(359 days)
HemosILTM AcuStar Anti-ß2 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.
HemosILTM 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.
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.
The provided text describes performance data for the HemosIL AcuStar Anti-B2 Glycoprotein-I IgG and IgM assays, which are in vitro diagnostic (IVD) devices. The acceptance criteria and performance studies for IVDs differ significantly from those for algorithm-based medical devices or AI. Therefore, much of the requested information (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set details) is not applicable or cannot be directly extracted from this document in the context of an AI/algorithm-based device.
However, I can extract information related to the performance characteristics provided for these IVDs, which serve as their "acceptance criteria" and "proof of meeting acceptance criteria" in the context of a 510(k) submission for an IVD.
Here's the information extracted and adapted where possible:
Acceptance Criteria and Reported Device Performance
For IVD devices like those described, performance is typically assessed through precision, sensitivity, specificity, and agreement with predicate devices or clinical outcomes. The "acceptance criteria" are implicitly met if the reported performance characteristics are deemed sufficient for the device's intended use and demonstrate substantial equivalence to predicate devices during the 510(k) review process.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implicitly met by 510(k) clearance) | Reported Device Performance (HemosIL AcuStar Anti-β2 Glycoprotein-I IgG) | Reported Device Performance (HemosIL AcuStar Anti-β2 Glycoprotein-I IgM) |
|---|---|---|---|
| Precision | Adequate for clinical use and comparable to predicate | - Low Control: 19.1 U/mL (Mean), 7.8% CV (Within run), 11.2% CV (Total) | - Low Control: 4.32 U/mL (Mean), 3.4% CV (Within run), 6.4% CV (Total) |
| (% CV Within Run) | - High Control: 429 U/mL (Mean), 3.0% CV (Within run), 3.8% CV (Total) | - High Control: 63.0 U/mL (Mean), 2.4% CV (Within run), 4.3% CV (Total) | |
| (% CV Total) | - Plasma Samples A-F: CVs ranging from 2.5% to 6.9% (Within run) and 3.3% to 10.9% (Total) | - Plasma Samples A-F: CVs ranging from 2.4% to 4.5% (Within run) and 5.2% to 8.3% (Total) | |
| Clinical Sensitivity | Adequate for diagnosis (compared to clinical groups) | 64.1% (95% CI: 53.5%-73.9%) - (Vs. PAPS & SAPS combined) | 29.3% (95% CI: 20.3%-39.8%) - (Vs. PAPS & SAPS combined) |
| Clinical Specificity | Adequate for diagnosis (compared to clinical groups) | 90.8% (95% CI: 86.3%-94.2%) - (Vs. PAPS & SAPS combined) | 95.2% (95% CI: 91.6%-97.6%) - (Vs. PAPS & SAPS combined) |
| Overall % Agreement | Adequate for diagnosis (compared to clinical groups) | 83.2% (95% CI: 78.6%-87.1%) - (Vs. PAPS & SAPS combined) | 76.3% (95% CI: 71.3%-80.9%) - (Vs. PAPS & SAPS combined) |
| Positive Agreement (Vs. Predicate) | Comparable to predicate device | 100.0% (95% CI: 93.0%-100.0%) vs. REAADS IgG Anti-β2GPI | 63.8% (95% CI: 48.5%-77.3%) vs. REAADS IgM Anti-β2GPI |
| Negative Agreement (Vs. Predicate) | Comparable to predicate device | 80.8% (95% CI: 71.7%-88.0%) vs. REAADS IgG Anti-β2GPI | 96.8% (95% CI: 92.8%-99.0%) vs. REAADS IgM Anti-β2GPI |
| Overall Agreement (Vs. Predicate) | Comparable to predicate device | 87.3% (95% CI: 80.9%-92.2%) vs. REAADS IgG Anti-β2GPI | 89.3% (95% CI: 84.2%-93.2%) vs. REAADS IgM Anti-β2GPI |
2. Sample size used for the test set and the data provenance:
- Clinical Outcome Studies Test Set: 321 frozen citrated plasma samples.
- Provenance: Samples were "selected" from 6 different groups:
- Primary APS (PAPS)
- Secondary APS (SAPS)
- Systemic Lupus Erythematosus (SLE) but not APS
- SLE-like
- Patients with cardiovascular disorders (not classified in the above four groups)
- Apparently healthy people
- This implies a retrospective collection of samples, likely from multiple sources within a country or countries (not specified beyond "selected").
- Provenance: Samples were "selected" from 6 different groups:
- Method Comparison Studies Test Set:
- IgG: 150 samples (those from the clinical performance study that were within the compared methods' test ranges).
- IgM: 205 samples (those from the clinical performance study that were within the compared methods' test ranges).
