← Product Code [GJS](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS) · K230802

# Xprecia Prime Coagulation System (K230802)

_Universal Biosensors Pty, Ltd. · GJS · Mar 15, 2024 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS/K230802

## Device Facts

- **Applicant:** Universal Biosensors Pty, Ltd.
- **Product Code:** [GJS](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS.md)
- **Decision Date:** Mar 15, 2024
- **Decision:** SESE
- **Submission Type:** Dual Track
- **Regulation:** 21 CFR 864.7750
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

The Xprecia Prime™ Coagulation System, which includes the INR Coagulation Analyzer (Meter) and PT/INR Test Strips, is for the determinational Normalized Ratio (INR) for the monitoring of oral anticoagulation therapy with Warfarin (a vitamin K antagonist) in fresh capillary whole blood from a fingerstick. The results are reported in INR as well as in seconds. It is intended to be used to monitor patients 18 years of age or older who are stable on vitamin K antagonist therapy for at least six weeks and is not intended for use in patients who are transitioning from heparin treatment to vitamin K antagonist therapy. The Xprecia Prime™ Coagulation System is an in-vitro diagnostic device intended for multi-patient use in professional healthcare settings including CLIA Waived and Point of care settings.

## Device Story

Xprecia Prime Coagulation System monitors INR in patients on Warfarin therapy. System consists of handheld analyzer and disposable PT/INR test strips. Operator performs fingerstick; applies capillary blood sample to test strip inserted in analyzer. Device uses electrochemical technology with amperometric detection of thrombin activity to measure clotting time. Analyzer displays results in INR and seconds. Used in professional healthcare settings (CLIA Waived/Point-of-care) by clinicians. Provides rapid, point-of-care monitoring to assist in managing anticoagulation therapy; benefits patients by enabling immediate clinical decision-making regarding Warfarin dosage.

## Clinical Evidence

Clinical method comparison study conducted at 4 US sites (N=401) comparing Xprecia Prime to CoaguChek® XS (r=0.97) and to laboratory reference Sysmex® CS-2500 (N=397, r=0.98). Precision studies (CLSI EP05-A3) showed CV ≤5% for repeatability and ≤6% for reproducibility. Hematocrit range 25-55% does not significantly affect results. Interference testing performed for various drugs and endogenous substances.

## Technological Characteristics

Electrochemical/amperometric sensing of thrombin activity. Uses human recombinant thromboplastin reagent. Handheld analyzer form factor. Operates 15°C to 32°C. Closed system; test strips factory-calibrated to WHO International Reference Preparation. Connectivity includes data storage (640 patient results, 300 LQC).

## Regulatory Identification

A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

## Predicate Devices

- Coaguchek XS System ([K060978](/device/K060978.md))

## Reference Devices

- Xprecia Systems PT Controls ([K151964](/device/K151964.md))
- Ci-Trol Coagulation Control III ([K771346](/device/K771346.md))
- Sysmex Automated Blood Coagulation Analyzer CS-2500 ([K172286](/device/K172286.md))
- Sysmex XN-11 ([K141681](/device/K141681.md))
- Sysmex XN 9000 ([K112605](/device/K112605.md))
- Sysmex XS-1000i ([K081610](/device/K081610.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT

## I Background Information:

A 510(k) Number
K230802

B Applicant
Universal Biosensors Pty Ltd

C Proprietary and Established Names
Xprecia Prime Coagulation System

D Regulatory Information

|  Product Code(s) |  | Regulation |   |
| --- | --- | --- | --- |
|  GJS | Class II | 21 CFR 864.7750 - Prothrombin Time Test | HE - Hematology  |

## II Submission/Device Overview:

A Purpose for Submission:
New device

B Measurand:
Prothrombin Time (PT) in International Normalized Ratio (INR) and seconds

C Type of Test:
Electrochemical technology with amperometric detection of thrombin activity

## III Intended Use/Indications for Use:

A Intended Use(s):
See Indications for Use below.

