptable.

Table 2. Summary of Intermediate Precision Estimates with EDTA Blood Samples

| Donor | N | Avg | Repeatability | | Between Instrument | |
| --- | --- | --- | --- | --- | --- | --- |
| | | SeptiScore | SD | CV (%) | SD | CV (%) |
| 1 | 14 | 6.24 | 0.18 | 2.8% | 0.18 | 2.8% |
| 2 | 13 | 5.36 | 0.34 | 6.2% | 0.07 | 1.3% |

# 2. Linearity:

The SeptiCyte RAPID test was cleared previously under K203748. Please refer to the published decision summary for additional information. Equivalent performance in whole blood specimens collected in EDTA and PAXgene RNA tubes was evaluated in a method comparison study described below.

# 3. Analytical Specificity/Interference:

Potentially interfering substances in venous blood samples were evaluated for potential impact on SeptiCyte RAPID test results. Potential interferents were added to pooled EDTA

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whole blood from healthy donors at concentrations higher than the maxima of their normal or expected reference ranges. Three replicates of EDTA blood were tested at each concentration of potential interferent and compared to matched EDTA blood controls (containing the appropriate solvent but no interferent). A change in the mean SeptiScore values between EDTA blood samples containing the potential interferent and matched EDTA blood controls (containing the appropriate solvent but no interferent) was evaluated. The acceptance criteria required any difference in mean SeptiScore be less than 1.5 score units when calculated between replicates of each potential interferent, and its respective solvent control replicates. None of the potential interferents evaluated affected the SeptiScore by more than 0.65 score units satisfying the study acceptance criteria (Table 3). The results of the interference study are acceptable.

Table 3. Effect of Potential Interferants on SeptiScore Results

| Potential Interferent | Mean | SD | N | Delta SeptiScore |
| --- | --- | --- | --- | --- |
| Rheumatoid Factor | 5.70 | 0.17 | 3 | 0.23 |
| Heparin | 5.37 | 0.12 | 3 | 0.10 |
| Imipenem | 5.53 | 0.12 | 3 | 0.06 |
| Bilirubin | 5.72 | 0.47 | 3 | 0.65 |
| Triglycerides | 5.87 | 0.25 | 3 | 0.40 |
| Vancomycin | 5.90 | 0.10 | 3 | 0.43 |
| Cefotaxime | 5.00 | 0.20 | 3 | 0.47 |
| Dopamine | 5.27 | 0.32 | 3 | 0.20 |
| CRP | 5.30 | 0.17 | 3 | 0.17 |
| Noradrenaline | 5.30 | 0.10 | 3 | 0.17 |
| Dobutamine | 5.53 | 0.25 | 3 | 0.06 |
| Hemoglobin | 5.63 | 0.06 | 3 | 0.16 |
| Albumin | 5.67 | 0.15 | 3 | 0.20 |
| Furosemide | 5.33 | 0.23 | 3 | 0.00 |
| sCD14 | 5.80 | 0.22 | 3 | 0.33 |
| IL-6 | 5.93 | 0.15 | 3 | 0.46 |
| LBP | 5.37 | 0.15 | 3 | 0.14 |
| Solvent Control - Methanol/Blood | 5.33 | 0.12 | 3 | N/A |
| Solvent Control - Water/Blood | 5.53 | 0.13 | 3 | N/A |
| Solvent Control - PBS/Blood | 5.23 | 0.12 | 3 | N/A |

# 4. Assay Reportable Range:

The assay reportable range has not been altered from the original clearance. Please refer to the published decision summary for K203748 for additional information.

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5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

# Sample Stability

Sample stability was evaluated using EDTA whole blood collected from two healthy donors. Blood from each donor was collected directly in both a K2-EDTA tube and a PAXgene blood RNA collection tube and transported to an external laboratory for testing. K2-EDTA samples were transported either on ice $(0 - 4^{\circ}\mathrm{C})$ or at ambient room temperature. Samples were held on ice or at room temperature and tested at timepoints ranging from 0 hours to 24 hours. PAXgene whole blood samples were tested at $1.2\mathrm{h}$ and $24.7\mathrm{h}$ post-phlebotomy as a control. Acceptance criteria for this study required SeptiScore values for each healthy donor to not differ by more than 1.0 score units among incubation time points.

Results from stability testing of EDTA whole blood samples met the study acceptance criteria since SeptiScore values did not differ by more than 1.0 score units among time points. No appreciable difference in SeptiScore values was observed between samples collected in EDTA whole blood tubes and PAXgene Blood RNA tubes over the evaluated time points. These data support SeptiScore testing within 6 hours after collection as recommended in the instructions for use.

# Sample Processing Control

A sample processing control (SPC) is present in each cartridge. The SPC consists of a predefined quantity of inactivated bacteriophage MS2 particles, which are mixed with the sample after injection prior to further processing. The SPC is taken through the entire sample processing path, ultimately generating a PCR curve and Cq value, thereby serving as a positive control for both the extraction process and for the proper general functioning of the RT-qPCR enzymology.

