(256 days)
BK000043, K945271
No
The summary describes a standard automated coagulation analyzer with new pre-analytical features. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The studies focus on traditional analytical performance metrics like precision, linearity, and method comparison.
No.
The document states that the device is an in vitro diagnostic analyzer for hemostasis laboratory testing, which is used for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices "are designed specifically for in vitro diagnostic clinical use."
No
The device description clearly states it is a "fully automated coagulation analyzer" and describes physical components and testing methodologies that involve hardware (optical measurements, pre-analytical features like HIL check and clog detection). The performance studies also involve testing on physical instrument models.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the devices are "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." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description details how the device performs tests using biological samples (plasma) and measures parameters like coagulation, chromogenic, and immunological responses. These are all typical functions of an IVD used in a clinical laboratory setting.
- Intended User/Care Setting: The device is intended for use in a "hemostasis laboratory," which is a clinical laboratory setting where diagnostic testing is performed.
The information provided strongly indicates that this device is an IVD.
N/A
Intended Use / Indications for Use
The ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) are bench top, fully automated, random access analyzers 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 systems provide results for both direct hemostasis measurements and calculated parameters.
Product codes
GKP
Device Description
The ACL TOP Family 50 Series are fully automated coagulation analyzers that utilize the same intuitive software, the same consumables, reagents, calibrators and provide the same analytical methodology for routine and specialty assay result reporting as the predicate ACL TOP Family.
The ACL TOP Family 50 Series instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate ACL TOP Family:
- Coagulometric (Turbidimetric) Measurements
- Chromogenic (Absorbance) Measurements
- Immunological Measurements
The ACL TOP Family 50 Series also offers new pre-analytical features not available on the current ACL TOP Family as described below. These features are not intended to replace laboratory quality policies. The features simply alert the instrument operator to a potential HIL (Hemoglobin, Icteric and Lipemia) interference situation specific to the assays requested for a sample, underfilled sample tubes or a detected clog. The user will determine how to handle these situations (for example, by not reporting the results, or reporting the results with, or without, additional comments).
Pre-Analytical Features:
- The Pre-Analytical HIL Check detects and measures interference caused by the presence of hemoglobin, bilirubin, and light scattering lipids in patient samples. H – Hemolysis (hemoglobin) I – Icterus (bilirubin) L- Lipemia (turbidity). The Pre-Analytical HIL Check aids the coagulation laboratory in identifying and handling potential HIL interference issues. This feature flags samples to alert instrument operators of potential HIL interference specific to the tests requested for a sample.
NOTES: There are no analytical claims for hemoglobin, bilirubin or turbidity analysis with the introduction of the Pre-Analytical HIL Check.
Information provided by the check does not replace any interference information included in the package inserts of IL products.
A third measurement wavelength @535 nm and an additional emitter control channel (all models) have been introduced to support the new Pre-Analytical HIL Check feature.
- The Pre-Analytical Tube Fill Height (THF) Check aids laboratories by screening open and closed tube samples during the first sample aspiration to determine whether the tube fill meets the minimum level based on the tube manufacturer's recommendations.
The fill height check for each patient sample occurs before the analytical testing process begins and thus there is no effect on patient test results.
- A Pre-Analytical Clog Detection is performed on all samples during aspiration.
A pre-analytical error or warning for fluidic obstruction is an indication for the user to review the sample integrity, following established laboratory sample quality procedures.
A pressure transducer (all models) has been introduced to support this new Pre-Analytical Clog Detection feature.
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
Not Found
Intended User / Care Setting
Hemostasis laboratory
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 Study – Internal:
An internal 20-day precision study was performed on an ACL TOP 350 CTS, ACL TOP 550 CTS, ACL TOP 750 CTS and ACL TOP 750, using 12 representative commercially available assays and their assayed control materials, as well as a prepared patient plasma pool. All materials were tested in duplicate, twice a day for 20 days, for a total of 80 replicates per level for each assay on each instrument model.
Linearity Study – Internal:
An internal linearity study was performed on an ACL TOP 350 CTS, ACL TOP 550 CTS, ACL TOP 750 CTS and ACL TOP 750, using 10 representative commercially available assays and prepared plasma pool panels at a minimum of 9 levels. Each of the different panel levels was tested in quadruplicate on each instrument model with the resultant data supporting equivalent linearity range claims to the current ACL TOP Family. Linearity is not applicable to PT and APTT assays.
Precision Study – External:
An external 20-day precision study was performed at three US external sites on an ACL TOP 550 CTS by three different operators, using 11 representative commercially available assays each with two levels of assayed control materials. All materials were tested in duplicate, twice a day for 20 days, for a total of 80 replicates per level for each assay on each model. Precision data for derived fibrinogen with HemosIL RecombiPlasTin 2G were not collected under the scope of this study.
Reproducibility Study - External:
An external 5-day precision study was performed at three US sites on an ACL TOP 550 CTS by three different operators, using the same lot of 12 representative commercially available assays, each with two lot of assayed control materials. All materials were tested in triplicate, twice a day for 5 days, for a total of 30 replicates per level for each assay on each model.
Method Comparison Study – External:
Method comparison studies were conducted at three US external sites on patient samples following CLSI EP09-A3. Testing at each site compared a representative ACL TOP Family 50 Series model (ACL TOP 550 CTS) to an ACL TOP 500 model (predicate), using 12 representative commercially available assays. Results outside of the individual assay's linear range, samples with incomplete information and samples with instrument errors were removed from final calculations.
Method Comparison Study – External (Pre-Analytical HIL Check):
External method comparison studies for the new Pre-Analytical HIL Check feature were also conducted at three US sites on patient samples following CLSI EPO9-A3. Testing at each site compared a representative ACL TOP Family 50 Series model (ACL TOP 550 CTS) to the reference devices. The Pre-Analytical HIL Check feature flags sample results to alert instrument operators of potential HIL interference specific to the assays requested for a sample. There are no analytical claims for hemoglobin, bilirubin or turbidity analysis with the introduction of the Pre-Analytical HIL Check. Information provided by the check does not replace any interference information included in the package inserts of IL products.
Pre-Analytical Clog Detection Testing:
A Pre-Analytical Clog Detection test was conducted internally on ACL TOP Family 50 Series model instruments (2 ACL TOP 350 CTS models; 2 ACL TOP 550 CTS models; 2 ACL TOP 750 models; 2 ACL TOP 750 CTS models; 1 ACL TOP 750 LAS model). All instrument models correctly detected an occluded sample probe.
Pre-Analytical Tube Fill Height Check Testing:
A Pre-Analytical Tube Fill Height Check test was conducted internally on ACL TOP Family 50 Series model instruments (2 ACL TOP 350 CTS models; 2 ACL TOP 550 CTS models; 2 ACL TOP 750 models; 2 ACL TOP 750 CTS models). All instrument models correctly detected when tubes were underfilled.
Key Results:
Based on the shared indications for use, operating principle, consumables, reagents, controls and calibrators, and considering the above summary performance data, the ACL TOP Family 50 Series with its new pre-analytical features can be concluded to be substantially equivalent to the cleared and currently marketed predicate device, ACL TOP Family.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Precision and Linearity tables are provided in the study summary.
Predicate Device(s)
Reference Device(s)
BK000043, K945271
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 13, 2015
Instrumentation Laboratory (IL) Co. Carol Marble Regulatory Affairs Director 180 Hartwell Road Bedford, MA 01730
Re: K150877
Trade/Device Name: ACL TOP Family 50 Series Models: ACL TOP 350 CTS, ACL TOP 550 CTS, ACL TOP 750, ACL TOP 750 CTS, ACL TOP 750 LAS Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation Instrument Regulatory Class: Class II Product Code: GKP Dated: November 12, 2015 Received: November 13, 2015
Dear Ms. Marble:
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. 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 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 809); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Leonthena R. Carrington -S
Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
ACL TOP Family 50 Series (ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
Indications for Use (Describe)
The ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) are bench top, fully automated, random access analyzers 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 systems provide results for both direct hemostasis measurements and calculated parameters.
