ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
Device Facts
| Record ID | K150877 |
|---|---|
| Device Name | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS |
| Applicant | Instrumentation Laboratory CO |
| Product Code | GKP · Hematology |
| Decision Date | Dec 13, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5400 |
| Device Class | Class 2 |
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.
Device Story
The ACL TOP Family 50 Series are fully automated, random-access, benchtop coagulation analyzers for clinical hemostasis laboratories. They process citrated plasma samples to perform coagulometric (turbidimetric), chromogenic (absorbance), and immunological assays. The systems utilize optical measurement wavelengths to provide direct and calculated hemostasis results. New pre-analytical features include: an HIL (Hemolysis, Icterus, Lipemia) check using a 535 nm wavelength and emitter control channel; a Tube Fill Height (TFH) check to screen sample volume; and a clog detection system using a pressure transducer. These features flag potential issues for operator review but do not replace laboratory quality policies or package insert interference data. The devices are operated by laboratory personnel. Output is used by clinicians to assess patient thrombosis and hemostasis status.
Clinical Evidence
Bench testing only. Method comparison studies (n=244-304 per interferent) compared ACL TOP 50 series against HemoCue (hemoglobin) and Envoy 500 (bilirubin), showing strong correlation (r > 0.90, slopes 0.96-1.06). Precision/reproducibility studies (20-day, 80 replicates/level) confirmed performance across 12 representative assays. Linearity (9 levels) and carryover studies passed acceptance criteria. Clog and fill-height detection features verified internally.
Technological Characteristics
Benchtop, fully automated, random-access coagulation analyzer. Optical measurement (turbidimetric, absorbance). Features: 535 nm wavelength for HIL check, pressure transducer for clog detection. Connectivity: Windows 7-based software. Consumables, reagents, and calibrators are identical to the predicate ACL TOP Family.
Indications for Use
Indicated for in vitro diagnostic use in hemostasis laboratories for coagulation and fibrinolysis testing to assess thrombosis and hemostasis in patients requiring such clinical evaluation.
Regulatory Classification
Identification
A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.
Special Controls
*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.
Predicate Devices
Reference Devices
- HemosIL RecombiPlasTin 2G (K070005)
- HemosIL SynthASil (K060688)
- HemosIL Fibrinogen-C (K073367)
- HemosIL D-Dimer (K073042)
- HemosIL Liquid Antithrombin (K062431)
- HemosIL Protein C (K062430)
- HemosIL Free Protein S (K010379)
- HemosIL Factor V Deficient Plasma (K023839)
- HemosIL Factor VII Deficient Plasma (K024082)
- HemosIL Factor VIII Deficient Plasma (K034007)
- HemosIL Factor IX Deficient Plasma (K031829)
- HemoCue (BK000043)
- Envoy 500 (K945271)
Related Devices
- K233790 — ACL TOP 970 CL · Instrumentation Laboratory · Dec 29, 2023
- K231031 — ACL TOP Family 70 Series · Instrumentation Laboratory Company · Jun 21, 2023
- K242127 — ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) · Instrumentation Laboratory (IL) Co. · Aug 16, 2024
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
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)
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image contains the logo for Instrumentation Laboratory, a Werfen Company. The logo features a stylized graphic of two overlapping shapes in shades of green and blue, followed by the company name in a sans-serif font. Below the company name, the text "A Werfen Company" is displayed in a smaller font size.
# 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.<br>180 Hartwell Road<br>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 /<br>Intended Use | The ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS;<br>ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) are<br>bench top, fully automated, random access analyzers designed<br>specifically for <i>in vitro</i> diagnostic clinical use in the hemostasis<br>laboratory for coagulation and/or fibrinolysis testing in the<br>assessment of thrombosis and/or hemostasis. The systems<br>provide results for both direct hemostasis measurements and<br>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 <b>Pre-Analytical HIL Check</b> detects and measures interference caused by<br>the presence of hemoglobin, bilirubin, and light scattering lipids in patient<br>samples. H – Hemolysis (hemoglobin) I – Icterus (bilirubin) L- Lipemia (turbidity) The <b>Pre-Analytical HIL Check</b> aids the coagulation laboratory in identifying<br>and handling potential HIL interference issues. This feature flags samples to<br>alert instrument operators of potential HIL interference specific to the tests<br>requested for a sample.<br><br>NOTES: There are no analytical claims for hemoglobin, bilirubin or turbidity<br>analysis with the introduction of the <b>Pre-Analytical HIL Check</b> .<br><br>Information provided by the check does not replace any interference<br>information included in the package inserts of IL products.<br><br>A third measurement wavelength @535 nm and an additional emitter control<br>channel (all models) have been introduced to support the new <b>Pre-Analytical<br/>HIL Check</b> feature. |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The <b>Pre-Analytical Tube Fill Height (THF) Check</b> aids laboratories by<br>screening open and closed tube samples during the first sample aspiration to<br>determine whether the tube fill meets the minimum level based on the tube<br>manufacturer's recommendations.<br><br>The fill height check for each patient sample occurs before the analytical<br>testing process begins and thus there is no effect on patient test results. |
| | A <b>Pre-Analytical Clog Detection</b> is performed on all samples during<br>aspiration.<br><br>A pre-analytical error or warning for fluidic obstruction is an indication for the<br>user to review the sample integrity, following established laboratory sample<br>quality procedures.<br><br>A pressure transducer (all models) has been introduced to support this new<br><b>Pre-Analytical Clog Detection</b> 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<br>automated, random access analyzer<br>designed specifically for <i>in vitro</i><br>diagnostic clinical use in the hemostasis<br>laboratory for coagulation and/or<br>fibrinolysis testing in the assessment of<br>thrombosis and/or hemostasis.<br>The system provides results for both<br>direct hemostasis measurements and<br>calculated parameters. | The ACL TOP Family 50 Series<br>(ACL TOP 750, ACL TOP 750 CTS,<br>ACL TOP 750 LAS, ACL TOP 550<br>CTS and ACL TOP 350 CTS) are<br>bench top, fully automated,<br>random access analyzers<br>designed specifically for <i>in vitro</i><br>diagnostic clinical use in the<br>hemostasis laboratory for<br>coagulation and/or fibrinolysis<br>testing in the assessment of<br>thrombosis and/or hemostasis.<br>The systems provide results for<br>both direct hemostasis<br>measurements and calculated<br>parameters. |
