Coamatic® Plasminogen is an in vitro diagnostic test for the quantitative determination of plasminogen (Plg) activity in human citrated plasma on automated laboratory equipment and also using microplate and manual methods. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders.

Device Description

AI/ML Overview

The provided document describes the Coamatic® Plasminogen device, an in vitro diagnostic test for plasminogen activity. The study presented is a method comparison study between the new Coamatic® Plasminogen and the predicate device, Coatest® Plasminogen, rather than a separate device performance study with specific acceptance criteria that are explicitly stated in a table.

However, based on the information provided, we can infer the acceptance criteria and then list the reported performance.

Inferred Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Method Comparison	Strong correlation (r) to predicate device, typically > 0.90 for quantitative assays, across various instruments and methods.	Correlation (r) to Coatest® Plasminogen:- ACL 300 (n=59): 0.92- Cobas Mira S (n=41): 0.97- Cobas Bio (n=30): 0.97- Cobas Fara (n=30): 0.97- EPOS 5060 (n=32): 0.99- MLA (n=37): 0.98- Test tube method (n=23): 0.92- Microplate method (n=31): 0.93
Precision (Within-run)	Low Coefficient of Variation (CV) for reproducibility, typically < 5% for assays.	Within-run Precision (CV):- Mean Plasminogen 49%: 1.9%- Mean Plasminogen 96%: 1.5%

Additional Study Information:

Sample sizes used for the test set and the data provenance:
- ACL 300: n=59
- Cobas Mira S: n=41
- Cobas Bio: n=30
- Cobas Fara: n=30
- EPOS 5060: n=32
- MLA: n=37
- Test tube method: n=23
- Microplate method: n=31
- Precision study: Not explicitly stated, but includes data points for mean plasminogen concentrations of 49% and 96% over "multiple runs."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study design appears to be a prospective comparison of samples measured by both devices, given it's a "method comparison study."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is an in vitro diagnostic device for quantitative determination of plasminogen activity. The "ground truth" for the test set is established by the measurements obtained from the predicate device (Coatest® Plasminogen), which is a previously cleared and accepted test. Therefore, it does not rely on expert interpretation or consensus in the same way an imaging or diagnostic AI device might.
Adjudication method for the test set:
Not applicable. The study compares quantitative measurements between two laboratory devices, not subjective interpretations requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the study presents the performance of the Coamatic® Plasminogen device as a standalone analytical instrument. The correlation and precision data reflect the algorithm's (or device's) performance in determining plasminogen levels.
The type of ground truth used:
The ground truth for this method comparison study is the results obtained from the predicate device, Coatest® Plasminogen. The goal is to demonstrate substantial equivalence, meaning the new device provides comparable results to an already accepted device.
The sample size for the training set:
Not specified. Given this is a comparison of an in vitro diagnostic assay with a predicate, rather than an AI/ML model, there isn't typically a "training set" in the sense of machine learning. The device's reagents and methodology would have been developed and optimized, but the sample sizes for that development are not detailed here.
How the ground truth for the training set was established:
Not applicable, as a separate "training set" with ground truth in the context of machine learning is not described. The device's analytical performance relies on its chemical and enzymatic reactions, which are validated against a known standard (the predicate device in this case, and presumably internal standards during development).

Summary

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K9 74711

Section 3

MAY | 1998

Coamatic® Plasminogen - 510(k) SUMMARY (Summary of Safety and Effectiveness)

Submitted by: -

Carol Marble Regulatory Affairs Engineer 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:

December 16, 1997

Name of the device:

Coamatic® Plasminogen

Classification name(s):

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

Identification of predicate device(s):

Coatest® Plasminogen K854572

Description of the device/intended use(s):

Statement of How the Technological Characteristics of the Device Compare to the Predicate device:

Coamatic® Plasminogen uses the same general test principle as the predicate Coatest® Plasminogen with the exception that Fibrinogen is added to the Streptokinase reagent to avoid the risk of overestimation of plasminogen in pathological plasmas containing elevated levels of fibrinogen (fib) and/or fibrin degradation products (FDP). The tests are substantially equivalent in performance, intended use, and safety and effectiveness.

Summary of Performance Data:

In method comparison studies comparing the new Coamatic® Plasminogen to the predicate Coatest® Plasminogen, the correlation (r) on an ACL 300 (n=59) was 0.92, on a Cobas Mira S (n=41) was 0.97, on a Cobas Bio (n=30) was 0.97, on a Cobas Fara (n=30) was 0.97, on a EPOS 5060 (n=32) was 0.99, on an MLA (n=37) was 0.98 and using the test tube (n=23) and microplate (n=31) methods was 0.92 and 0.93, respectively.

Within run precision accessed over multiple runs gave a CV of 1.9% (at a mean plasminogen concentration of 49%) and 1.5% (at a mean plasminogen concentration of 96%).

Section 3

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

1 1998 MAY

Carol Marble Senior Regulatory Affairs Specialist Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190

・・ Re : K974711 Coamatic® Plasminogen Regulatory Class: II Product Code: GGP Dated: April 8, 1998 Received: April 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 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, Druq, 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 Requlations, Title 21, Parts 800 to 895. ಗಳ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlatory In addition, FDA may publish further announcements action. 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

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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 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 qeneral 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/dsmamain.html".

Sincerely yours,
Steven Gutman

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): K974711

Device Name: Coamatic® Plasminogen

Indications for Use:

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laborato
510(k) Number
Prescription Use (Per 21 CFR 801.019)	OR Over-The-Counter Use
Section 2	Coamatic® Plasminogen 510(k)
	Page 1 of 1

Regulation Number and Section

§ 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).