(258 days)
No
The description focuses on automation of standard laboratory procedures and optical density measurements, with no mention of AI or ML algorithms for data analysis or interpretation beyond standard calculations.
No.
This device is for in vitro diagnostic use, performing hemostasis testing by detecting changes in optical density in human plasma samples. It is not intended to treat or prevent disease in humans.
Yes
The QNext device is intended for "in vitro diagnostic use in clinical laboratories to perform hemostasis testing" by detecting changes in optical density. The DG-PT reagent is used with QNext for "quantitative determination of Prothrombin Time on human plasma samples" to evaluate coagulation pathways and monitor therapy, all of which are diagnostic functions.
No
The device description clearly outlines a physical instrument (QNext) that performs automated laboratory procedures involving sample and reagent management, optical measurement, and result calculation. It also includes a reagent (DG-PT). This is not a software-only device.
Yes, both the QNext instrument and the DG-PT reagent are explicitly stated to be IVDs (In Vitro Diagnostics).
Here's why:
- QNext: The "Intended Use / Indications for Use" section clearly states: "The QNext is a fully-automated, random-access instrument, intended for in vitro diagnostic use in clinical laboratories..."
- DG-PT: The "Intended Use / Indications for Use" section also states: "For in vitro diagnostic use."
The entire document describes devices and reagents used to perform tests on human plasma samples outside of the body (in vitro) to diagnose or monitor medical conditions related to blood coagulation. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
QNext:
The QNext is a fully-automated, random-access instrument, intended for in vitro diagnostic use in clinical laboratories to perform hemostasis testing by detecting the changes in optical density.
DG-PT:
DG-PT is a thromboplastin reagent for the quantitative determination of Prothrombin Time on human plasma samples collected in 3.2% sodium citrate.
The product is used for the evaluation of the extrinsic and common coagulation pathways in seconds and for the monitoring Oral Anticoagulant Therapy with warfarin in International Normalized Ratio (INR). For use with QNext.
For clinical professional laboratory and prescription use only.
For in vitro diagnostic use.
The performance of this device has not been established in neonate and pediatric patient populations.
Product codes (comma separated list FDA assigned to the subject device)
JPA, GJS
Device Description
QNext is designed to automatically perform all stages of the procedures associated to hemostasis tests allowing the operator to:
- Absorb the workload involved in running hemostasis laboratory tests profiles, optimizing the execution of these profiles in the shortest time possible, and ensuring the maximum possible precision and accuracy in the results.
- Increase the reliability of the analytical process, eliminating any possible errors in the identification ● and treatment of samples and products and in the revision and transcription of the results.
- Reduce the risk of Operator contamination by minimizing interaction between the Operator and ● samples and products during the analytical process.
To perform the operations for which it has been designed, QNext automatically follows the steps listed below:
- Sample management: loading, positive identification, dilution (if required) and dispensation into cuvettes.
- Reagent management: loading, positive identification, cooling, stirring, aspiration and dispensation into cuvettes.
- Cuvette management: loading, transport, incubation during the reactions and management of used cuvettes.
- Management of test requests. ●
- Execution of test procedures.
- Result management: optical measurement of the reactions, algorithm calculation of analytical parameters from reaction curves, validation of results, traceability, bi-directional transmission of requests and results to the LIS.
- Management of disposable components. ●
The data analyzed can be stored, displayed and printed. Additionally, the analyzer allows conducting integrated functions, such as the analysis of urgent samples or the Quality Control module.
DG-PT consists of a glass vial containing lyophilized thromboplastin (tissue factor and phospholipids) from rabbit brain tissue, buffer, calcium ions and preservative. The closure system includes a stopper and a screw cap.
DG-PT reagent is used to perform PT tests for:
- the evaluation of the extrinsic and common coagulation pathways.
- The monitoring Oral Anticoagulant Therapy with warfarin.