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K230802 - Page 2 of 13

## B Indication(s) for Use:

The Xprecia Prime Coagulation System, which includes the INR Coagulation Analyzer (Meter) and PT/INR Test Strips, is for the determination of International Normalized Ratio (INR) for the monitoring of oral anticoagulation therapy with Warfarin (a vitamin K antagonist) in fresh capillary whole blood from a fingerstick. The results are reported in INR as well as in seconds. It is intended to be used to monitor patients 18 years of age or older who are stable on vitamin K antagonist therapy for at least six weeks and is not intended for use in patients who are transitioning from heparin treatment to vitamin K antagonist therapy. The Xprecia Prime Coagulation System is an in-vitro diagnostic device intended for multi-patient use in professional healthcare settings including CLIA Waived and Point of care settings.

## C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

## D Special Instrument Requirements:

Xprecia Prime Coagulation Analyzer

## IV Device/System Characteristics:

### A Device Description:

The Xprecia Prime Coagulation System is intended to monitor the International Normalized Ratio (INR) of patients undergoing anticoagulation therapy with warfarin (Vitamin K antagonist). It consists of the Xprecia Prime Coagulation Analyzer (meter) and Xprecia Prime PT/INR Strips.

The Xprecia Prime system analyses a blood sample taken from the patient by fingerstick. The sample is transferred from the patient's finger to a test strip that has been inserted in the Xprecia Prime Coagulation Analyzer. The blood is mixed with a reagent contained within the test strip and the analyzer detects when clotting has occurred. The result is then displayed on the analyzer's screen in either units known as INR or in calibrated seconds.

### B Principle of Operation:

The Xprecia Prime Coagulation System uses electrochemical technology with amperometric (electric current) detection of thrombin activity to generate clot time. When a blood sample is transferred from the patient's finger to a test strip that has been inserted in the Xprecia Prime Coagulation Analyzer, thromboplastin activates the coagulation cascade which leads to the formation of thrombin. Thrombin cleaves the thrombin substrate creating an electrochemically active peptide, which generates an electrical signal. The signal is converted to an International Normalized Ratio (INR) value and the result is then displayed on the analyzer's screen in either units known as the INR or in calibrated seconds. The Xprecia Prime Coagulation System has been designed with integrated quality control functions in both the meter and the test strips. The meter performs a check of its electronic components and functions every time it is turned on. During each test, the meter looks for specific features in the strip's response that confirm the

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presence of the reagents in the strips and indicate if the strip has been unacceptably degraded due to exposure to extreme environmental conditions.

## C Instrument Description Information:

1. Instrument Name:
Xprecia Prime Coagulation Analyzer

2. Specimen Identification:
Barcode scanner or onscreen keyboard

3. Specimen Sampling and Handling:
Whole blood samples collected from a fingerstick (capillary). Specimen is applied directly to the test strip after collection.

4. Calibration:

**Xprecia System PT/INR strips:**
Each lot of Xprecia System PT/INR test strips is factory calibrated to a reference lot of human recombinant thromboplastin traceable to the World Health Organization (WHO) International Reference Preparation (IRP). An International Sensitivity Index (ISI) and Mean Normal Prothrombin Time (MNPT) values are assigned by calibration for each lot and embedded on the barcode label on the test strip vial along with the lot number and expiration date.

**Xprecia Prime Coagulation Analyzer:**
When the analyzer is first turned on, the instrument performs a series of electronics, signal, software and memory integrity checks, as well as ensuring there is sufficient battery voltage to operate the Xprecia Prime Coagulation Analyzer. Failure to pass any of these power-on tests will prevent further operation of the analyzer.

5. Quality Control:

**Internal Quality Control**
The Xprecia Prime Coagulation Analyzer has a number of integrated quality-control functions:

- Component and function check is performed every time the analyzer is turned on.
- Barcode information on the strip and vial are read by a scanner inside the Xprecia Prime analyzer. The analyzer then checks:
- the strip’s expiration date and lot information, and
- the strip’s integrity.
- During the test, the strip’s integrity is monitored. The strip’s temperature is also controlled to ensure test results are reproducible.

**External Quality Controls**
The Xprecia Prime Coagulation System is only to be used with the Xprecia Systems PT Controls (Liquid quality control (LQC) solution Level 1 and 2; K151964). External controls should be performed with every new lot, new shipment, or as required by local, state, and federal or national regulations. New operators should perform LQC prior to starting to

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perform patient testing. Use of external QC ensures that the Xprecia Prime Coagulation System is working as designed. Each Xprecia Systems PT Controls kit contains two levels of vials of plasma and diluent. The reconstitution of the LQC requires the user to pipette the diluent solution into the plasma vial and let the solution stand for at least 5 minutes. The INR target of the reconstituted LQC 1 will be around 1.0 INR and LQC 2 will be in the therapeutic range of oral anticoagulant therapy, INR of 2.0–4.5.

