(506 days)
No
The description focuses on the automated nature of the immunoassay and the measurement of relative light units, with no mention of AI or ML algorithms for data analysis or interpretation beyond direct proportionality.
No
Explanation: This device, the ACL TOP 970 CL, is an in vitro diagnostic (IVD) analyzer used to measure specific antibodies in patient samples as an aid in diagnosing Antiphospholipid Syndrome (APS). It does not provide therapy or treatment to patients.
Yes
The ACL TOP 970 CL is explicitly described as an "in vitro diagnostic use" analyzer, and the HemosIL CL assays are intended "as an aid in the diagnosis of Antiphospholipid Syndrome (APS)."
No
The device description clearly states it is an "instrument" (ACL TOP 970 CL) and includes descriptions of physical components and chemical reactions (chemiluminescent immunoassay, magnetic particles, reagents, optical system). This indicates it is a hardware-based medical device with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use statement for the ACL TOP 970 CL explicitly states it is "designed specifically for in vitro diagnostic use".
The Intended Use statements for both HemosIL CL Anti-Cardiolipin IgM and HemosIL CL Anti-ß2 Glycoprotein-I IgM describe them as "fully automated chemiluminescent immunoassay for the semi-quantitative measurement of... antibodies in human... plasma on the ACL TOP 970 CL in the laboratory setting by a healthcare professional, as an aid in the diagnosis of Antiphospholipid Syndrome (APS)". This clearly indicates they are used to test samples taken from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
ACL TOP 970 CL
The ACL TOP 970 CL is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic use by health care professionals in a clinical laboratory. The system provides results for both direct measurements and calculated parameters.
HemosIL CL Anti-Cardiolipin IgM
HemosIL CL Anti-Cardiolipin IgM is a fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgM antibodies in human 3.2% or 3.8% citrated plasma on the ACL TOP 970 CL in the laboratory setting by a healthcare professional, as an aid in the diagnosis of Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. For use with adult population. For prescription use only.
HemosIL CL Anti-ß2 Glycoprotein-I IgM
HemosIL CL Anti-B2 Glycoprotein-I IgM is a fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-B2 Glycoprotein-I (anti-B2GPI) IgM antibodies in human 3.2% or 3.8% citrated plasma on the ACL TOP 970 CL in the laboratory setting by a healthcare professional, as an aid in the diagnosis of Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. For use with adult population. For prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
JPA, MID, MSV
Device Description
ACL TOP 970 CL
The ACL TOP 970 CL is an instrument that integrates new chemiluminescent test capability similar to the ACL AcuStar, K083518.
HemosIL CL Anti-Cardiolipin IgM
HemosIL CL Anti-Cardiolipin IgM is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with cardiolipin and human purified beta2GPI, which capture, if present, the aCL antibodies from the sample. After incubation, magnetic separation, and a wash step, a tracer consisting of an isoluminol-labeled anti-human IgM antibody is added and may bind with the captured aCL IgM on the particles. After a second incubation, magnetic separation, and wash step, reagents that trigger the luminescent reaction are added, and the emitted light is measured as relative light units (RLU) by the ACL TOP 970 CL optical system. RLUs are directly proportional to the aCL IgM concentration in the sample.
HemosIL CL Anti-beta2 Glycoprotein-I IgM
HemosIL CL Anti-B2 Glycoprotein-I IgM is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with human purified beta2GPI, which capture, if present, the a beta2GPI antibodies from the sample. After incubation, magnetic separation, and a wash step, a tracer consisting of an isoluminol-labeled anti-human IgM antibody is added and may bind with the captured a beta2GPI IgM on the particles. After a second incubation, magnetic separation, and 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. RLUs are directly proportional to the a beta2GPI IgM concentration in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult population
Intended User / Care Setting
health care professionals in a clinical 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision
HemosIL CL Anti-Cardiolipin IgM
A precision study was performed in accordance with CLSI Edition), using three lots of HemosIL CL Anti-Cardiolipin IgM reagents. Repeatability and within laboratory precision were assessed. To span the assay range, the study tested 5 plasma samples (3 positive; 2 negative), 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.
HemosIL CL Anti-ß2 Glycoprotein-I IgM
A precision study was performed in accordance with CLSI Edition), using three lots of HemosIL CL Anti-beta2 Glycoprotein-I IgM reagents. Repeatability and within laboratory precision were assessed. To span the assay range, the study tested 5 plasma samples (3 positive; 2 negative), 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.
Reproducibility
HemosIL CL Anti-Cardiolipin IgM
Reproducibility studies were conducted at 3 external sites, in accordance with CLSI EP05-A3 (3rd Edition), using different operators (1 operator per site), on 3 different ACL TOP 970 CL systems (1 system per site), using 3 lots of HemosIL CL Anti-Cardiolipin IgM and 1 lot of HemosIL CL Multi-Ab Controls. To span the assay range, 4 plasma samples (3 positive and 1 negative) were also tested across the 3 sites. Each material was tested in triplicate, twice a day for 5 days, for a total of 30 replicates per level.
