(694 days)
The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
The technological characteristics are the same for all STA R Max® Family and STA Compact Max® family analyzers, including STA R Max 30 and STA Compact Max 30, which is based on two measurement principles: Chronometric measurement principle and Photometry measurement principle.
The analyzers use Diagnostica Stago reagents in addition to open adaptation of other available reagents. The instrument performs multiple test methodologies in random access, as selected by the user. These include clotting time or clot-based tests (i.e. chronometric measures) and photometric assays on plasma samples.
Changes include a redesigned PSR module to replace the Hamilton syringes and Valcor pump of the fluidic circuit and the addition of the HIL module for estimating interferences (Hemoglobin, Icterus, Lipemia).
The provided text describes the performance data for laboratory instruments (STA R Max 3® and STA Compact Max 3®) used for in vitro coagulation studies, not for an AI/ML-driven medical device for which the acceptance criteria would typically focus on diagnostic accuracy metrics like sensitivity, specificity, or AUC as evaluated by expert readers.
Therefore, the requested information regarding acceptance criteria and study design elements specific to AI/ML devices (e.g., sample size for test set with provenance, number of experts for ground truth, adjudication methods, MRMC study, standalone performance, training set details) is largely not applicable to the content of this FDA 510(k) summary, as it pertains to traditional in vitro diagnostic instruments and their analytical performance.
The document focuses on:
- Method Comparison: Comparing the new devices' measurements against predicate devices using standard regression analysis (Passing & Bablok, Deming) and correlation coefficients (Spearman's r).
- Precision/Reproducibility: Assessing the variability of measurements within a run, between runs, between days, and between instruments/sites using standard deviation (SD) and coefficient of variation (CV%).
- Interference Testing (HIL): Testing the impact of hemoglobin, icterus, and lipemia on results.
Below is a reinterpretation of the request based on the provided document, focusing on the analytical performance acceptance criteria and study details for these in vitro diagnostic instruments.
Acceptance Criteria and Device Performance for Coagulation Analyzers (STA R Max 3® and STA Compact Max 3®)
The provided document details the analytical performance of the STA R Max 3® and STA Compact Max 3® coagulation analyzers, demonstrating their substantial equivalence to predicate devices (STA R Max® and STA Compact Max®). The acceptance criteria are implicit in the presented method comparison and precision data, aiming to show comparable performance to the legally marketed predicates.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an in vitro diagnostic (IVD) device (a laboratory instrument) and not an AI/ML-driven diagnostic algorithm, the "acceptance criteria" are defined differently than for radiological AI tools. Here, they relate to statistical comparability (method comparison) and measurement reproducibility (precision). The specific quantitative "acceptance criteria" values (e.g., maximum allowable bias, maximum CV%) are not explicitly stated as discrete numbers in the document's summary tables, but rather are implied by the presentation of regression analysis results (slopes, intercepts, correlation coefficients) and precision statistics (SD, CV%). The expectation is that these values demonstrate strong agreement with the predicate devices and sufficient reproducibility for clinical use.
Performance Data Summary (Representing "Met Acceptance Criteria")
| Test/Characteristic | Acceptance Criteria (Implicit from comparability with predicate and clinical utility based on CLSI guidelines) | Reported Device Performance (Summary) |
|---|---|---|
| Method Comparison STA R Max 3® vs. STA R Max® | Slope near 1.00, Intercept near 0, High Spearman's r (close to 1.00) indicating strong correlation and minimal bias. | STA - Neoplastine CI Plus: Slope: 0.98, Intercept: 0.20 sec, rSpearman: 0.997STA - PTTA: Slope: 1.00, Intercept: -0.32, rSpearman: 0.997STA - Fibrinogen: Slope: 1.01, Intercept: 4.26 mg/dL, rSpearman: 0.996STA - Stachrom® ATIII: Slope: 1.03, Intercept: -1.03%, rSpearman: 0.980STA - Liatest D-Di: Slope: 1.02, Intercept: -0.02 µg/mL, rSpearman: 0.998 |
| Method Comparison STA Compact Max 3® vs. STA Compact Max® | Slope near 1.00, Intercept near 0, High Spearman's r (close to 1.00) indicating strong correlation and minimal bias. | STA - Neoplastine CI Plus: Slope: 0.99, Intercept: 0.20 sec, rSpearman: 0.994STA - PTTA: Slope: 0.99, Intercept: 0.06 sec, rSpearman: 0.996STA - Fibrinogen: Slope: 1.01, Intercept: 4.94 mg/dL, rSpearman: 0.995STA - Stachrom® ATIII: Slope: 1.00, Intercept: 0.00%, rSpearman: 0.981STA - Liatest D-Di: Slope: 1.02, Intercept: -0.01 µg/mL, rSpearman: 0.997 |
| Method Comparison HIL vs. Reference (cobas® 8000/spectrophotometer) | Strong correlation coefficients (r or rSpearman) and acceptable slopes/intercepts. | Hemolysis: Slope: 1.12 (with outliers), 1.11 (without outliers), rSpearman: 0.954 (with outliers), 0.948 (without outliers)Icterus: Slope: 0.99, Intercept: 0.26 mg/dL, rSpearman: 0.956Lipemia: Linear Regression (vs. Spectrophotometer) r = 0.91; (vs. cobas® 8000) r = 0.97. |
| Precision/Reproducibility | Low CV% for within-run, between-run, between-day, between-instrument/site, and total precision. Specific acceptable CV% ranges are not explicitly stated, but the values provided are generally low indicating high precision. The summary states: "The acceptance criteria were met for all samples in the studies." | Detailed tables are provided for 5 different assays (PT, APTT, FIB, AT, D-Dimer) across up to 5 samples per assay, showing SD and CV% for various precision components. For example, for STA R Max 3, combined total precision CV% ranges from 1.1% (PT) to 10.6% (D-Dimer). For STA Compact Max 3, combined total precision CV% ranges from 1.5% (PT) to 9.2% (AT). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Method Comparison: For each assay and each instrument (STA R Max 3 and STA Compact Max 3), samples were "selected in order to cover the entire measuring range." The exact number of samples (patients) for each method comparison is not explicitly stated as a single number but would be consistent with CLSI EP09c recommendations. For example, the precision data tables indicate 80 replicates per sample per analyzer for single-site precision (e.g., 240 N for "All instruments combined" across 3 analyzers), and 90 N per sample for multi-site precision (across 3 sites) for a total of 270 replicates per sample per parameter across all sites and analyzers.
- HIL Method Comparison: Not explicitly stated, but samples were "spiked plasma" to create various concentrations across designated indices.
- Data Provenance: The method comparison studies were conducted at "three external sites." Precision studies were conducted at "one external site" (single-site precision) and "three external sites" (multi-site precision). The country of origin is not specified but is implicitly within a region where FDA regulatory standards are applicable.
- Retrospective or Prospective: Not explicitly stated, but given the nature of instrument validation studies, they are typically purpose-generated (prospective) for the study rather than utilizing historical patient data. Spiked plasma for HIL analysis indicates prospective sample preparation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable in the context of this IVD device. For an in vitro diagnostic instrument like a coagulation analyzer, "ground truth" is established by the analytical method itself, often by comparison to a well-established reference method or the predicate device that has established analytical accuracy. There are no human "experts" establishing a diagnostic ground truth from images or clinical data in the way an AI/ML diagnostic device would require. The "truth" is the measured concentration or clotting time.
4. Adjudication Method for the Test Set
- Not applicable. As there are no human interpretations or classifications that require adjudication for this type of IVD instrument validation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This study pertains to the analytical performance of a laboratory instrument, not an AI-assisted diagnostic tool that aids human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in the context of an IVD analyzer. The "standalone" performance here refers to the analytical performance of the instrument itself when measuring samples. The entire document describes this "standalone" performance through method comparison and precision studies. The device measures various coagulation parameters directly from plasma samples.
7. The Type of Ground Truth Used
- Analytical Ground Truth: The ground truth for this device's performance is established by:
- Comparison to a Legally Marketed Predicate Device: The performance of the new devices (STA R Max 3 and STA Compact Max 3) is compared directly to the established performance of their previous versions (STA R Max and STA Compact Max) using patient samples. This is the primary method for demonstrating substantial equivalence.
- Reference Methods (for HIL): For the HIL interferences, the device's readings were compared against "reference methods, cobas® 8000 modular analyzer (Hemolysis, Icterus, and Lipemia) and spectrophotometer (Lipemia)."
- Theoretical/Expected Values (for HIL spiking): For HIL, "spiked plasmas were prepared" to provide known concentrations of interfering substances, and the results "matched the index determination for the subject devices and the theoretical index."
- Repeated Measurements (for Precision): For precision, repeated measurements demonstrating low variability around a mean value for different samples serve as the internal "ground truth" for reproducibility.
8. The Sample Size for the Training Set
- Not applicable for this type of conventional IVD instrument. These are not AI/ML devices that undergo "training" on a data set. Their "training" or calibration involves standard laboratory procedures and calibration materials according to manufacturer protocols.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no "training set" in the AI/ML sense for this traditional laboratory instrument.
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June 7, 2023
Diagnostica Stago SAS % Anthony Dennis Director of US Market Access Diagnostica Stago Inc. 5 Century Drive Parsippany, New Jersey 07054
Re: K212183
Trade/Device Name: STA R Max 3, STA Compact Max 3 Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System For In Vitro Coagulation Studies Regulatory Class: Class II Product Code: JPA Dated: September 30, 2022 Received: October 5, 2022
Dear Anthony Dennis:
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.
