(105 days)
K920012/B
K920012/B
No
The summary describes a standard in vitro diagnostic test based on chemical reactions and quantitative measurements, with no mention of AI or ML technologies.
No
The device is described as an "in vitro diagnostic test" for quantitative determination of plasmin inhibitor, not a device used for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "IL Test™ Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor in human citrated plasma."
No
The device description clearly states it is an "in vitro diagnostic test" based on a "synthetic chromogenic substrate and plasma inactivation," indicating it involves chemical reagents and laboratory procedures, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "IL Test™ Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor in human citrated plasma..."
This statement clearly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
IL Test™ Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor in human citrated plasma based on a synthetic chromogenic substrate and plasma inactivation. Plasmin inhibitor, the major fast acting inhibitor of the fibrinolytic system, also known as a -- antiplasmin is an important regulator of the fibrinolytic system. Congenital deficiencies are associated with haemorragic problems. Decreased levels of plasmin inhibitor are observed in liver diseases and DIC. Increased levels have been reported during post-operative episodes.
Product codes
GGP
Device Description
IL Test™ Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor in human citrated plasma based on a synthetic chromogenic substrate and plasma inactivation. Plasmin inhibitor, the major fast acting inhibitor of the fibrinolytic system, also known as a -- antiplasmin is an important regulator of the fibrinolytic system. Congenital deficiencies are associated with haemorragic problems. Decreased levels of plasmin inhibitor are observed in liver diseases and DIC. Increased levels have been reported during post-operative episodes.
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)
In method comparison studies evaluating normal and abnormal plasma samples, the correlation (r) of the new IL Test™ Plasmin Inhibitor to the predicate IL Test™ o2-Antiplasmin on the ACL 300 was 0.987 (n=46) and on the ACL Futura was 0.996 (n = 51).
On the ACL 300, within run precision assessed over multiple runs using 2 levels of plasma gave a CV of 2.7% (at a mean of 46.6% activity) and 1.3% (at a mean of 95.4% activity). On the ACL Futura, within run precision assessed over multiple runs using 2 levels of plasma gave a CV of 4.4% (at a mean of 51.9% activity) and 2.7% (at a mean of 96.8% activity).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation (r), CV
Predicate Device(s)
IL Test™ α2-Antiplasmin K920012/B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).
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Section 3
IL Test™ Plasmin Inhibitor - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (781) 861-4467 (781) 861-4464 Fax:
Contact Person:
Carol Marble Phone: (781) 861-4467
Summary Prepared:
May 13, 1998
Name of the device:
IL Test™ Plasmin Inhibitor
Classification name(s):
Class II 864.7290 Factor Deficiency Test Test, Qualitative and Quantitative Factor Deficient 81GGP
Identification of predicate device(s):
IL Test™ α2-Antiplasmin K920012/B
Description of the device/intended use(s):
IL Test™ Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor in human citrated plasma based on a synthetic chromogenic substrate and plasma inactivation. Plasmin inhibitor, the major fast acting inhibitor of the fibrinolytic system, also known as a -- antiplasmin is an important regulator of the fibrinolytic system. Congenital deficiencies are associated with haemorragic problems. Decreased levels of plasmin inhibitor are observed in liver diseases and DIC. Increased levels have been reported during post-operative episodes.
Statement of How the Technological Characteristics of the Device Compare to the Predicate device:
The new IL Test™ Plasmin Inhibitor uses the same test principle as the predicate IL Test™ o2-Antiplasmin and is substantially equivalent in performance, intended use and safety and effectiveness.
Summary of Performance Data:
In method comparison studies evaluating normal and abnormal plasma samples, the correlation (r) of the new IL Test™ Plasmin Inhibitor to the predicate IL Test™ x2-Antiplasmin on the ACL 300 was 0.987 (n=46) and on the ACL Futura was 0.996 (n = 51).
On the ACL 300, within run precision assessed over multiple runs using 2 levels of plasma gave a CV of 2.7% (at a mean of 46.6% activity) and 1.3% (at a mean of 95.4% activity). On the ACL Futura, within run precision assessed over multiple runs using 2 levels of plasma gave a CV of 4.4% (at a mean of 51.9% activity) and 2.7% (at a mean of 96.8% activity).
Section 3
IL Test™ Plasmin Inhibitor 510(k)
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows a partial view of a logo or emblem, featuring a stylized, abstract design. The design consists of three curved lines or strokes that appear to be interconnected or overlapping, creating a sense of movement or flow. The word "DEPARTMENT" is partially visible on the left side of the image, oriented vertically. The overall impression is that the image is a cropped section of a larger design, possibly from a government or organizational context.
AUG 27 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02173-3190
Re: K981696/S1 Trade Name: IL Test™ Plasmin Inhibitor Regulatory Class: II Product Code: GGP Dated: Auqust 10, 1998 Received: August 11, 1998
Dear Ms. Marble:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Toutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: IL Test™ Plasmin Inhibitor
Indications for Ùse:
IL Test™ Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor in human citrated plasma based on a synthetic chromogenic substrate and plasma inactivation. Plasmin inhibitor, the major fast acting inhibitor of the fibrinolytic system, also known as a -- antiplasmin is an important regulator of the fibrinolytic system. Congenital deficiencies are associated with haemorragic problems. Decreased levels of plasmin inhibitor are observed in liver diseases and DIC. Increased levels have been reported during post-operative episodes.
Peter E. Malin
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.019)
Over-The-Counter Use
Section 2
IL Test™ Plasmin Inhibitor 510(k)
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