HemosIL CL Anti-ß2 Glycoprotein-I IgM
Reproducibility studies were conducted at 3 external sites, in accordance with CLSI EPO5-A3 (3rd Edition), using different operator (1 operator per site), on 3 different ACL TOP 970 CL systems (1 system per site), using 3 lots of HemosIL CL Anti-beta2 Glycoprotein-I IgM and 1 lot of HemosIL CL Multi-Ab Low and High Controls. To span the assay range, 4 plasma samples (3 positive) were also tested across the 3 sites. Each material was tested in triplicate, twice a day for 5 days, for a total of 30 replicates per level.
Analytical Sensitivity
Limit of detection (LoD) was assessed per CLSI EP17-A2 (2nd Edition) using three different lots of HemosIL CL Anti-Cardiolipin IgM and three different lots of HemosIL CL Anti-ß2 Glycoprotein-I IgM reagent cartridges. LoD samples were prepared by combining Ab-positive donor plasma and normal donor plasma per protocol.
Linearity
Linearity was assessed per CLSI EP06 (2nd Edition) using three different lots of HemosIL CL Anti-Cardiolipin IgM and three different lots of HemosIL CL Anti-ß2 Glycoprotein-I IgM reagent cartridges. For each assay, a set of linearity samples were prepared by diluting a high antibody plasma sample with a negative antibody plasma sample to create the required sample concentrations. Each level was measured in seven replicates with the three lots for each assay. The linearity range was determined such that all acceptance criteria were met.
Analytical Specificity
Interference testing was performed in accordance with CLSI EP07 (3rd Edition) using HemosIL CL Anti-Cardiolipin IgM and HemosIL CL Anti-ß2 Glycoprotein-I IgM reagent cartridges.
Normal Reference Range
A normal range study was performed in accordance with CLSI EP28-A3c (3d Edition) using one lot of HemosIL CL Anti-Cardiolipin IgM and one lot of HemosIL CL Anti-B2 Glycoprotein-I IgM reagent cartridges. The normal range was verified on the ACL TOP 970 CL using 100 citrated plasma normal donor samples. The threshold for positive aCL IgM and positive aß2GPI IgM antibodies were established in the 99th percentile.
Method Comparison
A method comparison study was performed, comparing the performance of HemosIL CL Anti-Cardiolipin IgM and HemosIL CL Anti-ß2 Glycoprotein-I IgM reagent cartridges with the respective predicate devices.
HemosIL CL Anti-Cardiolipin IgM
A method comparison was performed comparing HemosIL CL Anti-Cardiolipin IgM with a commercially available chemiluminescence assay.
N: 131, Slope (95% CI): 1.00 (0.98 - 1.01), r: 1.00
HemosIL CL Anti-ß2 Glycoprotein-I IgM
A method comparison was performed comparing HemosIL CL Anti-l2 Glycoprotein-1 IgM with a commercially available chemiluminescence assay.
N: 123, Slope (95% CI): 0.94 (0.92 – 0.96), r: 0.99
APS Outcome Study
HemosIL CL Anti-Cardiolipin IgM
A diagnostic clinical performance study was performed comparing HemosIL CL Anti-Cardiolipin IgM with APS disease classification per 2006 International Consensus Statement from Miyakis et al.
N: 500, Sensitivity (95% CI): 40.5% (33.8% - 47.6%), Specificity (95% CI): 91.9% (88.4% - 94.5%)
HemosIL CL Anti-ß2 Glycoprotein-I IgM
A diagnostic clinical performance study was performed comparing HemosIL CL Anti-l2_Glycoprotein-1 IgM with APS disease classification per 2006 International Consensus Statement from Miyakis et al.
Sensitivity (95% CI): 33.0% (26.7% - 39.9%), Specificity (95% CI): 94.6% (91.4% - 96.6%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
HemosIL CL Anti-Cardiolipin IgM
Sensitivity (95% CI): 40.5% (33.8% - 47.6%)
Specificity (95% CI): 91.9% (88.4% - 94.5%)
HemosIL CL Anti-ß2 Glycoprotein-I IgM
Sensitivity (95% CI): 33.0% (26.7% - 39.9%)
Specificity (95% CI): 94.6% (91.4% - 96.6%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 29, 2023
Instrumentation Laboratory Co. Nikita Malladi Principal Regulatory Affairs Specialist 180 Hartwell Road Bedford, Massachusetts 01730
Re: K221359
Trade/Device Name: ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-R2 Glycoprotein-I IgM Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System For In Vitro Coagulation Studies Regulatory Class: Class II Product Code: JPA, MID, MSV Dated: May 10, 2022 Received: May 11, 2022
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
(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.
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).
Sincerely. Min Wu -S
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
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Indications for Use
510(k) Number (if known) K221359
Device Name
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM and HemosIL CL Anti-B2 Glycoprotein-I IgM
Indications for Use (Describe)
ACL TOP 970 CL
The ACL TOP 970 CL is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic use by health care professionals in a clinical laboratory. The system provides results for both direct measurements and calculated parameters.