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
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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 medical devices and radiation-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,
Image /page/1/Picture/5 description: The image contains the text "Min Wu-S" in a large, sans-serif font. The text is black and appears to be the main subject of the image. In the background, there is a faint, light blue watermark of the letters "FDA".
Min Wu, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212183
Device Name STA R Max 3® and STA Compact Max 3®
Indications for Use (Describe)
The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 FDA guidance 'The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]', issued July 28, 2014.
1. Submitter
Diagnostica Stago, Inc. 5 Century Drive Parsippany, NJ 07054 Primary Contact: Anthony Dennis, RAC, CBA (ASQ), MBA Director, US Market Access Phone: 1 - (973) - 775-1200 x4162
On Behalf of: Diagnostica Stago SAS
Date: 12 July 2021; Revised 05 June 2023
2. Device
| Device Name: | STA R Max 3® / STA Compact Max 3® |
|---|---|
| Common Name: | Automated Coagulation Analyzer |
| Classification Name: | System, Multipurpose for In Vitro Coagulation Studies |
| Regulatory Class: | Class II |
| Panel: | Hematology |
| Product Code: | JPA |
| Regulation Number | 21 CFR 864.5424 |
Note that as a successor of earlier instruments in their respective families, reference to "STA R Max 3" or "Compact Max 3" is in reference to these families of analyzers with the aforementioned improvements. As such, elements in this submission, such as the intended use below are not version specific.
Intended Use:
The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
3. Predicate Device
| Device Name: | STA R Max® (K151867) / STA Compact Max® (K130090) |
|---|---|
| Common Name: | Automated Coagulation Analyzer |
| Classification Name: | System, Multipurpose for In Vitro Coagulation Studies |
| Regulatory Class: | Class II |
| Panel: | Hematology |
| Product Code: | JPA |
| Regulation Number | 21 CFR 864.5424 |
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The predicate has not been subject to design-related recalls for any of the applications associated with this premarket notification. No reference devices were used in this submission.
4. Device Description / Test Principle
4.1.1. STA R Max 30 and STA Compact Max 30 Test Principle
The technological characteristics are the same for all STA R Max® Family and STA Compact Max® family analyzers, including STA R Max 30 and STA Compact Max 30, which is based on two measurement principles.
Chronometric measurement principle:
The principle consists of measuring the variation of the metal ball oscillation amplitude through inductive sensors. The ball has a pendula movement due to an alternating electromagnetic field generated by two independent drive coils and two curved rail tracks in the bottom of the cuvettes. The oscillation amplitude is constant when the viscosity of the reaction volume in the cuvette remains constant.
The oscillation amplitude decreases when the viscosity of the reaction volume in the cuvette increases. The amplitude of the oscillation ball is analyzed to determine coagulation time in the cuvette.
. Photometry measurement principle:
The principles consists of measuring the variation of absorbance (optical density, O.D.) of monochromatic light (405 nm or 540 nm) passing through a cuvette as an enzymatic or immunological reaction takes place.
The variation of absorbance is analyzed to determine enzymatic activity or quantification (by immune aggregation) of factors related to coagulation.
4.1.2. STA R Max 3® Device Description
Diagnostica Stago's STA R Max 30 analyzers are modified versions of the STA R Max® analyzer, originally cleared for marketing by the FDA under K151867 as an in-vitro diagnostic device.
The STA-R family of analyzers is composed of:
- STAR® cleared in 1998: K983460 ●
- . STA-R Evolution® cleared in 2008: K082675
- . STA-R Evolution® Expert Series cleared in 2009: K093001
- . STA R Max® cleared in 2015: K151867
All these analyzers are fully automatic systems designed to perform tests on human plasmas and to study coagulation parameters.
Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis and reporting of results are performed automatically. A central processing unit controls the instrument such as, management of patient results, quality control, system supervision, support for instrument maintenance and workload optimization.
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The analyzers use Diagnostica Stago reagents in addition to open adaptation of other available reagents. The instrument performs multiple test methodologies in random access, as selected by the user. These include clotting time or clot-based tests (i.e. chronometric measures) and photometric assays on plasma samples.
All the information on the analyzers, intended use and description, come from the instrument manual/labeling, which is the same for all STA R Max® family of analyzers (VOL_013, Labeling).
4.1.3. STA Compact Max 3® Device Description
Diagnostica Stago's STA Compact Max®3 analyzers are modified versions of the STA Compact Max® analyzer, originally cleared for marketing by the FDA under K130090 as an in-vitro diagnostic device.
The STA Compact® family of analyzers is composed of:
- STA Compact cleared in 1996: K961579, K093167 ●
- STA Compact with Cap piercing Options cleared in 1996, with an add to file •
- . STA Compact Max cleared in 2013: K130090
All these analyzers are fully automatic systems designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Once samples and test reagents are loaded onto the instrument, sample handling, reagent delivery, analysis and reporting of results are performed automatically. A central processing unit controls instrument functions, including management of patient's results, quality control, scheduling of instrument maintenance and workload organization.
The analyzers use Diagnostica Stago reagents in addition to open adaptation of other available reagents. The instrument performs multiple test methodologies in random access, as selected by the user. These include clotting time or clot-based tests (i.e. chronometric measures) and photometric assays on plasma samples.
All the information on the analyzers, intended use and description, come from the instrument manual/labeling, which is the same for all Compact Max® family of analyzers (VOL_013, Labeling).
4.1.4. Change to Control of Fluidic System and Addition of HIL Module
To facilitate in user maintenance and manufacturing process, the PSR module has been designed to replace the Hamilton syringes and Valcor pump of the fluidic circuit on all Diagnostica Stago analyzers.
The HIL module is a detection module developed to estimate interferences (Hemoglobin, Icterus, Lipemia) which may affect chromogenic and immune-turbidimetric tests. The analysis is performed before delivery in the cuvette and provides results of an index of interferences concentration to the biologist (display of the data on screen monitor). The plasma sample is not altered during HIL evaluation.
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4.1.5. Reagent Applications in this 510(k) Notification
Five assays were used to demonstrate substantial equivalence, i.e. STA® - Neoplastine CI Plus (10), STA® - PTTA (5), STA® - Fibrinogen (5), STA® - Stachrom® ATIII (6) and STA® -Liatest DDi. These assays cover the three measuring principles, i.e. chronometric, chromogenic and immuno-turbidimetric, and the different reaction set-ups regarding sample dilution (undiluted or diluted) and reagents (use of only the third needle for reagent, or use of both second and third needles for reagent). The table below describes the configuration used for each assay.
| Assay | MeasuringPrinciple | Sample DilutionSet-Up | Reagent Set-up | Priorregulatoryclearance (K#) |
|---|---|---|---|---|
| STA® - Neoplastine CI Plus (10) | Chronometric | Undiluted | Only the thirdneedle | K922040 |
| STA® - PTTA (5) | Chronometric | Undiluted | Second and thirdneedles for reagent | K861190 |
| STA® - Fibrinogen (5) | Chronometric | Diluted | Only the thirdneedle | K840211 |
| STA® - Stachrom ATIII (6) | Chromogenic | Diluted | Second and thirdneedles for reagent | K832592 |
| STA® - Liatest DDi | Immuno-turbidimetric | Undiluted | Second and thirdneedles for reagent | K162227 |
| Table 1: Description of the test configurations for the assays used for validation | ||
|---|---|---|
The intended Environment of Use is a clinical central/hospital laboratory.