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 being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
| Submitter's Information | Instrumentation Laboratory (IL) Co.
180 Hartwell Road
Bedford, MA 01730, USA |
| ------------------------- | ------------------------------------------------------------------------------------ |
|---|
| Contact Person | Carol Marble, Regulatory Affairs Director | |
|---|---|---|
| Phone: 781-861-4467 | ||
| Fax: 781-861-4207 | ||
| Email: cmarble@ilww.com |
| Preparation Date | November 12, 2015 |
|---|---|
| ------------------ | ------------------- |
| Device Trade Names | ACL TOP Family 50 Series Models: |
|---|---|
| • ACL TOP 350 CTS | |
| • ACL TOP 550 CTS | |
| • ACL TOP 750 | |
| • ACL TOP 750 CTS | |
| • ACL TOP 750 LAS |
| Regulatory Information | Classification: | Class II |
|---|---|---|
| Regulation No.: | 21 CFR 864.5400 | |
| Common Name: | Coagulation Instrument | |
| Panel: | Hematology (81) | |
| Product Code: | GKP |
| Predicate Device | ACL TOP: K073377; K091980 for LAS model |
|---|---|
| ------------------ | ----------------------------------------- |
| Device Indications for Use /
Intended Use | The ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS;
ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) are
bench top, fully automated, random access analyzers 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 systems
provide results for both direct hemostasis measurements and
calculated parameters. |
| ---------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
4
Description
The ACL TOP Family 50 Series are fully automated coagulation analyzers that utilize the same intuitive software, the same consumables, reagents, calibrators and provide the same analytical methodology for routine and specialty assay result reporting as the predicate ACL TOP Family.
The ACL TOP Family 50 Series instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate ACL TOP Family:
- . Coagulometric (Turbidimetric) Measurements
- Chromogenic (Absorbance) Measurements
- Immunological Measurements
The ACL TOP Family 50 Series also offers new pre-analytical features not available on the current ACL TOP Family as described below. These features are not intended to replace laboratory quality policies. The features simply alert the instrument operator to a potential HIL (Hemoglobin, Icteric and Lipemia) interference situation specific to the assays requested for a sample, underfilled sample tubes or a detected clog. The user will determine how to handle these situations (for example, by not reporting the results, or reporting the results with, or without, additional comments).
| Pre-Analytical Features | The Pre-Analytical HIL Check detects and measures interference caused by
the presence of hemoglobin, bilirubin, and light scattering lipids in patient
samples. H – Hemolysis (hemoglobin) I – Icterus (bilirubin) L- Lipemia (turbidity) The Pre-Analytical HIL Check aids the coagulation laboratory in identifying
and handling potential HIL interference issues. This feature flags samples to
alert instrument operators of potential HIL interference specific to the tests
requested for a sample.
NOTES: There are no analytical claims for hemoglobin, bilirubin or turbidity
analysis with the introduction of the Pre-Analytical HIL Check .
Information provided by the check does not replace any interference
information included in the package inserts of IL products.
A third measurement wavelength @535 nm and an additional emitter control
channel (all models) have been introduced to support the new Pre-Analytical
HIL Check feature. |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Pre-Analytical Tube Fill Height (THF) Check aids laboratories by
screening open and closed tube samples during the first sample aspiration to
determine whether the tube fill meets the minimum level based on the tube
manufacturer's recommendations.
The fill height check for each patient sample occurs before the analytical
testing process begins and thus there is no effect on patient test results. |
| | A Pre-Analytical Clog Detection is performed on all samples during
aspiration.
A pre-analytical error or warning for fluidic obstruction is an indication for the
user to review the sample integrity, following established laboratory sample
quality procedures.
A pressure transducer (all models) has been introduced to support this new
Pre-Analytical Clog Detection feature. |
5
| Comparison to Predicate | ||
|---|---|---|
| Item | Predicate | New Device |
| Trade Names | ACL TOP Family Models ACL TOP 700 (Base) ACL TOP 700 CTS ACL TOP 700 LAS ACL TOP 500 CTS ACL TOP 300 CTS | ACL TOP Family 50 Series Models ACL TOP 750 ACL TOP 750 CTS ACL TOP 750 LAS ACL TOP 550 CTS ACL TOP 350 CTS |
| Manufacturer | Instrumentation Laboratory Co. | Same |
| Product Code | GKP | Same |
| Regulation Section | 864.5400 | Same |
| Classification | Class II | Same |
| Regulation Description | Coagulation Instrument | Same |
| Similarities | ||
| Indications for Use | 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. | The ACL TOP Family 50 Series | |
| (ACL TOP 750, ACL TOP 750 CTS, | ||
| ACL TOP 750 LAS, ACL TOP 550 | ||
| CTS and ACL TOP 350 CTS) are | ||
| bench top, fully automated, | ||
| random access analyzers | ||
| 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 systems provide results for | ||
| both direct hemostasis | ||
| measurements and calculated | ||
| parameters. | ||
| Matrix | 3.2% Citrated Plasma | Same |
| Methodology | The ACL TOP Family performs the | |
| following types of tests: Coagulometric (Turbidimetric) | ||
| Measurements (405 nm or 671 nm) Chromogenic (Absorbance) | ||
| Measurements (405 nm) Immunological Measurements | ||
| (405 nm or 671 nm) | Same | |
| Test Menu | Clotting, chromogenic and | |
| immunological assays | Same | |
| Quality Control | Automated QC | Same |
| Comparison to Predicate (Cont.) | ||
| Item | Predicate | New Device |
| Trade Names | ACL TOP Family Models ACL TOP 700 (Base) ACL TOP 700 CTS ACL TOP 700 LAS ACL TOP 500 CTS ACL TOP 300 CTS | ACL TOP Family 50 Series Models ACL TOP 750 ACL TOP 750 CTS ACL TOP 750 LAS ACL TOP 550 CTS ACL TOP 350 CTS |
| Differences | ||
| Pre-Analytical HIL Check | Not Available | Standard for All Models |
| A third measurement wavelength | ||
| @535 nm and an additional | ||
| emitter control channel (all | ||
| models) have been introduced to | ||
| support this new feature. | ||
| Pre-Analytical Tube Fill Height | ||
| Check | Not Available | Standard for All Models |
| Pre-Analytical Clog Detection | Not Available | Standard for All Models |
| A pressure transducer (all models) | ||
| has been introduced to support | ||
| this new feature. | ||
| Software | Windows XP | Windows 7 |
| Not Applicable | Support for new features |
6
7
Precision Study – Internal
In compliance with CLSI EP05-A2, an internal 20-day precision study was performed on an ACL TOP 350 CTS, ACL TOP 550 CTS, ACL TOP 750 CTS and ACL TOP 750, using 12 representative commercially available assays and their assayed control materials, as well as a prepared patient plasma pool. All materials were tested in duplicate, twice a day for 20 days, for a total of 80 replicates per level for each assay on each instrument model as summarized below.