The assay is based on the activation of the extrinsic coagulation pathway by the addition of the reagent to the plasma sample. The thromboplastin interacts with FVII and calcium ions activating a series of specific enzymes that comprise the extrinsic and common pathways of the coagulation cascade ultimately leading to the formation of a fibrin clot. The QNext reader measures the light change produced during the reaction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The performance of this device has not been established in neonate and pediatric patient populations.
Intended User / Care Setting
For clinical professional laboratory and prescription use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Testing:
- Study Type: Precision studies designed in accordance with CLSI EP05-A3.
- Repeatability and Within-laboratory precision study.
- Reproducibility study.
- Sample Size:
- Repeatability and Within-laboratory: Seven patient derived samples.
- Reproducibility: Seven patient derived samples.
- Key Results:
- Repeatability and Within-Laboratory Precision:
- Prothrombin time (seconds): Repeatability %CV ranged from 1.4 to 2.1; Within-laboratory %CV ranged from 2.4 to 5.7.
- Prothrombin time (INR): Repeatability %CV ranged from 1.6 to 2.4; Within-laboratory %CV ranged from 2.2 to 8.2.
- Reproducibility:
- Prothrombin time (seconds): Repeatability %CV ranged from 1.6 to 3.1; Reproducibility %CV ranged from 3.1 to 6.0.
- Prothrombin time (INR): Repeatability %CV ranged from 1.9 to 3.7; Reproducibility %CV ranged from 5.5 to 9.2.
- Repeatability and Within-Laboratory Precision:
Reference Interval Study:
- Study Type: Designed in accordance with CLSI C28-A3.
- Sample Size: 243 reference samples.
- Key Results: Reference Intervals for DG-PT:
- Prothrombin time (seconds): 12.1 to 16.1
- Prothrombin time (INR): 0.83 to 1.17
Sensitivity Study:
- Study Type: Factor sensitivity study designed in accordance with CLSI H47-A2.
- Key Results: Sensitivity of Prothrombin Time to factor deficiency (II, V, VII and X) plasmas:
- FII: 29 IU/dL
- FV: 45 IU/dL
- FVII: 44 IU/dL
- FX: 43 IU/dL
Specificity Study:
- Study Type: Designed in accordance with CLSI EP7-A2 and EP7-A3.
- Sample Size: Two sample levels (pooled normal samples and pooled abnormal samples).
- Key Results: Maximum concentration of interfering substances for DG-PT Prothrombin Time:
- Hemoglobin (g/L): 10.0 (Normal and Abnormal levels)
- Conjugated bilirubin (mg/dL): 43.3 (Normal and Abnormal levels)
- Triglycerides (mg/dL): 3000 (Normal and Abnormal levels)
- Citrate (%): 0.6 (Normal and Abnormal levels)
- UFH (IU/mL): Normal level: 1.1, Abnormal level: 0.7
- LMWH (IU/mL): Normal level: 2.3, Abnormal level: 1.6
- Interference of argatroban, dabigatran and rivaroxaban was observed at all concentrations tested.
Method Comparison Study:
- Study Type: Designed in accordance with CLSI EP09-A3.
- Sample Size: Minimum of 100 patient derived samples per test at each of three clinical sites.