5. Substantial Equivalence
| Attributes or Characteristics | Predicate DeviceSTA R Max (K151867) | Candidate DeviceSTA R Max 3 |
|---|---|---|
| Regulatory Classification | JPA, Class IISystem, Multipurpose for in vitrocoagulation studies | Same |
| Indications for use | The STA R Max is a fully automaticclinical instrument designed to performtests on human plasmas, the results ofwhich aid in the diagnosis of coagulationabnormalities or in monitoringanticoagulant therapy. | The STA R Max 3® and STA CompactMax 3® are fully automatic clinicalanalyzers designed to be used byprofessional laboratory personnel and toperform tests on human venous plasmas(in 3.2% trisodium citrate tubes) theresults of which aid in the diagnosis ofcoagulation abnormalities or inmonitoring anticoagulant therapy. |
| Anatomical Sites | In vitro testing of human plasma | Same |
| Sample Matrix | Human plasma3.2% sodium citrate | Same |
| Where Used: hospital, home,ambulance, etc. | Hospital Laboratory or other Health CareLaboratory. | Same |
| Attributes or Characteristics | Predicate DeviceSTA R Max (K151867) | Candidate DeviceSTA R Max 3 |
| Measurement Principle | Chronometric method (clotting time):mechanical measurement of theoscillation of the metal ball placed in thecuvettePhotometric method: light absorptiontechnique provided by a filtered lightsource(405nm, 540nm). | Same |
| Cap Piercing | Available as an option | Available as an option with HIL pre-analytical module.New needle connector, new cappiercing foot and evolution of the locksystem. |
| Control of FluidicSystem | Valcor pump and Hamilton syringes | PSR (Pipettor Simple Resolution)in replacement of Valcor pumpand Hamilton syringes |
| Needles | One sample, Two reagent | Same |
| Operating EnvironmentTemperature | 59° - 89.5°F | Same |
| User/Patient Data Input | Touchscreen, keyboard, and/or barcodescanner | Same |
| Specimen Processing | Automatic pipetting and dilution | Same |
| Random Access | Yes | Same |
| Liquid Level Sensing | Yes | Same |
| Stat Testing | Yes | Same |
| Parameters | Prothrombin Time (PT) seconds, PT INR,Activated Partial Thromboplastin Time(APTT), Fibrinogen, Thrombin Time(TT), Reptilase, Extrinsic pathwayfactors, Intrinsic pathway factors, Anti-Xa(UFH, LMWH), Antithrombin (AT)activity, D-Dimer, Protein C activity,Protein S activity, Free Protein S antigen,Lupus anticoagulant, vWF antigen,Plasminogen | Same |
| Attributes or Characteristics | Predicate DeviceSTA R Max (K151867) | Candidate DeviceSTA R Max 3 |
| HIL Pre-analyticalModule | Not available | Avalable as an option: Semi quantitativedetermination of hemolysis, icterus andLipemia (HIL) in patient plasma, reportedas indices according to CLSI C56-Adocument. No predefined alerts are set-upin the analyzer; users are responsible forsetting thresholds according to practices.Any evaluation of indices as potentialinterfering substances are left to the endusers. |
| Data Storage Capacity | 160 GB | 320 GB |
| Software | Windows XP | Windows 10 |
| Cybersecurity | In 2019, Stago implemented a new PC-Gen with a new Windows 10 OperatingSystem (OS), updated software, and theintroduction of cybersecurity via internaldocumentation agreed with FDA duringQ181507. | Introduced with user account management(reinforced passwords, restrictive access,log history...), firewall, antivirus, anddata encryption. |
Table 2: STA R Max 3 Similarities Between Candidate and Predicate Devices
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Table 3: STA R Max 3 Differences Between Candidate and Predicate Devices
Table 4: STA Compact Max 3 Similarities Between Candidate and Predicate Devices
| Attributes or Characteristics | Predicate DeviceSTA Compact Max (K130090) | Candidate DeviceSTA Compact Max 3 |
|---|---|---|
| Regulatory Classification | JPA, Class IISystem, Multipurpose for in vitrocoagulation studies | Same |
| Indications for use | The STA Compact Max is a fullyautomatic clinical analyzer designed toperform tests on human plasmas, theresults of which aid in the diagnosis~ ofcoagulation abnormalities or inmonitoring anticoagulant therapy. | The STA R Max 3® and STA CompactMax 3® are fully automatic clinicalanalyzers designed to be used byprofessional laboratory personnel and toperform tests on human venous plasmas(in 3.2% trisodium citrate tubes) theresults of which aid in the diagnosis ofcoagulation abnormalities or inmonitoring anticoagulant therapy. |
| Anatomical Sites | In vitro testing of human plasma | Same |
| Sample Matrix | Human plasma3.2% sodium citrate | Same |
| Where Used: hospital, home,ambulance, etc. | Hospital Laboratory or other Health CareLaboratory. | Same |
| Measurement Principle | Chronometric method (clotting time):mechanical measurement of theoscillation of the metal ball placed in thecuvettePhotometric method: light absorptiontechnique provided by a filtered lightsource | Same |
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Image /page/9/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in red, with a stylized graphic above it. The graphic appears to be an abstract shape in red and brown, possibly representing a drop or a leaf.
| Attributes or Characteristics | Predicate Device STA Compact Max (K130090) | Candidate Device STA Compact Max 3 |
|---|---|---|
| (405nm, 540nm). | ||
| Cap Piercing | Available as an option | Available as an option with HIL pre- analytical module.New needle connector, new cap piercing foot and evolution of the lock system. |
| Control of Fluidic System | Valcor pump and Hamilton syringes | PSR (Pipettor Simple Resolution) in replacement of Valcor pump and Hamilton syringes |
| Needles | One sample, Two reagent | One sample, Two reagent |
| Operating Environment Temperature | 59° - 89.5°F | Same |
| User/Patient Data Input | Touchscreen, keyboard, and/or barcode scanner | Same |
| Specimen Processing | Automatic pipetting and dilution | Same |
| Random Access | Yes | Same |
| Liquid Level Sensing | Yes | Same |
| Stat Testing | Yes | Same |
| Parameters | Prothrombin Time (PT) seconds, PT INR, Activated Partial Thromboplastin Time (APTT), Fibrinogen, Thrombin Time (TT), Reptilase, Extrinsic pathway factors, Intrinsic pathway factors, Anti-Xa (UFH, LMWH), Antithrombin (AT) activity, D-Dimer, Protein C activity, Protein S activity, Free Protein S antigen, Lupus anticoagulant, vWF antigen, Plasminogen | Same |
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Image /page/10/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in red, with a stylized graphic above it. The graphic appears to be two curved shapes, one red and one brown, arranged in a circular fashion. The overall design is simple and modern.
| Table 5: STA Compact Max 3 Differences Between Candidate and Predicate Devices | |||||
|---|---|---|---|---|---|
| -- | -- | -- | -------------------------------------------------------------------------------- | -- | -- |
| Attributes or Characteristics | Predicate DeviceSTA Compact Max (K130090) | Candidate DeviceSTA Compact Max 3 |
|---|---|---|
| HIL Pre-analyticalModule | Not available | Avalable as an option: Semi quantitativedetermination of hemolysis, icterus andLipemia (HIL) in patient plasma, reportedas indices according to CLSI C56-Adocument. No predefined alerts are set-upin the analyzer; users are responsible forsetting thresholds according to practices.Any evaluation of indices as potentialinterfering substances are left to the endusers. |
| Data Storage Capacity | 160 GB | 320 GB |
| Software | Windows XP | Windows 10 |
| Cybersecurity | In 2019, Stago implemented a new PC-Gen with a new Windows 10 OperatingSystem (OS), updated software, and theintroduction of cybersecurity via internaldocumentation agreed with FDA duringQ181507. | Introduced with user account management(reinforced passwords, restrictive access,log history...), firewall, antivirus, anddata encryption. |
Standards/Guidance Documents Referenced:
- . CLSI EP09c, Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline
- CLSI EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition.
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Method Comparison: STA R Max 3
Method comparison studies designed according to CLSI EP09c recommendations were conducted at three external sites.
Samples were selected in order to cover the entire measuring range of each assay and measured on both the predicate device (STA R Max) and subject device (STA R Max 3). Results were compared by either Passing & Bablok or Deming regression analysis based on the distribution. The following summary shows the results of this analysis without outliers across the analytical measuring range and targeted medical decision points per parameter.
STA R Max 3: STA - Neoplastine CI Plus Passing-Bablok Regression Numerical Results
| Site | Slope(95% CI) | Intercept(95% CI) | rSpearman(95% CI) |
|---|---|---|---|
| All Sites | 0.98(0.97 to0.98) | 0.20 sec(0.06 to 0.30) | 0.997(0.996 to0.998) |
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Image /page/11/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a red, serif font. Above the word is an abstract graphic element that resembles a stylized, incomplete circle or crescent shape. The top portion of the shape is red, while the bottom portion is brown. The overall design is simple and modern.
| Site | Slope(95% CI) | Intercept(95% CI) | rSpearman(95% CI) |
|---|---|---|---|
| All Sites | 1.00(0.98 to1.01) | -0.32(-1.02 to 0.32) | 0.997 (0.996to 0.998) |
STA R Max 3: STA - PTTA Passing-Bablok Regression Numerical Results
STA R Max 3: STA - Fibrinogen Passing-Bablok Regression Numerical Results
| Site | Slope(95% CI) | Intercept(95% CI) | rSpearman (95% CI) |
|---|---|---|---|
| All Sites | 1.01(0.99 to 1.03) | 4.26 mg/dL(-1.83 ; 10.14) | 0.996 (0.995 to 0.997) |
STA R Max 3: STA - Stachrom ATIII Passing-Bablok Regression Numerical Results
| Site | Slope(95% CI) | Intercept(95% CI) | rSpearman(95% CI) |
|---|---|---|---|
| All Sites | 1.03(1.00 to 1.07) | -1.03%(-3.15 ; 2.00) | 0.980(0.972 to0.985) |
STA R Max 3: STA - Liatest D-DI Passing-Bablok Regression Numerical Results
| Site | Slope(95% CI) | Intercept(95% CI) | rSpearman(95% CI) |
|---|---|---|---|
| All Sites | 1.02(1.01 to 1.03) | -0.02 µg/mL(-0.04 ; 0,01) | 0.998(0.998 to0.999) |
Method Comparison: STA Compact Max 3
Method comparison studies designed according to CLSI EP09c recommendations were conducted at three external sites.
Samples were selected in order to cover the entire measuring range of each assay and measured on both the predicate device (STA Compact Max) and subject device (STA Compact Max 3). Results were compared by either Passing & Bablok or Deming regression analysis based on the distribution. The following summary shows the results of this analysis without outliers across the analytical measuring range and targeted medical decision points per parameter.
