(58 days)
No
The summary describes a diagnostic assay and its performance characteristics, with no mention of AI or ML technologies.
No.
The device is an in vitro diagnostic (IVD) intended for the detection of Lupus Anticoagulants, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use."
No
The device description explicitly states it uses "reagents sensitized to phospholipid dependent antibodies" and is used "on the IL Coagulation Systems," indicating it is a laboratory diagnostic test involving physical reagents and hardware, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
N/A
Intended Use / Indications for Use
HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.
For in vitro diagnostic use.
Product codes
GFO
Device Description
HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.
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)
Method Comparison
In an in-house study of 210 citrated plasma samples (120 normals/90 abnormals) on an ACL Advance, comparing HemosIL Silica Clotting Time to the predicate devices, the following correlation data were obtained:
| Unit | slope | intercept | r | Reference method |
|---|---|---|---|---|
| Normalized LAC ratio | 1.099 | -0.086 | 0.874 | LAC Screen/Confirm |
In a clinical study of 206 citrated plasma samples (121 normals/85 abnormals), comparing HemosIL Silica Clotting Time (cut-off > 1.24) to the predicate devices (cut-off ≥ 1.20) on an ACL Futura, a relative Sensitivity of 92.4% (95% C.I. = 82.1-97.0) and a relative Specificity of 100% (95% C.I. = 97.6-100.0) were determined. All known Lupus Anticoagulant samples (n=48) tested as part of this study gave SCT normalized ratios > 1.24.
Within Run Precision
Within run and between run precision was assessed over multiple runs (n=80) using three levels of controls.
| Instrument | Control | Mean Normalized Ratio | Within run %CV | Total %CV |
|---|---|---|---|---|
| ACL Advance | Normal Control | 1.05 | 2.47 | 2.95 |
| ACL Advance | Low LA Control | 1.90 | 4.05 | 6.00 |
| ACL Advance | High LA Control | 2.77 | 5.24 | 5.60 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
relative Sensitivity of 92.4% (95% C.I. = 82.1-97.0) and a relative Specificity of 100% (95% C.I. = 97.6-100.0)
Predicate Device(s)
K990302 HemosIL LAC Screen and HemosIL LAC Confirm
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).
0
Kōsozz/
Section 3 HemosIL Silica Clotting Time - 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4207
Contact Person:
Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
January 28, 2005
Name of the Device:
HemosIL Silica Clotting Time
Regulatory Information:
Regulation Section: Partial Thromboplastin Time Tests (864.7925) Classification: Class II Product Code: GFO Panel: Hematology
Identification of Predicate Device(s):
K990302 HemosIL LAC Screen and HemosIL LAC Confirm
Description of the Device/Intended Use(s):
HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
The HemosIL Silica Clotting Time is substantially equivalent to the commercially available predicate devices (HemosIL LAC Screen and HemosIL LAC Confirm) in performance and intended use.
1
Section 3 HemosIL Silica Clotting Time - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Method Comparison
In an in-house study of 210 citrated plasma samples (120 normals/90 abnormals) on an ACL Advance, comparing HemosIL Silica Clotting Time to the predicate devices, the following correlation data were obtained:
| Unit | slope | intercept | r | Reference method |
|---|---|---|---|---|
| Normalized | ||||
| LAC ratio | 1.099 | -0.086 | 0.874 | LAC Screen/Confirm |
In a clinical study of 206 citrated plasma samples (121 normals/85 abnormals), comparing HemosIL Silica Clotting Time (cut-off > 1.24) to the predicate devices (cut-off ≥ 1.20) on an ACL Futura, a relative Sensitivity of 92.4% (95% C.I. = 82.1-97.0) and a relative Specificity of 100% (95% C.I. = 97.6-100.0) were determined. All known Lupus Anticoagulant samples (n=48) tested as part of this study gave SCT normalized ratios > 1.24.
Within Run Precision
Within run and between run precision was assessed over multiple runs (n=80) using three levels of controls.
| Instrument | Control | Mean
Normalized Ratio | Within run
%CV | Total
%CV |
|-------------|-----------------|--------------------------|-------------------|--------------|
| ACL Advance | Normal Control | 1.05 | 2.47 | 2.95 |
| ACL Advance | Low LA Control | 1.90 | 4.05 | 6.00 |
| ACL Advance | High LA Control | 2.77 | 5.24 | 5.60 |
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of several curved lines that create the impression of feathers or wings.
MAR 3 0 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421
Re: K050221
Trade/Device Name: HemosIL Silica Clotting Time Regulation Number: 21 CFR 864.7925 Regulation Name: Partial thromboplastin time tests Regulatory Class: Class II Product Code: GFO Dated: January 28, 2005 Received: January 31, 2005
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, I Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: HemosIL Silica Clotting Time
Indications for Use:
HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.
For in vitro diagnostic use.
Prescription Use
(Part 21 CFR 801 Subpart D)
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)
Josephine Bautista
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050221