-Discuss carryOver: possible voltage surge from high/low results

V Substantial Equivalence Information:

A Predicate Device Name(s): Coaguchek XS System

B Predicate 510(k) Number(s): K060978

C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K230802 | K060978  |
| --- | --- | --- |
|  Device Trade Name | Xprecia Prime Coagulation System | Coaguchek XS System  |
|  General Device Characteristic Similarities |  |   |
|  Intended Use/Indications For Use | The Xprecia Prime Coagulation System, which includes the INR Coagulation Analyzer (Meter) and PT/INR Test Strips, is for the determination of International Normalized Ratio (INR) for the monitoring of oral anticoagulation therapy with Warfarin (a vitamin K antagonist) in fresh capillary whole blood from a fingerstick. The results are reported in INR as well as in seconds. It is intended to be used to monitor patients 18 years of age or older who are stable on vitamin K antagonist | The CoaguChek XS system is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The CoaguChek XS System uses fresh capillary or nonanticoagulated venous whole blood.  |

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K230802 - Page 5 of 13
|   | therapy for at least six weeks and is not intended for use in patients who are transitioning from heparin treatment to vitamin K antagonist therapy. The Xprecia Prime Coagulation System is an in-vitro diagnostic device intended for multi-patient use in professional healthcare settings including CLIA Waived and Point of care settings. |   |
| --- | --- | --- |
|  Measuring Range | 0.8 – 8.0 INR | Same  |
|  Operating Principle/Technology | Electrochemical technology with amperometric (electric current) detection of thrombin activity | Same  |
|  Test Strip Reagents | Human recombinant thromboplastin | Same  |
|  Test Strip Use Time | 10 minutes | Same  |
|  Traceability | WHO International Reference Preparation | Same  |
|  Calibration Traceability | Each lot of test strips is calibrated to a reference lot traceable to the WHO International Reference Preparation | Same  |
|  Operating temperature | 15°C to 32°C
80% maximum (non-condensing) Relative Humidity | Same  |
|  Quality Control | Internal and External | Same  |
|  On-Board Quality Control | On-board fully integrated quality controls which use electrochemical signals to detect test strip integrity | Same  |
|  Reference Range | INR: 0.9 to 1.1 | Same  |

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|  Hematocrit Range | 25–55% | Same  |
| --- | --- | --- |
|  General Device Characteristic Differences |  |   |
|  Specimen Type | Capillary whole blood | Capillary whole blood and non-anticoagulated whole blood  |
|  External Liquid Quality Control | Liquid quality control in the normal and therapeutic range | No external liquid quality control  |
|  QC Lock-Out | Available through programming | Not Available  |
|  Calibration | Lot specific programmed into strip lot barcode | Lot specific code chip selected by end user  |
|  Sample Volume | 8 μL | 10 μL  |
|  Memory Capacity | 640 patient results
300 LQC results
300 system messages | 300 test results with date & time  |
|  Test Strip Stability | 24 months | 21 months  |
|  Testing Strip Sample Application | Top side only | Top and side application  |
|  Heparin | Warfarin patient test results are unaffected by heparin concentrations up to 3U/mL | Warfarin patient test results are unaffected by heparin concentrations up to 0.8U/mL  |

VI Standards/Guidance Documents Referenced:

- CLSI EP05-A3 – Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition
- CLSI EP07-A2 – Interference Testing in Clinical Chemistry; Approved Guideline – Third Edition
- CLSI EP09c – Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline – Third Edition
- CLSI EP14-A3 – Evaluation of Commutability of Processed Samples; Approved Guideline -Third Edition
- CLSI GP41 – Collection of Diagnostic Venous Blood Specimens, 7th edition
- CLSI H47-A2 – One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.
- CLSI POCT14-ED2 – Point-of-care Coagulation Testing and Anticoagulation Monitoring, Second edition

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VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Intermediate Precision