| HemosIL RecombiPlasTin 2G (K070005) | ||||
|---|---|---|---|---|
| Measurand: | Prothrombin Time (Seconds) | |||
| Model: | ACL TOP 350 CTS | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL | |||
| Abnormal Control | HemosIL High | |||
| Abnormal Control | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 0.7 | 0.9 | 0.8 | 1.0 |
| Total %CV (Observed) | 1.2 | 1.7 | 2.2 | 1.5 |
| Grand Mean (seconds) | 11.47 | 22.03 | 38.67 | 30.40 |
| Model: | ACL TOP 550 CTS | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL | |||
| Abnormal Control | HemosIL High | |||
| Abnormal Control | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 0.6 | 0.8 | 0.9 | 0.7 |
| Total %CV (Observed) | 1.4 | 2.4 | 3.0 | 1.8 |
| Grand Mean (seconds) | 11.59 | 22.21 | 38.82 | 30.79 |
| Model: | ACL TOP 750 CTS | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL | |||
| Abnormal Control | HemosIL High | |||
| Abnormal Control | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 0.6 | 0.9 | 0.9 | 0.7 |
| Total %CV (Observed) | 1.4 | 2.0 | 2.9 | 1.5 |
| Grand Mean (seconds) | 11.51 | 22.25 | 38.76 | 30.66 |
| Model: | ACL TOP 750 | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL | |||
| Abnormal Control | HemosIL High | |||
| Abnormal Control | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 0.6 | 1.0 | 0.6 | 0.8 |
| Total %CV (Observed) | 1.6 | 2.4 | 3.0 | 2.0 |
| Grand Mean (seconds) | 11.40 | 22.06 | 38.78 | 30.33 |
8
| HemosIL RecombiPlasTin 2G (K070005) | ||||
|---|---|---|---|---|
| Derived Fibrinogen (mg/dL) | ||||
| Measurand: | ||||
| Model: | ||||
| ACL TOP 350 CTS | ||||
| Sample | HemosIL | |||
| Normal Control | HemosIL Low | |||
| Abnormal Control | HemosIL Low | |||
| Fibrinogen Control | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.4 | 1.3 | 2.9 | 2.7 |
| Total %CV (Observed) | 1.8 | 1.7 | 3.7 | 3.3 |
| Grand Mean (mg/dL) | 323.8 | 144.1 | 137.6 | 385.4 |
| Model: | ACL TOP 550 CTS | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL Low | |||
| Abnormal Control | HemosIL Low | |||
| Fibrinogen Control | HemosIL | |||
| Normal Control | ||||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.0 | 1.3 | 4.0 | 2.1 |
| Total %CV (Observed) | ਹ ਤ | 1.7 | 4.4 | 2.2 |
| Grand Mean (mg/dL) | 320.8 | 143.6 | 137.0 | 379.2 |
| Model: | ACL TOP 750 CTS | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL Low | |||
| Abnormal Control | HemosIL Low | |||
| Fibrinogen Control | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.1 | 1.5 | 4.4 | 3.1 |
| Total %CV (Observed) | 1.4 | 1.8 | 4.8 | 3.6 |
| Grand Mean (mg/dL) | 323.7 | 144.4 | 141.1 | 389.0 |
| ACL TOP 750 | ||||
| Model: | ||||
| Sample | HemosIL | |||
| Normal Control | HemosIL Low | |||
| Abnormal Control | HemosIL Low | |||
| Fibrinogen Control | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.0 | 1.8 | 4.2 | 2.3 |
| Total %CV (Observed) | 1.5 | 1.9 | 4.2 | 2.3 |
| Grand Mean (mg/dL) | 320.1 | 139.8 | 133.9 | 384.4 |
9
Г
| HemosIL SynthASil (K060688) | ||||
|---|---|---|---|---|
| Measurand: APTT (Seconds) | ||||
| Model: | ACL TOP 350 CTS | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL Low | |||
| Abnormal Control | HemosIL High | |||
| Abnormal Control | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 0.7 | 0.8 | 0.60 | 1.4 |
| Total %CV (Observed) | 0.9 | 0.9 | 1.3 | 2.5 |
| Grand Mean (seconds) | 31.65 | 43.93 | 56.54 | 57.21 |
| Model: | ACL TOP 550 CTS | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL Low | |||
| Abnormal Control | HemosIL High | |||
| Abnormal Control | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.3 | 1.5 | 1.4 | 1.6 |
| Total %CV (Observed) | 1.4 | 1.6 | 1.7 | 2.0 |
| Grand Mean (seconds) | 32.09 | 44.60 | 57.65 | 58.46 |
| Model: | ACL TOP 750 CTS | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL Low | |||
| Abnormal Control | HemosIL High | |||
| Abnormal Control | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 0.8 | 0.9 | 1.1 | 1.2 |
| Total %CV (Observed) | 1.2 | 1.3 | 1.5 | 1.6 |
| Grand Mean (seconds) | 32.00 | 44.40 | 57.05 | 58.12 |
| Model: | ACL TOP 750 | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL Low | |||
| Abnormal Control | HemosIL High | |||
| Abnormal Control | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.3 | 1.2 | 1.5 | 1.7 |
| Total %CV (Observed) | 1.4 | 1.5 | 2.1 | 2.3 |
| Grand Mean (seconds) | 32.01 | 44.60 | 57.26 | 58.95 |
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| Precision Study - Internal (Cont.) | |
|---|---|
| HemosIL Fibrinogen-C (K073367) | |||
|---|---|---|---|
| Measurand: Fibrinogen Clauss (mg/dL) | |||
| Model: ACL TOP 350 CTS | |||
| Sample | HemosIL | ||
| Normal Control | HemosIL | ||
| Low Fibrinogen Control | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 3.7 | 3.4 | 2.5 |
| Total %CV (Observed) | 4.1 | 3.8 | 2.9 |
| Grand Mean (mg/dL) | 317.2 | 105.0 | 361.5 |
| Model: ACL TOP 550 CTS | |||
| Sample | HemosIL | ||
| Normal Control | HemosIL | ||
| Low Fibrinogen Control | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 2.9 | 5.5 | 2.3 |
| Total %CV (Observed) | 3.5 | 5.6 | 3.4 |
| Grand Mean (mg/dL) | 327.9 | 104.3 | 374.4 |
| Model: ACL TOP 750 CTS | |||
| Sample | HemosIL | ||
| Normal Control | HemosIL | ||
| Low Fibrinogen Control | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 2.4 | 4.8 | 2.2 |
| Total %CV (Observed) | 2.9 | 4.9 | 2.6 |
| Grand Mean (mg/dL) | 328.7 | 110.3 | 371.8 |
| Model: ACL TOP 750 | |||
| Sample | HemosIL | ||
| Normal Control | HemosIL | ||
| Low Fibrinogen Control | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 2.4 | 4.5 | 1.8 |
| Total %CV (Observed) | 2.7 | 4.6 | 2.4 |
| Grand Mean (mg/dL) | 324.6 | 106.9 | 368.8 |
11
Precision Study – Internal (Cont.)
