(233 days)
No
The device description details a standard immunoassay with a predefined curve fitting method (4 Parameter Logistic Curve) for data reduction. There is no mention of adaptive learning, pattern recognition beyond the immunoassay itself, or any other characteristics typically associated with AI/ML. The performance studies are standard clinical validation studies, not AI/ML model training or testing.
No
This device is an immunoassay system designed for the semi-quantitative measurement of anti-cardiolipin antibodies, aiding in the diagnosis of thrombotic disorders. It does not provide any treatment or therapy to a patient.
Yes
The device is explicitly stated as an "aid in the diagnosis of thrombotic disorders" in its intended use, indicating its function in diagnosing medical conditions.
No
The device description clearly outlines physical components like magnetic particles, isoluminol-labeled antibodies, and reagents, which are integral to the immunoassay process. While there is data reduction software mentioned (4PLC), the core of the device is a chemical and optical system, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the devices are for the "semi-quantitative measurement of anti-cardiolipin (aCL) IgG/IgM antibodies in human citrate plasma and serum" and are used "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." This clearly indicates that the device is intended to be used in vitro (outside the body) to examine specimens from the human body for the purpose of providing information for diagnosis.
- Device Description: The description details a "chemiluminescent immunoassay" that uses "human citrate plasma and serum" as samples. This further confirms the in vitro nature of the testing.
- Controls: The inclusion of controls for quality control of the assays is standard practice for IVD devices to ensure the accuracy and reliability of the test results.
- Performance Studies: The document describes performance studies including "Precision," "Outcome Studies," and "Method Comparison Studies" using human samples (plasma). These types of studies are conducted to demonstrate the analytical and clinical performance of an IVD device.
- Predicate Device: The mention of a "Predicate Device" (K022992 REAADS Anti-Cardiolipin IgG/IgM Semi-Quantitative Test Kit) is common in regulatory submissions for IVD devices, where a new device is compared to a previously cleared device.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
- . 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.
Product codes
MID, JJX
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.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
Within run and total precision assessed over multiple runs using the respective assays with their two control levels and a plasma sample.
HemosIL AcuStar Anti-Cardiolipin IgG:
Low aCL IgG Control: Mean 16.4 U/mL, CV% (Within run) 6.8%, CV% (Total) 8.2%
High aCL IgG Control: Mean 158 U/mL, CV% (Within run) 6.1%, CV% (Total) 6.9%
aCL IgG plasma sample A: Mean 13.8 U/mL, CV% (Within run) 4.0%, CV% (Total) 4.4%
aCL IgG plasma sample B: Mean 19.1 U/mL, CV% (Within run) 3.7%, CV% (Total) 4.2%
aCL IgG plasma sample C: Mean 47.2 U/mL, CV% (Within run) 4.8%, CV% (Total) 7.2%
aCL IgG plasma sample D: Mean 515 U/mL, CV% (Within run) 3.7%, CV% (Total) 5.4%
aCL IgG plasma sample E: Mean 1029 U/mL, CV% (Within run) 3.5%, CV% (Total) 6.7%
HemosIL AcuStar Anti-Cardiolipin IgM:
Low aCL IgM Control: Mean 6.79 U/mL, CV% (Within run) 3.3%, CV% (Total) 4.9%
High aCL IgM Control: Mean 86.1 U/mL, CV% (Within run) 3.5%, CV% (Total) 4.0%
aCL IgG plasma sample A: Mean 14.7 U/mL, CV% (Within run) 3.0%, CV% (Total) 3.3%
aCL IgM plasma sample B: Mean 19.2 U/mL, CV% (Within run) 2.6%, CV% (Total) 4.7%
aCL IgG plasma sample C: Mean 19.5 U/mL, CV% (Within run) 2.6%, CV% (Total) 2.9%
aCL IgG plasma sample D: Mean 207 U/mL, CV% (Within run) 3.6%, CV% (Total) 4.4%
aCL IgG plasma sample E: Mean 556 U/mL, CV% (Within run) 6.8%, CV% (Total) 8.4%
Outcome Studies:
Study Type: Clinical Study
Sample Size: 321 frozen citrated plasma samples from 6 different groups (primary APS, secondary APS, SLE, SLE-like, cardiovascular disorders not classified above, and apparently healthy people).
