(359 days)
Not Found
No
The device description details a standard immunoassay process and data reduction using a 4 Parameter Logistic Curve (4PLC), which is a conventional statistical method, not AI/ML. There is no mention of AI, ML, or related concepts in the document.
No
The device is described as an immunoassay used for the semi-quantitative measurement of antibodies as an aid in the diagnosis of thrombotic disorders. It does not provide any treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is used "as an aid in the diagnosis of thrombotic disorders."
No
The device description clearly outlines a chemiluminescent immunoassay involving physical components like magnetic particles, reagents, and an optical system (ACL AcuStar) to measure light emitted. While software is used for data reduction (4PLC curve fitting), the core functionality relies on hardware and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "semi-quantitative measurement of anti-ß, Glycoprotein-I (anti-B>GPI) IgG antibodies in human citrated plasma and serum" and "anti-B2 Glycoprotein-I (anti-B>GPI) IgM antibodies in human citrated plasma and serum". It also states it is used "as an aid in the diagnosis of thrombotic disorders related to primary and secondary Antiphospholipid Syndrome (APS)". These are all characteristics of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a "chemiluminescent immunoassay" that uses "human citrated plasma and serum" samples. This describes a laboratory test performed on biological samples outside of the body.
- Controls: The inclusion of "HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls" and "HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls" for "quality control of the assay" is standard practice for IVD devices to ensure the accuracy and reliability of the test results.
- Performance Studies: The document describes "Outcome Studies" and "Method Comparison Studies" performed on "human citrated plasmas" to evaluate the device's performance in a clinical context, which is a requirement for IVD devices seeking regulatory approval.
- Predicate Devices: The mention of "Predicate Device(s)" with K numbers (K031208) indicates that this device is being compared to previously cleared IVD devices, a common pathway for demonstrating substantial equivalence for new IVDs.
All of these elements strongly indicate that the HemosILTM AcuStar Anti-ß2 Glycoprotein-I IgG and IgM assays, along with their associated controls, are intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
- HemosILTM AcuStar Anti-ß2 Glycoprotein-I IgG: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-ß2 Glycoprotein-I (anti-ß2GPI) IgG 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.
- HemosILTM AcuStar Anti-B2 Glycoprotein-I IgM: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-B2 Glycoprotein-I (anti-B2GPI) 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 AcuStar Anti-B2 Glycoprotein-I IgG Controls: For the quality control of the Anti-B2 Glycoprotein-I IgG assay performed on the ACL AcuStar.
- HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls: For the quality control of the Anti-B2 Glycoprotein-I IgM assay performed on the ACL AcuStar.
Product codes (comma separated list FDA assigned to the subject device)
MSV, JJX
Device Description
-
HemosIL AcuStar Anti-B2 Glycoprotein-I IgG is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with human purified B2GPI which capture, if present, the anti-B2GPI antiphospholipid 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 anti-B2GPI IgG 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 AcuStar optical system. The RLUs are directly proportional to the anti-ß2GPI IgG concentration in the sample.
The ACL AcuStar anti-B2GPI IgG assay utilizes a 4 Parameter Logistic Curve (4PLC) fit 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 calibrator tube barcodes. -
HemosIL AcuStar Anti-B2 Glycoprotein-I IgM is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with human purified B2GPI which capture, if present, the anti-B2GPI antiphospholipid 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 anti-ß2GPI 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 AcuStar optical system. The RLUs are directly proportional to the anti-B2GPI IgM concentration in the sample.
The ACL AcuStar anti-B3GPI IgM assay utilizes a 4 Parameter Logistic Curve (4PLC) fit 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 calibrator tube barcodes. -
HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls: The Low and High Anti-B2 Glycoprotein-I IgG Controls are prepared by means of a dedicated process and contain different concentrations of human anti-ß2 Glycoprotein-I IgG antibodies.
- Low Anti-B2 Glycoprotein-I IgG Control: Control intended for the assessment of precision and accuracy of the assay at the normal or around cut-off anti-B2 Glycoprotein-I IgG levels.
- High Anti-B2 Glycoprotein-I IgG Control: Control intended for the assessment of precision and accuracy of the assay at the abnormal anti-B2 Glycoprotein-I IgG levels.
-
HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls: The Low and High Anti-B2 Glycoprotein-I IgM Controls are prepared by means of a dedicated process and contain different concentrations of human anti-B2 Glycoprotein-I IgM antibodies.