- Key Results: Regression results comparing QNext with DG-PT and ACL Top 700 with HemosIL PT Fibrinogen HS Plus:
- Results from the two US sites (n=360):
- PT (seconds): Slope 0.913 (95% CI: 0.893-0.938), Intercept 1.118 (95% CI: 0.706-1.477), r=0.983
- PT (INR): Slope 1.034 (95% CI: 1.010-1.060), Intercept -0.024 (95% CI: -0.054-0.009), r=0.980
- Results from the ex-US site (n=271):
- PT (seconds): Slope 0.985 (95% CI: 0.962-1.003), Intercept 0.272 (95% CI: -0.078-0.716), r=0.988
- PT (INR): Slope 1.000 (95% CI: 0.978-1.022), Intercept -0.070 (95% CI: -0.099--0.042), r=0.990
- Results from the two US sites (n=360):
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (IU/dL) for Factor Deficiency:
- FII: 29
- FV: 45
- FVII: 44
- FX: 43
Method Comparison Study Regression Results:
- PT (seconds): Slope, Intercept, r
- PT (INR): Slope, Intercept, r
Precision Study:
- %CV (Coefficient of Variation) for Repeatability, Within-laboratory, and Reproducibility
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ACL Top 700 (K160276), HemosIL PT Fibrinogen HS Plus (K060931)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 21, 2019
Diagnostic Grifols, S.A. Joaquin Tamparillas Technical Director at Diagnostic Industrial Group of Grifols S.A. Passeig Fluvial, 24 Parets del Valles, Barcelona 08150 Spain
Re: K183390
Trade/Device Name: ONext and DG-PT Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA, GJS Dated: July 20, 2019 Received: July 22, 2019
Dear Joaquin Tamparillas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Takeesha Taylor-Bell Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K183390
Device Name QNext and DG-PT
Indications for Use (Describe)
QNext:
The QNext is a fully-automated, random-access instrument, intended for in vitro diagnostic use in clinical laboratories to perform hemostasis testing by detecting the changes in optical density.
DG-PT:
DG-PT is a thromboplastin reagent for the quantitative determination of Prothrombin Time on human plasma samples collected in 3.2% sodium citrate.
The product is used for the evaluation of the extrinsic and common coagulation pathways in seconds and for the monitoring Oral Anticoagulant Therapy with warfarin in International Normalized Ratio (INR).
For use with ONext.
For clinical professional laboratory and prescription use only.
For in vitro diagnostic use.
The performance of this device has not been established in neonate and pediatric patient populations.
| Type of Use (Select one or both, as applicable): |
|---|
| Research Use Only (Per 21 CFR 201.122 - Sponsor-Investigator) |
| For-Profit Commercial Use (Per 21 CFR 201.128 - Sponsor-Investigator) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510 (k) Summary
This 510(k) Summary of Safety and Effectiveness is submitted in accordance with the requirements of 21 CFR 807.92 and follows the FDA guidance 'The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]', issued July 28, 2014.
5.1 Submitter Information
| Company Information: | Diagnostic Grifols S.A.
Passeig Fluvial, 24, Parets del Valles
Barcelona, 08150, Spain |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joaquín Alberto Tamparillas, GH Diagnostic Techical Director
Phone: (34) 670 924 632
Fax: (34) 935 731 132
Email: joaquin.alberto@grifols.com |
| Date Prepared: | June 13, 2019 |
5.2 Devices
| Trade Names: | QNext and DG-PT. |
|---|---|
| Common Names: | Multipurpose System for In Vitro Coagulation and Prothrombin Time. |
| Regulation Number: | 864.5425 and 864.7750 |
| Regulatory Class: | Class II |
| Product Codes: | JPA and GJS |
5.3 Predicate Devices
| Trade Names: | ACL Top 700 (K160276) and HemosIL PT Fibrinogen HS Plus
(K060931). |
|--------------------|-----------------------------------------------------------------------|
| Common Names: | Instrument Coagulation Automated and Prothrombin Time. |
| Regulation Number: | 864.5400 and 864.7750 |
| Regulatory Class: | Class II |
| Product Codes: | GKP and GJS |
4
5.4 Device Description
QNext is designed to automatically perform all stages of the procedures associated to hemostasis tests allowing the operator to:
- Absorb the workload involved in running hemostasis laboratory tests profiles, optimizing the execution of these profiles in the shortest time possible, and ensuring the maximum possible precision and accuracy in the results.
- Increase the reliability of the analytical process, eliminating any possible errors in the identification ● and treatment of samples and products and in the revision and transcription of the results.
- Reduce the risk of Operator contamination by minimizing interaction between the Operator and ● samples and products during the analytical process.
