IL TEST PLASMIN INHIBITOR

K981696 · Instrumentation Laboratory CO · GGP · Aug 27, 1998 · Hematology

Device Facts

• Record ID: K981696
• Device Name: IL TEST PLASMIN INHIBITOR
• Applicant: Instrumentation Laboratory CO
• Product Code: GGP · Hematology
• Decision Date: Aug 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

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.

Device Story

IL Test™ Plasmin Inhibitor is an in vitro diagnostic reagent kit for quantitative measurement of plasmin inhibitor (α2-antiplasmin) in human citrated plasma. The device utilizes a synthetic chromogenic substrate and plasma inactivation principle to measure inhibitor activity. It is intended for use in clinical laboratory settings by trained laboratory personnel. The assay is performed on automated coagulation analyzers (e.g., ACL 300, ACL Futura). The output is a quantitative value representing plasmin inhibitor activity, which assists clinicians in evaluating fibrinolytic system status, diagnosing congenital deficiencies, or monitoring conditions like liver disease, DIC, and post-operative states. The test provides objective data to support clinical decision-making regarding patient coagulation and fibrinolytic health.

Clinical Evidence

Bench testing only. Method comparison studies performed on 46 and 51 plasma samples comparing the subject device to the predicate on ACL 300 and ACL Futura analyzers, respectively. Correlation coefficients (r) were 0.987 and 0.996. Within-run precision (CV) ranged from 1.3% to 4.4% across two levels of plasma activity.

Technological Characteristics

In vitro diagnostic reagent kit; utilizes synthetic chromogenic substrate and plasma inactivation principle; designed for use on automated coagulation analyzers (ACL 300, ACL Futura).

Indications for Use

Indicated for quantitative determination of plasmin inhibitor in human citrated plasma to assess fibrinolytic system regulation in patients with suspected congenital deficiencies, liver disease, DIC, or post-operative monitoring.

Predicate Devices

• IL Test™ α2-Antiplasmin (K920012/B)

Submission Summary (Full Text)

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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: [phone] [phone] Fax:

### Contact Person:

Carol Marble Phone: [phone]

#### 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)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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## 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

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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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