(210 days)
No
The device description and intended use clearly indicate that this is a quality control material (lyophilized plasma preparations) used to assess the performance of existing coagulation systems and assays. There is no mention of any computational analysis, algorithms, or learning processes that would suggest the use of AI or ML.
No.
These devices are quality controls for in-vitro diagnostic tests, not therapeutic agents. They are used to assess the precision and accuracy of Lupus Anticoagulant (LA) tests, not to treat or diagnose a patient directly.
No
These devices are quality controls for diagnostic assays, not diagnostic devices themselves. They are used to assess the precision and accuracy of Lupus Anticoagulant (LA) tests.
No
The device description clearly states the device is a "lyophilized preparation" from human donors or plasma, indicating it is a biological reagent, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the controls are "For use as an LA Positive Quality Control of Lupus Anticoagulant assays" and "For use as an LA Negative Quality Control of Lupus Anticoagulant assays". These assays are performed on "IL Coagulation systems". This clearly indicates the device is intended to be used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description details the composition of the controls (lyophilized preparations from human donors/plasma) and their purpose in assessing the "precision and accuracy of Lupus Anticoagulant (LA) tests". This aligns with the function of an IVD control.
- Performance Studies: The inclusion of performance studies (Precision) and key metrics (CV%) further supports its role as a quality control for diagnostic testing.
- Predicate Device(s): The mention of predicate devices like "LAtrol Abnormal Control and LAtrol Normal Control" (K935254) which are known IVD controls, reinforces the classification of this device as an IVD.
The device is a quality control material used to ensure the reliability of in vitro diagnostic tests for Lupus Anticoagulant. This is a core function of an IVD.
N/A
Intended Use / Indications for Use
- HemosIL LA Positive Control .
For use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.
- . HemosIL LA Negative Control
For use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.
Product codes (comma separated list FDA assigned to the subject device)
GGN, GIZ, GGC
Device Description
- . HemosIL LA Positive Control
The LA Positive Control is a lyophilized preparation from human donors exhibiting the presence of anti-phospholipid antibodies with added buffer, which has been determined to be positive for LA in accordance with the Guidelines from ISTH1.
The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.
- HemosIL LA Negative Control
The LA Negative Control is a lyophilized preparation using human citrated platelet-poor plasma to make a Pooled Normal Plasma with added buffer. The guidelines from ISTH', recommends a plateletpoor plasma as a negative control for Lupus Anticoagulant (LA).
The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.
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 Study:
Standard: EP05-A2: Evaluation of Precision Performance of Quantitative Measurement Methods, 2nd Edition, 08/20/2004.
Materials: HemosIL LA Positive Control and HemosIL LA Negative Control (2 Lots of Each Control, with one representative lot shown on the following pages), HemosIL LAC Screen and Confirm (K990302), HemosIL Silica Clotting Time - Screen and Confirm (K050221).
Protocol: N=80 (2 replicates per run/2 runs per day/20 days) using two lots of each control level with two different LA assays* per instrument platform. The data from a representative lot of each control are shown on the following pages.
*NOTE: Only HemosIL LAC Screen/LAC Confirm was tested on the ACL Classic models (ACL 300+, ACL 3000 and ACL 6000). There is no test application on these models for HemosIL Silica Clotting Time.
Representative IL Coagulation Systems:
• ACL TOP Family Members: TOP (base model) and 500 CTS
• ACL 10000
• ACL Advance
• ACL 300+
• ACL 3000
• ACL 6000
Specifications:
• HemosIL LA Negative Control: Within run and Total
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
Revised 4/5/11
Image /page/0/Picture/1 description: The image shows the logos of Werfen Group and Instrumentation Laboratory. The Werfen Group logo is on the left and consists of a stylized globe with horizontal lines and the text "Werfen Group" below it. To the right of the Werfen Group logo is the Instrumentation Laboratory logo, which features a geometric shape resembling a cube with missing faces, followed by the text "Instrumentation Laboratory".