- Low Anti-B2 Glycoprotein-I IgM Control intended for the assessment of precision and accuracy of the assay at the normal or around cut-off anti-B2 Glycoprotein-I IgM levels.
- High Anti-B2 Glycoprotein-I IgM Control: Control intended for the assessment of precision and accuracy of the assay at the abnormal anti-B2 Glycoprotein-I IgM levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Study:
- Study Type: Within run and total precision assessment over multiple runs.
- Sample Size: Not explicitly stated as a number of samples, but assessed using two control levels and various plasma samples (A-F) for both IgG and IgM assays.
- Key Results (IgG):
- Low anti-ß2GPI IgG Control: Mean 19.1 U/mL, CV% (Within run) 7.8%, CV% (Total) 11.2%
- High anti-ß2GPI IgG Control: Mean 429 U/mL, CV% (Within run) 3.0%, CV% (Total) 3.8%
- Plasma sample A: Mean 14.7 U/mL, CV% (Within run) 6.9%, CV% (Total) 10.9%
- Plasma sample B: Mean 20.9 U/mL, CV% (Within run) 4.7%, CV% (Total) 7.3%
- Plasma sample C: Mean 58.1 U/mL, CV% (Within run) 3.2%, CV% (Total) 5.0%
- Plasma sample D: Mean 508 U/mL, CV% (Within run) 2.5%, CV% (Total) 3.3%
- Plasma sample E: Mean 1470 U/mL, CV% (Within run) 2.5%, CV% (Total) 3.7%
- Plasma sample F: Mean 2694 U/mL, CV% (Within run) 3.7%, CV% (Total) 3.7%
- Key Results (IgM):
- Low anti-ß2GPI IgM Control: Mean 4.32 U/mL, CV% (Within run) 3.4%, CV% (Total) 6.4%
- High anti-ß2GPI IgM Control: Mean 63.0 U/mL, CV% (Within run) 2.4%, CV% (Total) 4.3%
- Plasma sample A: Mean 11.0 U/mL, CV% (Within run) 3.6%, CV% (Total) 5.8%
- Plasma sample B: Mean 13.6 U/mL, CV% (Within run) 4.5%, CV% (Total) 8.3%
- Plasma sample C: Mean 16.3 U/mL, CV% (Within run) 2.7%, CV% (Total) 6.6%
- Plasma sample D: Mean 91.9 U/mL, CV% (Within run) 2.4%, CV% (Total) 5.7%
- Plasma sample E: Mean 302 U/mL, CV% (Within run) 3.0%, CV% (Total) 5.2%
- Plasma sample F: Mean 510 U/mL, CV% (Within run) 4.1%, CV% (Total) 6.0%
Outcome Studies:
- Study Type: Clinical performance study based on patient groups.
- Sample Size: 321 selected frozen citrated plasmas.
- Data Source: From 6 different groups:
- Primary APS (PAPS)
- Secondary APS (SAPS)
- Systemic lupus erythematosus (SLE) but not APS
- SLE-like
- Patients with cardiovascular disorders but not classified in the previous four groups ("Others")
- Apparently healthy people ("Normals")
- Key Results (HemosIL AcuStar Anti-B2 Glycoprotein-I IgG, cut-off 20 U/mL):
- PAPS: N=23, N (Positive)=14, % Positive=60.9%
- SAPS: N=69, N (Positive)=45, % Positive=65.2%
- SLE: N=115, N (Positive)=20, % Positive=17.4%
- SLE-like: N=5, N (Positive)=0, % Positive=0.0%
- Others: N=6, N (Positive)=1, % Positive=16.7%
- Normals: N=103, N (Positive)=0, % Positive=0.0%
- Clinical Sensitivity (PAPS and SAPS positive): 64.1% (95% CI: 53.5%-73.9%)
- Clinical Specificity (PAPS and SAPS positive): 90.8% (95% CI: 86.3%-94.2%)
- Overall % Agreement (PAPS and SAPS positive): 83.2% (95% CI: 78.6%-87.1%)
- Key Results (HemosIL AcuStar Anti-β2 Glycoprotein-I IgM, cut-off 20 U/mL):
- PAPS: N=23, N (Positive)=7, % Positive=30.4%
- SAPS: N=69, N (Positive)=20, % Positive=29.0%
- SLE: N=115, N (Positive)=10, % Positive=8.7%
- SLE-like: N=5, N (Positive)=0, % Positive=0.0%
- Others: N=6, N (Positive)=1, % Positive=16.7%
- Normals: N=103, N (Positive)=0, % Positive=0.0%
- Clinical Sensitivity (PAPS and SAPS positive): 29.3% (95% CI: 20.3%-39.8%)
- Clinical Specificity (PAPS and SAPS positive): 95.2% (95% CI: 91.6%-97.6%)
- Overall % Agreement (PAPS and SAPS positive): 76.3% (95% CI: 71.3%-80.9%)
Method Comparison Studies:
- Study Type: Comparison with Predicate Device (ELISA Assay).