T
| HemosIL D-Dimer (K073042) | |||
|---|---|---|---|
| Measurand: D-Dimer (ng/mL) | |||
| Model: ACL TOP 350 CTS | |||
| Sample | HemosIL | ||
| D-Dimer Low Control | HemosIL | ||
| D-Dimer High Control | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 3.9 | 2.9 | 8.5 |
| Total %CV (Observed) | 4.9 | 3.0 | 9.6 |
| Grand Mean (ng/mL) | 362.4 | 690.7 | 175.8 |
| Model: ACL TOP 550 CTS | |||
| Sample | HemosIL | ||
| D-Dimer Low Control | HemosIL | ||
| D-Dimer High Control | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 6.6 | 3.6 | 9.2 |
| Total %CV (Observed) | 7.1 | 3.7 | 11.4 |
| Grand Mean (ng/mL) | 367.6 | 698.1 | 175.0 |
| Model: ACL TOP 750 CTS | |||
| Sample | HemosIL | ||
| D-Dimer Low Control | HemosIL | ||
| D-Dimer High Control | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 4.3 | 2.5 | 6.1 |
| Total %CV (Observed) | 5.2 | 2.7 | 8.7 |
| Grand Mean (ng/mL) | 351.6 | 695.0 | 168.0 |
| Model: ACL TOP 750 | |||
| Sample | HemosIL | ||
| D-Dimer Low Control | HemosIL | ||
| D-Dimer High Control | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 4.5 | 3.1 | 9.7 |
| Total %CV (Observed) | 5.6 | 3.2 | 10.5 |
| Grand Mean (ng/mL) | 328.4 | 658.8 | 149.3 |
12
Г
| HemosIL Liquid Antithrombin (K062431) | ||||
|---|---|---|---|---|
| Measurand: Antithrombin (%) | ||||
| Model: ACL TOP 350 CTS | ||||
| Sample | HemosIL Normal Control | HemosIL Special Test Level 1 | HemosIL Special Test Level 2 | Plasma Pool |
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 2.5 | 4.1 | 8.9 | 2.4 |
| Total %CV (Observed) | 2.7 | 7.8 | 11.0 | 4.5 |
| Grand Mean (%) | 101.2 | 55.7 | 23.1 | 112.9 |
| Model: ACL TOP 550 CTS | ||||
| Sample | HemosIL Normal Control | HemosIL Special Test Level 1 | HemosIL Special Test Level 2 | Plasma Pool |
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 2.0 | 2.6 | 5.4 | 2.2 |
| Total %CV (Observed) | 2.8 | 5.4 | 7.9 | 4.0 |
| Grand Mean (%) | 103.5 | 58.6 | 28.4 | 114.9 |
| Model: ACL TOP 750 CTS | ||||
| Sample | HemosIL Normal Control | HemosIL Special Test Level 1 | HemosIL Special Test Level 2 | Plasma Pool |
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 2.0 | 2.5 | 6.6 | 2.0 |
| Total %CV (Observed) | 2.1 | 5.3 | 8.2 | 3.4 |
| Grand Mean (%) | 99.6 | 57.7 | 27.7 | 108.9 |
| Model: ACL TOP 750 | ||||
| Sample | HemosIL Normal Control | HemosIL Special Test Level 1 | HemosIL Special Test Level 2 | Plasma Pool |
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.6 | 2.0 | 6.6 | 1.6 |
| Total %CV (Observed) | 2.2 | 4.9 | 7.4 | 3.1 |
| Grand Mean (%) | 98.7 | 56.7 | 26.7 | 109.7 |
13
Г
| HemosIL Protein C (K062430) | ||||
|---|---|---|---|---|
| Measurand: Protein C (%) | ||||
| Model: | ACL TOP 350 CTS | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL Special | |||
| Test Level 1 | HemosIL Special | |||
| Test Level 2 | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.6 | 1.1 | 1.6 | 1.2 |
| Total %CV (Observed) | 2.1 | 2.2 | 2.2 | 1.8 |
| Grand Mean (%) | 100.6 | 59.1 | 26.8 | 119.2 |
| Model: | ACL TOP 550 CTS | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL Special | |||
| Test Level 1 | HemosIL Special | |||
| Test Level 2 | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.3 | 1.6 | 2.0 | 1.3 |
| Total %CV (Observed) | 1.6 | 2.1 | 2.3 | 2.2 |
| Grand Mean (%) | 101.3 | 59.1 | 25.9 | 120.2 |
| Model: | ACL TOP 750 CTS | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL Special | |||
| Test Level 1 | HemosIL Special | |||
| Test Level 2 | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.2 | 1.2 | 1.2 | 1.1 |
| Total %CV (Observed) | 1.4 | 1.9 | 2.3 | 1.7 |
| Grand Mean (%) | 99.3 | 58.7 | 27.1 | 117.8 |
| Model: | ACL TOP 750 | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL Special | |||
| Test Level 1 | HemosIL Special | |||
| Test Level 2 | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.5 | 1.3 | 1.9 | 1.5 |
| Total %CV (Observed) | 2.1 | 2.3 | 2.3 | 1.8 |
| Grand Mean (%) | 100.6 | 58.0 | 25.3 | 120.0 |
14
Г
| HemosIL Free Protein S (K010379) | ||||
|---|---|---|---|---|
| Measurand: | ||||
| Free Protein S (%) | ||||
| Model: | ACL TOP 350 CTS | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL Special | |||
| Test Level 1 | HemosIL Special | |||
| Test Level 2 | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.3 | 1.4 | 1.7 | 1.1 |
| Total %CV (Observed) | 2.2 | 2.6 | 3.2 | 2.6 |
| Grand Mean (%) | 94.64 | 59.56 | 28.47 | 85.12 |
| Model: | ACL TOP 550 CTS | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL Special | |||
| Test Level 1 | HemosIL Special | |||
| Test Level 2 | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.1 | 1.4 | 1:5 | 0.9 |
| Total %CV (Observed) | 2.8 | 2.8 | 2.8 | 2.6 |
| Grand Mean (%) | 93.76 | 59.21 | 28.48 | 84.65 |
| Model: | ACL TOP 750 CTS | |||
| Sample | HemosIL | |||
| Normal Control | HemosIL Special | |||
| Test Level 1 | HemosIL Special | |||
| Test Level 2 | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 0.8 | 1.4 | 1.8 | 0.8 |
| Total %CV (Observed) | 2.7 | 2.8 | 2.8 | 2.2 |
| Grand Mean (%) | 97.87 | 60.97 | 29.03 | 87.68 |
| Model: | ||||
| ACL TOP 750 | ||||
| Sample | HemosIL | |||
| Normal Control | HemosIL Special | |||
| Test Level 1 | HemosIL Special | |||
| Test Level 2 | Plasma Pool | |||
| N | 80 | 80 | 80 | 80 |
| Within-run %CV (Observed) | 0.8 | 1.0 | 1.6 | 1.0 |
| Total %CV (Observed) | 2.6 | 2.4 | 2.8 | 2.6 |
| Grand Mean (%) | 96.10 | 59.81 | 28.10 | 86.95 |
15
| HemosIL Factor V Deficient Plasma (K023839) with HemosIL RecombiPlasTin 2G (K070005) | |||
|---|---|---|---|
| Measurand: Factor V (%) | |||
| Model: | ACL TOP 350 CTS | ||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 3.8 | 2.9 | 3.8 |
| Total %CV (Observed) | 5.1 | 5.6 | 10.1 |
| Grand Mean (%) | 109.33 | 28.27 | 7.51 |
| Model: | ACL TOP 550 CTS | ||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 4.0 | 3.2 | 4.5 |
| Total %CV (Observed) | 5.8 | 5.8 | 9.1 |
| Grand Mean (%) | 110.04 | 27.32 | 7.79 |
| Model: | ACL TOP 750 CTS | ||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 2.6 | 2.5 | 2.6 |
| Total %CV (Observed) | 4.8 | 5.3 | 8.6 |
| Grand Mean (%) | 108.18 | 28.90 | 7.86 |
| Model: | ACL TOP 750 | ||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.9 | 1.8 | 2.1 |
| Total %CV (Observed) | 3.9 | 4.7 | 8.3 |
| Grand Mean (%) | 108.65 | 28.86 | 7.80 |
16
| HemosIL Factor VII Deficient Plasma (K024082) with HemosIL RecombiPlasTin 2G (K070005) | |||
|---|---|---|---|
| Measurand: | |||
