IL Test™ Plasminogen is an in vitro diagnostic test for the quantitative determination of plasminogen in human citrated plasma based on a synthetic chromogenic substrate. Dysplasminogenemia is associated with recurrent venous thrombosis. Acquired deficiencies of Plasminogen are associated with thrombolytic therapy, sepsis and Disseminated Intravascular Coagulation.

Device Description

IL Test™ Plasminogen is an in vitro diagnostic test for the quantitative determination of plasminogen in human citrated plasma based on a synthetic chromogenic substrate.

AI/ML Overview

The provided text describes the IL Test™ Plasminogen, an in vitro diagnostic test. Analyzing the text, we can extract the following information regarding its acceptance criteria and the study that proves its performance:

1. Table of acceptance criteria and the reported device performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Correlation (r) to Predicate (ACL 300)	Substantially equivalent to predicate, implying high correlation.	0.983
Correlation (r) to Predicate (ACL Futura)	Substantially equivalent to predicate, implying high correlation.	0.989
Within-run Precision (ACL 300, 50.1% activity)	Substantially equivalent to predicate, implying acceptable CV.	CV of 4.4%
Within-run Precision (ACL 300, 95.7% activity)	Substantially equivalent to predicate, implying acceptable CV.	CV of 2.8%
Within-run Precision (ACL Futura, 52.5% activity)	Substantially equivalent to predicate, implying acceptable CV.	CV of 1.8%
Within-run Precision (ACL Futura, 97.6% activity)	Substantially equivalent to predicate, implying acceptable CV.	CV of 1.7%

Note: The document states that the new device "is substantially equivalent in performance, intended use and safety and effectiveness" to the predicate device. Therefore, the "acceptance criteria" are not explicitly defined as numerical thresholds but rather by demonstrating performance comparable to the legally marketed predicate device.

2. Sample size used for the test set and the data provenance

Sample Size: 51 plasma samples
Data Provenance: Not specified (e.g., country of origin). The study is retrospective in nature, as it uses existing plasma samples for method comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The "ground truth" for method comparison is essentially the results obtained from the predicate device; therefore, expert consensus on the true value of plasminogen in these samples is not explicitly mentioned as a separate step.

4. Adjudication method for the test set

This information is not applicable to this type of study. Adjudication methods (like 2+1, 3+1) are typically used in diagnostic studies where multiple readers interpret images or clinical data to establish a consensus ground truth. Here, the "ground truth" for performance comparison is the result from the predicate device.

5. 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is for an in vitro diagnostic test for plasminogen, not an AI-assisted diagnostic tool that would involve human readers interpreting output.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was done. The reported performance metrics (correlation and precision) are based on the device's quantitative measurements of plasminogen activity directly from plasma samples. There is no human interpretation involved in the measurement process itself, making this an algorithm-only (or device-only) performance assessment.

7. The type of ground truth used

The "ground truth" used for comparison in this study is the results obtained from the predicate device (IL Test™ Plasminogen K864212/A) using the same plasma samples. This indicates a comparative effectiveness study against an established method.

8. The sample size for the training set

This information is not applicable to this device. The IL Test™ Plasminogen appears to be a laboratory reagent-based test with a fixed assay protocol, not a machine learning or AI-based device that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established

This information is not applicable as there is no "training set" for this type of device.

Summary

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MAY 2 6 1998

K981200

Section 3 IL Test™ Plasminogen - 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:

April 1, 1998

Name of the device:

IL Test™ Plasminogen

Classification name(s):

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

Identification of predicate device(s):

IL Test™ Plasminogen K864212/A

Description of the device/intended use(s):

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

The new IL Test™ Plasminogen uses the same test principle as the predicate II. Test™ Plasminogen and is substantially equivalent in performance, intended use and safety and effectiveness.

Summary of Performance Data:

In method comparison studies evaluating 51 plasma samples, the correlation (r) of the new IL Test™ Plasminogen to the predicate IL Test™ Plasminogen on the ACL 300 was 0.983 and on the ACL Futura was 0.989.

On the ACL 300, within run precision assessed over multiple runs using 2 levels of plasma gave a CV of 4.4% (at a mean of 50.1% activity) and 2.8% (at a mean of 95.7% activity). On the ACL Futura, within run precision assessed over multiple runs using 2 levels of plasma gave a CV of 1.8% (at a mean of 52.5% activity) and 1.7% (at a mean of 97.6% activity).

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 6 1998

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

K981200 Re : Il Test Plasminogen Regulatory Class: II Product Code: GGP April 1, 1998 Dated: Received: April 2, 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, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ್ಗೆ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 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 Litman

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™ Plasminogen

Indications for Use:

IL Test™ Plasminogen is an in viro diagnostic test for the quantitative determination of plasminogen in human citrated plasma based on a synthetic chromogenic substrate. Dysplasminogenemia is associated with recurrent venous thrombosis. Acquired deficiencies of Plasminogen are associated with thrombolytic therapy, sepsis and Disseminated Intravascular Coagulation.

(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 Laboratory Devices
510(k) Number	K981200

Prescription Use	✓	OR	Over-The-Counter Use
(Per 21 CFR 801.019)

Section 2	IL Test™ Plasminogen 510(k)	Page 1 of 1
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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).