- Sample Size (IgG): 150 samples.
- Key Results (HemosIL AcuStar Anti-B2 Glycoprotein-I IgG):
- % Positive Agreement: 100.0% (93.0%-100.0%)
- % Negative Agreement: 80.8% (71.7%-88.0%)
- % Overall Agreement: 87.3% (80.9%-92.2%)
- Sample Size (IgM): 205 samples.
- Key Results (HemosIL AcuStar Anti-β2 Glycoprotein-I IgM):
- % Positive Agreement: 63.8% (48.5%-77.3%)
- % Negative Agreement: 96.8% (92.8%-99.0%)
- % Overall Agreement: 89.3% (84.2%-93.2%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
IgG Assay:
- Clinical Sensitivity: 64.1% (95% CI: 53.5%-73.9%)
- Clinical Specificity: 90.8% (95% CI: 86.3%-94.2%)
- Overall % Agreement: 83.2% (95% CI: 78.6%-87.1%)
- Method Comparison vs. ELISA Assay:
- % Positive Agreement: 100.0% (93.0%-100.0%)
- % Negative Agreement: 80.8% (71.7%-88.0%)
- % Overall Agreement: 87.3% (80.9%-92.2%)
IgM Assay:
- Clinical Sensitivity: 29.3% (95% CI: 20.3%-39.8%)
- Clinical Specificity: 95.2% (95% CI: 91.6%-97.6%)
- Overall % Agreement: 76.3% (95% CI: 71.3%-80.9%)
- Method Comparison vs. ELISA Assay:
- % Positive Agreement: 63.8% (48.5%-77.3%)
- % Negative Agreement: 96.8% (92.8%-99.0%)
- % Overall Agreement: 89.3% (84.2%-93.2%)
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
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
0
510(k) Summary
MAY 2 ] 2010
Applicant Contact Information:
| Applicant:
Address: | Instrumentation Laboratory Co.
113 Hartwell Avenue
Lexington, MA 02421 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:
Phone Number:
Fax Number: | Carol Marble, Regulatory Affairs Director
781-861-4467
781-861-4207 |
| Preparation Date: | March 3, 2010 |
| Device Trade Names: | HemosILTM AcuStar Anti-β2 Glycoprotein-I IgG
HemosILTM AcuStar Anti-β2 Glycoprotein-I IgM
HemosILTM AcuStar Anti-β2 Glycoprotein-I IgG Controls
HemosILTM AcuStar Anti-β2 Glycoprotein-I IgM Control. |
Regulatory Information:
| Classification Name: | Multiple autoantibodies immunological test system;
Single (specified) analyte controls (assayed and unassayed) |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| Device Class: | Class II (Assays); Class I (Controls) |
| Regulation No.: | 21 CFR 866.5660 (Assays); 21 CFR 862.1660 (Controls) |
| Product Code: | MSV (Antibodies, β2 Glycoprotein I); JJX (Controls) |
| Panel: | Immunology |
Identification of Predicate Devices:
| K031208 | REAADS IgG anti-β2 GPI Test Kit |
|---|---|
| K031208 | REAADS IgM anti-β2 GPI Test Kit |
Device Indications for Uses:
- HemosIL AcuStar Anti-B2 Glycoprotein-I IgG: Fully automated chemiluminescent immunoassay for . the semi-quantitative measurement of anti-ß, Glycoprotein-I (anti-B>GPI) IgG 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 AcuStar Anti-B2 Glycoprotein-I IgM: Fully automated chemiluminescent immunoassay for . the semi-quantitative measurement of anti-B2 Glycoprotein-I (anti-B>GPI) 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 AcuStar Anti-B2 Glycoprotein-I IgG Controls: For the quality control of the Anti-B2 Glycoprotein-I IgG assay performed on the ACL AcuStar.
- . HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls: For the quality control of the Anti-B2 Glycoprotein-I IgM assay performed on the ACL AcuStar.
K091556: HemosIL AcuStar anti-B2GPI IgG and IgM Assays and Controls Attachment C Page 1 of 6
1
Device Description:
-
HemosIL AcuStar Anti-B2 Glycoprotein-I IgG is a chemiluminescent two-step immunoassay . consisting of magnetic particles coated with human purified ByGPI which capture, if present, the anti-ByGPI antiphospholipid 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 anti-B2GPI IgG 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 AcuStar optical system. The RLUs are directly proportional to the anti-ß2GPI IgG concentration in the sample.
The ACL AcuStar anti-B2GPI IgG assay utilizes a 4 Parameter Logistic Curve (4PLC) fit 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 calibrator tube barcodes. -
. HemosIL AcuStar Anti-B2 Glycoprotein-I IgM is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with human purified ByGPI which capture, if present, the anti-B2GPI antiphospholipid 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 anti-ß2GPI 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 AcuStar optical system. The RLUs are directly proportional to the anti-B2GPI IgM concentration in the sample.
The ACL AcuStar anti-B3GPI IgM assay utilizes a 4 Parameter Logistic Curve (4PLC) fit 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 calibrator tube barcodes. -
HemosIL AcuStar Anti-B2 Glycoprotein-I IgG Controls: The Low and High Anti-S, Glycoprotein-I . IgG Controls are prepared by means of a dedicated process and contain different concentrations of human anti-ß2 Glycoprotein-I IgG antibodies.
- . Low Anti-B2 Glycoprotein-I IgG Control: Control intended for the assessment of precision and accuracy of the assay at the normal or around cut-off anti-B2 Glycoprotein-I IgG levels.
- . High Anti-B2 Glycoprotein-I IgG Control: Control intended for the assessment of precision and accuracy of the assay at the abnormal anti-B2 Glycoprotein-I IgG levels.
-
. HemosIL AcuStar Anti-B2 Glycoprotein-I IgM Controls: The Low and High Anti-B2 Glycoprotein-I IgM Controls are prepared by means of a dedicated process and contain different concentrations of human anti-B2 Glycoprotein-I IgM antibodies.
- . Low Anti-B2 Glycoprotein-I IgM Control intended for the assessment of precision and accuracy of the assay at the normal or around cut-off anti-B2 Glycoprotein-I IgM levels.
- . High Anti-B2 Glycoprotein-I IgM Control: Control intended for the assessment of precision and accuracy of the assay at the abnormal anti-B2 Glycoprotein-I IgM levels.
2
echnological Characteristic Summar
The Hemol. Anti-A Glycoproteir I IgG assy used with Hemo. AcuSar Ani-fo Glycoprotein- I IgO Control are eurolant o the urrent
marketel REAADS IgG Ani-I-CPT Test Kit (K0
Substantial Equivalence Comparison Table
| Characteristic | Intended Use | Predicate Device:
REAADS IgG Anti-β2GPI
(K031208) | Predicate Device:
REAADS IgM Anti-β2GPI
(K031208) |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| New Device:
HemosIL AcuStar
Anti-β2 GPI IgG | Fully automated chemiluminescent
immunoassay for the semi-
quantitative measurement of anti-
β2 Glycoprotein-1 (anti-β2GPI)
IgG 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. | For the detection and semi-
quantitation of IgG anti-β2 GPI
antibodies in human serum or
plasma as an aid for assessing
the risk of thrombosis in
individuals with systemic lupus
erythematosus (SLE) and
lupus-like disorders (anti-
phospholipid syndrome). | For the detection and semi-
quantitation of IgM anti-β2GPI
antibodies in human serum or
plasma as an aid for assessing
the risk of thrombosis in
individuals with systemic lupus
erythematosus (SLE) and
lupus-like disorders (anti-