To perform the operations for which it has been designed, QNext automatically follows the steps listed below:
- Sample management: loading, positive identification, dilution (if required) and dispensation into cuvettes.
- Reagent management: loading, positive identification, cooling, stirring, aspiration and dispensation into cuvettes.
- Cuvette management: loading, transport, incubation during the reactions and management of used cuvettes.
- Management of test requests. ●
- Execution of test procedures.
- Result management: optical measurement of the reactions, algorithm calculation of analytical parameters from reaction curves, validation of results, traceability, bi-directional transmission of requests and results to the LIS.
- Management of disposable components. ●
The data analyzed can be stored, displayed and printed. Additionally, the analyzer allows conducting integrated functions, such as the analysis of urgent samples or the Quality Control module.
DG-PT consists of a glass vial containing lyophilized thromboplastin (tissue factor and phospholipids) from rabbit brain tissue, buffer, calcium ions and preservative. The closure system includes a stopper and a screw сар.
DG-PT reagent is used to perform PT tests for:
- the evaluation of the extrinsic and common coagulation pathways.
- The monitoring Oral Anticoagulant Therapy with warfarin.
The assay is based on the activation of the extrinsic coagulation pathway by the addition of the reagent to the plasma sample. The thromboplastin interacts with FVII and calcium ions activating a series of specific enzymes that comprise the extrinsic and common pathways of the coagulation cascade ultimately leading to the formation of a fibrin clot. The QNext reader measures the light change produced during the reaction.
5
ર્સ્ડ Indications for Use
QNext:
The QNext is a fully-automated, random-access instrument, intended for in vitro diagnostic use in clinical laboratories to perform hemostasis testing by detecting the changes in optical density.
DG-PT:
DG-PT is a thromboplastin reagent for the quantitative determination of Prothrombin Time on human plasma samples collected in 3.2% sodium citrate.
The product is used for the evaluation of the extrinsic and common coagulation pathways in seconds and for the monitoring Oral Anticoagulant Therapy with warfarin in International Normalized Ratio (INR). For use with QNext.
For clinical professional laboratory and prescription use only.
For in vitro diagnostic use.
The performance of this device has not been established in neonate and pediatric patient populations.
ર્સ્વ Comparison to Predicate Devices
5.6.1 Similarities
| Item | Subject Device
QNext | Predicate Device
ACL Top 700 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The QNext is a fully-automated, random-access instrument, intended for in vitro diagnostic use in clinical laboratories to perform hemostasis testing by detecting the changes in optical density. | The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurements and calculated parameters. |
| Specimen type | 3.2% Citrated Plasma | Same |
| Methodology | Cloting tests.
Note: QNext doesn't include the chromogenic and turbidimetric methods in the intended use. This indication will be presented in a future 510(k) submission. | - Cloting tests.
- Chromogenic
- Turbidimetric |
| | | |
| | | |
| | | |
| Quality Control | Automated QC | Same |
| Modes of
Operation | Automated and continuous | Same |
| Cuvettes
loading | Continuous | Same |
6
| Item | Subject Device
QNext | Predicate Device
ACL Top 700 |
|--------------------------------------------|-------------------------|---------------------------------|
| Samples and
Reagents bar
code reader | Yes | Same |
| Sample pre-
dilution | Yes | Same |
| Sample liquid
level detection | Yes | Same |
| Reagent
container | Original container | Same |
