(90 days)
No
The description details a standard chemiluminescent immunoassay with a predefined curve fitting method (4PLC). There is no mention of AI, ML, or any learning algorithms used for data analysis or interpretation beyond this standard curve fitting.
No.
The device is an in vitro diagnostic (IVD) assay designed to detect IgG antibodies related to Heparin Induced Thrombocytopenia (HIT), which aids in determining risk but does not directly treat or prevent a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.00 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings." This clearly indicates its use in identifying a disease state or condition.
No
The device is an in vitro diagnostic assay that utilizes chemical reagents and a specific hardware platform (ACL TOP 970 CL) to perform a chemiluminescent immunoassay. While it involves data reduction and curve fitting software, it is fundamentally a hardware-based diagnostic system with associated software, not a standalone software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is for use in human 3.2% citrated plasma in a laboratory setting to detect IgG antibodies. This is a classic definition of an in vitro diagnostic test, as it analyzes a biological sample (plasma) outside of the body to aid in diagnosis or risk assessment (determining the risk for heparin induced thrombocytopenia).
- Device Description: The description details a chemiluminescent immunoassay that analyzes components of the plasma sample. This process is performed in vitro.
- Laboratory Setting: The intended user is a laboratory setting, which is where IVD tests are typically performed.
- Analysis of Biological Sample: The device analyzes human plasma, a biological sample.
The information provided clearly indicates that this device is designed to perform a diagnostic test on a biological sample outside of the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HemosIL CL HIT-IgG(PF4-H) is a qualitative, fully automated, chemiluminescent immunoassay (CIA) for the detection of IgG antibodies that react with Platelet Factor 4 (PF4) when complexed to heparin. The assay is for use in human 3.2% citrated plasma on the ACL TOP 970 CL in a laboratory setting.
The result provided by the assay should be interpreted as either positive or negative based on the assay cut-off (1.00 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings.
Anti-PF4/heparin antibodies are commonly found in patients with HIT. For use with adult population suspected of HIT. Not for use in isolation to exclude HIT.
For prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
LCO
Device Description
HemosIL CL HIT-IgG(PF4-H) assay is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with PF4 complexed to polyvinyl sulfonate (PVS) which capture, if present, PF4/H antibodies from the sample. After incubation, magnetic separation, and a wash step, a tracer consisting of an isoluminol-labeled anti-human IgG antibody is added and may bind with the captured PF4/H IgG on the particles. After a second incubation, magnetic separation, and a wash step, reagents that trigger the luminescent reaction are added, and the emitted light is measured as relative light units (RLUs) by the ACL TOP 970 CL optical system. The RLUs are directly proportional to the PF4/H IgG concentration in the sample.
The HemosIL CL HIT-IgG(PF4-H) assay utilizes a 4 Parameter Logistic Curve fit (4PLC) data reduction method to generate a Master Curve. The Master Curve is predefined and lot dependent and it is stored in the instrument through the cartridge barcode. With the measurement of calibrators, the predefined Master Curve is transformed to a new, instrument specific 4PLC Working Curve. The concentration values of the calibrators are included in the reagent kit calibrator value sheet 2D barcode.
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
Adult population
Intended User / Care Setting
Laboratory setting
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:
- Study Type: Precision study in accordance with CLSI EPU5-A3 (3rd Edition).
- Sample Size: 5 plasma samples, 2 levels of HemosIL CL Multi-Ab Controls, and 3 lots of HemosIL CL Multi-Ab Controls (low and high). Each material was run in duplicate, twice per day over 20 days.