A single site intermediate precision study was performed by two trained operators over the course of 20 non-consecutive days with two runs per day and two replicates per run. Each operator used three Xprecia Prime PT/INR strips lots, six Xprecia Prime Coagulation Analyzers, and three levels of quality control material (K151964 – Xprecia System PT Control Level 1 and 2 and K771346 Ci-Trol Coagulation Control III). The 20-day precision of the Xprecia Prime Coagulation System has been demonstrated to be within the acceptance criteria at each control level and for each cartridge lot. The results of this study demonstrated acceptable within-laboratory precision for all three control levels.

|  Intermediate Precision - INR  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   | Repeatability |   | Between Run |   | Between Day |   | Within Lot |   | Between Lot |   | Within Lab  |   |
|  QC | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV  |
|  1 | 240 | 1.18 | 0.03 | 2.2 | 0.02 | 1.6 | 0.00 | 0.0 | 0.03 | 2.7 | 0.03 | 2.8 | 0.05 | 3.9  |
|  2 | 240 | 2.81 | 0.03 | 1.0 | 0.01 | 0.5 | 0.00 | 0.0 | 0.03 | 1.1 | 0.01 | 0.4 | 0.03 | 1.2  |
|  3 | 240 | 6.52 | 0.07 | 1.1 | 0.11 | 1.6 | 0.04 | 0.6 | 0.13 | 2.0 | 0.13 | 2.0 | 0.18 | 2.8  |
|  Intermediate Precision - Seconds  |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   | Repeatability |   | Between Run |   | Between Day |   | Within Lot |   | Between Lot |   | Within Lab  |   |
|  QC | N | Mean | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV | SD | %CV  |
|  1 | 240 | 13.95 | 0.09 | 0.6 | 0.11 | 0.8 | 0.00 | 0.0 | 0.14 | 1.0 | 0.16 | 1.2 | 0.22 | 1.5  |
|  2 | 240 | 33.76 | 0.23 | 0.7 | 0.22 | 0.6 | 0.00 | 0.0 | 0.32 | 0.9 | 0.23 | 0.7 | 0.39 | 1.2  |
|  3 | 240 | 78.28 | 0.79 | 1.0 | 1.23 | 1.6 | 0.55 | 0.7 | 1.56 | 2.0 | 1.50 | 1.9 | 2.17 | 2.8  |

Repeatability

The repeatability data was collected from the method comparison study performed at four CLIA-waived sites. Two capillary samples (two fingersticks) collected from each subject were tested by the same untrained operator using the same meter and the same strip lot, resulting into a total of 399 paired tests (132 normal subjects and 267 warfarin subjects). The study was performed by 11 untrained operators using three Xprecia Prime PT/INR test strip lots and 12 Xprecia Prime Coagulation Analyzers. Data analysis was carried out by site, all sites combined and by clinically relevant ranges. The mean, pooled standard deviation, %CV and their respective 95% confidence intervals (CI) for INR were calculated for each subject level. The table below summarizes this data for all sites combined. The results of the study for capillary samples demonstrate the Xprecia Prime Coagulation System repeatability is acceptable.

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|  Capillary Whole Blood Repeatability Summary Prothrombin Time (INR)  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  INR | N | Mean | SD (95% CI) | % CV (95% CI)  |
|  < 1.9 | 350 | 1.17 | 0.05 (0.05, 0.6) | 4.2 (4.3, 5.1)  |
|  2–3.59 | 234 | 2.71 | 0.14 (0.12, 0.16) | 5.2 (4.4, 5.9)  |
|  3.6–4.59 | 116 | 4.07 | 0.17 (0.14, 0.21) | 4.2 (3.4, 5.2)  |
|  4.6–8.0 | 98 | 5.87 | 0.34 (0.28, 0.42) | 5.8 (4.6, 7.2)  |
|  Capillary Whole Blood Repeatability Summary Prothrombin Time (seconds)  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  PT Range | N | Mean | SD (95% CI) | % CV (95% CI)  |
|  9.6–24.3 | 360 | 14.32 | 0.44 (0.40, 0.49) | 3.1 (2.8, 3.4)  |
|  24.4–56.8 | 346 | 38.73 | 1.96 (1.77, 2.18) | 5.1 (4.6, 5.6)  |
|  56.9–96.0 | 92 | 71.39 | 4.14 (3.40, 5.14) | 5.8 (4.8, 7.2)  |

