(233 days)
HemosIL AcuStar Anti-Cardiolipin IgG: Fully automated chemiluminescent immunoassay for the . semi-quantitative measurement of anti-cardiolipin (aCL) IgG antibodies in human citrate 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-Cardiolipin IgM: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgM antibodies in human citrated plasma and serum on the ACL™ AcuStar, as an aid in the diagnosis of thrombotic disorders related to primary and secondary Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings.
HemosIL AcuStar Anti-Cardiolipin IgG Controls: For the quality control of the Anti-Cardiolipin . IgG assay performed on the ACL AcuStar.
HemosIL AcuStar Anti-Cardiolipin IgM Controls: For the quality control of the Anti-Cardiolipin . IgM assay performed on the ACL AcuStar.
HemosIL AcuStar Anti-Cardiolipin IgG is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with cardiolipin and human purified B2GPI which capture, if present, the aCL 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 aCL 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 aCL IgG concentration in the sample.
The ACL AcuStar aCL 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 cartidge 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.
Hemos L AcuStar Anti-Cardiolipin IgM is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with cardiolipin and human purified B2GPI which capture, if present, the aCL 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 aCL IgM on the particles. After a second incubation, magnetic separation, and wash step, reagents that trigger the luminescent reaction are added, and the emitted light is measured as relative light units (RLUs) by the ACL AcuStar optical system. The RLUs are directly proportional to the aCL IgM concentration in the sample.
The ACL AcuStar aCL 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.
Hemos L AcuStar Anti-Cardiolipin IgG Controls: The Low and High Anti-Cardiolipin IgG Controls are prepared by means of a dedicated process and contain different concentrations of human aCL IgG antibodies.
Low Anti-Cardiolipin IgG Control: Control intended for the assessment of precision and accuracy of the assay at the normal or around cut-off aCL IgG levels.
High Anti-Cardiolipin IgG Control: Control intended for the assessment of precision and accuracy of the assay at the abnormal aCL IgG levels.
Hemos L AcuStar Anti-Cardiolipin IgM Controls: The Low and High Anti-Cardiolipin IgM ● Controls are prepared by means of a dedicated process and contain different concentrations of human aCL IgM antibodies.
Low Anti-Cardiolipin IgM Control: Control intended for the assessment of precision and accuracy of the assay at the normal or around cut-off aCL IgM levels.
High Anti-Cardiolipin IgM Control: Control intended for the assessment of precision and accuracy of the assay at the abnormal aCL IgM levels.
The provided text describes the performance data for the HemosIL AcuStar Anti-Cardiolipin IgG and IgM assays and their respective controls, which are automated chemiluminescent immunoassays used to aid in the diagnosis of thrombotic disorders related to Antiphospholipid Syndrome (APS).
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the clinical performance in a quantifiable manner (e.g., a required minimum sensitivity or specificity). However, it presents performance data for precision, clinical sensitivity, specificity, and agreement with a predicate device. For the purpose of this response, I will list the reported performance metrics.
| Performance Metric | Acceptance Criteria (Implicit from Study) | Reported Device Performance (HemosIL AcuStar Anti-Cardiolipin IgG) | Reported Device Performance (HemosIL AcuStar Anti-Cardiolipin IgM) |
|---|---|---|---|
| Precision (CV%) - Low Control | Not explicitly stated | Within run: 6.8%; Total: 8.2% | Within run: 3.3%; Total: 4.9% |
| Precision (CV%) - High Control | Not explicitly stated | Within run: 6.1%; Total: 6.9% | Within run: 3.5%; Total: 4.0% |
| Clinical Sensitivity (PAPS & SAPS groups) | Not explicitly stated | 54.3% (95% CI: 43.6%-64.8%) | 33.7% (95% CI: 24.2%-44.3%) |
| Clinical Specificity (PAPS & SAPS groups excluded) | Not explicitly stated | 95.6% (95% CI: 92.1%-97.9%) | 94.8% (95% CI: 91.0%-97.3%) |
| Overall Clinical Agreement | Not explicitly stated | 83.8% (95% CI: 79.3%-87.7%) | 77.3% (95% CI: 72.3%-81.7%) |
| Method Comparison: % Positive Agreement with Predicate | Not explicitly stated | 80.0% (95% CI: 63.1%-91.6%) | 43.8% (95% CI: 32.2%-55.9%) |
| Method Comparison: % Negative Agreement with Predicate | Not explicitly stated | 75.2% (95% CI: 65.7%-83.3%) | Missing data in document |
| Method Comparison: % Overall Agreement with Predicate | Not explicitly stated | 76.5% (95% CI: 68.4%-83.3%) | Missing data in document |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Outcome Study: 321 frozen citrated plasma samples.