| Factor VII (%) | |||
| Model: | ACL TOP 350 CTS | ||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 3.9 | 5.4 | 5.0 |
| Total %CV (Observed) | 4.2 | 5.9 | 6.2 |
| Grand Mean (%) | 86.69 | 18.39 | 11.73 |
| Model: | ACL TOP 550 CTS | ||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 3.9 | 4.8 | 5.5 |
| Total %CV (Observed) | 4.2 | 5.4 | 6.0 |
| Grand Mean (%) | 87.70 | 18.40 | 11.89 |
| Model: | ACL TOP 750 CTS | ||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 2.5 | 3.0 | 2.9 |
| Total %CV (Observed) | 3.2 | 4.9 | 5.1 |
| Grand Mean (%) | 83.59 | 19.27 | 12.36 |
| Model: | ACL TOP 750 | ||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 1.6 | 1.7 | 2.3 |
| Total %CV (Observed) | 3.2 | 4.0 | 4.4 |
| Grand Mean (%) | 86.33 | 20.01 | 12.91 |
17
| HemosIL Factor VIII Deficient Plasma (K034007) with HemosIL SynthASil (K060688) | |||
|---|---|---|---|
| Measurand: Factor VIII (%) | |||
| Model: | ACL TOP 350 CTS | ||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 3.4 | 3.3 | 3.8 |
| Total %CV (Observed) | 3.9 | 4.2 | 7.6 |
| Grand Mean (%) | 87.66 | 24.39 | 6.91 |
| Model: | ACL TOP 550 CTS | ||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 3.9 | 4.0 | 4.9 |
| Total %CV (Observed) | 5.3 | 5.7 | 7.9 |
| Grand Mean (%) | 85.10 | 22.75 | 6.68 |
| Model: | ACL TOP 750 CTS | ||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 3.3 | 3.3 | 3.1 |
| Total %CV (Observed) | 4.1 | 4.7 | 6.8 |
| Grand Mean (%) | 86.49 | 24.60 | 7.09 |
| Model: | ACL TOP 750 | ||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 2.2 | 3.4 | 3.6 |
| Total %CV (Observed) | 3.9 | 4.2 | 6.4 |
| Grand Mean (%) | 86.42 | 25.82 | 7.35 |
18
| HemosIL Factor IX Deficient Plasma (K031829) with HemosIL SynthASil (K060688) | |||
|---|---|---|---|
| Measurand: | |||
| Factor IX (%) | |||
| ACL TOP 350 CTS | |||
| Model: | |||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 3.8 | 3.0 | 3.5 |
| Total %CV (Observed) | 4.6 | 4.0 | 4.6 |
| Grand Mean (%) | 110.40 | 29.44 | 10.14 |
| Model: | ACL TOP 550 CTS | ||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 4.9 | 3.8 | 4.6 |
| Total %CV (Observed) | 6:5 | 4.8 | 5.8 |
| Grand Mean (%) | 107.06 | 29.03 | 10.74 |
| Model: | ACL TOP 750 CTS | ||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 3.9 | 4.3 | 3.7 |
| Total %CV (Observed) | 4.2 | 4.8 | 4.6 |
| Grand Mean (%) | 110.50 | 31.39 | 11.45 |
| ACL TOP 750 | |||
| Model: | |||
| Sample | HemosIL | ||
| Normal Control | HemosIL Special | ||
| Test Level 2 | Plasma Pool | ||
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 2.5 | 3.2 | 2.9 |
| Total %CV (Observed) | 2.9 | 3.6 | 4.5 |
| Grand Mean (%) | 108.72 | 31.29 | 11.64 |
19
Linearity Study – Internal
An internal linearity study was performed on an ACL TOP 350 CTS, ACL TOP 550 CTS, ACL TOP 750 CTS and ACL TOP 750, using 10 representative commercially available assays* and prepared plasma pool panels at a minimum of 9 levels. Each of the different panel levels was tested in quadruplicate on each instrument model with the resultant data supporting equivalent linearity range claims to the current ACL TOP Family.
| HemosIL RecombiPlasTin 2G (K070005) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Derived Fibrinogen (mg/dL) | ||||||||
| Measurand: | ||||||||
| Instrument Model | ACL TOP 350 CTS | ACL TOP 550 CTS | ACL TOP 750 CTS | ACL TOP 750 | ||||
| Slope | 1.0222 | 1.0152 | 1.0147 | 1.015 | ||||
| Y-Intercept | 15.296 | 13.272 | 15.901 | 16.143 | ||||
| r² | 0.9894 | 0.9927 | 0.991 | 0.991 | ||||
| Range (mg/dL) | 59-722 | 54-754 | 60-731 | 58-732 | ||||
| HemosIL Fibrinogen-C (K073367) | ||||||||
| Fibrinogen Clauss (mg/dL) | ||||||||
| Measurand: | ||||||||
| Instrument Model | ACL TOP 350 CTS | ACL TOP 550 CTS | ACL TOP 750 CTS | ACL TOP 750 | ||||
| Slope | 1.0529 | 1.0832 | 1.0691 | 1.0804 | ||||
| Y-Intercept | 8.1556 | 1.5763 | 5.1815 | 5.3006 | ||||
| r2 | 0.9913 | 0.9891 | 0.9873 | 0.987 | ||||
| Range (mg/dL) | 27-1207 | 30-1216 | 26-1165 | 30-1154 | ||||
| HemosIL D-Dimer (K073042) | ||||||||
| Measurand: | D-Dimer (ng/mL) | |||||||
| Instrument Model | ACL TOP 350 CTS | ACL TOP 550 CTS | ACL TOP 750 CTS | ACL TOP 750 | ||||
| Slope | 0.9898 | 1.0195 | 1.0312 | 1.0217 | ||||
| Y-Intercept | 143.83 | 93.588 | 83.203 | 74.254 | ||||
| r² | 0.9781 | 0.9838 | 0.9837 | 0.9877 | ||||
| Range (ng/mL) | 133-5415 | 122-5362 | 106-5383 | 95-5296 |
*NOTE: Linearity is not applicable to PT and APTT assays.
20
| HemosIL Liquid Antithrombin (K062431) | ||||
|---|---|---|---|---|
| Measurand: | Antithrombin (%) | |||
| Instrument Model | ACL TOP 350 CTS | ACL TOP 550 CTS | ACL TOP 750 CTS | ACL TOP 750 |
| Slope | 0.9427 | 0.996 | 0.968 | 0.9652 |
| Y-Intercept | 3.4053 | -1.3815 | 0.6826 | 0.6046 |
| r2 | 0.9987 | 0.9997 | 0.9971 | 0.9993 |
| Range (%) | 9.3-158.0 | 6.0-152.0 | 6.5-157.8 | 6.8-159.0 |
| HemosIL Protein C (K062430) | ||||
| Measurand: | Protein C (%) | |||
| Instrument Model | ACL TOP 350 CTS | ACL TOP 550 CTS | ACL TOP 750 CTS | ACL TOP 750 |
| Slope | 0.9956 | 1.0043 | 0.9972 | 1.0049 |
| Y-Intercept | -1.1765 | -2.6449 | -2.3988 | -1.4761 |
| r2 | 0.9991 | 0.9991 | 0.9991 | 0.9995 |
| Range (%) | 5.5-160.5 | 4.0-158.8 | 4.5-163.8 | 5.8-166.5 |
| HemosIL Free Protein S (K010379) | ||||
| Measurand: | Free Protein S (%) | |||
| Instrument Model | ACL TOP 350 CTS | ACL TOP 550 CTS | ACL TOP 750 CTS | ACL TOP 750 |
| Slope | 1.03 | 1.0461 | 1.0414 | 1.0455 |
| Y-Intercept | -4.8376 | -6.169 | -6.0499 | -6.4417 |
| r2 | 0.9983 | 0.9963 | 0.9974 | 0.998 |
| Range (%) | 10.4-325.3 | 9.8-318.1 | 9.7-309.1 | 9.3-309.8 |
| HemosIL Factor V Deficient Plasma (K023839) with HemosIL RecombiPlasTin 2G (K070005) | ||||
| Measurand: | Factor V (%) | |||
| Instrument Model | ACL TOP 350 CTS | ACL TOP 550 CTS | ACL TOP 750 CTS | ACL TOP 750 |
| Slope | 0.974 | 0.972 | 0.924 | 0.9328 |
| Y-Intercept | 0.1607 | 0.4778 | 3.0972 | 3.6627 |
| r2 | 0.9991 | 0.9984 | 0.9966 | 0.9969 |
| Range (%) | 0.4-157.6 | 0.3-151.2 | 0.3-159.6 | 0.3-154.3 |
| HemosIL Factor VII Deficient Plasma (K024082) with HemosIL RecombiPlasTin 2G (K070005) | ||||
| Measurand: | Factor VII (%) | |||
| Instrument Model | ACL TOP 350 CTS | ACL TOP 550 CTS | ACL TOP 750 CTS | ACL TOP 750 |
| Slope | 0.9533 | 0.9698 | 0.9233 | 0.9136 |
| Y-Intercept | 1.4091 | 3.1770 | 4.4044 | 4.5945 |
| r2 | 0.9987 | 0.9972 | 0.9965 | 0.9962 |
| Range (%) | 0.3-159.5 | 0.4-170.0 | 0.2-163.2 | 0.3-159.6 |
21
Linearity Study – Internal (Cont.)