## Reproducibility

The reproducibility of the Xprecia Prime Coagulation System was performed at three external CLIA-waived sites. Testing at each site was performed over five non-consecutive days in the hands of two untrained operators at each site (n=6 operators). Each operator tested two levels of quality control materials (K151964 – Xprecia System PT Control Level 1 and 2) twice per day with a minimum of two hours between each run. Each quality control level was tested in triplicate (2 operators x 1 run/operator x 3 replicates x 5 days = 30 observations for each site per QC level). All results passed the established acceptance criteria.

|  All Sites Combined (INR)  |   |   |   |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  QC Level | N | Mean | Repeatability |   | Between Run |   | Between Day |   | Between Operator |   | Between Site |   | Overall Reproducibility  |
|   |   |   |  SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD  |
|  1 | 90 | 1.19 | 0.02 | 2.0 | 0.02 | 1.3 | 0.02 | 1.8 | 0.04 | 3.0 | 0.02 | 1.8 | 0.04  |
|  2 | 90 | 2.62 | 0.03 | 1.3 | 0.00 | 0.0 | 0.00 | 0.0 | 0.03 | 1.3 | 0.03 | 1.0 | 0.04  |
|  All Sites Combined (Seconds) |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  QC Level | N | Mean | Repeatability |   | Between Run |   | Between Day |   | Between Operator |   | Between Site |   | Overall Reproducibility  |   |
|   |   |   |  SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD  |   |
|  1 | 90 | 14.26 | 0.14 | 1.0 | 0.24 | 1.7 | 0.00 | 0.0 | 0.28 | 1.9 | 0.37 | 2.6 | 0.46  |   |
|  2 | 90 | 31.45 | 0.23 | 0.7 | 0.11 | 0.3 | 0.14 | 0.4 | 0.29 | 0.9 | 0.30 | 1.0 | 0.42  |   |

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2. Linearity:
Not applicable.

3. Analytical Specificity/Interference:
The interference performance of the Xprecia Prime Coagulation System was evaluated in the presence of potentially interfering endogenous or exogenous substances. The effect of each substance at each INR level (normal and therapeutic) was evaluated by comparing the performance of a test sample spiked to a high concentration of the substance and a control sample spiked with an equal volume of solvent. For an identified interferent, a dose-response was performed to determine the degree of interference as a function of the substance concentration. The common exogenous and endogenous interfering substances and their interference results are listed below and showed no significant interference up to the indicated concentration for all samples tested.

|  Substance | Maximum Test Concentration with no Interference  |
| --- | --- |
|  Acetaminophen | 20 mg/L  |
|  Amoxicillin | 5.4 mg/dL  |
|  Atorvastatin | 96 mg/dL  |
|  Cefitriaxone | 84 mg/dL  |
|  Clexane | 3 IU/mL  |
|  Conjugated Bilirubin | 40 mg/dL  |
|  Dexamethasone | 12 mg/L  |
|  Ethinyl Estradiol | 0.288 mg/L  |
|  Fondaparinux Sodium | 5 mg/L  |
|  Hemoglobin | 1000 mg/dL  |
|  Heparin | 3300 U/L  |
|  Ibuprofen | 219 mg/L  |
|  Lactate Dehydrogenase | 250 U/L  |
|  Levonorgestrel | 1.8 mg/L  |
|  Potassium Chloride | 5 mmol/L  |
|  Prasugrel | 72 mg/L  |
|  Prednisolone | 3 mg/L  |
|  Sodium Salicylate | 0.0695 g/dL  |
|  Testosterone | 480 mg/L  |
|  Ticagrelor | 108 mg/L  |
|  Triglycerides | 1500 mg/dL  |
|  Unconjugated Bilirubin | 40 mg/dL  |
|  Uric Acid | 24 mg/dL  |

For the identified INR test interferents Apixaban, Calcium Dobesilate, Dabigatran, Daptomycin, Edoxaban, L-Ascorbic Acid, Protamine Sulfate, and Rivaroxaban, a dose-response experiment was performed.