STA Compact Max 3: STA - Neoplastine CI Plus Passing-Bablok Regression Numerical Results
| Site | Slope(95% CI) | Intercept(95% CI) | r Spearman(95% CI) |
|---|---|---|---|
| All Sites | 0.99 (0.98 to 1.00) | 0.20 sec (0.05 to 0.35) | 0.994 (0.993 to 0.996) |
STA Compact Max 3: STA - PTTA Passing-Bablok Regression Numerical Results
| Site | Slope (95% CI) | Intercept (95% CI) | rSpearman (95% CI) |
|---|---|---|---|
| All Sites | 0.99 (0.97 to 1.00) | 0.06 sec (-0.56 to 0.81) | 0.996 (0.995 to 0.997) |
STA Compact Max 3: STA - Fibrinogen Passing-Bablok Regression Numerical Results
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Image /page/12/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in red, with a stylized graphic above it. The graphic appears to be an abstract representation of a drop or a leaf, with the top portion in red and the bottom portion in brown. The overall design is simple and modern.
| Site | Slope(95% CI) | Intercept(95% CI) | rSpearman(95% CI) |
|---|---|---|---|
| All Sites | 1.01 (1.00to 1.03) | 4.94 mg/dL(0.67 to 11.25) | 0.995 (0.993to 0.996) |
STA Compact Max 3: STA - Stachrom ATIII Passing-Bablok Regression Numerical Results
| Site | Slope(95% CI) | Intercept(95% CI) | r Spearman (95% CI) |
|---|---|---|---|
| All Sites | 1.00 (1.00 to 1.03) | 0.00% (-1.63 to 0.00) | 0.981 (0.975 to 0.986) |
STA Compact Max 3: STA - Liatest D-DI Passing-Bablok Regression Numerical Results
| Site | Slope(95% CI) | Intercept(95% CI) | r Spearman(95% CI) |
|---|---|---|---|
| All Sites | 1.02 (1.01 to 1.03) | -0.01 μg/mL (-0.04 to 0.01) | 0.997 (0.996 to 0.998) |
Method Comparison: HIL
The candidate instrument STA R Max 3 was compared to the reference methods, cobas® 8000 modular analyzer (Hemolyis, Icterus, and Lipemia) and spectrophotometer (Lipemia) in a method comparison study performed in accordance with CLSI EP09c guideline at one site.
| Hemolysis Passing-Bablok Regression | |||
|---|---|---|---|
| Analysis | Slope(95% CI) | Intercept(95% CI) | RSpearman(95% CI) |
| HemolysisWithOutliers | 1.12 (1.08to 1.19) | -0.03 g/L (-0.06to -0.01) | 0.954(0.916 to0.975) |
| HemolysisWithoutOutliers | 1.11 (1.07to 1.14) | -0.03 g/L (-0.05to -0.01) | 0.948(0.904 to0.972) |
Hemolysis Passing-Rablok Regression
Icterus Passing-Bablok Regression
| Analysis | Slope(95% CI) | Intercept(95% CI) | RSpearman(95% CI) |
|---|---|---|---|
| Icterus | 0.99 (0.96to 1.07) | 0.26 mg/dL(0.02 to 0.48) | 0.956(0.920 to0.976) |
Lipemia Linear Regression versus Spectrophotometer
| Analysis | Regression coefficient (r) |
|---|---|
| Lipemia | 0.91 ; P<0.001 |
Lipemia Linear Regression versus cobas® 8000
| Analysis | Regression coefficient (r) |
|---|---|
| Lipemia | 0.97 ; P<0.001 |
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Image /page/13/Picture/0 description: The image shows the logo for Stago. The logo features the word "Stago" in a red, serif font. Above the word is an abstract graphic element that resembles a stylized leaf or flame in two colors: red and brown. The red portion is larger and positioned above the brown portion, creating a sense of depth and movement.
Precision/Reproducibility
Single-site precision testing was performed in accordance with CLSI EP05-A3 over 20 days at one external site. Three samples per parameter were tested across the applicable measuring ranges, with two runs per day and two replicates per day. Each run was at least two hours apart. The acceptance criteria were met for all samples in the studies.
| STA-Neoplastine CI Plus (sec) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analyzer | Sample | N | Mean sec | Within-Run | Between-Run(= Between-Operator) | Between-Day | Between-Instrument | Within-Site | |||||
| SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | ||||
| 403 | 1 | 80 | 15.8 | 0.139 | 0.9 | 0.104 | 0.7 | 0.036 | 0.2 | 0.177 | 1.1 | ||
| 403 | 2 | 80 | 39.7 | 0.243 | 0.6 | 0.417 | 1.1 | 0.000 | 0.0 | 0.483 | 1.2 | ||
| 403 | 3 | 80 | 61.1 | 0.415 | 0.7 | 0.606 | 1.0 | 0.326 | 0.5 | 0.804 | 1.3 | ||
| 403 | 4 | 80 | 14.0 | 0.092 | 0.7 | 0.034 | 0.2 | 0.044 | 0.3 | 0.108 | 0.8 | ||
| 403 | 5 | 80 | 24.0 | 0.186 | 0.8 | 0.176 | 0.7 | 0.000 | 0.0 | 0.256 | 1.1 | ||
| 404 | 1 | 80 | 15.7 | 0.101 | 0.6 | 0.145 | 0.9 | 0.000 | 0.0 | 0.177 | 1.1 | ||
| 404 | 2 | 80 | 39.5 | 0.188 | 0.5 | 0.309 | 0.8 | 0.170 | 0.4 | 0.400 | 1.0 | ||
| 404 | 3 | 80 | 60.7 | 0.376 | 0.6 | 0.691 | 1.1 | 0.271 | 0.4 | 0.832 | 1.4 | ||
| 404 | 4 | 80 | 13.8 | 0.096 | 0.7 | 0.158 | 1.1 | 0.000 | 0.0 | 0.185 | 1.3 | ||
| 404 | 5 | 80 | 23.7 | 0.165 | 0.7 | 0.294 | 1.2 | 0.000 | 0.0 | 0.337 | 1.4 | ||
| 426 | 1 | 80 | 15.7 | 0.088 | 0.6 | 0.140 | 0.9 | 0.027 | 0.2 | 0.168 | 1.1 | ||
| 426 | 2 | 80 | 39.5 | 0.306 | 0.8 | 0.326 | 0.8 | 0.181 | 0.5 | 0.483 | 1.2 | ||
| 426 | 3 | 80 | 60.6 | 0.281 | 0.5 | 0.723 | 1.2 | 0.048 | 0.1 | 0.777 | 1.3 | ||
| 426 | 4 | 80 | 13.8 | 0.075 | 0.5 | 0.079 | 0.6 | 0.000 | 0.0 | 0.109 | 0.8 | ||
| 426 | 5 | 80 | 23.8 | 0.158 | 0.7 | 0.147 | 0.6 | 0.027 | 0.1 | 0.218 | 0.9 | ||
| All instruments combined | 1 | 240 | 15.7 | 0.112 | 0.7 | 0.131 | 0.8 | 0.000 | 0.0 | 0.065 | 0.4 | 0.184 | 1.2 |
| All instruments combined | 2 | 240 | 39.6 | 0.251 | 0.6 | 0.355 | 0.9 | 0.111 | 0.3 | 0.113 | 0.3 | 0.462 | 1.2 |
| All instruments combined | 3 | 240 | 60.8 | 0.363 | 0.6 | 0.672 | 1.1 | 0.253 | 0.4 | 0.186 | 0.3 | 0.826 | 1.4 |
| All instruments combined | 4 | 240 | 13.9 | 0.088 | 0.6 | 0.104 | 0.7 | 0.000 | 0.0 | 0.105 | 0.8 | 0.172 | 1.2 |
| All instruments combined | 5 | 240 | 23.8 | 0.169 | 0.7 | 0.218 | 0.9 | 0.000 | 0.0 | 0.151 | 0.6 | 0.314 | 1.3 |
PT (STA-Neoplastine CI Plus (10) (sec))
APTT (STA-PTTA (5) (sec))
| STA-PTTA(sec) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analyzer | Sample | N | Mean | Within-Run | Between-Run(= Between-Operator) | Between-Day | Between-Instrument | Within-Site | |||||
| sec | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | |||
| 403 | 1 | 80 | 31.5 | 0.195 | 0.6 | 0.238 | 0.8 | 0.000 | 0.0 | 0.308 | 1.0 | ||
| 2 | 80 | 89.5 | 1.123 | 1.3 | 1.433 | 1.6 | 1.244 | 1.4 | 2.205 | 2.5 | |||
| 3 | 80 | 133.2 | 2.237 | 1.7 | 2.239 | 1.7 | 1.792 | 1.3 | 3.637 | 2.7 | |||
| 4 | 80 | 31.9 | 0.138 | 0.4 | 0.167 | 0.5 | 0.000 | 0.0 | 0.216 | 0.7 | |||
| 5 | 80 | 55.5 | 0.504 | 0.9 | 0.716 | 1.3 | 0.393 | 0.7 | 0.960 | 1.7 | |||
| 404 | 1 | 80 | 31.5 | 0.185 | 0.6 | 0.253 | 0.8 | 0.000 | 0.0 | 0.313 | 1.0 | ||
| 2 | 80 | 88.6 | 0.772 | 0.9 | 1.238 | 1.4 | 0.694 | 0.8 | 1.616 | 1.8 | |||
| 3 | 80 | 131.5 | 1.057 | 0.8 | 2.378 | 1.8 | 1.184 | 0.9 | 2.859 | 2.2 | |||
| 4 | 80 | 31.9 | 0.116 | 0.4 | 0.167 | 0.5 | 0.000 | 0.0 | 0.203 | 0.6 | |||
| 5 | 80 | 55.0 | 0.236 | 0.4 | 0.563 | 1.0 | 0.425 | 0.8 | 0.744 | 1.4 | |||
| 426 | 1 | 80 | 31.2 | 0.165 | 0.5 | 0.244 | 0.8 | 0.000 | 0.0 | 0.294 | 0.9 | ||
| 2 | 80 | 88.6 | 0.486 | 0.5 | 1.653 | 1.9 | 0.662 | 0.7 | 1.846 | 2.1 | |||
| 3 | 80 | 129.0 | 2.241 | 1.7 | 1.322 | 1.0 | 2.124 | 1.6 | 3.359 | 2.6 | |||
| 4 | 80 | 31.6 | 0.165 | 0.5 | 0.189 | 0.6 | 0.000 | 0.0 | 0.251 | 0.8 | |||
| 5 | 80 | 54.8 | 0.370 | 0.7 | 0.796 | 1.5 | 0.283 | 0.5 | 0.922 | 1.7 | |||
| Allinstrumentscombined | 1 | 240 | 31.4 | 0.181 | 0.6 | 0.244 | 0.8 | 0.000 | 0.0 | 0.152 | 0.5 | 0.340 | 1.1 |
| 2 | 240 | 88.9 | 0.837 | 0.9 | 1.456 | 1.6 | 0.897 | 1.0 | 0.441 | 0.5 | 1.955 | 2.2 | |
| 3 | 240 | 131.2 | 1.935 | 1.5 | 2.035 | 1.6 | 1.734 | 1.3 | 2.003 | 1.5 | 3.861 | 2.9 | |
| 4 | 240 | 31.8 | 0.141 | 0.4 | 0.175 | 0.6 | 0.000 | 0.0 | 0.200 | 0.6 | 0.301 | 0.9 | |
| 5 | 240 | 55.1 | 0.388 | 0.7 | 0.700 | 1.3 | 0.367 | 0.7 | 0.330 | 0.6 | 0.940 | 1.7 |
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Image /page/14/Picture/0 description: The image shows the logo for Stago. The logo features the word "Stago" in red, with a stylized graphic above it. The graphic consists of two curved shapes, one red and one brown, that appear to be overlapping or interacting with each other.