Key Results for Anti-Cardiolipin IgG (cut-off 20 U/mL):
Patient group PAPS: N=23, N (Positive)=13, % Positive=56.5%
Patient group SAPS: N=69, N (Positive)=37, % Positive=53.6%
Patient group SLE: N=115, N (Positive)=9, % Positive=7.8%
Patient group SLE-like: N=5, N (Positive)=0, % Positive=0.0%
Patient group Others: N=6, N (Positive)=1, % Positive=16.7%
Patient group Normals: N=103, N (Positive)=0, % Positive=0.0%
Method Comparison Studies:
Study Type: Method Comparison Study with REAADS Anti-Cardiolipin IgG Semi-Quantitative Test Kit.
HemosIL AcuStar Anti-Cardiolipin IgG:
Sample size: 136
Overall Agreement: 76.5% (68.4%-83.3%)
Study Type: Method Comparison Study with REAADS Anti-Cardiolipin IgM Semi-Quantitative Test Kit.
HemosIL AcuStar Anti-Cardiolipin IgM:
Sample size: 267
Positive Agreement: 43.8% (32.2%-55.9%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
For Anti-Cardiolipin IgG (considering PAPS and SAPS as positive):
Sensitivity (95% CI): 54.3% (43.6%-64.8%)
Specificity (95% CI): 95.6% (92.1%-97.9%)
% Agreement (95% CI): 83.8% (79.3%-87.7%)
For Anti-Cardiolipin IgM (considering PAPS and SAPS as positive):
Sensitivity (95% CI): 33.7% (24.2%-44.3%)
Specificity (95% CI): 94.8% (91.0%-97.3%)
Agreement (95% CI): 77.3% (72.3%-81.7%)
Method Comparison HemosIL AcuStar Anti-Cardiolipin IgG:
% Positive Agreement (95% CI): 80.0% (63.1%-91.6%)
% Negative Agreement (95% CI): 75.2% (65.7%-83.3%)
% Overall Agreement (95% CI): 76.5% (68.4%-83.3%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Applicant Contact Information:
MAR ] 1 2010
| Applicant: | Instrumentation Laboratory Co. |
|---|---|
| Address: | 113 Hartwell Avenue |
| Lexington, 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 IgG |
| HemosIL TM AcuStar Anti-Cardiolipin IgM | |
| HemosIL TM AcuStar Anti-Cardiolipin IgG Controls | |
| HemosIL 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.
2
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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 AcuStar
Anti-Cardiolipin IgG | Predicate Device:
REAADS
Anti-Cardiolipin IgG
(K022992) | New Device:
HemosIL AcuStar
Anti-Cardiolipin IgM | Predicate Device:
REAADS
Anti-Cardiolipin IgM
(K022992) |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Fully automated
chemiluminescent immunoassay
for the semi-quantitative
measurement of anti-cardiolipin
(aCL) IgG antibodies in human
citrate 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. | An enzyme-linked
immunoassay for the semi-
quantitative determination of
anti-cardiolipin IgG antibodies
in human serum or plasma.
For the detection and semi-
quantitation of anti-cardiolipin
antibodies in individuals with
systemic lupus erythematosus
(SLE) and lupus-like disorders
(anti-phospholipid syndrome). | 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. | An enzyme-linked
immunoassay for the semi-
quantitative determination of
anti-cardiolipin IgM antibodies
in human serum or plasma.
For the detection and semi-
quantitation of anti-cardiolipin
antibodies in individuals with
systemic lupus erythematosus
(SLE) and lupus-like disorders
(anti-phospholipid syndrome). |
| Technology | Two-step chemiluminescent
immunoassay | ELISA | Two-step chemiluminescent
immunoassay | 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
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-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:
| System
STATE 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 the | ||||
| ELISA Assay | 267 - | 43.8% (32.2%-55.9%) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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 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
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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/
9
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/