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|  Substance | Maximum Test Concentration with no Interference  |
| --- | --- |
|  Apixaban | 0.08 mg/L  |
|  Calcium Dobesilate | 30 mg/L  |
|  Dabigatran | 0.005 mg/L  |
|  Daptomycin | 552 mg/L  |
|  Edoxaban | 0.06 mg/L  |
|  L-Ascorbic Acid | 3 mg/dL  |
|  Protamine Sulfate | 7.5 mg/L  |
|  Rivaroxaban | 0.06 mg/L  |

## Hematocrit

The hematocrit range was evaluated for the Xprecia Prime Coagulation System using capillary samples from 371 patients across four intended use sites in the Method Comparison study. Capillary samples for INR determinations using the Xprecia Prime Coagulation System, citrated plasma samples for the central laboratory INR using the Sysmex Automated Blood Coagulation Analyzer CS-2500 (K172286), and the measured EDTA venous whole blood hematocrit for each test subject were used in the analysis. Hematocrit was determined using Sysmex XN-11 (K141681), Sysmex XN 9000 (K112605), or Sysmex XS-1000i (K081610) analyzers. Data analysis demonstrated that hematocrit range between 25–55% does not significantly affect test results.

## Factor Sensitivity

The factor sensitivity for factors FII, FV, FVII and FX was determined using samples prepared by combining normal plasma, red blood cells, and factor-deficient plasma with various percent (%) factor activity ranging from 0%–100%. Each factor was tested at 11 factor activity levels with three strip lots and eight replicates per lot on 24 Xprecia Prime Coagulation Analyzers. The mean clot time calculated for the normal plasma sample (sample without pooled factor deficient plasma) is the average clot time in 24 Xprecia Prime Coagulation Analyzers (8 analyzers x 3 strip lots). Based on CLSI H47: One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition, factor sensitivity was calculated based on the factor level at which the PT rises above the upper limit of the established reference interval. The sensitivity of the Xprecia Prime Coagulation System has been characterized to Factor II–50%, Factor V–60%, Factor VII–50%, and Factor X–60%.

## 4. Assay Reportable Range:

The assay reportable range of the Xprecia Prime Coagulation System was established through method comparison studies. The reportable range for INR is 0.8–8.0 and for PT in seconds is 9.6–96.0.

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

### Traceability

The traceability of the prothrombin time test on the Xprecia Prime Coagulation System has been established against a reference lot of human recombinant thromboplastin traceable to the World Health Organization (WHO) International Reference Preparation (IRP). Xprecia System PT/INR test strips lots manufactured by Universal Biosensors have been calibrated

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using the rTF/16 (WHO 5th International Standard Thromboplastin, Human, Recombinant, Plain).

## Shelf-life Stability for Xprecia Prime PT/INR Strips

A real-time shelf-life stability study was conducted using three lots of Xprecia Prime PT/INR Strip lots at 5°C with ambient relative humidity (RH) and 30°C with 75% RH storage conditions. Three levels of quality control material (K151964–Xprecia System PT Control Level 1 and 2 and K771346–Ci-Trol Coagulation Control III), unaltered whole blood samples to reflect normal INR range and warfarin treated samples to reflect therapeutic INR range were tested at time zero and ten different test events: 4.5, 6, 7, 9, 12, 15, 18, 21, 24, and 27 months. The stability results for the Xprecia Prime PT/INR Strip lots support a shelf-life of 24 months at 5°C–30°C with &lt; 75% RH.

## Open Vial Stability

An open vial stability study was conducted using one lot of Xprecia Prime PT/INR Strips. The vials were opened 25 times over a 3-month period at both 5°C with ambient relative humidity (40 ± 20% RH) and 30°C with 75% RH storage conditions. Three levels of quality control material (K151964–Xprecia System PT Control Level 1 and 2 and K771346–Ci-Trol Coagulation Control III), unaltered whole blood samples to reflect normal INR range and warfarin treated samples to reflect therapeutic INR range were tested at time zero and three different test events: 7, 15, and 24 months. The stability results for the Xprecia Prime PT/INR Strip lots support an open vial storage claim of 20 months at 5°C–30°C with &lt; 75% RH.

## In-Use/Out of Vial Stability

An in-use stability study was conducted using one lot of Xprecia Prime PT/INR Strip lots at 5°C with ambient relative humidity (RH) and 30°C with 75% RH storage conditions. Three levels of quality control material (K151964–Xprecia System PT Control Level 1 and 2 and K771346–Ci-Trol Coagulation Control III), unaltered whole blood samples to reflect normal INR range and warfarin treated samples to reflect therapeutic INR range were tested at time zero and ten different test events: 4.5, 6, 7, 9, 12, 15, 18, 21, 24, and 27 months. Strips were assessed by exposing strips out of the vial for the following times at each test event: 0, 2.5, 5, 7.5, 10, and 12.5 minutes out of the vial. The stability results for the Xprecia Prime PT/INR Strip lots support an in-use or out of vial storage claim of 10 minutes 5°C–30°C with &lt; 75% RH for the entire 24 months of the shelf-life.