FIB (STA-Fibrinogen (5) (mg/dL))
| STA-Fibrinogen(mg/dL) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analyzer | Sample | N | Mean | Within-Run | Between-Run(= Between-Operator) | Between-Day | Between-Instrument | Within-Site | |||||
| mg/dL | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | |||
| 403 | 1 | 80 | 553 | 8.042 | 1.5 | 5.749 | 1.0 | 0.000 | 0.0 | 9.886 | 1.8 | ||
| 403 | 2 | 80 | 736 | 10.434 | 1.4 | 8.252 | 1.1 | 0.000 | 0.0 | 13.303 | 1.8 | ||
| 403 | 3 | 80 | 992 | 20.287 | 2.0 | 0.000 | 0.0 | 8.186 | 0.8 | 21.876 | 2.2 | ||
| 403 | 4 | 80 | 252 | 4.970 | 2.0 | 2.966 | 1.2 | 1.099 | 0.4 | 5.891 | 2.3 | ||
| 403 | 5 | 80 | 110 | 1.761 | 1.6 | 1.204 | 1.1 | 0.000 | 0.0 | 2.133 | 1.9 | ||
| 404 | 1 | 80 | 562 | 9.145 | 1.6 | 6.271 | 1.1 | 3.673 | 0.7 | 11.681 | 2.1 | ||
| 404 | 2 | 80 | 747 | 12.298 | 1.6 | 7.388 | 1.0 | 5.236 | 0.7 | 15.272 | 2.0 | ||
| 404 | 3 | 80 | 1021 | 16.929 | 1.7 | 7.893 | 0.8 | 3.941 | 0.4 | 19.090 | 1.9 | ||
| 404 | 4 | 80 | 254 | 3.362 | 1.3 | 5.261 | 2.1 | 0.000 | 0.0 | 6.243 | 2.5 | ||
| 404 | 5 | 80 | 110 | 1.419 | 1.3 | 0.935 | 0.9 | 0.222 | 0.2 | 1.714 | 1.6 | ||
| 426 | 1 | 80 | 565 | 7.305 | 1.3 | 3.298 | 0.6 | 6.510 | 1.2 | 10.326 | 1.8 | ||
| 426 | 2 | 80 | 752 | 12.748 | 1.7 | 6.718 | 0.9 | 3.415 | 0.5 | 14.808 | 2.0 | ||
| 426 | 3 | 80 | 1025 | 18.465 | 1.8 | 12.045 | 1.2 | 0.000 | 0.0 | 22.046 | 2.2 | ||
| 426 | 4 | 80 | 262 | 5.527 | 2.1 | 0.000 | 0.0 | 2.157 | 0.8 | 5.933 | 2.3 | ||
| 426 | 5 | 80 | 113 | 1.265 | 1.1 | 1.378 | 1.2 | 0.000 | 0.0 | 1.871 | 1.7 | ||
| Allinstrumentscombined | 1 | 240 | 560 | 8.221 | 1.5 | 5.282 | 0.9 | 4.104 | 0.7 | 6.208 | 1.1 | 12.283 | 2.2 |
| Allinstrumentscombined | 2 | 240 | 745 | 11.893 | 1.6 | 7.442 | 1.0 | 3.140 | 0.4 | 8.405 | 1.1 | 16.653 | 2.2 |
| Allinstrumentscombined | 3 | 240 | 1013 | 18.689 | 1.8 | 7.642 | 0.8 | 1.630 | 0.2 | 17.832 | 1.8 | 26.987 | 2.7 |
| Allinstrumentscombined | 4 | 240 | 256 | 4.719 | 1.8 | 3.237 | 1.3 | 0.521 | 0.2 | 2.167 | 0.8 | 7.728 | 3.0 |
| Allinstrumentscombined | 5 | 240 | 111 | 1.501 | 1.4 | 1.189 | 1.1 | 0.000 | 0.0 | 1.556 | 1.4 | 2.467 | 2.2 |
AT (STA-Stachrom ATIII (6 (%))
| Analyzer | Sample | N | Mean% | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 403 | 1 | 80 | 31 | 1.251 | 4.0 | 1.332 | 4.3 | 0.000 | 0.0 | 1.828 | 5.9 | ||
| 403 | 2 | 80 | 71 | 1.043 | 1.5 | 2.234 | 3.1 | 0.000 | 0.0 | 2.466 | 3.5 | ||
| 403 | 3 | 80 | 113 | 1.347 | 1.2 | 2.461 | 2.2 | 0.000 | 0.0 | 2.806 | 2.5 | ||
| 403 | 4 | 80 | 99 | 1.265 | 1.3 | 1.479 | 1.5 | 0.000 | 0.0 | 1.947 | 2.0 | ||
| 403 | 5 | 80 | 46 | 0.873 | 1.9 | 1.364 | 3.0 | 0.000 | 0.0 | 1.619 | 3.5 | ||
| 404 | 1 | 80 | 31 | 1.045 | 3.4 | 1.989 | 6.4 | 0.000 | 0.0 | 2.247 | 7.2 | ||
| 404 | 2 | 80 | 70 | 1.172 | 1.7 | 1.755 | 2.5 | 0.000 | 0.0 | 2.111 | 3.0 | ||
| 404 | 3 | 80 | 111 | 1.574 | 1.4 | 1.362 | 1.2 | 0.000 | 0.0 | 2.081 | 1.9 | ||
| 404 | 4 | 80 | 98 | 1.277 | 1.3 | 2.143 | 2.2 | 0.000 | 0.0 | 2.494 | 2.5 | ||
| 404 | 5 | 80 | 46 | 0.665 | 1.4 | 1.924 | 4.2 | 0.000 | 0.0 | 2.036 | 4.4 | ||
| 426 | 1 | 80 | 31 | 1.160 | 3.7 | 1.962 | 6.3 | 0.000 | 0.0 | 2.280 | 7.4 | ||
| 426 | 2 | 80 | 72 | 0.998 | 1.4 | 1.854 | 2.6 | 0.891 | 1.2 | 2.286 | 3.2 | ||
| 426 | 3 | 80 | 114 | 1.324 | 1.2 | 1.259 | 1.1 | 0.807 | 0.7 | 1.997 | 1.8 | ||
| 426 | 4 | 80 | 101 | 1.226 | 1.2 | 1.670 | 1.7 | 0.440 | 0.4 | 2.118 | 2.1 | ||
| 426 | 5 | 80 | 46 | 0.802 | 1.7 | 2.036 | 4.4 | 0.000 | 0.0 | 2.188 | 4.8 | ||
| Allinstrumentscombined | 1 | 240 | 31 | 1.159 | 3.7 | 1.791 | 5.8 | 0.000 | 0.0 | 0.000 | 0.0 | 2.133 | 6.9 |
| Allinstrumentscombined | 2 | 240 | 71 | 1.064 | 1.5 | 1.962 | 2.8 | 0.177 | 0.2 | 0.827 | 1.2 | 2.387 | 3.4 |
| Allinstrumentscombined | 3 | 240 | 113 | 1.425 | 1.3 | 1.781 | 1.6 | 0.000 | 0.0 | 1.723 | 1.5 | 2.858 | 2.5 |
| Allinstrumentscombined | 4 | 240 | 99 | 1.260 | 1.3 | 1.790 | 1.8 | 0.000 | 0.0 | 1.480 | 1.5 | 2.643 | 2.7 |
| Allinstrumentscombined | 5 | 240 | 46 | 0.788 | 1.7 | 1.802 | 3.9 | 0.000 | 0.0 | 0.197 | 0.4 | 1.976 | 4.3 |
D-Dimer (STA-Liatest D-DI (µg/mL))
| STA-Liatest D-DI (µg/mL) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analyzer | Sample | N | Mean | Within-Run | Between-Run(= Between-Operator) | Between-Day | Between-Instrument | Within-Site | ||||||
| µg/mL | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | ||||
| 403 | 1 | 80 | 0.53 | 0.036 | 6.8 | 0.021 | 4.0 | 0.000 | 0.0 | 0.042 | 7.9 | |||
| 2 | 80 | 7.16 | 0.242 | 3.4 | 0.106 | 1.5 | 0.048 | 0.7 | 0.268 | 3.7 | ||||
| 3 | 80 | 16.04 | 0.369 | 2.3 | 0.143 | 0.9 | 0.000 | 0.0 | 0.396 | 2.5 | ||||
| 4 | 80 | 0.27 | 0.011 | 4.1 | 0.000 | 0.0 | 0.000 | 0.0 | 0.011 | 4.1 | ||||
| 5 | 80 | 2.21 | 0.055 | 2.5 | 0.000 | 0.0 | 0.000 | 0.0 | 0.055 | 2.5 | ||||
| 404 | 1 | 80 | 0.59 | 0.043 | 7.3 | 0.020 | 3.4 | 0.022 | 3.7 | 0.052 | 8.8 | |||
| 2 | 80 | 7.45 | 0.231 | 3.1 | 0.138 | 1.9 | 0.000 | 0.0 | 0.269 | 3.6 | ||||
| 3 | 80 | 16.61 | 0.337 | 2.0 | 0.214 | 1.3 | 0.000 | 0.0 | 0.399 | 2.4 | ||||
| 4 | 80 | 0.28 | 0.025 | 8.9 | 0.009 | 3.2 | 0.000 | 0.0 | 0.026 | 9.3 | ||||
| 5 | 80 | 2.25 | 0.044 | 2.0 | 0.018 | 0.8 | 0.000 | 0.0 | 0.047 | 2.1 | ||||
| 426 | 1 | 80 | 0.56 | 0.034 | 6.1 | 0.024 | 4.3 | 0.000 | 0.0 | 0.041 | 7.3 | |||