HemosIL CL Anti-Cardiolipin IgM
HemosIL CL Anti-Cardiolipin IgM is a fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgM antibodies in human 3.2% or 3.8% citrated plasma on the ACL TOP 970 CL in the laboratory setting by a healthcare professional, as an aid in the diagnosis of Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. For use with adult population. For prescription use only.
HemosIL CL Anti-ß2 Glycoprotein-I IgM
HemosIL CL Anti-B2 Glycoprotein-I IgM is a fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-B2 Glycoprotein-I (anti-B2GPI) IgM antibodies in human 3.2% or 3.8% citrated plasma on the ACL TOP 970 CL in the laboratory setting by a healthcare professional, as an aid in the diagnosis of Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. For use with adult population. For prescription use only.
| 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) |
[X] Prescription Use (Part 21 CFR 801 Subpart DI Counter Use (21 CFR 801 Subbart 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 21 CFR 807.92.
| Submitter's Information | Instrumentation Laboratory (IL) Co.
180 Hartwell Road
Bedford, MA 01730, USA |
|-------------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact 1 (Primary) | Nikita Malladi, Regulatory Affairs Manager I
Phone: 781-353-1486
Fax: 781-861-4207
Email: nmalladi@werfen.com |
| Preparation Date | September 28, 2023 |
| Device Trade Names | ACL TOP 970 CL |
|---|---|
| HemosIL CL Anti-Cardiolipin IgM | |
| HemosIL CL Anti-β2 Glycoprotein-I IgM |
| Predicate Devices
| and 510(k) Numbers | Instrument | ACL AcuStar | K083518 | |
|---|---|---|---|---|
| Assays | HemosIL AcuStar Anti-Cardiolipin IgM | K092181 | ||
| HemosIL AcuStar Anti-β₂ Glycoprotein-I IgM | K091556 |
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| Regulatory Information | |
|---|---|
| ACL TOP 970 CL | Instrument |
| Regulation Section No. | 21 CFR 864.5425 |
| Regulation Description | Multipurpose system for in vitro coagulation studies |
| Classification | Class II |
| Product Code | JPA |
| Panel | Hematology (81) |
| Chemiluminescent Assays | |
| HemosIL CL | |
| Anti-Cardiolipin IgM | |
| Regulation Section No. | 21 CFR 866.5660 |
| Regulation Description | System, Test, Anti-cardiolipin Immunological |
| Classification | Class II |
| Product Code | MID |
| Panel | Immunology (82) |
| HemosIL CL | |
| Anti-β2 Glycoprotein-I IgM | |
| Regulation Section No. | 21 CFR 866.5660 |
| Regulation Description | System, Test, Antibodies, β2 - Glycoprotein I (β2 - Gpi) |
| Classification | Class II |
| Product Code | MSV |
| Panel | Immunology (82) |
Reasons for Submission
This Traditional 510(k) is submitted by Instrumentation Laboratory Co. for the following reasons:
- To obtain FDA clearance for the ACL TOP 970 CL instrument ●
- To obtain FDA clearance for two new immunoassays (HemosIL CL Anti-Cardiolipin IgM and HemosIL CL . Anti-ß2 Glycoprotein-I IgM)
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| Device Description | Intended Use / Indications for Use | ||
|---|---|---|---|
| Instrument | Instrument | ||
| ACL TOP 970 CL | |||
| Instrument | The ACL TOP 970 CL is an instrument that integrates new chemiluminescent | ||
| test capability similar to the ACL AcuStar, K083518. | ACL TOP 970 CL | The ACL TOP 970 CL is a bench top, fully automated, random access analyzer | |
| designed specifically for in vitro diagnostic use by health care professionals in a | |||
| clinical laboratory. | |||
| The system provides results for both direct measurements and calculated | |||
| parameters. | |||
| Chemiluminescent Assays | Chemiluminescent Assays | ||
| HemosIL CL | |||
| Anti-Cardiolipin IgM | HemosIL CL Anti-Cardiolipin IgM is a chemiluminescent two-step | ||
| immunoassay consisting of magnetic particles coated with cardiolipin and | |||
| human purified \u03b22GPI, which capture, if present, the aCL antibodies from the | |||
| sample. After incubation, magnetic separation, and a wash step, a tracer | |||
| consisting of an isoluminol-labeled anti-human IgM antibody is added and | |||
| may bind with the captured aCL IgM on the particles. After a second | |||
| incubation, magnetic separation, and wash step, reagents that trigger the | |||
| luminescent reaction are added, and the emitted light is measured as relative | |||
| light units (RLU) by the ACL TOP 970 CL optical system. RLUs are directly | |||
| proportional to the aCL IgM concentration in the sample. | HemosIL CL | ||
| Anti-Cardiolipin IgM | HemosIL CL Anti-Cardiolipin IgM is a fully automated chemiluminescent | ||
| immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) | |||
| IgM antibodies in human 3.2% or 3.8% citrated plasma on the ACL TOP® 970 | |||