APR - 5 2011
510(k) Summary (per 21 CFR 807.92)
Applicant Contact Information:
| Applicant: | Instrumentation Laboratory Co. |
|---|---|
| Address: | 180 Hartwell Road |
| Bedford, MA 01730 | |
| Contact Person: | Carol Marble, Regulatory Affairs Director |
| Phone Number: | 781-861-4467 |
| Fax Number: | 781-861-4207 |
| Preparation Date: | April 5, 2011 |
Device Trade Names (Products Sold Separately):
HemosIL® LA Positive Control
HemosIL® LA Negative Control
.. . . . . Device Regulatory Information:
| Positive Control: | Class II | Product Code: GGN | 21 CFR 864.5425 |
|---|---|---|---|
| Negative Control: | Class II | Product Code: GIZ | 21 CFR 864.5425 |
Predicate Devices:
LAtrol Abnormal Control and LAtrol Normal Control (Manufacturer: American Diagnostica)
Device Descriptions:
- . HemosIL LA Positive Control
The LA Positive Control is a lyophilized preparation from human donors exhibiting the presence of anti-phospholipid antibodies with added buffer, which has been determined to be positive for LA in accordance with the Guidelines from ISTH1.
The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.
- HemosIL LA Negative Control
The LA Negative Control is a lyophilized preparation using human citrated platelet-poor plasma to make a Pooled Normal Plasma with added buffer. The guidelines from ISTH', recommends a plateletpoor plasma as a negative control for Lupus Anticoagulant (LA).
The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.
' Update of the Guidelines for Lupus Anticoagulant detection (ISTH 2009) Journal of Thrombosis and Haemostasis, 2009, 7:1737-1740.
1
Device Intended Uses:
- HemosIL LA Positive Control: For use as an LA Positive Quality Control of Lupus Anticoagulant . assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on L Coagulation systems [ACL TOP® Family, ACL ELITE®/ELITE PRO/8/9/10000, ACL Futura/ACL Advance, ACL Classic (100-7000)].
- HemosIL LA Negative Control: For use as an LA Negative Quality Control of Lupus Anticoagulant . assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family, ACL ELITE®/ELITE PRO/8/9/10000, ACL Futura/ACL Advance, ACL Classic (100-7000)].
Statement of Technological Characteristics of the Device Compared to Predicate Devices:
HemosIL LA Positive Control and HemosIL LA Negative Control are substantially equivalent to LAtrol Abnormal Control and LAtrol Normal Control (K935254).
| Characteristic | New Devices (Sold Separately):
HemosIL LA Positive Control and
HemosIL LA Negative Control | Predicate Devices:
LAtrol Abnormal Control and
LAtrol Normal Control
(K935254) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | HemosIL LA Positive Control:
For use as an LA Positive Quality
Control of Lupus Anticoagulant assays
(HemosIL LAC Screen/LAC Confirm;
HemosIL Silica Clotting Time) on IL
Coagulation systems [ACL TOP®
Family, ACL ELITE®/ELITE
PRO/8/9/10000, ACL Futura/ACL
Advance, ACL Classic (100-7000)]. HemosIL LA Negative Control:
For use as an LA Negative Quality
Control of Lupus Anticoagulant assays
(HemosIL LAC Screen/LAC Confirm;
HemosIL Silica Clotting Time) on IL
Coagulation systems [ACL TOP®
Family, ACL ELITE®/ELITE
PRO/8/9/10000, ACL Futura/ACL
Advance, ACL Classic (100-7000)]. | The LAtrol Abnormal Control and
LAtrol Normal Control plasmas