| 2 | 80 | 7.38 | 0.157 | 2.1 | 0.079 | 1.1 | 0.093 | 1.3 | 0.199 | 2.7 | ||||
| 3 | 80 | 16.14 | 0.272 | 1.7 | 0.165 | 1.0 | 0.075 | 0.5 | 0.327 | 2.0 | ||||
| 4 | 80 | 0.28 | 0.013 | 4.6 | 0.011 | 3.9 | 0.000 | 0.0 | 0.017 | 6.1 | ||||
| 5 | 80 | 2.23 | 0.034 | 1.5 | 0.02 | 0.9 | 0.019 | 0.9 | 0.043 | 1.9 | ||||
| Allinstrumentscombined | 1 | 240 | 0.56 | 0.038 | 6.8 | 0.020 | 3.6 | 0.009 | 1.6 | 0.033 | 5.9 | 0.055 | 9.8 | |
| 2 | 240 | 7.33 | 0.212 | 2.9 | 0.108 | 1.5 | 0.029 | 0.4 | 0.145 | 2.0 | 0.280 | 3.8 | ||
| 3 | 240 | 16.26 | 0.328 | 2.0 | 0.174 | 1.1 | 0.000 | 0.0 | 0.298 | 1.8 | 0.477 | 2.9 | ||
| 4 | 240 | 0.28 | 0.017 | 6.1 | 0.008 | 2.9 | 0.000 | 0.0 | 0.006 | 2.1 | 0.020 | 7.1 | ||
| 5 | 240 | 2.23 | 0.045 | 2.0 | 0.007 | 0.3 | 0.000 | 0.0 | 0.021 | 0.9 | 0.050 | 2.2 |
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image contains the logo for Stago. The logo consists of the word "Stago" in a red serif font, with a stylized graphic above it. The graphic appears to be an abstract representation of a drop or leaf, with the top portion in red and the bottom portion in brown. The overall design is simple and modern.
STA Compact Max 3
PT (STA-Neoplastine CI Plus (10 (sec))
| Analyzer | Sample | N | Meansec | Within-Run | Between-Run(= Between-Operator) | Between-Day | Between-Instrument | Within-Site | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | ||||
| 3522 | 1 | 80 | 13.0 | 0.173 | 1.3 | 0.019 | 0.1 | 0.036 | 0.3 | 0.178 | 1.4 | ||
| 2 | 80 | 38.2 | 0.232 | 0.6 | 0.477 | 1.2 | 0.315 | 0.8 | 0.617 | 1.6 | |||
| 3 | 80 | 60.3 | 0.623 | 1.0 | 1.041 | 1.7 | 0.000 | 0.0 | 1.213 | 2.0 | |||
| 4 | 80 | 14.0 | 0.089 | 0.6 | 0.096 | 0.7 | 0.000 | 0.0 | 0.131 | 0.9 | |||
| 5 | 80 | 23.1 | 0.203 | 0.9 | 0.256 | 1.1 | 0.043 | 0.2 | 0.33 | 1.4 | |||
| 3524 | 1 | 80 | 12.8 | 0.152 | 1.2 | 0.065 | 0.5 | 0.065 | 0.5 | 0.178 | 1.4 | ||
| 2 | 80 | 38.1 | 0.241 | 0.6 | 0.355 | 0.9 | 0.182 | 0.5 | 0.466 | 1.2 | |||
| 3 | 80 | 59.2 | 0.521 | 0.9 | 0.795 | 1.3 | 0.000 | 0.0 | 0.95 | 1.6 | |||
| 4 | 80 | 13.9 | 0.117 | 0.8 | 0.119 | 0.9 | 0.000 | 0.0 | 0.167 | 1.2 | |||
| 5 | 80 | 23.0 | 0.254 | 1.1 | 0.239 | 1.0 | 0.142 | 0.6 | 0.376 | 1.6 | |||
| 3525 | 1 | 80 | 12.8 | 0.184 | 1.4 | 0.000 | 0.0 | 0.006 | 0.0 | 0.184 | 1.4 | ||
| 2 | 80 | 38.0 | 0.297 | 0.8 | 0.471 | 1.2 | 0.276 | 0.7 | 0.621 | 1.6 | |||
| 3 | 80 | 60.1 | 0.509 | 0.8 | 0.767 | 1.3 | 0.350 | 0.6 | 0.985 | 1.6 | |||
| 4 | 80 | 14.0 | 0.084 | 0.6 | 0.104 | 0.7 | 0.000 | 0.0 | 0.133 | 1.0 | |||
| 5 | 80 | 23.1 | 0.178 | 0.8 | 0.263 | 1.1 | 0.000 | 0.0 | 0.318 | 1.4 | |||
| Allinstrumentscombined | 1 | 240 | 12.9 | 0.171 | 1.3 | 0.000 | 0.0 | 0.041 | 0.3 | 0.068 | 0.5 | 0.188 | 1.5 |
| 2 | 240 | 38.1 | 0.259 | 0.7 | 0.439 | 1.2 | 0.261 | 0.7 | 0.079 | 0.2 | 0.578 | 1.5 | |
| 3 | 240 | 59.8 | 0.553 | 0.9 | 0.880 | 1.5 | 0.000 | 0.0 | 0.568 | 0.9 | 1.185 | 2.0 | |
| 4 | 240 | 14.0 | 0.097 | 0.7 | 0.107 | 0.8 | 0.000 | 0.0 | 0.058 | 0.4 | 0.156 | 1.1 | |
| 5 | 240 | 23.1 | 0.213 | 0.9 | 0.254 | 1.1 | 0.061 | 0.3 | 0.081 | 0.4 | 0.347 | 1.5 |
APTT (STA-PTTA (5) (sec))
| Analyzer | Sample | N | Mean | Within-Run | Between-Run(= Between-Operator) | Between-Day | Between-Instrument | Within-Site | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| sec | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | |||
| 3522 | 1 | 80 | 31.9 | 0.328 | 1.0 | 0.230 | 0.7 | 0.199 | 0.6 | 0.447 | 1.4 | ||
| 2 | 80 | 102.2 | 1.114 | 1.1 | 1.972 | 1.9 | 2.174 | 2.1 | 3.140 | 3.1 | |||
| 3 | 80 | 118.9 | 1.060 | 0.9 | 1.746 | 1.5 | 0.771 | 0.6 | 2.183 | 1.8 | |||
| 4 | 80 | 32.8 | 0.409 | 1.2 | 0.011 | 0.0 | 0.105 | 0.3 | 0.422 | 1.3 | |||
| 5 | 80 | 53.8 | 0.327 | 0.6 | 0.716 | 1.3 | 0.000 | 0.0 | 0.788 | 1.5 | |||
| 3524 | 1 | 80 | 31.7 | 0.199 | 0.6 | 0.372 | 1.2 | 0.173 | 0.5 | 0.456 | 1.4 | ||
| 2 | 80 | 100.8 | 0.944 | 0.9 | 1.697 | 1.7 | 1.448 | 1.4 | 2.422 | 2.4 | |||
| 3 | 80 | 121.3 | 1.010 | 0.8 | 1.950 | 1.6 | 1.202 | 1.0 | 2.503 | 2.1 | |||
| 4 | 80 | 32.5 | 0.307 | 0.9 | 0.196 | 0.6 | 0.123 | 0.4 | 0.384 | 1.2 | |||
| 5 | 80 | 53.9 | 0.338 | 0.6 | 0.695 | 1.3 | 0.353 | 0.7 | 0.850 | 1.6 | |||
| 3525 | 1 | 80 | 31.8 | 0.400 | 1.3 | 0.292 | 0.9 | 0.000 | 0.0 | 0.495 | 1.6 | ||
| 2 | 80 | 100.9 | 1.036 | 1.0 | 1.158 | 1.1 | 1.327 | 1.3 | 2.043 | 2.0 | |||
| 3 | 80 | 120.8 | 0.942 | 0.8 | 1.802 | 1.5 | 0.942 | 0.8 | 2.052 | 1.7 | |||
| 4 | 80 | 32.7 | 0.355 | 1.1 | 0.202 | 0.6 | 0.147 | 0.4 | 0.435 | 1.3 | |||
| 5 | 80 | 54.2 | 0.306 | 0.6 | 0.785 | 1.4 | 0.000 | 0.0 | 0.843 | 1.6 | |||
| Allinstrumentscombined | 1 | 240 | 31.8 | 0.321 | 1.0 | 0.302 | 0.9 | 0.152 | 0.5 | 0.104 | 0.3 | 0.478 | 1.5 |
| 2 | 240 | 101.3 | 1.037 | 1.0 | 1.648 | 1.6 | 1.685 | 1.7 | 0.591 | 0.6 | 2.642 | 2.6 | |
| 3 | 240 | 120.4 | 1.009 | 0.8 | 1.820 | 1.5 | 0.866 | 0.7 | 1.217 | 1.0 | 2.562 | 2.1 | |
| 4 | 240 | 32.7 | 0.360 | 1.1 | 0.161 | 0.5 | 0.126 | 0.4 | 0.188 | 0.6 | 0.455 | 1.4 | |
| 5 | 240 | 54.0 | 0.318 | 0.6 | 0.727 | 1.3 | 0.135 | 0.3 | 0.146 | 0.3 | 0.818 | 1.5 |
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in red, with a stylized symbol above it. The symbol appears to be made of three curved shapes, one red and two brown, arranged in a circular pattern.