| CL in the laboratory setting by a healthcare professional, as an aid in the | |||
| diagnosis of Antiphospholipid Syndrome (APS) when used in conjunction with | |||
| other laboratory and clinical findings. | |||
| For use with adult population. For prescription use only. | |||
| HemosIL CL | |||
| Anti-\u03b22 Glycoprotein-I IgM | HemosIL CL Anti-\u03b22 Glycoprotein-I IgM is a chemiluminescent two-step | ||
| immunoassay consisting of magnetic particles coated with human purified | |||
| \u03b22GPI, which capture, if present, the a\u03b22GPI antibodies from the sample. After | |||
| incubation, magnetic separation, and a wash step, a tracer consisting of an | |||
| isoluminol-labeled anti-human IgM antibody is added and may bind with the | |||
| captured a\u03b22GPI IgM on the particles. After a second incubation, magnetic | |||
| separation, and 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. RLUs are directly proportional to the | |||
| a\u03b22GPI IgM concentration in the sample. | HemosIL CL | ||
| Anti-ß2 Glycoprotein-I IgM | HemosIL CL Anti-ß2 Glycoprotein-I IgM is a fully automated chemiluminescent | ||
| immunoassay for the semi-quantitative measurement of anti-ß2 Glycoprotein-I | |||
| (anti-ß2GPI) IgM antibodies in human 3.2% or 3.8% citrated plasma on the ACL | |||
| TOP® 970 CL in the laboratory setting by a healthcare professional, as an aid in | |||
| the diagnosis of Antiphospholipid Syndrome (APS) when used in conjunction | |||
| with other laboratory and clinical findings. | |||
| For use with adult population. For prescription use only. |
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| ACL TOP 970 CL Instrument Comparison to Predicate Device | |||
|---|---|---|---|
| Item | Predicate Device No .: K083518 | Subject Device | |
| Trade Names | ACL AcuStar | ACL TOP 970 CL | |
| Intended Use/ | |||
| Indications for Use | The ACL AcuStar is an automated | ||
| immunoassay analyzer designed | |||
| specifically for in vitro diagnostic use in a | |||
| clinical laboratory. The assay analysis is | |||
| based on chemiluminescent technology. | |||
| The system provides results for both direct | |||
| measurements and calculated parameters. | The ACL TOP 970 CL is a bench top, fully | ||
| automated, random access analyzer designed | |||
| specifically for in vitro diagnostic use by health | |||
| care professionals in a clinical laboratory. | |||
| The system provides results for both direct | |||
| measurements and calculated parameters. | |||
| Quality Control | Automated QC | Automated QC | |
| Methodology | Chemiluminescence reading unit and photo | ||
| multiplier tube (PMT) | Similar chemiluminescence reading unit and Photo | ||
| Multiplier Tube (PMT) to the ACL AcuStar. | |||
| Interface | Windows 7 Operating System | Windows 10 Operating System | |
| Item | Predicate Device: K092181 | Subject Device | |
| Trade Name | HemosIL AcuStar Anti-Cardiolipin IgM | HemosIL CL Anti-Cardiolipin IgM | |
| Intended Use/ | |||
| Indications for Use | HemosIL AcuStar Anti-Cardiolipin IgM is a | ||
| fully automated chemiluminescent assay for the | |||
| semi-quantitative measurement of anti- | |||
| cardiolipin (aCL) IgM antibodies in human | |||
| citrated plasma and serum on the ACL AcuStar, | |||
| as an aid in the diagnosis of thrombotic disorders | |||
| related to primary and secondary | |||
| Antiphospholipid Syndrome (APS) when used in | |||
| conjunction with other laboratory and clinical | |||
| findings. | HemosIL CL Anti-Cardiolipin IgM is a fully | ||
| automated chemiluminescent immunoassay for | |||
| the semi-quantitative measurement of anti- | |||
| cardiolipin (aCL) IgM antibodies in human 3.2% | |||
| or 3.8% citrated plasma on the ACL TOP® 970 | |||
| CL in the laboratory setting by a healthcare | |||
| professional, as an aid in the diagnosis of | |||
| Antiphospholipid Syndrome (APS) when used in | |||
| conjunction with other laboratory and clinical | |||
| findings. | |||
| For use with adult population. For prescription | |||
| use only. | |||
| Type of Test | Semi-quantitative | Same | |
| Technology | Two-step chemiluminescent immunoassay | Same | |
| Clinical Cut-off | 20.0 U/mL | Same | |
| Calibrator | Calibrator 1: 1 x 1 mL barcoded tube of a solution | ||
| with aCL IgM in saline solution containing bovine | |||
| fetal serum, stabilizers, and preservative. |
Calibrator 2: 1 x 1 mL barcoded tube of a solution
with aCL IgM in saline solution containing bovine
fetal serum, stabilizers, and preservative. | Calibrator 1: 1 x 1.2 mL barcoded vial of a
solution with aCL IgM in saline solution
containing bovine fetal serum, stabilizers, and
preservative.