- Key Results:
- Low CL Multi-Ab Control: Mean (U/mL) = 0.446, Repeatability (% CV) = 5.2, Within Laboratory (% CV) = 7.4
- High CL Multi-Ab Control: Mean (U/mL) = 3.231, Repeatability (% CV) = 3.0, Within Laboratory (% CV) = 5.9
- Plasma Sample A (Pool): Mean (U/mL) = 0.248, Repeatability (% CV) = 8.2, Within Laboratory (% CV) = 10.7
- Plasma Sample B (Pool): Mean (U/mL) = 0.907, Repeatability (% CV) = 2.9, Within Laboratory (% CV) = 5.7
- Plasma Sample C (Pool): Mean (U/mL) = 1.346, Repeatability (% CV) = 3.1, Within Laboratory (% CV) = 6.5
- Plasma Sample D (Unadulterated): Mean (U/mL) = 1.910, Repeatability (% CV) = 3.4, Within Laboratory (% CV) = 6.3
- Plasma Sample E (Pool): Mean (U/mL) = 19.677, Repeatability (% CV) = 2.6, Within Laboratory (% CV) = 6.0
- Aggregated data for 3 reagent lots:
- Low CL Multi-Ab Control: Mean (U/mL) = 0.440, Lot-to-Lot Variability (% CV) = 2.1
- High CL Multi-Ab Control: Mean (U/mL) = 3.260, Lot-to-Lot Variability (% CV) = 2.0
- Plasma Sample A: Mean (U/mL) = 0.272, Lot-to-Lot Variability (% EV) = 8.1
- Plasma Sample B: Mean (U/mL) = 0.777, Lot-to-Lot Variability (% CV) = 14.5
- Plasma Sample C: Mean (U/mL) = 1.210, Lot-to-Lot Variability (% CV) = 9.7
- Plasma Sample D: Mean (U/mL) = 1.817, Lot-to-Lot Variability (% CV) = 4.5
- Plasma Sample E: Mean (U/mL) = 21.451, Lot-to-Lot Variability (% CV) = 9.5
Reproducibility Study:
- Study Type: Reproducibility study.
- Sample Size: 6 plasma samples and HemosIL CL Multi-Ab Controls tested across 3 sites, with 3 different operators, on 3 different ACL TOP 970 CL systems, using 3 lots of reagent. Each level was tested twice per day over 5 days with 3 replicates.
- Key Results (pooled data for a representative reagent lot):
- Low CL Multi-Ab Control: Mean (U/mL) = 0.515, Reproducibility (Total) % CV = 7.6
- High CL Multi-Ab Control: Mean (U/mL) = 3.487, Reproducibility (Total) % CV = 5.5
- Plasma Sample 1 (Pool): Mean (U/mL) = 0.405, Reproducibility (Total) % CV = 14.4
- Plasma Sample 2 (Unadulterated): Mean (U/mL) = 0.050, All Replicates
§ 864.7695 Platelet factor 4 radioimmunoassay.
(a)
Identification. A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
January 28, 2025
Instrumentation Laboratory (IL) Co. Nikita Malladi Regulatory Affairs Manager II 180 Hartwell Rd Bedford, Massachusetts 01730
Re: K243374
Trade/Device Name: HemosIL CL HIT-IgG(PF4-H) Regulation Number: 21 CFR 864.7695 Regulation Name: Platelet Factor 4 Radioimmunoassay Regulatory Class: Class II Product Code: LCO Dated: October 30, 2024 Received: October 30, 2024
Dear Nikita Malladi:
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
YAN CÀI S
for
Min Wu, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
Device Name HemosIL CL HIT-IgG(PF4-H)
Indications for Use (Describe)
HemosIL CL HIT-IgG(PF4-H) is a qualitative, fully automated, chemiluminescent immunoassay (CIA) for the detection of IgG antibodies that react with Platelet Factor 4 (PF4) when complexed to heparin. The assay is for use in human 3.2% citrated plasma on the ACL TOP 970 CL in a laboratory setting.
The result provided by the assay should be interpreted as etther positive based on the assay cut-off (1.00 U/mL). The positive or negative result aids in determining the risk for heparin induced thrombocytopenia (HIT) when used in conjunction with other laboratory and clinical findings.
Anti-PF4/Heparin antibodies are commonly found in patients with HT. For use in adult population suspected of HIT. Not for use in isolation to exclude HIT.
For prescription use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| 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."
4
Image /page/4/Picture/0 description: The image shows the word "werfen" in a bold, sans-serif font. The color of the text is a dark blue. The letters are evenly spaced and the word is horizontally oriented.