have been developed for use as part
of daily quality control procedures
for Lupus Anticoagulant (LA)
testing. |
| Analyte Being Tested | Lupus Anticoagulant | Same |
| Format | Lyophilized Plasma | Same |
| Constituent Material | HemosIL LA Positive Control:
Lyophilized preparation from human
donors exhibiting the presence of anti-
phospholipid antibodies with added
buffer. HemosIL LA Negative Control:
Lyophilized preparation using human
citrated platelet-poor plasma to make a
Pooled Normal Plasma with added
buffer. | LAtrol Abnormal Control:
Lyophilized preparation of a
Lupus Anticoagulant plasma
with Buffer. LAtrol Normal Control:
Lyophilized preparation of a
multi-donor Normal plasma
pool with Buffer. |
| Reconstituted Stability | 24 Hours at 2-8° C | 8 Hours at 2-8° C |
Substantial Equivalence Comparison Table:
2
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Summary Performance Data:
| Precision | |||||
|---|---|---|---|---|---|
| Standard: | EP05-A2: Evaluation of Precision Performance of Quantitative Measurement Methods, | ||||
| 2nd Edition, 08/20/2004 | |||||
| Materials: | HemosIL LA Positive Control and HemosIL LA Negative Control (2 Lots of Each | ||||
| Control, with one representative lot shown on the following pages) | |||||
| HemosIL LAC Screen and Confirm (K990302) | |||||
| HemosIL Silica Clotting Time - Screen and Confirm (K050221) | |||||
| Protocol: | N=80 (2 replicates per run/2 runs per day/20 days) using two lots of each control level | ||||
| with two different LA assays* per instrument platform. The data from a representative | |||||
| lot of each control are shown on the following pages. | |||||
| *NOTE: Only HemosIL LAC Screen/LAC Confirm was tested on the ACL Classic | |||||
| models (ACL 300+, ACL 3000 and ACL 6000). There is no test application | |||||
| on these models for HemosIL Silica Clotting Time. | |||||
| Representative IL Coagulation Systems: | |||||
| • ACL TOP Family Members: TOP (base model) and 500 CTS |
| | | | |
| | • ACL 10000 | | | | |
| | • ACL Advance | | | | |
| | • ACL 300+ | | | | |
| | • ACL 3000
| | | | |
| | • ACL 6000 | | | | |
| Specifications: | | | | | |
| | • HemosIL LA Negative Control: Within run and Total ≤ 6% CV | | | | |
| | • HemosIL LA Negative Control: Within run and Total ≤ 6% CV | | | | |
| Conclusion: | | | | | |
| | • All results were well within specification for both lots of controls tested.
| | | | |
.
3
Summary Performance Data (Cont.):
Precision
| Instrument: | ACL TOP |
|---|---|
| Reagent: | HemosIL LAC Screen/Confirm |
| Reagent | Control | Control
Lot No. | Grand
Mean(s) | CV%
Within Run | CV%
Between
Run | CV%
Total |
|---------------------|--------------------------------|--------------------|------------------|-------------------|-----------------------|--------------|
| LAC
Confirm | HemosIL LA
Negative Control | N1190682 | 32.1 | 0.6 | 1.4 | 1.6 |
| | HemosIL LA
Positive Control | N1190681 | 30.8 | 0.6 | 1.4 | 1.6 |
| LAC Screen | HemosIL LA
Negative Control | N1190682 | 32.9 | 0.5 | 0.5 | 0.9 |
| | HemosIL LA
Positive Control | N1190681 | 56.2 | 0.7 | 1.2 | 1.5 |
| Normalized
Ratio | HemosIL LA
Negative Control | N1190682 | 1.00 | 0.8 | 1.7 | 1.9 |
| | HemosIL LA
Positive Control | N1190681 | 1.64 | 1.0 | 2.1 | 2.5 |