Calibrator 2: 1 x 1.2 mL barcoded vial of a
solution with aCL IgM in saline solution
containing bovine fetal serum, stabilizers, and
preservative. | |
| Composition | 1 cartridge containing 1 vial of magnetic particle
suspension coated with bovine cardiolipin and
human purified β2GPI, 1 vial of assay buffer, 1 vial
of tracer consisting of an anti-human IgM antibody
labeled with isoluminol, and 1 vial of sample
diluent used for the regular predilution of the
sample and automated dilution in the rerun. The
reagents are in a phosphate or borate buffer
containing bovine serum albumin, bovine
cardiolipin, human β2GPI, mouse monoclonal IgM,
stabilizers, and preservative. | 1 cartridge containing 1 vial of magnetic particle
suspension coated with bovine cardiolipin and
human purified β2GPI, 1 vial of assay buffer, 1
vial of tracer consisting of an anti-human IgM
antibody labeled with isoluminol, and 1 vial of
sample diluent. The reagents are in a phosphate
or borate buffer containing bovine serum
albumin, bovine cardiolipin, human β2GPI,
mouse monoclonal IgM, stabilizers, and
preservative. | |
| HemosIL CL Anti-Cardiolipin IgM Comparison to Predicate Device (Cont.) | | | |
| Item | Predicate Device: K092181 | Subject Device | |
| Trade Name | HemosIL AcuStar Anti-Cardiolipin IgM | HemosIL CL Anti-Cardiolipin IgM | |
| Sample Type | Serum or Citrated Plasma | Human 3.2% or 3.8% citrated plasma | |
| Quality Control | Low and high controls (sold separately) | Different control material, with two levels at or
near cut-off and at abnormal level | |
| Detection Limit | 1.0 U/mL | 2.0 U/mL | |
| Linearity | 1.0 - 774 U/mL | 2.7 - 500.0 U/mL | |
| | When the rerun capability of the instrument is
activated, the instrument makes an automatic
dilution and corrects the final result for the dilution
factor (20x), thereby expanding the test range to
15,480 U/mL. | The assay is not affected by prozone effect. The
assay protocol has a washing step after the sample
incubation that precludes the prozone effect. | |
| Item | Predicate Device: K091556 | Subject Device | |
| Trade Name | HemosIL AcuStar Anti-β2 Glycoprotein-I IgM | HemosIL CL Anti-β2 Glycoprotein-I IgM | |
| Intended Use/
Indications for Use | HemosIL AcuStar Anti-β2 Glycoprotein-I IgM is a fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-β2 Glycoprotein-I (anti-β2GPI) IgM antibodies in human citrated plasma and serum on the ACL AcuStar, as an aid in the diagnosis of thrombotic disorders related to primary and secondary Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. | HemosIL CL Anti-β2 Glycoprotein-I IgM is a fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-β2 Glycoprotein-I (anti-β2GPI) IgM antibodies in human 3.2% or 3.8% citrated plasma on the ACL TOP® 970 CL in the laboratory setting by a healthcare professional, as an aid in the diagnosis of Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings.
For use with adult population. For prescription use only. | |
| Type of Test | Semi-quantitative | Same | |
| Technology | Two-step chemiluminescent immunoassay | Same | |
| Clinical Cut-off | 20.0 U/mL | Same | |
| Calibrator | Calibrator 1: 1 x 1 mL barcoded tube of a solution with aβ2GPI IgM in a phosphate buffer containing bovine serum albumin, stabilizers, and preservative.
Calibrator 2: 1 x 1 mL barcoded tube of a solution with aβ2GPI IgM in a phosphate buffer containing bovine serum albumin, stabilizers, and preservative. | Calibrator 1: 1 x 1.2 mL barcoded vial of a solution with aβ2GPI IgM in a phosphate buffer containing bovine serum albumin, stabilizers, and preservative.
Calibrator 2: 1 x 1.2 mL barcoded vial of a solution with aβ2GPI IgM in a phosphate buffer containing bovine serum albumin, stabilizers, and preservative. | |
| Composition | 1 cartridge containing 1 vial of a magnetic particle suspension coated with human purified β2GPI, 1 vial of assay buffer, 1 vial of tracer consisting of an anti-human IgM antibody labeled with isoluminol, and 1 vial of sample diluent used for the regular predilution of the sample and automatic dilution in rerun. The reagents are in a phosphate buffer containing bovine serum albumin, human β2GPI, mouse monoclonal IgM, stabilizers, and preservative. | 1 cartridge containing 1 vial of a magnetic particle suspension coated with human purified β2GPI, 1 vial of assay buffer, 1 vial of tracer consisting of an anti-human IgM antibody labeled with isoluminol, and 1 vial of sample diluent. The reagents are in a phosphate buffer containing bovine serum albumin, human β2GPI, mouse monoclonal IgM, stabilizers, and preservative. | |
| HemosIL CL Anti-B2 Glycoprotein-I IgM Comparison to Predicate Device (Cont.) | | | |
| Item | Predicate Device: K091556 | Subject Device | |
| Trade Name | HemosIL AcuStar Anti-β2 Glycoprotein-I IgM | HemosIL CL Anti-β2 Glycoprotein-I IgM | |
| Sample Type | Serum or Citrated Plasma | Human 3.2% or 3.8% citrated plasma | |
| Quality Control | Low and high controls (sold separately) | Different control material with two levels at or
near cut-off and at abnormal level | |
| Detection Limit | 1.1 U/mL | 1.0 U/mL | |
| Linearity | 1.1 - 841 U/mL | 1.9 - 400.0 U/mL | |
| | When the rerun capability of the instrument is
activated, the instrument makes an automatic
dilution and corrects the final result for the dilution
factor (20x), thereby expanding the test range to
16,820 U/mL. | The assay is not affected by prozone effect. The
assay protocol has a washing step after the
sample incubation that precludes the prozone
effect. | |
8
HemosIL CL Anti-Cardiolipin IgM Comparison to Predicate Device
This table provides a comparative description of the similarities and differences between the subject device, HemosIL CL Anti-Cardiolipin IgM, and its predicate device, the currently marketed HemosIL AcuStar Anti-Cardiolipin IgM (K092181).