510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Submitter | Instrumentation Laboratory (IL) Company
180 Hartwell Road
Bedford, MA 01730-2443 (USA)
Establishment Registration: 1217183 | | | Chemiluminescent Assay | Device Description |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact | Nikita Malladi
Regulatory Affairs Manager II
Phone: 781-353-1486
Fax: 781-861-4207
Email: nmalladi@werfen.com | | | HemosIL CL HIT IgG(PF4-H) | HemosIL CL HIT-IgG(PF4-H) assay is a chemiluminescent two-step immunoassay
consisting of magnetic particles coated with PF4 complexed to polyvinyl sulfonate
(PVS) which capture, if present, PF4/H antibodies from the sample. After incubation,
magnetic separation, and a wash step, a tracer consisting of an isoluminol-labeled anti-
human IgG antibody is added and may bind with the captured PF4/H IgG on the
particles. After a second incubation, magnetic separation, and a wash step, reagents that
trigger the luminescent reaction are added, and the emitted light is measured as relative
light units (RLUs) by the ACL TOP 970 CL optical system. The RLUs are directly
proportional to the PF4/H IgG concentration in the sample. |
| Preparation Date | October 30, 2024 | | | | The HemosIL CL HIT-IgG(PF4-H) assay utilizes a 4 Parameter Logistic Curve fit (4PLC)
data reduction method to generate a Master Curve. The Master Curve is predefined and
lot dependent and it is stored in the instrument through the cartridge barcode. With the
measurement of calibrators, the predefined Master Curve is transformed to a new,
instrument specific 4PLC Working Curve. The concentration values of the calibrators
are included in the reagent kit calibrator value sheet 2D barcode. |
| Device Trade Name | HemosIL CL HIT-IgG(PF4-H) | | | Intended Use / Indication for Use | |
| Predicate Devices
and 510(k) Number | HemosIL AcuStar HIT-IgG(PF4-H) | | K170854 | | HemosIL CL HIT-IgG(PF4-H) is a qualitative, fully automated, chemiluminescent
immunoassay (CIA) for the detection of IgG antibodies that react with Platelet Factor 4
(PF4) when complexed to heparin. The assay is for use in human 3.2% citrated plasma
on the ACL TOP 970 CL in a laboratory setting. |
| Regulatory Information | Chemiluminescent Assay | | | The result provided by the assay should be interpreted as either positive or negative
based on the assay cut-off (1.00 U/mL). The positive or negative result aids in
determining the risk for heparin induced thrombocytopenia (HIT) when used in
conjunction with other laboratory and clinical findings. | |
| HemosIL CL HIT-IgG(PF4-H) | Classification | Class II | | Anti-PF4/heparin antibodies are commonly found in patients with HIT. For use with
adult population suspected of HIT. Not for use in isolation to exclude HIT. | |
| HemosIL CL HIT-IgG(PF4-H) | Classification Panel | Hematology (81) | | For prescription use only. | |
| HemosIL CL HIT-IgG(PF4-H) | Regulation Section No. | 21 CFR 864.7695 | | | |
| HemosIL CL HIT-IgG(PF4-H) | Regulation Description | Platelet factor 4
radioimmunoassay | | | |
| HemosIL CL HIT-IgG(PF4-H) | Product Code | LCO | | | |
5
6
| HemosIL CL HIT-IgG(PF4-H) Comparison to Predicate Device | ||
|---|---|---|
| Item | Predicate Device (K170854) | New Device |
| Trade Names | HemosIL AcuStar HIT-IgG(PF4-H) | HemosIL CL HIT-IgG(PF4-H) |
| Manufacturer | Instrumentation Laboratory Co. | Same |
| Measurand | Anti-PF4/Heparin IgG Antibodies | Same |
| Assay Type | Qualitative | Same |
| Product Code | LCO | Same |
| Regulation Section | 21 CFR 864.7695 | Same |
| Classification | Class II | Same |
| Intended Use | HemosIL AcuStar HIT-IgG(PF4-H) is a | |
| qualitative, fully automated, chemiluminescent | ||
| immunoassay (CIA) for the detection of IgG | ||
| antibodies that react with Platelet Factor 4 | ||
| (PF4) when complexed to heparin. The assay is | ||
| for use in human 3.2% or 3.8% citrated plasma | ||
| and serum on the ACL AcuStar instrument in a | ||
| laboratory setting. |
The result provided by the assay should be
interpreted as either positive or negative based
on the assay cut-off (1.00 U/mL). The positive
or negative result aids in determining the risk
for heparin induced thrombocytopenia (HIT)
when used in conjunction with other laboratory
and clinical findings.