- Sample Size for Method Comparison Study:
- HemosIL AcuStar Anti-Cardiolipin IgG: 136 samples (those within the compared methods' test ranges from the clinical performance study).
- HemosIL AcuStar Anti-Cardiolipin IgM: 267 samples (those within the compared methods' test ranges from the clinical performance study).
- Data Provenance: The text does not explicitly state the country of origin. The samples were "frozen citrated plasmas" from "6 different groups," including patients diagnosed with primary APS (PAPS), secondary APS (SAPS), systemic lupus erythematosus (SLE) with and without APS, cardiovascular disorders, and apparently healthy people. This indicates a retrospective collection of samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not provide information about the number of experts or their qualifications used to establish the ground truth for the test set. It mentions "individuals diagnosed as primary APS (SAPS), secondary APS (SAPS), systemic lupus erythematosus (SLE) but not APS and SLE-like by standard objective tests." This implies that the diagnosis (ground truth) was established through existing clinical assessments and standard objective tests, but not necessarily through a de novo expert consensus review for the purpose of this study.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing the ground truth or resolving discrepancies for the test set. The diagnoses were seemingly pre-existing.
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
This section is not applicable to this device. The HemosIL AcuStar Anti-Cardiolipin assays are laboratory diagnostic tests (immunoassays) performed on an automated instrument (ACL™ AcuStar) to measure specific antibodies in patient samples. They are not AI-assisted imaging or clinical decision support tools that involve human "readers" or directly improve human "readers" with AI assistance. The results are quantitative measurements.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented (precision, clinical sensitivity/specificity, method comparison) reflects the standalone performance of the HemosIL AcuStar assays. These are automated chemiluminescent immunoassays, meaning the algorithm (the assay's chemical reactions and instrument's measurement/calculation) provides a result without direct human intervention in the measurement or interpretation, beyond loading samples and controls and routine instrument operation. The results are then interpreted clinically by healthcare professionals.
7. The Type of Ground Truth Used
The ground truth used for the clinical outcome studies was based on the clinical diagnosis of the patient groups. Specifically, patients were categorized into groups such as Primary APS (PAPS), Secondary APS (SAPS), Systemic Lupus Erythematosus (SLE), SLE-like, cardiovascular disorders, and apparently healthy people. The "cut-off of 20 U/mL" was applied to the assay results to determine positive/negative status relative to these clinical diagnoses.
8. The Sample Size for the Training Set
The document does not explicitly mention a separate "training set" for the development of any algorithm or model. The description of the device (Section "Device Description") indicates that the instrument uses a "4 Parameter Logistic Curve (4PLC) fit data reduction method to generate a Master Curve," which is "predefined and lot dependent" and stored via a barcode. This suggests that the master curve might be established during manufacturing/development using a set of reference materials, but no specific "training set" of patient samples for algorithm refinement is mentioned in the context of the regulatory submission.
9. How the Ground Truth for the Training Set was Established
As no explicit "training set" is described for an AI/machine learning algorithm based on patient data, this question is not applicable in the context of this document. The "Master Curve" mentioned for calibration is established using calibrators with known concentrations, not a patient-derived training set with clinical ground truth.