| Matrix | 3.2% Citrated Plasma | Same |
| Methodology | The ACL TOP Family performs the<br>following types of tests: Coagulometric (Turbidimetric)<br>Measurements (405 nm or 671 nm) Chromogenic (Absorbance)<br>Measurements (405 nm) Immunological Measurements<br>(405 nm or 671 nm) | Same |
| Test Menu | Clotting, chromogenic and<br>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<br>A third measurement wavelength<br>@535 nm and an additional<br>emitter control channel (all<br>models) have been introduced to<br>support this new feature. |
| Pre-Analytical Tube Fill Height<br>Check | Not Available | Standard for All Models |
| Pre-Analytical Clog Detection | Not Available | Standard for All Models<br>A pressure transducer (all models)<br>has been introduced to support<br>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<br>Normal Control | HemosIL<br>Abnormal Control | HemosIL High<br>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<br>Normal Control | HemosIL<br>Abnormal Control | HemosIL High<br>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<br>Normal Control | HemosIL<br>Abnormal Control | HemosIL High<br>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<br>Normal Control | HemosIL<br>Abnormal Control | HemosIL High<br>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)<br>Measurand: | | | | |
| Model:<br>ACL TOP 350 CTS | | | | |
| Sample | HemosIL<br>Normal Control | HemosIL Low<br>Abnormal Control | HemosIL Low<br>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<br>Normal Control | HemosIL Low<br>Abnormal Control | HemosIL Low<br>Fibrinogen Control | HemosIL<br>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<br>Normal Control | HemosIL Low<br>Abnormal Control | HemosIL Low<br>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<br>Model: | | | | |
| Sample | HemosIL<br>Normal Control | HemosIL Low<br>Abnormal Control | HemosIL Low<br>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<br>Normal Control | HemosIL Low<br>Abnormal Control | HemosIL High<br>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<br>Normal Control | HemosIL Low<br>Abnormal Control | HemosIL High<br>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<br>Normal Control | HemosIL Low<br>Abnormal Control | HemosIL High<br>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<br>Normal Control | HemosIL Low<br>Abnormal Control | HemosIL High<br>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 |
{10}------------------------------------------------
| Precision Study - Internal (Cont.) | |
|------------------------------------|--|
| | |
| HemosIL Fibrinogen-C (K073367) | | | |
|--------------------------------------|---------------------------|-----------------------------------|-------------|
| Measurand: Fibrinogen Clauss (mg/dL) | | | |
| Model: ACL TOP 350 CTS | | | |
| Sample | HemosIL<br>Normal Control | HemosIL<br>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<br>Normal Control | HemosIL<br>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<br>Normal Control | HemosIL<br>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<br>Normal Control | HemosIL<br>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<br>D-Dimer Low Control | HemosIL<br>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<br>D-Dimer Low Control | HemosIL<br>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<br>D-Dimer Low Control | HemosIL<br>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<br>D-Dimer Low Control | HemosIL<br>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<br>Normal Control | HemosIL Special<br>Test Level 1 | HemosIL Special<br>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<br>Normal Control | HemosIL Special<br>Test Level 1 | HemosIL Special<br>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<br>Normal Control | HemosIL Special<br>Test Level 1 | HemosIL Special<br>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<br>Normal Control | HemosIL Special<br>Test Level 1 | HemosIL Special<br>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:<br>Free Protein S (%) | | | | |
| Model: | ACL TOP 350 CTS | | | |
| Sample | HemosIL<br>Normal Control | HemosIL Special<br>Test Level 1 | HemosIL Special<br>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<br>Normal Control | HemosIL Special<br>Test Level 1 | HemosIL Special<br>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<br>Normal Control | HemosIL Special<br>Test Level 1 | HemosIL Special<br>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:<br>ACL TOP 750 | | | | |
| Sample | HemosIL<br>Normal Control | HemosIL Special<br>Test Level 1 | HemosIL Special<br>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<br>Normal Control | HemosIL Special<br>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<br>Normal Control | HemosIL Special<br>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<br>Normal Control | HemosIL Special<br>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<br>Normal Control | HemosIL Special<br>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:<br>Factor VII (%) | | | |
| Model: | ACL TOP 350 CTS | | |
| Sample | HemosIL<br>Normal Control | HemosIL Special<br>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<br>Normal Control | HemosIL Special<br>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<br>Normal Control | HemosIL Special<br>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<br>Normal Control | HemosIL Special<br>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<br>Normal Control | HemosIL Special<br>Test Level 2 | Plasma Pool |
| N | 80 | 80 | 80 |
| Within-run %CV (Observed) | 3.4 | 3.3…