Anti-PF4/Heparin antibodies are commonly
found in patients with HIT. For use in adult
population suspected of HIT. Not for use in
isolation to exclude HIT.
For prescription use. | HemosIL CL HIT-IgG(PF4-H) is a qualitative, fully
automated, chemiluminescent immunoassay (CIA) for
the detection of IgG antibodies that react with Platelet
Factor 4 (PF4) when complexed to heparin. The assay is
for use in human 3.2% citrated plasma on the ACL TOP
970 CL in a laboratory setting.
The result provided by the assay should be interpreted as
either positive or negative based on the assay cut-off
(1.00 U/mL). The positive or negative result aids in
determining the risk for heparin induced
thrombocytopenia (HIT) when used in conjunction with
other laboratory and clinical findings.
Anti-PF4/heparin antibodies are commonly found in
patients with HIT. For use with adult population
suspected of HIT. Not for use in isolation to exclude
HIT.
For prescription use only. |
| HemosIL CL HIT-IgG(PF4-H) Comparison to Predicate Device (Cont.) | | |
| Item | Predicate Device (K170854) | New Device |
| Methodology | Chemiluminescent immunoassay (CIA) | Same |
| Reagents | Cartridge containing magnetic particle
suspension coated with PF4 complexed to
polyvinyl sulfonate (PVS) | Same |
| Antibodies | Mouse monoclonal anti-human IgG antibody | Same |
| Conjugate | Isoluminol conjugated anti-human IgG | Same |
| Cut-off | Fixed clinical cut-off:
• Positive: $\ge$ 1.00 U/mL
• Negative: $\lt$ 1.00 U/mL | Same |
| Composition | 1 cartridge containing 1 vial of magnetic
particle suspension coated with PF4/PVS
complex, 1 vial of assay buffer, 1 vial of tracer
consisting of an mAb anti-human IgG antibody
labeled with isoluminol, and 1 vial of sample
diluent used for the regular predilution of the
sample. The reagents are in a phosphate or Tris
buffer containing bovine serum albumin,
bovine fetal serum, PF4/PVS complex, mouse
monoclonal IgG, stabilizers, and preservative. | 1 cartridge containing 1 vial of magnetic particle
suspension coated with PF4/PVS complex, 1 vial of
assay buffer, 1 vial of tracer consisting of an mAb
anti-human IgG antibody labeled with isoluminol,
and 1 vial of sample diluent used for the regular
predilution of the sample. The reagents are in a
phosphate or HEPES buffer containing bovine
serum albumin, bovine fetal serum, PF4/PVS
complex, mouse monoclonal IgG, stabilizers, and
preservative. |
| Calibrators | Two calibrator levels (included in the kit):
• Calibrator 1 target value: 1.00 U/mL
• Calibrator 2 target value: 16.00 U/mL
Liquid format | Two calibrator levels (included in the kit):
• Calibrator 1 target value: 1.00 U/mL
• Calibrator 2 target value: 16.50 U/mL
Liquid format |
| Controls | Two control levels (sold separately):
• Low Control target value: 0.60 U/mL
• High Control target value: 3.00 U/mL
Liquid format | Two control levels (sold separately):
• Low Control target value: 0.60 U/mL
• High Control target value: 3.50 U/mL
Liquid format |
| Sample Type | Human citrated plasma or serum | Human 3.2% citrated plasma |
| Instrumentation | ACL AcuStar | ACL TOP 970 CL |
7
8
Precision
HemosIL CL HIT-IgG(PF4-H)
A precision study was performed in accordance with CLSI EPU5-A3 (3" Edition), using three lots of HET-IgGrew, reagent. Repeatability and within laboratory precision were assessed. To span the study tested 5 plasma samples and 2 levels of HemosIL CL Multi-Ab Controls and 3 lots of HemosIL CL Multi-Ab Controls (low and high). Each material was run in duplicate, twice per day over 20 days on an ACL TOP 970 CL.