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510(k) Summary
Applicant Contact Information:
MAR ] 1 2010
| Applicant: | Instrumentation Laboratory Co. |
|---|---|
| Address: | 113 Hartwell AvenueLexington, MA 02421 |
| Contact Person: | Carol Marble, Regulatory Affairs Director |
| Phone Number: | 781-861-4467 |
| Fax Number: | 781-861-4207 |
| Preparation Date: | March 3, 2010 |
| Device Trade Names: | HemosIL TM AcuStar Anti-Cardiolipin IgGHemosIL TM AcuStar Anti-Cardiolipin IgMHemosIL TM AcuStar Anti-Cardiolipin IgG ControlsHemosIL TM AcuStar Anti-Cardiolipin IgM Controls |
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: | MID (System Test, Anti-Cardiolipin Immunological); JJX (Controls) |
| Panel: | Immunology (82) |
Identification of Predicate Devices:
REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit
Device Indications for Uses:
- HemosIL AcuStar Anti-Cardiolipin IgG: Fully automated chemiluminescent immunoassay for the . semi-quantitative measurement of anti-cardiolipin (aCL) IgG antibodies in human citrate 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-Cardiolipin IgM: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgM antibodies in human citrated plasma and serum on the ACL™ AcuStar, as an aid in the diagnosis of thrombotic disorders related to primary and secondary Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings.
- HemosIL AcuStar Anti-Cardiolipin IgG Controls: For the quality control of the Anti-Cardiolipin . IgG assay performed on the ACL AcuStar.
- HemosIL AcuStar Anti-Cardiolipin IgM Controls: For the quality control of the Anti-Cardiolipin . IgM assay performed on the ACL AcuStar.
{1}------------------------------------------------
Device Description:
-
HemosIL AcuStar Anti-Cardiolipin IgG is a chemiluminescent two-step immunoassay consisting of . magnetic particles coated with cardiolipin and human purified B2GPI which capture, if present, the aCL 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 aCL 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 aCL IgG concentration in the sample.
The ACL AcuStar aCL 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 cartidge 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. -
. Hemos L AcuStar Anti-Cardiolipin IgM is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with cardiolipin and human purified B2GPI which capture, if present, the aCL 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 aCL IgM on the particles. After a second incubation, magnetic separation, and wash step, reagents that trigger the luminescent reaction are added, and the emitted light is measured as relative light units (RLUs) by the ACL AcuStar optical system. The RLUs are directly proportional to the aCL IgM concentration in the sample.
The ACL AcuStar aCL 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. -
. Hemos L AcuStar Anti-Cardiolipin IgG Controls: The Low and High Anti-Cardiolipin IgG Controls are prepared by means of a dedicated process and contain different concentrations of human aCL IgG antibodies.
- Low Anti-Cardiolipin IgG Control: Control intended for the assessment of precision and . accuracy of the assay at the normal or around cut-off aCL IgG levels.
- . High Anti-Cardiolipin IgG Control: Control intended for the assessment of precision and accuracy of the assay at the abnormal aCL IgG levels.
-
Hemos L AcuStar Anti-Cardiolipin IgM Controls: The Low and High Anti-Cardiolipin IgM ● Controls are prepared by means of a dedicated process and contain different concentrations of human aCL IgM antibodies.
- . Low Anti-Cardiolipin IgM Control: Control intended for the assessment of precision and accuracy of the assay at the normal or around cut-off aCL IgM levels.
- High Anti-Cardiolipin IgM Control: Control intended for the assessment of precision and . accuracy of the assay at the abnormal aCL IgM levels.
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recimodel colariterently summary.