FIB (STA-Fibrinogen (5) (mg/dL))
| STA-Fibrinogen | (mg/dL) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Analyzer | Sample | N | Mean | Within-Run | Between-Run(= Between-Operator) | Between-DayBetween-Instrument | Within-Site | ||||||
| mg/dL | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | |||
| 80 | 555 | 14.551 | 2.6 | 15.116 | 2.7 | 8.198 | 1.5 | 22.526 | 4.1 | ||||
| 2 | 80 | 772 | 9.317 | 1.2 | 17.028 | 2.2 | 12.600 | 1.6 | 23.142 | 3.0 | |||
| 3522 | 3 | 80 | 1046 | 18.238 | 1.7 | 25.567 | 2.4 | 26.377 | 2.5 | 41.013 | 3.9 | ||
| 4 | 80 | 270 | 5.106 | 1.9 | 5.780 | 2.1 | 0.000 | 0.0 | 7.713 | 2.9 | |||
| 5 | 80 | 114 | 1.383 | 1.2 | 2.704 | 2.4 | 0.000 | 0.0 | 3.037 | 2.7 | |||
| 1 | 80 | 551 | 15.199 | 2.8 | 5.415 | 1.0 | 16.011 | 2.9 | 22.731 | 4.1 | |||
| 2 | 80 | 764 | 13.896 | 1.8 | 13.301 | 1.7 | 16.895 | 2.2 | 25.601 | 3.4 | |||
| 3524 | 3 | 80 | 1044 | 24.405 | 2.3 | 22.802 | 2.2 | 24.648 | 2.4 | 41.510 | 4.0 | ||
| 4 | 80 | 269 | 5.835 | 2.2 | 4.141 | 1.5 | 3.700 | 1.4 | 8.055 | 3.0 | |||
| 5 | 80 | 112 | 1.792 | 1.6 | 2.764 | 2.5 | 0.000 | 0.0 | 3.294 | 2.9 | |||
| 1 | 80 | 557 | 11.584 | 2.1 | 7.269 | 1.3 | 10.763 | 1.9 | 17.404 | 3.1 | |||
| 2 | 80 | 767 | 13.374 | 1.7 | 14.352 | 1.9 | 13.520 | 1.8 | 23.825 | 3.1 | |||
| 3525 | 3 | 80 | 1027 | 18.555 | 1.8 | 12.260 | 1.2 | 19.363 | 1.9 | 29.488 | 2.9 | ||
| 4 | 80 | 270 | 4.503 | 1.7 | 3.834 | 1.4 | 4.965 | 1.8 | 7.722 | 2.9 | |||
| 5 | 80 | 114 | 1.673 | 1.5 | 1.684 | 1.5 | 0.424 | 0.4 | 2.412 | 2.1 | |||
| 1 | 240 | 554 | 13.892 | 2.5 | 10.152 | 1.8 | 12.092 | 2.2 | 0.000 | 0.0 | 21.030 | 3.8 | |
| All | 2 | 240 | 768 | 12.404 | 1.6 | 15.003 | 2.0 | 14.391 | 1.9 | 0.343 | 0.0 | 24.211 | 3.2 |
| instruments | 3 | 240 | 1039 | 20.659 | 2.0 | 21.019 | 2.0 | 23.579 | 2.3 | 8.053 | 0.8 | 38.593 | 3.7 |
| combined | 4 | 240 | 270 | 5.094 | 1.9 | 4.666 | 1.7 | 3.654 | 1.4 | 0.000 | 0.0 | 7.815 | 2.9 |
| ર્ડ | 240 | 113 | 1.611 | 1.4 | 2.436 | 2.2 | 0.000 | 0.0 | 0.510 | 0.5 | 2.965 | 2.6 |
AT (STA-Stachrom ATIII (6) (%))
| Analyzer | Sample | N | Mean | Within-Run | Between-Run(= Between-Operator) | Between-Day | Between-Instrument | Within-Site | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | |||
| 3522 | 1 | 80 | 22 | 1.064 | 4.8 | 0.969 | 4.4 | 0.000 | 0.0 | 1.439 | 6.5 | ||
| 3522 | 2 | 80 | 58 | 1.236 | 2.1 | 0.981 | 1.7 | 0.000 | 0.0 | 1.578 | 2.7 | ||
| 3522 | 3 | 80 | 109 | 0.975 | 0.9 | 1.027 | 0.9 | 0.000 | 0.0 | 1.416 | 1.3 | ||
| 3522 | 4 | 80 | 98 | 0.936 | 1.0 | 1.042 | 1.1 | 0.000 | 0.0 | 1.400 | 1.4 | ||
| 3522 | 5 | 80 | 41 | 2.049 | 5.0 | 0.000 | 0.0 | 0.304 | 0.7 | 2.071 | 5.1 | ||
| 3524 | 1 | 80 | 23 | 1.006 | 4.4 | 0.533 | 2.3 | 0.596 | 2.6 | 1.285 | 5.6 | ||
| 3524 | 2 | 80 | 58 | 0.924 | 1.6 | 0.875 | 1.5 | 0.000 | 0.0 | 1.273 | 2.2 | ||
| 3524 | 3 | 80 | 108 | 1.200 | 1.1 | 0.579 | 0.5 | 0.575 | 0.5 | 1.451 | 1.3 | ||
| 3524 | 4 | 80 | 97 | 1.047 | 1.1 | 0.705 | 0.7 | 0.731 | 0.8 | 1.459 | 1.5 | ||
| 3524 | 5 | 80 | 42 | 2.058 | 4.9 | 0.000 | 0.0 | 0.572 | 1.4 | 2.136 | 5.1 | ||
| 3525 | 1 | 80 | 24 | 0.802 | 3.3 | 1.111 | 4.6 | 0.000 | 0.0 | 1.370 | 5.7 | ||
| 3525 | 2 | 80 | 60 | 0.798 | 1.3 | 1.573 | 2.6 | 0.000 | 0.0 | 1.764 | 2.9 | ||
| 3525 | 3 | 80 | 110 | 0.859 | 0.8 | 0.998 | 0.9 | 0.000 | 0.0 | 1.317 | 1.2 | ||
| 3525 | 4 | 80 | 98 | 0.912 | 0.9 | 1.520 | 1.6 | 0.000 | 0.0 | 1.772 | 1.8 | ||
| 3525 | 5 | 80 | 44 | 1.598 | 3.6 | 0.810 | 1.8 | 0.542 | 1.2 | 1.872 | 4.3 | ||
| All instrumentscombined | 1 | 240 | 23 | 0.967 | 4.2 | 0.902 | 3.9 | 0.000 | 0.0 | 1.105 | 4.8 | 1.723 | 7.5 |
| All instrumentscombined | 2 | 240 | 59 | 0.999 | 1.7 | 1.187 | 2.0 | 0.000 | 0.0 | 0.821 | 1.4 | 1.755 | 3.0 |
| All instrumentscombined | 3 | 240 | 109 | 0.971 | 0.9 | 0.956 | 0.9 | 0.000 | 0.0 | 0.855 | 0.8 | 1.609 | 1.5 |
| All instrumentscombined | 4 | 240 | 98 | 0.959 | 1.0 | 1.152 | 1.2 | 0.000 | 0.0 | 0.916 | 0.9 | 1.757 | 1.8 |
| All instrumentscombined | 5 | 240 | 42 | 1.913 | 4.6 | 0.000 | 0.0 | 0.462 | 1.1 | 1.376 | 3.3 | 2.401 | 5.7 |
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in red, with a stylized graphic above it. The graphic appears to be two teardrop shapes, one red and one brown, arranged to suggest a stylized leaf or abstract design. The overall design is simple and modern.