The tables below show data for 1 representative reagent lot and also aggregated data for the 3 reagent lots.
| ACL TOP 970 CL | Mean (U/mL) | Repeatability (% CV) | Within Laboratory (% CV) |
|---|---|---|---|
| Low CL Multi-Ab Control | 0.446 | 5.2 | 7.4 |
| High CL Multi-Ab Control | 3.231 | 3.0 | 5.9 |
| Plasma Sample A (Pool) | 0.248 | 8.2 | 10.7 |
| Plasma Sample B (Pool) | 0.907 | 2.9 | 5.7 |
| Plasma Sample C (Pool) | 1.346 | 3.1 | 6.5 |
| Plasma Sample D (Unadulterated) | 1.910 | 3.4 | 6.3 |
| Plasma Sample E (Pool) | 19.677 | 2.6 | 6.0 |
9
| Performance Characteristics: New HemosIL CL Reagent (Cont.) | |||||||
|---|---|---|---|---|---|---|---|
| Precision (Cont.) | |||||||
| HemosIL CL HIT-IgG(PF4-H) | |||||||
| Aggregated data (Reagent Lots 1, 2, and 3) | |||||||
| Material | Mean (U/mL) | Lot-to-Lot Variability (% CV) | |||||
| Low CL Multi-Ab Control | 0.440 | 2.1 | |||||
| High CL Multi-Ab Control | 3.260 | 2.0 | |||||
| Plasma Sample A | 0.272 | 8.1 | |||||
| Plasma Sample B | 0.777 | 14.5 | |||||
| Plasma Sample C | 1.210 | 9.7 | |||||
| Plasma Sample D | 1.817 | 4.5 | |||||
| Plasma Sample E | 21.451 | 9.5 |
10
Reproducibility
HemosIL CL HIT-IgG(PF4-H)
Reproducibility studies were contucted at 3 extenal cliferent operators (1 operator per site), on 3 different ACL TOP 970 CL system (1 system per site), using 3 lots of HemosIL CL HIT-IgGyerin To span the same 6 plasma samples were tested across the 3 sites, with the HemosIL CL Multi-Ab Controls.
Each level for all materials was tested across 3 sites twice per day over 5 days with 3 replicates for each of the 3 reagent lots.
The pooled data for a representative reagent lot is presented below.
| Level | Mean
(U/mL) | N | Repeatability | | Between-run | | Between-day | | Between-site | | Between-lot | | Reproducibility
(Total) | | | |
|------------------------------------|----------------|-----|----------------------------|------|-------------|------|-------------|------|--------------|------|-------------|------|----------------------------|------|--|--|
| | | | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV | | |
| Low CL Multi-
Ab Control | 0.515 | 270 | 0.0212 | 4.1 | 0.0241 | 4.7 | 0.0000 | 0.0 | 0.0195 | 3.8 | 0.0107 | 2.1 | 0.0390 | 7.6 | | |
| High CL Multi-
Ab Control | 3.487 | 270 | 0.1047 | 3.0 | 0.1214 | 3.5 | 0.0530 | 1.5 | 0.0464 | 1.3 | 0.0803 | 2.3 | 0.1926 | 5.5 | | |
| Plasma Sample
1 (Pool) | 0.405 | 270 | 0.0521 | 12.9 | 0.0050 | 1.2 | 0.0098 | 2.4 | 0.0242 | 6.0 | 0.0000 | 0.0 | 0.0585 | 14.4 | | |
| Plasma Sample 2
(Unadulterated) | 0.050 | 270 | All Replicates