Instrument: ACL TOP Reagent: HemosIL Silica Clotting Time (Screen/Confirm)
| Reagent | Control | Control
Lot No. | Grand
Mean(s) | CV%
Within Run | CV%
Between
Run | CV%
Total |
|---------------------|--------------------------------|--------------------|------------------|-------------------|-----------------------|--------------|
| SCT
Confirm | HemosIL LA
Negative Control | N1190682 | 35.7 | 2.0 | 1.8 | 2.7 |
| | HemosIL LA
Positive Control | N1190681 | 37.3 | 1.9 | 1.0 | 2.4 |
| SCT Screen | HemosIL LA
Negative Control | N1190682 | 33.4 | 1.2 | 0.0 | 1.2 |
| | HemosIL LA
Positive Control | N1190681 | 75.0 | 2.3 | 0.0 | 2.7 |
| Normalized
Ratio | HemosIL LA
Negative Control | N1190682 | 1.00 | 2.3 | 1.4 | 2.8 |
| | HemosIL LA
Positive Control | N1190681 | 2.15 | 3.4 | 0.0 | 4.2 |
4
Summary Performance Data (Cont.):
Precision
Instrument: ACL TOP 500 CTS Reagent: HemosIL LAC Screen/Confirm
| Reagent | Control | Control
Lot No. | Grand
Mean(s) | CV%
Within Run | CV%
Between
Run | CV%
Total |
|---------------------|--------------------------------|--------------------|------------------|-------------------|-----------------------|--------------|
| LAC
Confirm | HemosIL LA
Negative Control | N1190682 | 31.0 | 1.0 | 1.0 | 1.4 |
| | HemosIL LA
Positive Control | N1190681 | 32.2 | 1.0 | 0.9 | 1.4 |
| LAC Screen | HemosIL LA
Negative Control | N1190682 | 33.1 | 0.5 | 0.8 | 0.9 |
| | HemosIL LA
Positive Control | N1190681 | 56.3 | 0.6 | 1.1 | 1.3 |
| Normalized
Ratio | HemosIL LA
Negative Control | N1190682 | 0.96 | 0.9 | 1.5 | 1.8 |
| | HemosIL LA
Positive Control | N1190681 | 1.58 | 0.9 | 1.5 | 1.8 |
Instrument: ACL TOP 500 CTS Reagent: HemosIL Silica Clotting Time (Screen/Confirm)
| Reagent | Control | Control
Lot No. | Grand
Mean(s) | CV%
Within Run | CV%
Between
Run | CV%
Total |
|---------------------|--------------------------------|--------------------|------------------|-------------------|-----------------------|--------------|
| SCT
Confirm | HemosIL LA
Negative Control | N1190682 | 35.7 | 1.1 | 0.9 | 1.7 |
| | HemosIL LA
Positive Control | N1190681 | 36.8 | 2.5 | 0.0 | 2.6 |
| SCT Screen | HemosIL LA
Negative Control | N1190682 | 32.7 | 1.0 | 0.0 | 1.2 |
| | HemosIL LA
Positive Control | N1190681 | 74.1 | 0.9 | 1.2 | 1.6 |
| Normalized
Ratio | HemosIL LA
Negative Control | N1190682 | 1.00 | 1.5 | 0.0 | 2.0 |
| | HemosIL LA
Positive Control | N1190681 | 2.20 | 2.3 | 0.0 | 2.3 |
5
.
Summary Performance Data (Cont.):
. .
Precision
| Instrument: | ACL 10000 |
|---|---|
| Reagent: | HemosIL LAC Screen/Confirm |
| Reagent | Control | Control
Lot No. | Grand
Mean(s) | CV%
Within Run | CV%
Between
Run | CV%
Total |
|---------------------|--------------------------------|--------------------|------------------|-------------------|-----------------------|--------------|
| LAC
Confirm | HemosIL LA
Negative Control | N1190682 | 30.4 | 0.4 | 1.8 | 2.1 |
| | HemosIL LA
Positive Control | N1190681 | 31.9 | 0.8 | 1.5 | 2.0 |
| LAC Screen | HemosIL LA
Negative Control | N1190682 | 33.8 | 0.4 | 3.0 | 3.1 |
| | HemosIL LA
Positive Control | N1190681 | 58.1 | 2.3 | 2.9 | 3.7 |
| Normalized
Ratio | HemosIL LA
Negative Control | N1190682 | 1.00 | 0.6 | 2.7 | 2.8 |
| | HemosIL LA
Positive Control | N1190681 | 1.64 | 1.7 | 2.5 | 3.0 |
.