- Provenance: Same as the clinical outcome studies (retrospective, unspecified country/countries).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For IVD devices, "ground truth" is typically established by existing diagnostic criteria (e.g., standard objective tests, clinical diagnosis) or comparison to a gold standard method. In this case, the ground truth for the clinical outcome study groups (PAPS, SAPS, SLE, etc.) was established based on "standard objective tests" and clinical findings. It does not involve a panel of human experts reviewing individual cases directly.
- Therefore, this information (number of experts, qualifications, adjudication method) is not applicable in the context of this IVD submission as it would be for an image-based AI device.
4. Adjudication method for the test set:
- Not applicable for this type of IVD study where ground truth is based on established clinical classifications and standard objective tests, rather than subjective expert review needing adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this was not an MRMC study. This is an in vitro diagnostic assay designed to be read by automated equipment (ACL AcuStar) and generate quantitative results, not an AI device assisting human readers in interpreting images or other complex data. This question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this is a standalone performance study. The device itself (HemosIL AcuStar assay on the ACL AcuStar instrument) provides a semi-quantitative measurement of antibodies. The performance metrics presented (precision, sensitivity, specificity, agreement with predicate) are for the device operating independently to produce these measurements. There is no human-in-the-loop component in the direct measurement process. The results are then used by clinicians, but the device's performance is standalone.
7. The type of ground truth used:
- Clinical Diagnosis and Standard Objective Tests: For the clinical outcome studies, the patient groups (PAPS, SAPS, SLE, etc.) were defined based on their clinical diagnosis and results from "standard objective tests." This serves as the clinical ground truth.
- Predicate Device Results: For the method comparison studies, the results of the "REAADS IgG Anti-β2GPI Test Kit" and "REAADS IgM Anti-β2GPI Test Kit" (ELISA assays) served as the comparative ground truth (or reference method).
8. The sample size for the training set:
- Not explicitly stated in this summary. For IVD assays, there isn't a "training set" in the same sense as machine learning. Assay development involves numerous experiments, reagent optimization, and calibration curve generation (which itself uses calibrators and a 4PLC fit model as described). The 4PLC Master Curve is "predefined and lot dependent" and is stored in the instrument, indicating a developmental process to establish this curve. However, a distinct "training set" size for an algorithm is not provided or applicable.
9. How the ground truth for the training set was established:
- Not applicable in the context of an AI training set. For IVD assays, the "ground truth" for developing and calibrating the assay would involve using known-concentration standards (calibrators) and characterized patient samples. The document mentions "calibrators" with "concentration values... included in the calibrator tube barcodes" and a 4PLC data reduction method to generate a "Master Curve," which is "predefined and lot dependent." This process inherently uses reference materials to establish the curve, which is analogous to "ground truth" for the assay's quantitative output.
{0}------------------------------------------------
510(k) Summary
MAY 2 ] 2010
Applicant Contact Information:
| Applicant:Address: | Instrumentation Laboratory Co.113 Hartwell AvenueLexington, MA 02421 |
|---|---|
| Contact Person:Phone Number:Fax Number: | Carol Marble, Regulatory Affairs Director781-861-4467781-861-4207 |
| Preparation Date: | March 3, 2010 |
| Device Trade Names: | HemosILTM AcuStar Anti-β2 Glycoprotein-I IgGHemosILTM AcuStar Anti-β2 Glycoprotein-I IgMHemosILTM AcuStar Anti-β2 Glycoprotein-I IgG ControlsHemosILTM 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 AcuStarAnti-β2 GPI IgG | Fully automated chemiluminescentimmunoassay for the semi-quantitative measurement of anti-β2 Glycoprotein-1 (anti-β2GPI)IgG antibodies in human citratedplasma and serum on the ACLAcuStar, as an aid in the diagnosisof thrombotic disorders related toprimary and secondaryAntiphospholipid Syndrome(APS) when used in conjunctionwith other laboratory and clinicalfindings. | For the detection and semi-quantitation of IgG anti-β2 GPIantibodies in human serum orplasma as an aid for assessingthe risk of thrombosis inindividuals with systemic lupuserythematosus (SLE) andlupus-like disorders (anti-phospholipid syndrome). | For the detection and semi-quantitation of IgM anti-β2GPIantibodies in human serum orplasma as an aid for assessingthe risk of thrombosis inindividuals with systemic lupuserythematosus (SLE) andlupus-like disorders (anti-phospholipid syndrome). |
| New Device:HemosIL AcuStarAnti-β2 GPI IgM | Fully automatedchemiluminescent immunoassayfor the semi-quantitativemeasurement of anti-β2Glycoprotein-I (anti-β2GPI) IgMantibodies in human citratedplasma and serum on the ACLAcuStar as an aid in the diagnosisof thrombotic disorders related toprimary and secondaryAntiphospholipid Syndrome(APS) when used in conjunctionwith other laboratory and clinicalfindings. | ||
| Technology | Two-step chemiluminescentimmunoassay | 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%) |
{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
§ 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).