| HemosIL Factor VIII Deficient Plasma (K034007) with HemosIL SynthASil (K060688) | ||||
|---|---|---|---|---|
| Measurand: Factor VIII (%) | ||||
| Instrument Model | ACL TOP 350 CTS | ACL TOP 550 CTS | ACL TOP 750 CTS | ACL TOP 750 |
| Slope | 0.9842 | 1.0597 | 0.9903 | 0.9586 |
| Y-Intercept | -0.8923 | -2.4208 | 0.3118 | 2.1453 |
| r² | 0.9991 | 0.999 | 0.9992 | 0.9969 |
| Range (%) | 0.2-151.6 | 0.3-159.9 | 0.1-160.5 | 0.3-150.6 |
| HemosIL Factor IX Deficient Plasma (K031829) with HemosIL SynthASil (K060688) | ||||
| Measurand: Factor IX (%) | ||||
| Instrument Model | ACL TOP 350 CTS | ACL TOP 550 CTS | ACL TOP 750 CTS | ACL TOP 750 |
| Slope | 0.9979 | 0.9913 | 0.9719 | 0.9999 |
| Y-Intercept | -1.7626 | -1.7805 | 0.6774 | -0.8352 |
| r² | 0.9993 | 0.9977 | 0.9989 | 0.9996 |
| Range (%) | 0.2-161.8 | 0.3-163.0 | 0.5-158.1 | 0.5-153.4 |
22
Precision Study – External
An external 20-day precision study was performed at the same three US external sites on an ACL TOP 550 CTS by three different operators, using 11 representative commercially available assays each with two levels of assayed control materials were tested in duplicate, twice a day for 20 days, for a total of 80 replicates per level for each assay on each model as summarized below.
- NOTE: Precision data for derived fibrinogen with HemosIL RecombiPlasTin 2G were not collected under the scope of this study
| External Site No. 1 | ||||||
|---|---|---|---|---|---|---|
| Assay | Measurand | Control | N | Mean | Within-run | |
| CV% | Total | |||||
| CV% | ||||||
| HemosIL RecombiPlasTin 2G | ||||||
| (K070005) | Prothrombin | |||||
| Time (seconds) | HemosIL Normal Control | |||||
| HemosIL High Abnormal | 80 | |||||
| 80 | 11.5 | |||||
| 40.8 | 1.0% | |||||
| 1.4% | 1.6% | |||||
| 3.5% | ||||||
| HemosIL SynthASil | ||||||
| (K060688) | APTT | |||||
| (Seconds) | HemosIL Normal Control | |||||
| HemosIL High Abnormal | 80 | |||||
| 80 | 29.9 | |||||
| 52.5 | 1.0% | |||||
| 1.4% | 1.2% | |||||
| 1.9% | ||||||
| HemosIL Fibrinogen-C | ||||||
| (K073367) | Fibrinogen | |||||
| Clauss (mg/dL) | HemosIL Normal Control | |||||
| HemosIL Low Fibrinogen | 80 | |||||
| 80 | 264 | |||||
| 90 | 4.3% | |||||
| 4.3% | 4.5% | |||||
| 4.7% | ||||||
| HemosIL D-Dimer | ||||||
| (K073042) | D-Dimer | |||||
| (ng/mL) | HemosIL D-Dimer Low | |||||
| HemosIL D-Dimer High | 80 | |||||
| 80 | 344 | |||||
| 739 | 6.9% | |||||
| 2.8% | 11.2% | |||||
| 4.4% | ||||||
| HemosIL Liquid Antithrombin | ||||||
| (K062431) | Antithrombin | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 100 | |||||
| 23 | 2.1% | |||||
| 6.0% | 2.5% | |||||
| 7.7% | ||||||
| HemosIL Protein C | ||||||
| (K062430) | Protein C | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 99 | |||||
| 26 | 1.4% | |||||
| 3.8% | 2.3% | |||||
| 4.0% | ||||||
| HemosIL Free Protein S | ||||||
| (K010379) | Free Protein S | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 99 | |||||
| 30 | 1.9% | |||||
| 3.0% | 6.3% | |||||
| 9.1% | ||||||
| HemosIL Factor V Deficient | ||||||
| Plasma (K023839) with | ||||||
| HemosIL RecombiPlasTin 2G | ||||||
| (K070005) | Factor V | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 102 | |||||
| 32 | 3.6% | |||||
| 4.5% | 6.7% | |||||
| 6.7% | ||||||
| HemosIL Factor VII Deficient | ||||||
| Plasma (K024082) with | ||||||
| HemosIL RecombiPlasTin 2G | ||||||
| (K070005) | Factor VII | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 103 | |||||
| 26 | 3.2% | |||||
| 3.8% | 4.7% | |||||
| 5.7% | ||||||
| HemosIL Factor VIII Deficient | ||||||
| Plasma (K034007) with | ||||||
| HemosIL SynthASil (K060688) | Factor VIII | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 87 | |||||
| 25 | 4.5% | |||||
| 4.0% | 9.1% | |||||
| 12.6% | ||||||
| HemosIL Factor IX Deficient | ||||||
| Plasma (K031829) with | ||||||
| HemosIL SynthASil (K060688) | Factor IX | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 102 | |||||
| 31 | 4.7% | |||||
| 9.2% | 8.4% | |||||
| 10.1% |
23
| External Site No. 2 | ||||||
|---|---|---|---|---|---|---|
| Assay | Measurand | Control | N | Mean | Within-run | |
| CV% | Total | |||||
| CV% | ||||||
| HemosIL RecombiPlasTin 2G | ||||||
| (K070005) | Prothrombin | |||||
| Time (seconds) | HemosIL Normal Control | |||||
| HemosIL High Abnormal | 80 | |||||
| 80 | 11.4 | |||||
| 38.7 | 1.7% | |||||
| 1.5% | 2.3% | |||||
| 3.2% | ||||||
| HemosIL SynthASil | ||||||
| (K060688) | APTT | |||||
| (Seconds) | HemosIL Normal Control | |||||
| HemosIL High Abnormal | 80 | |||||
| 80 | 30.5 | |||||
| 55.9 | 1.6% | |||||
| 1.6% | 1.8% | |||||
| 1.8% | ||||||
| HemosIL Fibrinogen-C | ||||||
| (K073367) | Fibrinogen | |||||