The Standil Ath-Catilinin Igo assey used with HemosL Acustar Anti-Cardolini Igo Courcol on Italia Anti-Cardicipio Igolio Inti-Cardiolini Ig
Substantial Equivalence Comparison Table
| Characteristic | New Device:HemosIL AcuStarAnti-Cardiolipin IgG | Predicate Device:REAADSAnti-Cardiolipin IgG(K022992) | New Device:HemosIL AcuStarAnti-Cardiolipin IgM | Predicate Device:REAADSAnti-Cardiolipin IgM(K022992) |
|---|---|---|---|---|
| Intended Use | Fully automatedchemiluminescent immunoassayfor the semi-quantitativemeasurement of anti-cardiolipin(aCL) IgG antibodies in humancitrate plasma and serum on theACLTM AcuStar as an aid in thediagnosis of thrombotic disordersrelated to primary and secondaryAntiphospholipid Syndrome(APS) when used in conjunctionwith other laboratory and clinicalfindings. | An enzyme-linkedimmunoassay for the semi-quantitative determination ofanti-cardiolipin IgG antibodiesin human serum or plasma.For the detection and semi-quantitation of anti-cardiolipinantibodies in individuals withsystemic lupus erythematosus(SLE) and lupus-like disorders(anti-phospholipid syndrome). | Fully automatedchemiluminescent immunoassayfor the semi-quantitativemeasurement of anti-cardiolipin(aCL) IgM antibodies in humancitrated plasma and serum on theACLTM AcuStar, as an aid in thediagnosis of thrombotic disordersrelated to primary and secondaryAntiphospholipid Syndrome(APS) when used in conjunctionwith other laboratory and clinicalfindings. | An enzyme-linkedimmunoassay for the semi-quantitative determination ofanti-cardiolipin IgM antibodiesin human serum or plasma.For the detection and semi-quantitation of anti-cardiolipinantibodies in individuals withsystemic lupus erythematosus(SLE) and lupus-like disorders(anti-phospholipid syndrome). |
| Technology | Two-step chemiluminescentimmunoassay | ELISA | Two-step chemiluminescentimmunoassay | ELISA |
| Assay format | Semi-quantitative | Same | Semi-quantitative | Same |
| Sample type | Serum or Citrated Plasma | Same | Serum or Citrated Plasma | Same |
| Calibrator | Two Calibrator Levels(Included in test kit) | Three Calibrator Levels(Included in Test Kit) | Two 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) | Low and High Controls(Sold Separately) | Normal and Positive Controls(Included in Test Kit) |
| Clinical Cut-off | 20 U/mL | 23 GPL | 20 U/mL | 11 MPL |
1092181: HemosIL AcuStar anti-Cardiolipin IgG and IgM Assays and Contro
Attachment C
Page 3 of 5
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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-Cardiolipin IgG | |||
|---|---|---|---|
| ACL AcuStar | Mean (U/mL) | CV% (Within run) | CV% (Total) |
| Low aCL IgG Control | 16.4 | 6.8% | 8.2% |
| High aCL IgG Control | 158 | 6.1% | 6.9% |
| aCL IgG plasma sample A | 13.8 | 4.0% | 4.4% |
| aCL IgG plasma sample B | 19.1 | 3.7% | 4.2% |
| aCL IgG plasma sample C | 47.2 | 4.8% | 7.2% |
| aCL IgG plasma sample D | 515 | 3.7% | 5.4% |
| aCL IgG plasma sample E | 1029 | 3.5% | 6.7% |
| HemosIL AcuStar Anti-Cardiolipin IgM | |||
|---|---|---|---|
| ACL AcuStar | Mean (U/mL) | CV% (Within run) | CV% (Total) |
| Low aCL IgM Control | 6.79 | 3.3% | 4.9% |
| High aCL IgM Control | 86.1 | 3.5% | 4.0% |
| aCL IgG plasma sample A | 14.7 | 3.0% | 3.3% |
| aCL IgM plasma sample B | 19.2 | 2.6% | 4.7% |
| aCL IgG plasma sample C | 19.5 | 2.6% | 2.9% |
| aCL IgG plasma sample D | 207 | 3.6% | 4.4% |
| aCL IgG plasma sample E | 556 | 6.8% | 8.4% |
{4}------------------------------------------------
Outcome Studies
An outcome study was performed on 321 frozen citrated plasmas were from 6 different groups, including selected individuals diagnosed as primary APS (SAPS), 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:
| Patient group | N | N (Positive) | % Positive |
|---|---|---|---|
| PAPS | 23 | 13 | 56.5% |
| SAPS | 69 | 37 | 53.6% |
| SLE | 115 | 9 | 7.8% |
| 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 | 54.3% (43.6%-64.8%) | 95.6% (92.1%-97.9%) | 83.8% (79.3%-87.7%) |
| HemosIL AcuStar Anti-Cardiolipin IgM | |||
|---|---|---|---|
| Patient group | N | N (Positive) | % Positive |
| PAPS | 23 | 8 | 34.8% |
| SAPS | 69 | 23 | 33.3% |
| SLE | 115 | 10 | 8.7% |
| SLE-like | 5 | 0 | 0.0% |
| Others | 6 | 1 | 16.7% |
| Normals | 103 | 1 | 1.0% |
Considering as positive the patient groups PAPS and SAPS, the clinical Sensitivity, Specificity and Overall % Agreement were:
| SystemSTATE CONTRACT CONTRACT CONTRACT COLLECTION COLLECTION CONSULTION CONSULTIONAL CONSULTIONAL | Sensitivity (95% CI) | Specificity (95% CI) | Agreement (95% CI)A Comments of the program and the commend of the first of the first of the first of the first and | |
|---|---|---|---|---|
| ACL AcuStar | 321 | " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "33.7% (24.2%-44.3%) | 94.8% (91.0%-97.3%) | 77.3% (72.3%-81.7%) |
{5}------------------------------------------------
Summary of Performance Data (Cont.):
Method Comparison Studies
HemosIL AcuStar Anti-Cardiolipin 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 Anti-Cardiolipin IgG Semi-Quantitative Test Kit. % Positive, Negative and Overall Agreement were:
| ELISA Assay | ||
|---|---|---|
| HemosIL AcuStar aCL IgG | Negative | Positive |
| Negative | 76 | 7 |
| Positive | 25 | 28 |
| Predicate Device | N | % Positive Agreement(95% CI) | % Negative Agreement(95% CI) | % Overall Agreement(95% CI) |
|---|---|---|---|---|
| ELISA Assay | 136 | 80.0% (63.1%-91.6%) | 75.2% (65.7%-83.3%) | 76.5% (68.4%-83.3%) |
HemosIL AcuStar Anti-Cardiolipin IgMI
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 Anti-Cardiolipin IgM Semi-Quantitative Test Kit. % Positive, Negative and Overall Agreement were:
| ELISA Assay | ||
|---|---|---|
| HemosIL AcuStar aCL IgM | Negative | Positive |
| Negative | 190 | 41 |
| Positive | 4 | 32 |
| % Positive Agreement % Negative Agreement % Overall Agreement | ||||
|---|---|---|---|---|
| Predicate Device N | (95% CI) | (95% CI) | (95% CI) | |
| And and the controlled of the commend of the commend of the comments of the comments of theELISA Assay | 267 - | 43.8% (32.2%-55.9%) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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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 stylized depiction of an eagle or bird in flight, with three curved lines representing the wings and body. The bird is positioned to the right of the circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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
Instrumentation Laboratory, Inc. c/o Ms. Carol Marble Regulatory Affairs Director 113 Hartwell Avenue Lexington, MA 02421
MAR 1 1 2010
Re: K092181
Trade/Device Name: HemoSIL™ AcuStar Anti-Cardiolipin IgG
HemoSIL™ AcuStar Anti-Cardiolipin IgM HemoSIL™ AcuStar Anti-Cardiolipin IgG Controls HemoSIL™ AcuStar Anti-Cardiolipin IgM Controls
Regulation Number: 21 CFR §866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MID, JJX Dated: March 3, 2010 Received: March 8, 2010
Dear Ms. 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 (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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
{7}------------------------------------------------
Page 2 – Ms. Carol Marble
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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Maria M. Chen
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):
Devices Name: HemosIL™ AcuStar Anti-Cardiolipin IgG HemosIL™ AcuStar Anti-Cardiolipin IgG Controls
Indications for Use: -
- . HemosIL AcuStar Anti-Cardiolipin IgG: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgG antibodies in human citrate 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.
- . Hemos L AcuStar Anti-Cardiolipin IgG Controls: For the quality control of the Anti-Cardiolipin 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)
Maria Mckan
Division Sign-Of
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K09218/
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Indications for Use Statement
510(k) Number (if known):
1092181
Devices Name: HemosIL™ AcuStar Anti-Cardiolipin IgM HemosILTM AcuStar Anti-Cardiolipin IgM Controls
Indications for Use:
- HemosIL AcuStar Anti-Cardiolipin IgM: Fully automated chemiluminescent immunoassay . for the semi-quantitative measurement of anti-cardiolipin (aCL) IgM antibodies in human citrated plasma and serum on the ACLTM 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.
- Hemos L AcuStar Anti-Cardiolipin IgM Controls: For the quality control of the Anti-. Cardiolipin 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)
Mana M. Clan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K09218/
§ 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).