# 6. Detection Limit:

The limit of detection in EDTA whole blood was determined using serial dilutions of white blood cells (WBC) in platelet-depleted plasma. Twenty sample replicates of WBC at each concentration were tested with SeptiCyte RAPID and the lowest concentration at which 19/20 replicates generated a SeptiScore was reported as the limit of detection. The limit of detection in EDTA whole blood samples using the SeptiCyte RAPID was determined to be 400 cells/μL (Table 4). The limit of quantitation, the lowest WBC concentration for which 19/20 replicates generate a SeptiScore with a standard deviation of $< 1.0$ Score units, was also determined to be 400 cells/μL. The results from the limit of detection study are acceptable.

Table 4. Results for Limit of Detection

| WBC Concentration (cells/μl) | Invalid Tests (N) | Total Tests (N) | Failure Rate | Result |
| --- | --- | --- | --- | --- |
| 6000 | 0 | 2 | 0% | Above LoD |
| 4000 | 0 | 2 | 0% | Above LoD |
| 2100 | 0 | 2 | 0% | Above LoD |

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| WBC Concentration (cells/μl) | Invalid Tests (N) | Total Tests (N) | Failure Rate | Result |
| --- | --- | --- | --- | --- |
| 690 | 0 | 2 | 0% | Above LoD |
| 400 | 0 | 22 | 0% | LoD, LoQ |
| 220 | 2 | 2 | 100% | Below LoD |
| 130 | 2 | 2 | 100% | Below LoD |
| 74 | 2 | 2 | 100% | Below LoD |
| 45 | 2 | 2 | 100% | Below LoD |
| 25 | 2 | 2 | 100% | Below LoD |

7. Assay Cut-Off:

The assay cut-off has not changed from the original clearance. Please refer to the published decision summary for K203748 for additional information.

B Comparison Studies:

1. Method Comparison with Predicate Device: N/A

2. Matrix Comparison:

The matrix comparison study was conducted at two US sites and evaluated whole blood collected from a total of 60 patients in matched EDTA or PAXgene blood RNA tubes (1 EDTA blood tube and 1 PAXgene blood RNA tube). Study participants were adults suspected of non-infectious systemic inflammation (i.e., systemic inflammatory response syndrome (SIRS)) or infection-positive systemic inflammation (i.e., sepsis) by the treating physician. Samples were collected at the time of enrollment and processed immediately in duplicate on the SeptiCyte RAPID. SeptiScores of matched samples of blood collected in PAXgene blood RNA tubes and EDTA blood tubes from the same subjects were compared using linear regression analysis. For matched EDTA and PAXgene blood samples from individual patients SeptiScores were within 1.0 score units among replicates resulting in interpretation bands that were either identical or adjacent for both matrices. The method comparison study results support agreement between SeptiScores from matched patient blood samples collected in EDTA and PAXgene tubes (Table 5) and are acceptable.

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Table 5. Linear Regression Analysis SeptiScore from Matched EDTA and PAXgene Tube Samples

# 3. K2-EDTA/K3-EDTA Comparison:

Blood samples from 7 donors were drawn into both K2-EDTA and K3-EDTA blood collection tubes. The two EDTA sample types were directly compared by testing 8 K2-EDTA replicates and 7 K3-EDTA replicates from each donor on 15 different Idylla instruments using the EDTA whole blood protocol (Table 6). The mean SeptiScore for samples collected in K2-EDTA compared to samples collected in K3-EDTA for each patient did not differ by more than 0.2 score units and support equivalent performance of both sample types on the SeptiCyte RAPID test. The data from this study are acceptable.

Table 6. Results from K2-EDTA and K3-EDTA Comparison Study

| Donor | Sample Type | Mean | SD | % CV | Delta Mean |
| --- | --- | --- | --- | --- | --- |
| 1 | K2 | 5.1 | 0.20 | 3.85% | 0.2 |
| | K3 | 4.9 | 0.24 | 4.78% | |
| 2 | K2 | 3.7 | 0.25 | 6.70% | 0.1 |
| | K3 | 3.6 | 0.22 | 6.16% | |
| 3 | K2 | 3.7 | 0.12 | 3.18% | 0.0 |
| | K3 | 3.7 | 0.13 | 3.54% | |
| 4 | K2 | 3.8 | 0.22 | 5.84% | 0.1 |
| | K3 | 3.7 | 0.21 | 5.68% | |
| 5 | K2 | 3.2 | 0.19 | 5.87% | 0.2 |
| | K3 | 3.3 | 0.18 | 5.37% | |
| 6 | K2 | 4.5 | 0.21 | 4.67% | 0.2 |
| | K3 | 4.3 | 0.14 | 3.23% | |
| 7 | K2 | 5.5 | 0.16 | 2.86% | 0.1 |
| | K3 | 5.7 | 0.14 | 2.42% | |

# C Clinical Studies:

# 1. Clinical Sensitivity:

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N/A

2. Clinical Specificity:

N/A

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

N/A

## D Clinical Cut-Off:

Clinical cut-offs remain unchanged from the previous clearance. Please refer to the published decision summary for K203748 for additional details.

## E Expected Values/Reference Range:

The reference range for the SeptiCyte RAPID test were established in presumably healthy individuals in the original clearance. Please refer to the published decision summary for K203748 for additional details.

## 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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