| Item | Subject Device | Predicate Device | |
|---|---|---|---|
| DG-PT | HemosIL PT-Fibrinogen HS PLUS | ||
| Intended Use | DG-PT is a thromboplastin reagent for | ||
| the quantitative determination of | |||
| Prothrombin Time on human plasma | |||
| samples collected in 3.2% sodium citrate. | |||
| The product is used for the evaluation of | |||
| the extrinsic and common coagulation | |||
| pathways in seconds and for the | |||
| monitoring Oral Anticoagulant Therapy | |||
| with warfarin in International | |||
| Normalized Ratio (INR). For use with | |||
| QNext. For clinical professional | |||
| laboratory and prescription use only. For | |||
| in vitro diagnostic use. The performance | |||
| of this device has not been established in | |||
| neonate and pediatric patient populations. | |||
| Note: DG-PT doesn't include the | |||
| determination of fibrinogen in the | |||
| intended use. This indication will be | |||
| presented in a future 510(k) submission. | A very high sensitivity calcium | ||
| thromboplastin for simultaneous | |||
| determinations of Prothrombin Time (PT) | |||
| and Fibrinogen (Fib), for the evaluation of | |||
| the extrinsic coagulation pathway and | |||
| monitoring Oral Anticoagulant Therapy in | |||
| human citrated plasma on the IL | |||
| Coagulation Systems. | |||
| Principle of the | |||
| test | The assay is based on the activation of | ||
| the extrinsic coagulation pathway by the | |||
| addition of a PT reagent to plasma. | |||
| Tissue thromboplastin interacts with | |||
| FVII and calcium ions activating a series | |||
| of specific enzymes that comprise the | |||
| extrinsic and common pathways of the | |||
| coagulation cascade, ultimately leading | |||
| to the formation of a fibrin clot. | |||
| The PT is the time (in seconds) from the | |||
| mixing of the plasma with a | |||
| thromboplastin reagent until a fibrin clot | |||
| is detected | Same |
7
| Vial content | Lyophilized | Same |
|---|---|---|
| Thromboplastin origin | Rabbit brain | Same |
| Reagent preparation required | Yes. Reconstitution | Same |
| Device Class | 2 | Same |
| Classification Product Code | GJS; CFR 864.7750 | Same |
| Common Name | Test, Time, Prothrombin | Same |
| Measurement | Quantitative | Same |
| Detection principle | Photometric | Same |
| Sample Type | Citrated plasma | Same |
| Reporting units | PT: seconds and INR | Same |
5.6.2 Differences
| Item | Subject Device
QNext | Predicate Device
ACL Top 700 |
|-----------------|------------------------------------------------------|----------------------------------------------------|
| Regulatory | JPA, Class II
864.5425 Multipurpose System For In | GKP, Class II
864.5400 Instrument, coagulation, |
| Classification | Vitro Coagulation | automated |
| Samples on- | 60 | 120 |
| board | | |
| Reagents on- | 30 | 60 |
| board | | |
| Wavelength | 405 nm and/or 620 nm | 405 nm and/or 671 nm |
| Item | Subject Device DG-PT | Predicate Device PT-Fibrinogen HS
PLUS |
| Package content | 6 vials of Thromboplastin | 5 vials of Thromboplastin |
| | | 5 vials of Buffer. |
| Quality control | 2 levels | 3 levels |
| In-use | Stability after reconstitution, stored at 2- | Stability after reconstitution, stored at 2-8 |
| Stability | 8 ℃ in the original vial: 10 days. | ℃ in the original vial: 5 days. |
| | On-board stability: 5 days. | On-board stability: 36 hours. |
8
5.7 Performance Testing
5.7.1 Precision
Precision studies were designed in accordance with CLSI EP05-A3.
Repeatability and Within-laboratory precision study was performed in a single site involving seven patient derived samples with tree lots of reagent during twenty days with two runs per day and two replicates per run.
Reproducibility study was performed in three sites assaying seven patient derived samples on two instruments during five days with two runs per day and three replicates per run.
