HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS
Device Facts
| Record ID | K091556 |
|---|---|
| Device Name | HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS |
| Applicant | Instrumentation Laboratory CO |
| Product Code | MSV · Immunology |
| Decision Date | May 21, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5660 |
| Device Class | Class 2 |
Intended Use
HemosIL AcuStar Anti-β₂ Glycoprotein-I IgG: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-β₂ Glycoprotein-I (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. HemosILTM AcuStar Anti-β₂ Glycoprotein-I IgG Controls: For the quality control of the Anti-β₂ Glycoprotein-I IgG assay performed on the ACL AcuStar. HemosIL AcuStar Anti-β₂ Glycoprotein-I 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. HemosIL AcuStar Anti-β2 Glycoprotein-I IgM Controls: For the quality control of the Anti-β2 Glycoprotein-I IgM assay performed on the ACL AcuStar.
Device Story
HemosIL AcuStar Anti-B2GPI IgG/IgM are chemiluminescent immunoassays for use on the ACL AcuStar instrument. Input: human citrated plasma or serum. Process: magnetic particles coated with purified B2GPI capture specific antibodies; isoluminol-labeled anti-human IgG/IgM tracer binds captured antibodies; luminescent reaction triggered; ACL AcuStar optical system measures relative light units (RLUs). Output: semi-quantitative concentration of anti-B2GPI antibodies. Used in clinical laboratories by trained personnel. Results aid clinicians in diagnosing thrombotic disorders associated with APS. Benefits include automation of testing compared to manual ELISA methods.
Clinical Evidence
Clinical study evaluated 321 frozen citrated plasma samples from patients with primary APS (PAPS), secondary APS (SAPS), SLE, SLE-like, other cardiovascular disorders, and healthy normals. IgG assay sensitivity 64.1%, specificity 90.8%. IgM assay sensitivity 29.3%, specificity 95.2%. Cut-off (20 U/mL) established at 99th percentile of 262 healthy volunteers.
Technological Characteristics
Two-step chemiluminescent immunoassay. Reagents: magnetic particles coated with purified human β₂GPI, isoluminol-labeled anti-human IgG/IgM tracer, phosphate/borate buffers. Form factor: cartridge-based system for ACL AcuStar analyzer. Connectivity: barcode-based master curve and lot-specific calibration. Sterilization: not specified.
Indications for Use
Indicated for semi-quantitative measurement of anti-β₂GPI IgG and IgM antibodies in human citrated plasma and serum to aid in diagnosis of thrombotic disorders related to primary and secondary Antiphospholipid Syndrome (APS). For prescription use only.
Regulatory Classification
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).
Predicate Devices
- REAADS IgG anti-β2 GPI Test Kit (k031208)
- REAADS IgM anti-β2 GPI Test Kit (k031208)
Related Devices
- K092181 — HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS · Instrumentation Laboratory CO · Mar 11, 2010
Submission Summary (Full Text)
{0}------------------------------------------------
# 510(k) Summary
# MAY 2 ] 2010
### Applicant Contact Information:
| Applicant:<br>Address: | Instrumentation Laboratory Co.<br>113 Hartwell Avenue<br>Lexington, MA 02421 |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:<br>Phone Number:<br>Fax Number: | Carol Marble, Regulatory Affairs Director<br>781-861-4467<br>781-861-4207 |
| Preparation Date: | March 3, 2010 |
| Device Trade Names: | HemosILTM AcuStar Anti-β2 Glycoprotein-I IgG<br>HemosILTM AcuStar Anti-β2 Glycoprotein-I IgM<br>HemosILTM AcuStar Anti-β2 Glycoprotein-I IgG Controls<br>HemosILTM AcuStar Anti-β2 Glycoprotein-I IgM Control. |
### Regulatory Information:
| Classification Name: | Multiple autoantibodies immunological test system;<br>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:<br>REAADS IgG Anti-β2GPI<br>(K031208) | Predicate Device:<br>REAADS IgM Anti-β2GPI<br>(K031208) |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| New Device:<br>HemosIL AcuStar<br>Anti-β2 GPI IgG | Fully automated chemiluminescent<br>immunoassay for the semi-<br>quantitative measurement of anti-<br>β2 Glycoprotein-1 (anti-β2GPI)<br>IgG antibodies in human citrated<br>plasma and serum on the ACL<br>AcuStar, as an aid in the diagnosis<br>of thrombotic disorders related to<br>primary and secondary<br>Antiphospholipid Syndrome<br>(APS) when used in conjunction<br>with other laboratory and clinical<br>findings. | For the detection and semi-<br>quantitation of IgG anti-β2 GPI<br>antibodies in human serum or<br>plasma as an aid for assessing<br>the risk of thrombosis in<br>individuals with systemic lupus<br>erythematosus (SLE) and<br>lupus-like disorders (anti-<br>phospholipid syndrome). | For the detection and semi-<br>quantitation of IgM anti-β2GPI<br>antibodies in human serum or<br>plasma as an aid for assessing<br>the risk of thrombosis in<br>individuals with systemic lupus<br>erythematosus (SLE) and<br>lupus-like disorders (anti-<br>phospholipid syndrome). |
| New Device:<br>HemosIL AcuStar<br>Anti-β2 GPI IgM | Fully automated<br>chemiluminescent immunoassay<br>for the semi-quantitative<br>measurement of anti-β2<br>Glycoprotein-I (anti-β2GPI) IgM<br>antibodies in human citrated<br>plasma and serum on the ACL<br>AcuStar as an aid in the diagnosis<br>of thrombotic disorders related to<br>primary and secondary<br>Antiphospholipid Syndrome<br>(APS) when used in conjunction<br>with other laboratory and clinical<br>findings. | | |
| Technology | Two-step chemiluminescent<br>immunoassay | ELISA | ELISA |
| Assay format | Semi-quantitative | Same | Same |
| Sample type | Serum or Citrated Plasma | Same | Same |
| Calibrator | Two Calibrator Levels<br>(Included in test kit) | Three Calibrator Levels<br>(Included in Test Kit) | Three Calibrator Levels<br>(Included in Test Kit) |
| Quality Control | Low and High Controls<br>(Sold Separately) | Normal and Positive Controls<br>(Included in Test Kit) | Normal and Positive Controls<br>(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<br>(95% CI) | % Negative Agreement<br>(95% CI) | % Overall Agreement<br>(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<br>(95% CI) | % Negative Agreement<br>(95% CI) | % Overall Agreement<br>(95% CI) |
|------------------|-----|----------------------------------|----------------------------------|---------------------------------|
| ELISA Assay | 205 | 63.8% (48.5%-77.3%) | 96.8% (92.8%-99.0%) | 89.3% (84.2%-93.2%) |
{6}------------------------------------------------
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.
{7}------------------------------------------------
### Page 2 - Carol Marble
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
{8}------------------------------------------------
# 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
{9}------------------------------------------------
# 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