| Clauss (mg/dL) | HemosIL Normal Control | |||||
| HemosIL Low Fibrinogen | 80 | |||||
| 80 | 285 | |||||
| 94 | 3.6% | |||||
| 3.2% | 4.4% | |||||
| 4.7% | ||||||
| HemosIL D-Dimer | ||||||
| (K073042) | D-Dimer | |||||
| (ng/mL) | HemosIL D-Dimer Low | |||||
| HemosIL D-Dimer High | 80 | |||||
| 80 | 333 | |||||
| 712 | 5.0% | |||||
| 2.6% | 7.5% | |||||
| 5.1% | ||||||
| HemosIL Liquid Antithrombin | ||||||
| (K062431) | Antithrombin | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 93 | |||||
| 25 | 1.7% | |||||
| 6.1% | 3.1% | |||||
| 9.0% | ||||||
| HemosIL Protein C | ||||||
| (K062430) | Protein C | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 93 | |||||
| 24 | 1.5% | |||||
| 1.8% | 2.5% | |||||
| 3.1% | ||||||
| HemosIL Free Protein S | ||||||
| (K010379) | Free Protein S | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 92 | |||||
| 29 | 2.4% | |||||
| 3.1% | 5.8% | |||||
| 6.0% | ||||||
| HemosIL Factor V Deficient | ||||||
| Plasma (K023839) with | ||||||
| HemosIL RecombiPlasTin 2G | ||||||
| (K070005) | Factor V | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 97 | |||||
| 30 | 5.3% | |||||
| 5.1% | 7.3% | |||||
| 6.9% | ||||||
| HemosIL Factor VII Deficient | ||||||
| Plasma (K024082) with | ||||||
| HemosIL RecombiPlasTin 2G | ||||||
| (K070005) | Factor VII | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 90 | |||||
| 23 | 3.2% | |||||
| 3.1% | 5.5% | |||||
| 6.2% | ||||||
| HemosIL Factor VIII Deficient | ||||||
| Plasma (K034007) with | ||||||
| HemosIL SynthASil (K060688) | Factor VIII | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 84 | |||||
| 26 | 3.1% | |||||
| 3.9% | 6.4% | |||||
| 7.8% | ||||||
| HemosIL Factor IX Deficient | ||||||
| Plasma (K031829) with | ||||||
| HemosIL SynthASil (K060688) | Factor IX | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 101 | |||||
| 31 | 4.9% | |||||
| 4.8% | 7.8% | |||||
| 7.7% |
24
| External Site No. 3 | ||||||
|---|---|---|---|---|---|---|
| Assay | Measurand | Control | N | Mean | Within-run | |
| CV% | Total | |||||
| CV% | ||||||
| HemosIL RecombiPlasTin 2G | Prothrombin | HemosIL Normal Control | 80 | । 1 | 1.1% | 2.5% |
| (K070005) | Time (seconds) | HemosIL High Abnormal | 80 | ਤੇ ਰੋ | 4.8% | 5.4% |
| HemosIL SynthASil | APTT | HemosIL Normal Control | 80 | 31 | 1.3% | 2.2% |
| (K060688) | (Seconds) | HemosIL High Abnormal | 80 | 54 | 1.8% | 2.1% |
| HemosIL Fibrinogen-C | Fibrinogen | HemosIL Normal Control | 80 | 320 | 3.0% | 4.6% |
| (K073367) | Clauss (mg/dL) | HemosIL Low Fibrinogen | 80 | 102 | 3.6% | 6.3% |
| HemosIL D-Dimer | D-Dimer | HemosIL D-Dimer Low | 80 | 398 | 4.5% | 6.1% |
| (K073042) | (ng/mL) | HemosIL D-Dimer High | 80 | 725 | 3.8% | 5.6% |
| HemosIL Liquid Antithrombin | Antithrombin | HemosIL Normal Control | 80 | ਰੇਖ | 2.3% | 3.7% |
| (K062431) | (%) | Special Test Level 2 | 80 | 22 | 5.1% | 7.4% |
| HemosIL Protein C | Protein C | HemosIL Normal Control | 80 | ਰੇਖ | 1.8% | 3.3% |
| (K062430) | (%) | Special Test Level 2 | 80 | 24 | 2.7% | 3.8% |
| HemosIL Free Protein S | Free Protein S | HemosIL Normal Control | 80 | ਰੇਟ | 3.8% | 4.3% |
| (K010379) | (%) | Special Test Level 2 | 80 | 28 | 2.0% | 3.5% |
| HemosIL Factor V Deficient | ||||||
| Plasma (K023839) with | ||||||
| HemosIL RecombiPlasTin 2G | ||||||
| (K070005) | Factor V | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 100 | |||||
| 32 | 4.1% | |||||
| 3.7% | 7.5% | |||||
| 9.6% | ||||||
| HemosIL Factor VII Deficient | ||||||
| Plasma (K024082) with | ||||||
| HemosIL RecombiPlasTin 2G | ||||||
| (K070005) | Factor VII | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 81 | |||||
| 21 | 2.7% | |||||
| 2.2% | 8.0% | |||||
| 7.3% | ||||||
| HemosIL Factor VIII Deficient | ||||||
| Plasma (K034007) with | ||||||
| HemosIL SynthASil (K060688) | Factor VIII | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | ਰੇਖ | |||||
| 28 | 2.3% | |||||
| 3.1% | 5.4% | |||||
| 4.7% | ||||||
| HemosIL Factor IX Deficient | ||||||
| Plasma (K031829) with | ||||||
| HemosIL SynthASil (K060688) | Factor IX | |||||
| (%) | HemosIL Normal Control | |||||
| Special Test Level 2 | 80 | |||||
| 80 | 107 | |||||
| 34 | 3.5% | |||||
| 4.1% | 4.8% | |||||
| 5.2% |
25
Reproducibility Study - External
An external 5-day precision study was performed at three US sites on an ACL TOP 550 CTS by three different operators, using the same lot of 12 representative commercially available assays, each with two lot of assayed control materials. All materials were tested in triplicate, twice a day for 5 days, for a total of 30 replicates per level for each assay on each model as summarized below.
