K Number
K981817
Device Name
COAMATIC PLASMIN INHIBITOR
Date Cleared
1998-09-28

(129 days)

Product Code
Regulation Number
864.7290
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma using microplate, test tube and automated methods. Plasmin inhibitor, the major fast-acting inhibitor of the fibrinolytic system, also know 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 Description
Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma using microplate, test tube and automated methods.
More Information

K833890 Coatest® Antiplasmin

Not Found

No
The document describes a standard in vitro diagnostic test kit and does not mention any AI or ML components.

No
The device is described as an "in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity." This indicates it is used to diagnose or measure a substance, not to treat a condition.

Yes

The device is explicitly stated to be an "in vitro diagnostic test" for the quantitative determination of plasmin inhibitor activity in human citrated plasma, which is used to identify congenital deficiencies, decreased levels in liver diseases/DIC, and increased levels post-operatively. This aligns with the definition of a diagnostic device.

No

The device is described as an in vitro diagnostic test kit, which inherently includes reagents and other physical components for performing laboratory assays, not solely software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The document explicitly states "Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma". This directly aligns with the definition of an IVD, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality.
  • Device Description: The description reiterates that it is "an in vitro diagnostic test".
  • Predicate Device: The mention of a "Predicate Device(s)" with a K number (K833890 Coatest® Antiplasmin) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.

N/A

Intended Use / Indications for Use

Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma using microplate, test tube and automated methods. Plasmin inhibitor, the major fast-acting inhibitor of the fibrinolytic system, also know as α-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

Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma using microplate, test tube and automated methods.

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

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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

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

In method comparison studies comparing the new Coamatic® Plasmin Inhibitor to the predicate Coatest® Antiplasmin, the correlation (r) on an ACL 300 (n=61) was 0.95, on a Cobas Mira (n=43) was 0.97, on an MLA Electra (n=43) was 0.97, and using the test tube (n=32) and microplate (n=54) methods was 0.96 and 0.94, respectively.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Within run precision assessed over multiple runs gave a CV of 5.9% (at a mean plasmin inhibitor concentration of 44.8%) and 2.7% (at a mean plasmin inhibitor concentration of 99.3%).

Predicate Device(s)

K833890 Coatest® Antiplasmin

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).

0

SEP 28 1998

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D

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Section 3 Coamatic® 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 Fax: (781) 861-4464

Contact Persons:

Carol Marble Phone: (781) 861-4467

Summary Prepared:

May 21, 1998

Name of the device:

Coamatic® Plasmin Inhibitor

Classification name(s):

864.7290 Factor Deficiency Test Class II 81GGP Test, Qualitative and Quantitative Factor Deficient

Identification of predicate device(s):

K833890 Coatest® Antiplasmin

Description of the device/intended use(s):

Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma using microplate, test tube and automated methods. Plasmin inhibitor, the major fast-acting inhibitor of the fibrinolytic system, also know 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:

Coamatic® Plasmin Inhibitor uses the same test principle as the predicate Coatest® Antiplasmin and is substantially equivalent in performance, intended use, and safety and effectiveness.

Summary of Performance Data:

In method comparison studies comparing the new Coamatic® Plasmin Inhibitor to the predicate Coatest® Antiplasmin, the correlation (r) on an ACL 300 (n=61) was 0.95, on a Cobas Mira (n=43) was 0.97, on an MLA Electra (n=43) was 0.97, and using the test tube (n=32) and microplate (n=54) methods was 0.96 and 0.94, respectively.

Within run precision assessed over multiple runs gave a CV of 5.9% (at a mean plasmin inhibitor concentration of 44.8%) and 2.7% (at a mean plasmin inhibitor concentration of 99.3%).

Section 3

Coamatic® Plasmin Inhibitor 510(k)

Page 1 of 1

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles facing to the right.

SEP 28 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Requlatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173

Re : K981817/S1 Trade Name: Coamatic® Plasmin Inhibitor Regulatory Class: II Product Code: GGP Dated: September 8, 1998 Received: September 9, 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 against 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 Reqister. 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.

2

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 requiation 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 Sutman

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: Coamatic® Plasmin Inhibitor

Indications for Use:

Coamatic® Plasmin Inhibitor is an in vitro diagnostic test for the quantitative determination of plasmin inhibitor activity in human citrated plasma using microplate, test tube and automated methods. Plasmin inhibitor, the major fast-acting inhibitor of the fibrinolytic system, also know as ca-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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) NumberK981817
Prescription Use (Per 21 CFR 801.019)OROver-The-Counter Use
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Section 2 Coamatic® Plasmin Inhibitor 510(k) Page 1 of 1