9
10
HemosIL CL Anti-ß2 Glycoprotein-I IgM Comparison to Predicate Device
This table provides a comparative description of the similarities and differences between the subject device, HemosIL CL Anti-13 Glycoprotein-I IgM, and its predicate device, the currently marketed HemosIL AcuStar Anti-ß2 Glycoprotein-I I IgM (K091556).
11
12
Precision
HemosIL CL Anti-Cardiolipin IgM
A precision study was performed in accordance with CLSI Edition), using three lots of HemosIL CL Anti-Cardiolipin IgM reagents. Repeatability and within laboratory precision were assessed. To span the study tested 5 plasma samples (3 positive; 2 negative), and 3 lots of Hemos!L 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 table below shows the aggregated data for the 3 reagent lots.
| Material | Mean (U/mL) | Lot-to-Lot Variability (% CV) |
|---|---|---|
| Low Multi-Ab Control | 8.4 | 1.6 |
| High Multi-Ab Control | 86.1 | 1.2 |
| Plasma Sample A | 5.5 | 9.6 |
| Plasma Sample B | 15.7 | 5.2 |
| Plasma Sample C | 24.3 | 2.7 |
| Plasma Sample D | 107.5 | 1.6 |
| Plasma Sample E | 396.4 | 2.3 |
13
Precision (Cont.)
HemosIL CL Anti-ß2 Glycoprotein-I IgM
A precision study was performed in accordance with CLSI Edition), using three lots of HemosIL CL Ant-1» Glycoprotein-I Igh reagens. Repeatability and within laboratory precision were assay range, the study tested 5 plasma samples (3 positive; 2 regative), 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 table below shows aggregated data for the 3 reagent lots.
| Material | Mean (U/mL) | Lot-to-Lot Variability (% CV) |
|---|---|---|
| Low Multi-Ab Control | 4.1 | 12.8 |
| High Multi-Ab Control | 51.5 | 11.5 |
| Plasma Sample A | 8.4 | 5.6 |
| Plasma Sample B | 15.0 | 4.4 |
| Plasma Sample C | 21.7 | 3.6 |
| Plasma Sample D | 96.9 | 7.2 |
| Plasma Sample E | 297.3 | 7.1 |
14
Reproducibility
HemosIL CL Anti-Cardiolipin IgM
Reproducibility studies were conducted at 3 external sith CLSI EP05-A3 (3" Edition), using different operators (1 operator per site), on 3 different ACL TOP 970 CL systems (1 system per site), using 3 lots of HemosIL CL Anti-Cardiolipin IgM and 1 lot of HemosIL CL Multi-Ab Controls. To span the assay range, 4 plasma samples (3 positive and 1 negative) were also tested across the 3 sites.
Each material was tested in triplicate, twice a day for 5 days, for a total of 30 replicates per level.
The pooled data for a representative reagent lot is presented below.
| Level | Mean
(U/mL) | N | Repeatability | | Between-run | | Between-day | | Between-site | | Reproducibility | |
|---------------------------------------------|----------------|----|---------------|------|-------------|------|-------------|------|--------------|------|-----------------|------|
| | | | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV |
| Low Multi-
Ab Control | 8.6 | 90 | 0.40 | 4.6 | 0.28 | 3.3 | 0.00 | 0.0 | 0.36 | 4.2 | 0.61 | 7.0 |
| High
Multi-Ab
Control | 100.3 | 90 | 3.86 | 3.8 | 5.24 | 5.2 | 0.00 | 0.0 | 3.47 | 3.5 | 7.37 | 7.4 |
| Clinical
Sample 1
(pool) | 5.5 | 90 | 0.22 | 3.9 | 0.38 | 6.9 | 0.16 | 2.9 | 0.24 | 4.4 | 0.52 | 9.5 |
| Clinical
Sample 2
(pool) | 30.0 | 90 | 1.01 | 3.4 | 0.70 | 2.3 | 0.00 | 0.0 | 0.58 | 1.9 | 1.36 | 4.5 |
| Clinical
Sample 3
(unadultera
ted) | 97.7 | 90 | 4.49 | 4.6 | 2.82 | 2.9 | 0.00 | 0.0 | 3.67 | 3.8 | 6.45 | 6.6 |
| Clinical
Sample 4
(pool) | 402.9 | 90 | 12.42 | 3.1 | 24.89 | 6.2 | 10.12 | 2.5 | 9.47 | 2.3 | 31.08 | 7.7 |
15
Reproducibility (Cont.)