The following results were demonstrated:
| Sample | Mean Value | N | Repeatability | Within-laboratory | |||
|---|---|---|---|---|---|---|---|
| Test | %CV | Upper One-sided 95% Limit | %CV | Upper One-sided 95% Limit | |||
| Prothrombin time | |||||||
| (seconds) | 1 | 10.65 | 240 | 1.4 | 1.6 | 2.4 | 3.3 |
| 2 | 17.02 | 238 | 1.6 | 1.8 | 3.5 | 5.1 | |
| 3 | 27.68 | 240 | 1.7 | 1.9 | 3.6 | 6.3 | |
| 4 | 29.40 | 240 | 1.9 | 2.1 | 3.4 | 5.9 | |
| 5 | 37.48 | 240 | 1.8 | 2.0 | 3.9 | 8.6 | |
| 6 | 53.82 | 240 | 1.7 | 1.9 | 4.4 | 10.4 | |
| 7 | 85.08 | 240 | 2.1 | 2.3 | 5.7 | 15.5 | |
| Prothrombin time | |||||||
| (INR) | 1 | 0.729 | 240 | 1.6 | 1.8 | 2.2 | 2.4 |
| 2 | 1.250 | 238 | 1.7 | 1.9 | 3.9 | 5.6 | |
| 3 | 2.186 | 240 | 2.0 | 2.2 | 4.4 | 8.3 | |
| 4 | 2.343 | 240 | 2.2 | 2.5 | 4.5 | 9.8 | |
| 5 | 3.098 | 240 | 2.0 | 2.3 | 5.3 | 13.4 | |
| 6 | 4.698 | 240 | 2.0 | 2.3 | 6.2 | 17.4 | |
| 7 | 7.959 | 240 | 2.4 | 2.7 | 8.2 | 26.2 |
Table 1. Summary of Repeatability and Within-Laboratory Precision Study Results
CV=Coefficient of Variation
9
| Test | Sample | Mean
Value | N | Repeatability | | Reproducibility | |
|-------------------------------|--------|---------------|-----|---------------|------------------------------|-----------------|------------------------------|
| | | | | %CV | Upper One-sided
95% Limit | %CV | Upper One-sided
95% Limit |
| Prothrombin time
(seconds) | 1 | 10.70 | 180 | 2.2 | 2.5 | 3.1 | 4.0 |
| | 2 | 16.78 | 180 | 1.6 | 1.8 | 3.1 | 4.2 |
| | 3 | 27.08 | 180 | 1.9 | 2.1 | 4.2 | 6.1 |
| | 4 | 29.06 | 180 | 1.7 | 1.9 | 4 | 6.1 |
| | 5 | 36.87 | 180 | 1.7 | 1.9 | 4 | 8.3 |
| | 6 | 52.27 | 180 | 1.7 | 1.9 | 5.7 | 9.1 |
| | 7 | 80.65 | 180 | 3.1 | 3.4 | 6 | 13.1 |
| Prothrombin time
(INR) | 1 | 0.712 | 180 | 2.6 | 2.9 | 5.5 | 11.3 |
| | 2 | 1.212 | 180 | 1.9 | 2.1 | 5.5 | 10.9 |
| | 3 | 2.133 | 180 | 2.2 | 2.5 | 6.9 | 13.9 |
| | 4 | 2.318 | 180 | 2.1 | 2.3 | 6.9 | 14.4 |
| | 5 | 3.070 | 180 | 2 | 2.2 | 6.7 | 17.3 |
| | 6 | 4.637 | 180 | 2 | 2.3 | 8.7 | 18.3 |
| | 7 | 7.735 | 180 | 3.7 | 4.1 | 9.2 | 24.7 |
Table 2. Summary of Reproducibility Study Results
CV=Coefficient of Variation
5.7.2 Reference Interval Study
The reference interval study was designed in accordance with CLSI C28-A3.
The study was performed at two sites using one lot of reagents. A total of 243 reference samples were tested with each reagent.
The Reference Intervals of DG-PT in seconds and INR are shown in the following tables:
| Test(units) | Reference Interval |
|---|---|
| Prothrombin time (seconds) | 12.1 to 16.1 |
| Prothrombin time (INR) | 0.83 to 1.17 |
10
5.7.3. Sensitivity Study
Factor sensitivity study was designed in accordance with CLSI H47-A2. DG-PT Prothrombin Time determination was made for factors II, V, VII and X in a set of samples spanning from 100% to