## Transport Stability

All the Xprecia Prime PT/INR Test Strips vials tested for real-time shelf-life, open vial, and in-use studies were subjected to the described shipping simulation prior to placing them into their respective storage conditions (5°C / 30°C) to ensure that the stability studies performed would reflect real world performance of the product. Three lots of strip vials were subjected to Pressure Decay Testing and then placed into an environmental chamber for the shipping simulation. The shipping trial consists of a transport simulation followed by a 3-day freeze/thaw cycle to simulate temperature stress as they are transported. Strips have met all acceptance criteria for closed vial, out of vial, and open vial studies, after being subjected to an AR4 temperature profile followed by three freeze-thaw cycles, to represent worst-case transport conditions. Therefore, the transport simulation requirements have been met and the product is appropriate for ambient shipping/ transport.

K230802 - Page 11 of 13

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6. Detection Limit:

Not applicable.

7. Assay Cut-Off:

Not applicable.

8. Accuracy (Instrument):

Refer to Method Comparison below.

9. Carry-Over:

Not applicable.

## B Comparison Studies:

1. Method Comparison:

The method comparison study was performed at four U.S. point-of-care clinical sites with CLIA Waiver certificates. Group 1 consisted of 320 patients on warfarin therapy for at least six weeks prior to enrollment and Group 2 consisted of 130 healthy, normal subjects. The study was conducted with three lots of Xprecia Prime PT/INR strips and 12 Xprecia Prime Coagulation Analyzers by 11 untrained operators. Each patient had two fingerstick samples collected by the untrained operator for testing on the Xprecia Prime Coagulation System and the predicate, Coaguchek XS (K060978). The Xprecia Prime Coagulation System is substantially equivalent to the CoaguChek XS System.

|  Method Comparison Results for Xprecia Prime Coagulation System vs. Roche Coaguchek  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Analyte | N | Xprecia Range | CoaguChek Range | Slope (95% CI) | Intercept (95% CI) | (r)  |
|  INR | 401 | 0.8–7.7 | 0.9–7.9 | 0.96 (0.939, 0.985) | -0.01 (-0.083, 0.065) | 0.97  |
|  PT (seconds) | 401 | 9.7–91.5 | 10.5–95.3 | 0.962 (0.940, 0.985) | -1.131 (-0.998, 0.736) | 0.97  |

In addition, a venipuncture was performed for PT and INR determinations on the laboratory method, Sysmex Automated Blood Coagulation Analyzer CS-2500 (K172286). Capillary results from the Xprecia Prime Coagulation System demonstrates acceptable comparison to venous whole blood collected in 3.2% citrated tubes on the Sysmex Automated Blood Coagulation Analyzer CS-2500.

K230802 - Page 12 of 13

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|  Method Comparison Results for Xprecia Prime Coagulation System (FS) vs. Sysmex CS-2500 (venous)  |   |   |   |   |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Result | N | Xprecia Range | Sysmex Range | Slope (95% CI) | Intercept (95% CI) | (r)  |
|  INR | 397 | 0.8–7.7 | 0.9–7.2 | 1.1 (1.073, 1.117) | -0.12 (-0.183, -0.056) | 0.98  |
|  PT (seconds) | 397 | 9.7–95.5 | 9.7–72.6 | 1.307 (1.28, 1.33) | -2.341 (-3.12, -1.56) | 0.98  |

## C Clinical Studies:

1. Clinical Sensitivity:

Not applicable.

2. Clinical Specificity:

Not applicable.

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

Not applicable.

## D Clinical Cut-Off:

Not applicable.

## E Expected Values/Reference Range:

Normal range testing was conducted on 120 healthy subjects who were not on oral anticoagulant therapy from the Method Comparison study. Samples were tested on three lots of Xprecia Prime PT/INR strips. Results demonstrated a normal range of 0.9 to 1.1 INR with more than 95% of all results falling within that range.

## 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.

K230802 - Page 13 of 13

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS/K230802](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS/K230802)

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