HemosIL CL Anti-ß2 Glycoprotein-I IgM
Reproducibility studies were conducted at 3 external sites, in accordance with CLSI EPO5-A3 (3ª Edition), using different operator (1 operator per site), on 3 different ACL TOP 970 CL systems (1 system per site), using 3 lots of Hemos!L CL Anti-19 Glycoprotein-I IgM and 1 lot of Hemos!L CL Multi-Ab Low and High Controls. To span the assay range, 4 plasma samples (3 positive) were also tested across the 3 sites.
Each material was tested in triplicate, twice a day for 5 days, for a total of 30 replicates per level.
The pooled data for a representative reagent lot is presented below.
| Level | Mean
(U/ML) | N | Repeatability | | Between-run | | Between-day | | Between-site | | Reproducibility | |
|---------------------------------------------|----------------|----|---------------|------|-------------|------|-------------|------|--------------|------|-----------------|------|
| | | | SD | % CV | SD | % CV | SD | % CV | SD | % CV | SD | % CV |
| Low
Multi-Ab
Control | 9.9 | 90 | 0.42 | 4.2 | 0.58 | 5.9 | 0.00 | 0.0 | 0.40 | 4.1 | 0.82 | 8.3 |
| High
Multi-Ab
Control | 125.3 | 90 | 4.72 | 3.8 | 6.45 | 5.1 | 0.00 | 0.0 | 5.36 | 4.3 | 9.62 | 7.7 |
| Clinical
Sample 1
(pool) | 8.5 | 90 | 0.24 | 2.8 | 0.41 | 4.8 | 0.00 | 0.0 | 0.52 | 6.1 | 0.71 | 8.3 |
| Clinical
Sample 2
(pool) | 27.9 | 90 | 0.70 | 2.5 | 0.78 | 2.8 | 0.37 | 1.3 | 1.20 | 4.3 | 1.64 | 5.9 |
| Clinical
Sample 3
(unadulte
rated) | 94.4 | 90 | 2.57 | 2.7 | 3.12 | 3.3 | 1.59 | 1.7 | 4.98 | 5.3 | 6.61 | 7.0 |
| Clinical
Sample 4
(unadulte
rated) | 288.1 | 90 | 5.65 | 2.0 | 8.93 | 3.1 | 3.76 | 1.3 | 8.16 | 2.8 | 13.87 | 4.8 |
16
Analytical Sensitivity
Limit of detection (LoD) was assessed per CLSI EP17-A2 (2nd Edition) using three different lots of HemosIL CL Anti-Cardiolipin IgM and three different lots of HemosIL CL Anti-ß2 Glycoprotein-I IgM reagent cartridges. LoD samples were prepared by combining Ab-positive donor plasma and normal donor plasma per protocol. Based on the results, following are the limits of detection (LoDs) for the two assays:
| HemosIL CL Anti-Cardiolipin IgM | HemosIL CL Anti-β2 Glycoprotein-I IgM |
|---|---|
| LoD | 1.0 U/mL |
| LoQ | 1.0 U/mL |
| LoD | 2.0 U/mL |
| LoQ | 2.0 U/mL |
Linearity
Linearity was assessed per CLSI EP06 (2nd Edition) using three different lots of HemosIL CL Anti-Cardiolipin IgM and three different lots of HemosIL CL Anti-ß2 Glycoprotein-I IgM reagent cartridges. For each assay, a set of linearity samples were prepared by diluting a high antibody plasma sample with a negative antibody plasma sample to create the required sample concentrations. Each level was measured in seven replicates with the three lots for each assay. The linearity range was determined such that all acceptance criteria were met.
Based on the results, following are the linear ranges for the two assays:
| HemosIL CL Anti-Cardiolipin IgM | HemosIL CL Anti-β2 Glycoprotein-I IgM |
|---|---|
| Linearity Range | |
| 2.7 - 500.0 U/mL | Linearity Range |
| 1.9 - 400.0 U/mL | |
| The assay is not affected by prozone effect. The assay protocol has a washing step after the sample incubation that precludes the prozone effect. | The assay is not affected by prozone effect. The assay protocol has a washing step after the sample incubation that precludes the prozone effect. |
17
Analytical Specificity
Interference testing was performed in accordance with CLSI EP07 (3rd Edition) using HemosIL CL Anti-Cardiolipin IgM and HemosIL CL Anti-ß2 Glycoprotein-I IgM reagent cartridges.