phospholipid syndrome). |
| New Device:
HemosIL AcuStar
Anti-β2 GPI IgM | 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. | | |
| Technology | Two-step chemiluminescent
immunoassay | ELISA | ELISA |
| Assay format | Semi-quantitative | Same | Same |
| Sample type | Serum or Citrated Plasma | Same | Same |
| Calibrator | Two Calibrator Levels
(Included in test kit) | Three Calibrator Levels
(Included in Test Kit) | Three Calibrator Levels
(Included in Test Kit) |
| Quality Control | Low and High Controls
(Sold Separately) | Normal and Positive Controls
(Included in Test Kit) | Normal and Positive Controls
(Included in Test Kit) |
| Clinical Cut-off | 20.0 U/mL | 20 G Units | 20 M Units |
3
Summary of Performance Data:
Precision
Within run and total precision assessed over multiple runs using the respective assays with their two control levels and a plasma sample giving the following results:
| HemosIL AcuStar Anti-B2 Glycoprotein-I IgG | |||||
|---|---|---|---|---|---|
| ACL AcuStar | Mean (U/mL) | CV% (Within run) | CV% (Total) | ||
| Low anti-ß2GPI IgG Control | 19.1 | 7.8% | 11.2% | ||
| High anti-ß2GPI IgG Control | 429 | 3.0% | 3.8% | ||
| Anti-ß2GPI IgG plasma sample A | 14.7 | 6.9% | 10.9% | ||
| Anti-ß2GPI IgG plasma sample B | 20.9 | 4.7% | 7.3% | ||
| Anti-ß2GPI IgG plasma sample C | 58.1 | 3.2% | 5.0% | ||
| Anti-ß2GPI IgG plasma sample D | 508 | 2.5% | 3.3% | ||
| Anti-ß2GPI IgG plasma sample E | 1470 | 2.5% | 3.7% | ||
| Anti-ß2GPI IgG plasma sample F | 2694 | 3.7% | 3.7% |
| HemosIL AcuStar Anti-β2 Glycoprotein-I IgM | |||
|---|---|---|---|
| ACL AcuStar | Mean (U/mL) | CV% (Within run) | CV% (Total) |
| Low anti-β2GPI IgM Control | 4.32 | 3.4% | 6.4% |
| High anti-β2GPI IgM Control | 63.0 | 2.4% | 4.3% |
| Anti-β2GPI IgM plasma sample A | 11.0 | 3.6% | 5.8% |
| Anti-β2GPI IgM plasma sample B | 13.6 | 4.5% | 8.3% |
| Anti-β2GPI IgM plasma sample C | 16.3 | 2.7% | 6.6% |
| Anti-β2GPI IgM plasma sample D | 91.9 | 2.4% | 5.7% |
| Anti-β2GPI IgM plasma sample E | 302 | 3.0% | 5.2% |
| Anti-β2GPI IgM plasma sample F | 510 | 4.1% | 6.0% |
4
Outcome Studies
Outcome studies were performed on 321 selected frozen citrated plasmas were from 6 different groups including selected individuals diagnosed as primary APS (PAPS), secondary APS (SAPS) systemic lupus erythematosus (SLE) but not APS and SLE-like by standard objective tests. The fifth group was patients with cardiovascular disorders but not classified in the previous four groups. A group of apparently healthy people was also included.
The results summarized below are based on a cut-off of 20 U/mL:
| HemosIL AcuStar Anti-β2 Glycoprotein-I IgG | |||
|---|---|---|---|
| Patient group | N | N (Positive) | % Positive |
| PAPS | 23 | 14 | 60.9% |
| SAPS | 69 | 45 | 65.2% |
| SLE | 115 | 20 | 17.4% |
| SLE-like | 5 | 0 | 0.0% |
| Others | 6 | 1 | 16.7% |
| Normals | 103 | 0 | 0.0% |
Considering as positive the patient groups PAPS and SAPS the clinical Sensitivity, Specificity and Overall % Agreement were:
| System | N | Sensitivity (95% CI) | Specificity (95% CI) | % Agreement (95% CI) |
|---|---|---|---|---|
| ACL AcuStar | 321 | 64.1% (53.5%-73.9%) | 90.8% (86.3%-94.2%) | 83.2% (78.6%-87.1%) |
| Patient group | N | N (Positive) | % Positive |
|---|---|---|---|
| PAPS | 23 | 7 | 30.4% |
| SAPS | 69 | 20 | 29.0% |
| SLE | 115 | 10 | 8.7% |
| SLE-like | 5 | 0 | 0.0% |
| Others | 6 | 1 | 16.7% |
| Normals | 103 | 0 | 0.0% |
Considering as positive the patient groups PAPS and SAPS, the clinical Sensitivity, Specificity and Overall % Agreement were:
| System | N | Sensitivity (95% CI) | Specificity (95% CI) | Agreement (95% CI) |
|---|---|---|---|---|
| ACL AcuStar | 321 | 29.3% (20.3%-39.8%) | 95.2% (91.6%-97.6%) | 76.3% (71.3%-80.9%) |
5
Method Comparison Studies