ACL 10000 Instrument: Reagent: HemosIL Silica Clotting Time (Screen/Confirm)
.
| Reagent | Control | Control
Lot No. | Grand
Mean(s) | CV%
Within Run | CV%
Between
Run | CV%
Total |
|---------------------|--------------------------------|--------------------|------------------|-------------------|-----------------------|--------------|
| SCT
Confirm | HemosIL LA
Negative Control | N1190682 | 34.3 | 0.8 | 0.9 | 1.2 |
| | HemosIL LA
Positive Control | N1190681 | 33.6 | 0.8 | 0.7 | 1.2 |
| SCT Screen | HemosIL LA
Negative Control | N1190682 | 32.0 | 1.4 | 0.7 | 1.8 |
| | HemosIL LA
Positive Control | N1190681 | 69.5 | 2.3 | 0.9 | 3.0 |
| Normalized
Ratio | HemosIL LA
Negative Control | N1190682 | 1.00 | 1.6 | 1.2 | 2.2 |
| | HemosIL LA
Positive Control | N1190681 | 2.22 | 2.3 | 1.6 | 3.2 |
.
.
6
Summary Performance Data (Cont.):
Precision
Instrument: ACL Advance Reagent: HemosIL LAC Screen/Confirm
| Reagent | Control | Control
Lot No. | Grand
Mean(s) | CV%
Within Run | CV%
Between
Run | CV%
Total |
|---------------------|--------------------------------|--------------------|------------------|-------------------|-----------------------|--------------|
| LAC
Confirm | HemosIL LA
Negative Control | N1190682 | 28.7 | 0.9 | 2.1 | 2.3 |
| | HemosIL LA
Positive Control | N1190681 | 30.1 | 0.8 | 1.8 | 1.9 |
| LAC Screen | HemosIL LA
Negative Control | N1190682 | 32.0 | 0.8 | 1.1 | 1.7 |
| | HemosIL LA
Positive Control | N1190681 | 53.1 | 1.2 | 2.0 | 2.4 |
| Normalized
Ratio | HemosIL LA
Negative Control | N1190682 | 1.00 | 2.7 | 1.8 | 3.9 |
| | HemosIL LA
Positive Control | N1190681 | 1.58 | 1.6 | 2.8 | 3.3 |
Instrument: ACL Advance Reagent: HemosIL Silica Clotting Time (Screen/Confirm)
| Reagent | Control | Control
Lot No. | Grand
Mean(s) | CV%
Within Run | CV%
Between
Run | CV%
Total |
|---------------------|--------------------------------|--------------------|------------------|-------------------|-----------------------|--------------|
| SCT
Confirm | HemosIL LA
Negative Control | N1190682 | 31.8 | 1.9 | 0.0 | 2.2 |
| | HemosIL LA
Positive Control | N1190681 | 32.3 | 2.1 | 2.0 | 2.9 |
| SCT Screen | HemosIL LA
Negative Control | N1190682 | 32.2 | 1.1 | 1.1 | 1.7 |
| | HemosIL LA
Positive Control | N1190681 | 69.2 | 2.0 | 1.6 | 2.9 |
| Normalized
Ratio | HemosIL LA
Negative Control | N1190682 | 1.00 | 1.6 | 0.8 | 2.0 |
| | HemosIL LA
Positive Control | N1190681 | 2.12 | 3.5 | 2.3 | 4.2 |
.