| Analyzer | Sample | N | Mean | Within-Run | Between-Run(= Between-Operator) | Between-Day | Between-Instrument | Within-Site | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| µg/mL | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | |||
| 3522 | 1 | 80 | 0.68 | 0.035 | 5.1 | 0.013 | 1.9 | 0.000 | 0.0 | 0.037 | 5.4 | ||
| 3522 | 2 | 80 | 7.88 | 0.158 | 2.0 | 0.045 | 0.6 | 0.000 | 0.0 | 0.165 | 2.1 | ||
| 3522 | 3 | 80 | 16.49 | 0.317 | 1.9 | 0.000 | 0.0 | 0.038 | 0.2 | 0.320 | 1.9 | ||
| 3522 | 4 | 80 | 0.33 | 0.036 | 10.9 | 0.000 | 0.0 | 0.000 | 0.0 | 0.036 | 10.9 | ||
| 3522 | 5 | 80 | 2.39 | 0.035 | 1.5 | 0.000 | 0.0 | 0.000 | 0.0 | 0.035 | 1.5 | ||
| 3524 | 1 | 80 | 0.66 | 0.038 | 5.8 | 0.010 | 1.5 | 0.000 | 0.0 | 0.040 | 6.1 | ||
| 3524 | 2 | 80 | 7.75 | 0.176 | 2.3 | 0.048 | 0.6 | 0.000 | 0.0 | 0.182 | 2.3 | ||
| 3524 | 3 | 80 | 15.72 | 0.275 | 1.7 | 0.142 | 0.9 | 0.000 | 0.0 | 0.309 | 2.0 | ||
| 3524 | 4 | 80 | 0.34 | 0.041 | 12.1 | 0.000 | 0.0 | 0.010 | 2.9 | 0.042 | 12.4 | ||
| 3524 | 5 | 80 | 2.30 | 0.036 | 1.6 | 0.014 | 0.6 | 0.005 | 0.2 | 0.039 | 1.7 | ||
| 3525 | 1 | 80 | 0.66 | 0.031 | 4.7 | 0.000 | 0.0 | 0.000 | 0.0 | 0.031 | 4.7 | ||
| 3525 | 2 | 80 | 7.56 | 0.173 | 2.3 | 0.000 | 0.0 | 0.000 | 0.0 | 0.173 | 2.3 | ||
| 3525 | 3 | 80 | 15.35 | 0.279 | 1.8 | 0.000 | 0.0 | 0.000 | 0.0 | 0.279 | 1.8 | ||
| 3525 | 4 | 80 | 0.33 | 0.026 | 7.9 | 0.000 | 0.0 | 0.011 | 3.3 | 0.029 | 8.8 | ||
| 3525 | 5 | 80 | 2.27 | 0.04 | 1.8 | 0.000 | 0.0 | 0.014 | 0.6 | 0.042 | 1.9 | ||
| Allinstrumentscombined | 1 | 240 | 0.66 | 0.035 | 5.3 | 0.009 | 1.4 | 0.000 | 0.0 | 0.012 | 1.8 | 0.038 | 5.8 |
| Allinstrumentscombined | 2 | 240 | 7.73 | 0.169 | 2.2 | 0.038 | 0.5 | 0.000 | 0.0 | 0.162 | 2.1 | 0.238 | 3.1 |
| Allinstrumentscombined | 3 | 240 | 15.85 | 0.291 | 1.8 | 0.063 | 0.4 | 0.000 | 0.0 | 0.581 | 3.7 | 0.653 | 4.1 |
| Allinstrumentscombined | 4 | 240 | 0.33 | 0.035 | 10.6 | 0.000 | 0.0 | 0.007 | 2.1 | 0.002 | 0.6 | 0.036 | 10.9 |
| Allinstrumentscombined | 5 | 240 | 2.32 | 0.037 | 1.6 | 0.000 | 0.0 | 0.005 | 0.2 | 0.065 | 2.8 | 0.075 | 3.2 |
D-Dimer (STA-Liatest D-DI (µg/mL))
Multi-site precision testing was performed in accordance with CLSI EP05-A3 over 5 days at three external sites. Three samples per parameter were tested across the applicable measuring ranges, with two runs per day and two replicates per day. Each run was at least two hours apart. The acceptance criteria were met for all samples in the studies. A summary of the within-run, between run, between day between site, and total precision is provided below.
STA R Max 3
| Assay | Sample | N | Mean | Within-Run | Between-Run(=Between-Operator) | Between-Day | Between-Site(= Between-Instrument) | Total Precision | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | |||||
| All 3 sitescombined | PT(sec) | CCN | 90 | 13.8 | 0.116 | 0.8 | 0.000 | 0.0 | 0.080 | 0.6 | 0.067 | 0.5 | 0.156 | 1.1 |
| CCP | 90 | 22.8 | 0.227 | 1.0 | 0.221 | 1.0 | 0.000 | 0.0 | 0.149 | 0.7 | 0.350 | 1.5 | ||
| APTT(sec) | CCN | 90 | 28.7 | 0.210 | 0.7 | 0.146 | 0.5 | 0.120 | 0.4 | 0.143 | 0.5 | 0.317 | 1.1 | |
| CCP | 90 | 48.7 | 0.368 | 0.8 | 0.560 | 1.1 | 0.502 | 1.0 | 0.321 | 0.7 | 0.897 | 1.8 | ||
| FIB(mg/dL) | CCN | 90 | 304.0 | 8.413 | 2.8 | 2.472 | 0.8 | 0.000 | 0.0 | 5.272 | 1.7 | 10.231 | 3.4 | |
| CCP | 90 | 113 | 2.438 | 2.2 | 1.020 | 0.9 | 0.000 | 0.0 | 1.597 | 1.4 | 3.088 | 2.7 | ||
| AT(%) | CCN | 90 | 94.0 | 1.932 | 2.1 | 1.631 | 1.7 | 0.000 | 0.0 | 1.095 | 1.2 | 2.755 | 2.9 | |
| CCP | 90 | 45 | 0.960 | 2.1 | 1.604 | 3.6 | 0.000 | 0.0 | 0.689 | 1.5 | 1.993 | 4.4 | ||
| D-Dimer(µg/mL) | LCN | 90 | 0.31 | 0.027 | 8.7 | 0.008 | 2.6 | 0.008 | 2.6 | 0.014 | 4.5 | 0.033 | 10.6 | |
| LCP | 90 | 2.22 | 0.044 | 2.0 | 0.040 | 1.8 | 0.016 | 0.7 | 0.007 | 0.3 | 0.062 | 2.8 |
STA Compact Max 3
| Assay | Sample | N | Mean | Within-Run | Between-Run(=Between-Operator) | Between-Day | Between-Site(= Between-Instrument) | Total Precision | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | SD | CV(%) | |||||
| All 3 sitescombined | PT(sec) | CCN | 90 | 14.0 | 0.148 | 1.1 | 0.138 | 1.0 | 0.000 | 0.0 | 0.000 | 0.0 | 0.203 | 1.5 |
| PT(sec) | CCP | 90 | 23.9 | 0.304 | 1.3 | 0.338 | 1.4 | 0.000 | 0.0 | 0.254 | 1.1 | 0.521 | 2.2 | |
| APTT(sec) | CCN | 90 | 28.3 | 0.224 | 0.8 | 0.235 | 0.8 | 0.123 | 0.4 | 0.333 | 1.2 | 0.481 | 1.7 | |
| APTT(sec) | CCP | 90 | 47.0 | 0.330 | 0.7 | 1.316 | 2.8 | 0.000 | 0.0 | 0.439 | 0.9 | 1.426 | 3.0 | |
| All 3 sitescombined | FIB(mg/dL) | CCN | 90 | 277 | 5.361 | 1.9 | 3.291 | 1.2 | 0.000 | 0.0 | 0.952 | 0.3 | 6.362 | 2.3 |
| All 3 sitescombined | FIB(mg/dL) | CCP | 90 | 115 | 1.745 | 1.5 | 2.331 | 2.0 | 0.000 | 0.0 | 0.000 | 0.0 | 2.912 | 2.5 |
| AT(%) | CCN | 90 | 98 | 1.130 | 1.2 | 2.106 | 2.1 | 0.938 | 1.0 | 1.068 | 1.1 | 2.781 | 2.8 | |
| AT(%) | CCP | 90 | 42 | 1.160 | 2.8 | 2.443 | 5.8 | 0.592 | 1.4 | 2.681 | 6.4 | 3.854 | 9.2 | |
| D-Dimer(µg/mL) | LCN | 90 | 0.31 | 0.021 | 6.8 | 0.010 | 3.2 | 0.002 | 0.6 | 0.008 | 2.6 | 0.025 | 8.1 | |
| D-Dimer(µg/mL) | LCP | 90 | 2.30 | 0.056 | 2.4 | 0.031 | 1.3 | 0.022 | 1.0 | 0.042 | 1.8 | 0.08 | 3.5 |
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in red, with a stylized graphic above it. The graphic appears to be made of two curved shapes, one red and one brown, arranged in a circular fashion.
HIL Interferences
Cross-interferences were assessed by spiking plasma with hemoglobin, bilirubin and lipids (Intralipid®) at various concentrations in order to provide combinations of HIL concentrations to assess HIL measurement sensitivity for each interfering substance in the presence of other interfering substances at various concentrations. Spiked plasmas were prepared and each interfering substance was represented by various concentrations distributed across the designated indices. Each spiked plasmas concentration was assayed in triplicate on two subject devices. All results obtained matched the index determination for the subject devices and the theoretical index.
Detection Limit Not applicable
Assay Cut-off Not applicable
Clinical Studies
Clinical Sensitivity Not applicable
Clinical Specificity Not applicable
Clinical Cut-off Not applicable
Reference Interval Not applicable
CONCLUSION
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
§ 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.