| Level (unit) | N | Mean | Status | With-in Run | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Site | Measurand | %CV | Spec (%CV) | Status | %CV | Spec (%CV) | Status | ||||
| Site 1 | PT | Normal Ctrl (Sec) | 30 | 11.28 | PASS | 0.7% | $\le$ 3.0% | Pass | 1.9% | $\le$ 3.0% | Pass |
| Site 2 | 30 | 11.33 | PASS | 0.7% | $\le$ 3.0% | Pass | 1.9% | $\le$ 3.0% | Pass | ||
| Site 3 | 30 | 11.45 | PASS | 0.6% | $\le$ 3.0% | Pass | 1.1% | $\le$ 3.0% | Pass | ||
| Site 1 | PT | Abnormal Ctrl (Sec) | 30 | 38.50 | PASS | 2.1% | $\le$ 5.0% | Pass | 4.4% | $\le$ 8.0% | Pass |
| Site 2 | 30 | 40.50 | PASS | 2.1% | $\le$ 5.0% | Pass | 3.7% | $\le$ 8.0% | Pass | ||
| Site 3 | 30 | 39.83 | PASS | 1.8% | $\le$ 5.0% | Pass | 2.5% | $\le$ 8.0% | Pass | ||
| Site 1 | Derived Fib | Normal Ctrl (mg/dL) | 30 | 324.0 | PASS | 1.2% | $\le$ 15.0% | Pass | 2.4% | $\le$ 15.0% | Pass |
| Site 2 | 30 | 329.3 | PASS | 1.0% | $\le$ 15.0% | Pass | 1.1% | $\le$ 15.0% | Pass | ||
| Site 3 | 30 | 337.5 | PASS | 0.7% | $\le$ 15.0% | Pass | 2.5% | $\le$ 15.0% | Pass | ||
| Site 1 | Derived Fib | Low Fib Ctrl (mg/dL) | 30 | 140.4 | PASS | 2.9% | $\le$ 15.0% | Pass | 3.8% | $\le$ 15.0% | Pass |
| Site 2 | 30 | 145.4 | PASS | 3.7% | $\le$ 15.0% | Pass | 3.9% | $\le$ 15.0% | Pass | ||
| Site 3 | 30 | 151.7 | PASS | 2.9% | $\le$ 15.0% | Pass | 3.0% | $\le$ 15.0% | Pass | ||
| Site 1 | APTT | NormalCtrl (Sec) | 30 | 31.01 | PASS | 1.2% | $\le$ 2.5% | Pass | 1.2% | $\le$ 3.5% | Pass |
| Site 2 | 30 | 30.62 | PASS | 1.3% | $\le$ 2.5% | Pass | 1.4% | $\le$ 3.5% | Pass | ||
| Site 3 | 30 | 30.52 | PASS | 0.9% | $\le$ 2.5% | Pass | 1.3% | $\le$ 3.5% | Pass | ||
| Site 1 | APTT | Abnormal Ctrl (Sec) | 30 | 55.55 | PASS | 1.4% | $\le$ 4.0% | Pass | 1.6% | $\le$ 5.0% | Pass |
| Site 2 | 30 | 55.58 | PASS | 1.3% | $\le$ 4.0% | Pass | 1.5% | $\le$ 5.0% | Pass | ||
| Site 3 | 30 | 54.99 | PASS | 1.7% | $\le$ 4.0% | Pass | 1.8% | $\le$ 5.0% | Pass | ||
| Site 1 | Fib-C | Normal Ctrl (mg/dL) | 30 | 310.1 | PASS | 4.8% | $\le$ 8.0% | Pass | 4.8% | $\le$ 10.0% | Pass |
| Site 2 | 30 | 327.0 | PASS | 3.0% | $\le$ 8.0% | Pass | 4.5% | $\le$ 10.0% | Pass | ||
| Site 3 | 30 | 321.3 | PASS | 2.9% | $\le$ 8.0% | Pass | 4.4% | $\le$ 10.0% | Pass | ||
| Site 1 | Fib-C | Low Fib Ctrl (mg/dL) | 30 | 100.2 | PASS | 3.7% | $\le$ 8.0% | Pass | 4.2% | $\le$ 10.0% | Pass |
| Site 2 | 30 | 105.8 | PASS | 5.2% | $\le$ 8.0% | Pass | 5.9% | $\le$ 10.0% | Pass | ||
| Site 3 | 30 | 106.6 | PASS | 3.3% | $\le$ 8.0% | Pass | 5.3% | $\le$ 10.0% | Pass |
26
Reproducibility Study – External (Cont.)
| | | | N | Mean | Status | %CV | | With-in Run
Spec (%CV) | Status | %CV | | Total
Spec (%CV) | Status |
|--------|----------------|--------------------------|----|-------|--------|------|---|---------------------------|--------|------|---|---------------------|--------|
| Site | Measurand | Level (unit) | | | | | | | | | | | |
| Site 1 | D-Dimer | D-Dimer High (ng/mL) | 30 | 710.1 | PASS | 3.3% | ≤ | 8.0% | Pass | 3.4% | ≤ | 10.0% | Pass |
| Site 2 | | D-Dimer High (ng/mL) | 30 | 723 | PASS | 3.6% | ≤ | 8.0% | Pass | 4.0% | ≤ | 10.0% | Pass |
| Site 3 | | D-Dimer High (ng/mL) | 30 | 748.8 | PASS | 3.6% | ≤ | 8.0% | Pass | 3.6% | ≤ | 10.0% | Pass |
| Site 1 | D-Dimer | D-Dimer Low (ng/mL) | 29 | 355.9 | PASS | 4.9% | ≤ | 10.0% | Pass | 5.8% | ≤ | 12.0% | Pass |
| Site 2 | | D-Dimer Low (ng/mL) | 30 | 361.3 | PASS | 4.2% | ≤ | 10.0% | Pass | 5.6% | ≤ | 12.0% | Pass |
| Site 3 | | D-Dimer Low (ng/mL) | 30 | 397.3 | PASS | 4.6% | ≤ | 10.0% | Pass | 4.8% | ≤ | 12.0% | Pass |
| Site 1 | Antithrombin | Normal Ctrl (%) | 30 | 96.5 | PASS | 1.7% | ≤ | 6.0% | Pass | 2.0% | ≤ | 8.0% | Pass |
| Site 2 | | Normal Ctrl (%) | 30 | 97.6 | PASS | 1.9% | ≤ | 6.0% | Pass | 2.1% | ≤ | 8.0% | Pass |
| Site 3 | | Normal Ctrl (%) | 30 | 94.5 | PASS | 1.3% | ≤ | 6.0% | Pass | 2.8% | ≤ | 8.0% | Pass |
| Site 1 | Antithrombin | Special Ctrl Level 2 (%) | 30 | 23.4 | PASS | 7.1% | ≤ | 15.0% | Pass | 7.6% | ≤ | 15.0% | Pass |
| Site 2 | | Special Ctrl Level 2 (%) | 30 | 21.9 | PASS | 6.8% | ≤ | 15.0% | Pass | 7.2% | ≤ | 15.0% | Pass |
| Site 3 | | Special Ctrl Level 2 (%) | 30 | 22.2 | PASS | 5.9% | ≤ | 15.0% | Pass | 6.2% | ≤ | 15.0% | Pass |
| Site 1 | Protein C | Normal Ctrl (%) | 30 | 97.2 | PASS | 1.6% | ≤ | 5.0% | Pass | 1.8% | ≤ | 6.0% | Pass |
| Site 2 | | Normal Ctrl (%) | 30 | 98.2 | PASS | 1.3% | ≤ | 5.0% | Pass | 2.1% | ≤ | 6.0% | Pass |
| Site 3 | | Normal Ctrl (%) | 30 | 97.6 | PASS | 1.4% | ≤ | 5.0% | Pass | 3.0% | ≤ | 6.0% | Pass |
| Site 1 | Protein C | Special Ctrl Level 2 (%) | 30 | 23.9 | PASS | 1.9% | ≤ | 10.0% | Pass | 2.5% | ≤ | 12.0% | Pass |
| Site 2 | | Special Ctrl Level 2 (%) | 30 | 24.7 | PASS | 2.1% | ≤ | 10.0% | Pass | 2.5% | ≤ | 12.0% | Pass |
| Site 3 | | Special Ctrl Level 2 (%) | 30 | 24.4 | PASS | 1.8% | ≤ | 10.0% | Pass | 3.1% | ≤ | 12.0% | Pass |
| Site 1 | Free Protein S | Normal Ctrl (%) | 30 | 95.94 | PASS | 1.4% | ≤ | 6.0% | Pass | 2.3% | ≤ | 8.0% | Pass |
| Site 2 | | Normal Ctrl (%) | 30 | 97.53 | PASS | 1.4% | ≤ | 6.0% | Pass | 2.2% | ≤ | 8.0% | Pass |
| Site 3 | | Normal Ctrl (%) | 30 | 96.94 | PASS | 1.3% | ≤ | 6.0% | Pass | 2.1% | ≤ | 8.0% | Pass |
| Site 1 | Free Protein S | Special Ctrl Level 2 (%) | 30 | 25.09 | PASS | 3.4% | ≤ | 10.0% | Pass | 3.4% | ≤ | 12.0% | Pass |
| Site 2 | | Special Ctrl Level 2 (%) | 30 | 25.44 | PASS | 2.1% | ≤ | 10.0% | Pass | 2.6% | ≤ | 12.0% | Pass |
| Site 3 | | Special Ctrl Level 2 (%) | 30 | 24.23 | PASS | 2.6% | ≤ | 10.0% | Pass | 3.8% | ≤ | 12.0% | Pass |
27
Reproducibility Study – External (Cont.)
| Site | Measurand | Level (unit) | N | Mean | Status | With-in Run | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| %CV | Spec (%CV) | Status | %CV | Spec (%CV) | Status | ||||||||
| Site 1 | Factor V | Normal Ctrl (%) | 30 | 95.01 | PASS | 3.3% |