7
Summary Performance Data (Cont.):
Precision
Instrument: ACL 6000 Reagent: HemosIL LAC Screen/Confirm
| Reagent | Control | Control
Lot No. | Grand
Mean(s) | CV%
Within Run | CV%
Between
Run | CV%
Total |
|---------------------|--------------------------------|--------------------|------------------|-------------------|-----------------------|--------------|
| LAC
Confirm | HemosIL LA
Negative Control | N1190682 | 30.9 | 1.1 | 1.1 | 1.6 |
| | HemosIL LA
Positive Control | N1190681 | 32.0 | 0.6 | 1.1 | 1.5 |
| LAC Screen | HemosIL LA
Negative Control | N1190682 | 32.9 | 0.3 | 0.9 | 0.9 |
| | HemosIL LA
Positive Control | N1190681 | 56.5 | 0.5 | 1.1 | 1.2 |
| Normalized
Ratio | HemosIL LA
Negative Control | N1190682 | 1.00 | 1.1 | 1.4 | 1.9 |
| | HemosIL LA
Positive Control | N1190681 | 1.66 | 0.7 | 1.1 | 1.8 |
ACL 3000 Instrument: Reagent: HemosIL LAC Screen/Confirm
| Reagent | Control | Control
Lot No. | Grand
Mean(s) | CV%
Within Run | CV%
Between
Run | CV%
Total |
|---------------------|--------------------------------|--------------------|------------------|-------------------|-----------------------|--------------|
| LAC
Confirm | HemosIL LA
Negative Control | N1190682 | 30.9 | 0.4 | 0.8 | 1.3 |
| | HemosIL LA
Positive Control | N1190681 | 33.8 | 0.3 | 0.9 | 1.1 |
| LAC Screen | HemosIL LA
Negative Control | N1190682 | 32.1 | 0.3 | 0.7 | 1.2 |
| | HemosIL LA
Positive Control | N1190681 | 57.1 | 1.0 | 1.1 | 1.6 |
| Normalized
Ratio | HemosIL LA
Negative Control | N1190682 | 1.00 | 1.2 | 1.0 | 2.1 |
| | HemosIL LA
Positive Control | N1190681 | 1.64 | 0.9 | 0.7 | 1.6 |
8
Summary Performance Data (Cont.):
Precision
.
Instrument: ACL 300+ Reagent: HemosIL LAC Screen/Confirm
| Reagent | Control | Control
Lot No. | Grand
Mean(s) | CV%
Within Run | CV%
Between
Run | CV%
Total |
|---------------------|---------------------------------|--------------------|------------------|-------------------|-----------------------|--------------|
| LAC
Confirm | HemosIL LA
Negative Control | N1190682 | 31.9 | 0.3 | 1.1 | 1.7 |
| | HemosIL LA
Positive Control | N1190681 | 32.9 | 0.4 | 1.0 | 1.6 |
| LAC Screen | HemosIL LA
Negative Control | N1190682 | 34.0 | 0.3 | 1.0 | 1.0 |
| | HemosIL LA.
Positive Control | N1190681 | 58.2 | 0.8 | 1.1 | 1.7 |
| Normalized
Ratio | HemosIL LA
Negative Control | N1190682 | 0.98 | 0.5 | 1.3 | 1.9 |
| | HemosIL LA
Positive Control | N1190681 | 1.63 | 2.0 | 0.8 | 2.6 |
:
9
Image /page/9/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like figure incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Instrumentation Laboratory Co. c/o Ms. Carol Marble Regulatory Affairs Director 180 Hartwell Road Bedford, MA 01730
APR 0 5 2011
Re: K102552
Trade/Device Name: HemosIL® LA Positive Control and HemosIL® LA Negative Control Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGC, GIZ, GGN Dated: March 29, 2011 Received: March 30, 2011
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 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.
" Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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
10
Page 2 – Ms. Carol Marble
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 yours.
Reena Philip
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
11
Indications for Use Statement
510(k) Number (if known): K102552
Device Name:
HemosIL® LA Positive Control HemosIL® LA Negative Control
Indications for Use:
- HemosIL LA Positive Control .
For use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.
- . HemosIL LA Negative Control
For use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemosIL LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosIL LA assays.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 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)
Kevek R. Ki
Division Sign-Off
Division Sign-Off Office of In Vitro Diagnostic-Device Evaluation and Safety
510(k) 102552
. Attachment A
K102552: HemosIL LA Positive and LA Negative Controls
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