Based on the results, following are the interference claims for the two assays:
| HemosIL CL Anti-Cardiolipin IgM | HemosIL CL Anti-β₂ Glycoprotein-I IgM |
|---|---|
| No interference for: | No interference for: |
| • Hemoglobin up to 1000 mg/dL | • Hemoglobin up to 1000 mg/dL |
| • Bilirubin up to 40 mg/dL | • Bilirubin up to 40 mg/dL |
| • Triglycerides up to 1500 mg/dL | • Triglycerides up to 1500 mg/dL |
| • Heparin (LMW and UF) up to 3.3 IU/mL | • Heparin (LMW and UF) up to 3.3 IU/mL |
| • Rheumatoid Factor up to 500 IU/mL | • Rheumatoid Factor up to 500 IU/mL |
| • Acetylsalicylic acid up to 3 mg/dL | • Acetylsalicylic acid up to 3 mg/dL |
| • Atorvastatin up to 0.075 mg/dL | • Atorvastatin up to 0.075 mg/dL |
| • Warfarin up to 7.5 mg/dL | • Warfarin up to 7.5 mg/dL |
| • Prednisone up to 9.90E-03 mg/dL | • Prednisone up to 9.90E-03 mg/dL |
| • Acid Citric Dextrose up to 4.5 g/dL | • Acid Citric Dextrose up to 4.5 g/dL |
| • Hydroxychloroquine up to 777.6 ng/mL | • Hydroxychloroquine up to 777.6 ng/mL |
| • Rituximab up to 318 mcg/mL | • Rituximab up to 318 mcg/mL |
| The possible interference of cryoglobulins should be considered in the interpretation of the results.¹ |
- Miyakis S, Lockshin MD, Atsumi T, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006; 4: 295-306.
18
Normal Reference Range
A normal range study was performed in accordance with CLSI EP28-A3c (3d Edition) using one lot of HemosIL CL Anti-Cardiolipin IgM and one lot of HemosIL CL Anti-B2 Glycoprotein-I IgM reagent cartridges. The normal range was verified on the ACL TOP 970 CL using 100 citrated plasma normal donor samples. The threshold for positive aCL IgM and positive aß2GPI IgM antibodies were established in the 99th percentile.
Following are the resultant upper limits of the normal range for the two assays:
| HemosIL CL Anti-Cardiolipin IgM | HemosIL CL Anti-β2 Glycoprotein-I IgM |
|---|---|
| Upper Limit | |
| 20.0 U/mL | Upper Limit |
| 20.0 U/mL |
Due to many variables which may impact results, each laboratory should determine its own normal range.
Method Comparison
A method comparison study was performed, comparing the performance of HemosIL CL Anti-Cardiolipin IgM and HemosIL CL Anti-ß2 Glycoprotein-I IgM reagent cartridges with the respective predicate devices.
HemosIL CL Anti-Cardiolipin IgM
A method comparison was performed comparing HemosIL CL Anti-Cardiolipin IgM with a commercially available chemiluminescence assay.
| System | N | Slope (95% CI) | r | Reference Method |
|---|---|---|---|---|
| ACL TOP 970 CL | 131 | 1.00 (0.98 - 1.01) | 1.00 | ACL AcuStar |
HemosIL CL Anti-ß2 Glycoprotein-I IgM
A method comparison was performed comparing HemosIL CL Anti-l2 Glycoprotem-1 IgM with a commercially available chemiluminescence assay.
| System | N | Slope (95% CI) | r | Reference Method |
|---|---|---|---|---|
| ACL TOP 970 CL | 123 | 0.94 (0.92 – 0.96) | 0.99 | ACL AcuStar |
19
APS Outcome Study
HemosIL CL Anti-Cardiolipin IgM
A diagnostic clinical performance study was performed comparing HemosIL CL Anti-Cardiolipin IgM with APS disease classification per 2006 International Consensus Statement from Miyakis et al.'
| APS Classification | ||
|---|---|---|
| HemosIL CL | ||
| Anti-Cardiolipin IgM | Positive | Negative |
| Positive | 77 | 25 |
| Negative | 113 | 285 |
| Predicate Device | N | Sensitivity
(95% CI) | Specificity
(95% CI) |
|--------------------|-----|--------------------------|--------------------------|
| APS Classification | 500 | 40.5%
(33.8% - 47.6%) | 91.9%
(88.4% - 94.5%) |
HemosIL CL Anti-ß2 Glycoprotein-I IgM
A diagnostic clinical performance study was performed comparing HemosIL CL Anti-l2_Glycoprotein-1 IgM with APS disease classification per 2006 International Consensus Statement from Miyakis et al.1
| APS Classification | ||
|---|---|---|
| HemosIL CL | ||
| Anti-β2 Glycoprotein-I IgM | Positive | Negative |
| Positive | 63 | 17 |
| Negative | 128 | 295 |
| Predicate Device | N | Sensitivitv
(95% CI) | Specificity
(95% CI) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|--------------------------|
| APS Classification | રે રેણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ | 33.0%
(26.7% - 39.9%) | 94.6%
(91.4% - 96.6%) |
- Miyakis S, Lockshin MD, Atsumi T, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006; 4: 295-306.
20
Conclusion
Based on the substantial equivalence comparison and the results of the conducted performance evaluations, the HemosIL CL Anti-Cardiolipin IgM and the HemosIL CL Anti-B2 Glycoprotein-I IgM assays on the ACL TOP 970 CL were shown to be substantially equivalent to the cleared and currently marketed devices, HemosIL AcuStar Anti-Cardiolipin IgM (K092181) and HemosIL AcuStar Anti-B2 Glycoprotein-I IgM assays (K091556) on the ACL AcuStar (K083518). The differences between the subject and predicate devices do not impact safety and effectiveness.