HemosIL AcuStar Anti-B2 Glycoprotein-I IgG
The samples used in the clinical performance study that were within the compared methods' test ranges were measured in a Method Comparison study with REAADS IgG Anti-B2GPI Test Kit. % Positive, Negative and Overall Agreement were:
| ELISA Assay | ||
|---|---|---|
| HemosIL AcuStar Anti-β2GPI IgG | Negative | Positive |
| Negative | 80 | 0 |
| Positive | 19 | 51 |
| Predicate Device | N | % Positive Agreement
(95% CI) | % Negative Agreement
(95% CI) | % Overall Agreement
(95% CI) |
|------------------|-----|----------------------------------|----------------------------------|---------------------------------|
| ELISA Assay | 150 | 100.0% (93.0%-100.0%) | 80.8% (71.7%-88.0%) | 87.3% (80.9%-92.2%) |
HemosIL AcuStar Anti-β2 Glycoprotein-I IgM
The samples used in the clinical performance study that were within the compared methods' test ranges were measured in a Method Comparison study with REAADS IgM Anti-B2GPI Test Kit. % Positive, Negative and Overall Agreement were:
| ELISA Assay | ||
|---|---|---|
| HemosIL AcuStar Anti-β2GPI IgM | Negative | Positive |
| Negative | 153 | 17 |
| Positive | 5 | 30 |
| Predicate Device | N | % Positive Agreement
(95% CI) | % Negative Agreement
(95% CI) | % Overall Agreement
(95% CI) |
|------------------|-----|----------------------------------|----------------------------------|---------------------------------|
| ELISA Assay | 205 | 63.8% (48.5%-77.3%) | 96.8% (92.8%-99.0%) | 89.3% (84.2%-93.2%) |
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three arms or extensions reaching upwards, resembling a bird in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
MAY 2 1 2010
Instrumentation Laboratory Co. c/o Carol Marble Regulatory Affairs Director 113 Hartwell Avenue Lexington, MA 02421
Trade/Device Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Dated:
Received:
Re: K091556
HemosIL™ AcuStar Anti-ß2 Glycoprotein-I IgG HemosILTM AcuStar Anti-B2 Glycoprotein-I IgM HemosILTM AcuStar Anti-ß2 Glycoprotein-I IgG Controls HemosIL™ AcuStar Anti-ß2 Glycoprotein-I IgM Controls 21 CFR §866.5660 Multiple autoantibodies immunological test system Class II MSV, JJX May 14, 2010 May 17, 2010
Dear Carol 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Marci M. Chan
Maria M. Chan, Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K0911556
Devices Name: HemosIL™ AcuStar Anti-B2 Glycoprotein-I IgG HemosIL " AcuStar Anti-B2 Glycoprotein-I IgG Controls
Indications for Use:
- HemosILTM AcuStar Anti-ß2 Glycoprotein-I IgG: Fully automated chemiuminescent . immunoassay for the semi-quantitative measurement of anti-B2 Glycoprotein-I (anti-B2CPI) IgG 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™ AcuStar Anti-B2 Glycoprotein-I IgG Controls: For the quality control of the ● Anti-B2 Glycoprotein-I IgG assay performed on the ACL AcuStar.
| Prescription Use | √ |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Reena Philip
Division Sign-Off
Division Sign-Off
Office of In Vitro Dlagn Device Evaluation a
510K K091556
Attachment A
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Indications for Use Statement
510(k) Number (if known): K091556
Devices Name: HemosIL™ AcuStar Anti-B2 Glycoprotein-I IgM HemosIL™ AcuStar Anti-ß2 Glycoprotein-I IgM Controls
Indications for Use:
- HemosIL™ AcuStar Anti-ß2 Glycoprotein-I IgM: Fully automated chemiluminescent . immunoassay for the semi-quantitative measurement of anti-ß2 Glycoprotein-I (anti-ß2GPI) 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™ AcuStar Anti-B2 Glycoprotein-I IgM Controls: For the quality control of the . Anti-ß2 Glycoprotein-I IgM assay performed on the ACL AcuStar.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Reena Philip
Division Sign-Off
Office of In Vitro Diagn Device Evaluation and
510K