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 Description

AI/ML Overview

Here's an analysis of the provided text regarding the IL Test™ Plasmin Inhibitor, focusing on the acceptance criteria and study details:

This document is a 510(k) summary for a new in vitro diagnostic device, the IL Test™ Plasmin Inhibitor, seeking substantial equivalence to a predicate device. The primary study described is a method comparison study.

Acceptance Criteria and Device Performance

Based on the provided text, the acceptance criteria are implicitly derived from the comparison to the predicate device. The performance is assessed by correlation and precision.

Acceptance Criteria Category	Specific Metric	Acceptance Threshold (Implicit)	Reported Device Performance
Method Comparison	Correlation (r)	High correlation to predicate	ACL 300: 0.987 (n=46)
			ACL Futura: 0.996 (n=51)
Precision (Within-Run)	CV (%)	Low CV	ACL 300: 2.7% (46.6% mean)
			ACL 300: 1.3% (95.4% mean)
			ACL Futura: 4.4% (51.9% mean)
			ACL Futura: 2.7% (96.8% mean)

Note on Acceptance Thresholds: The document states that the new device "is substantially equivalent in performance" to the predicate. Therefore, the reported high correlation values (0.987 and 0.996) and the low CVs are considered to meet this implicit acceptance criterion of comparable performance. There are no explicit numerical thresholds given as "acceptance criteria" in this summary.

Study Details

Sample sizes used for the test set and the data provenance:
- ACL 300 comparison: n = 46 plasma samples (normal and abnormal)
- ACL Futura comparison: n = 51 plasma samples
- Precision (ACL 300): Not explicitly stated, but "2 levels of plasma" were used over "multiple runs."
- Precision (ACL Futura): Not explicitly stated, but "2 levels of plasma" were used over "multiple runs."
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). It mentions "normal and abnormal plasma samples," implying collection from human subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is an in vitro diagnostic test for quantitative determination, and the study involves method comparison against a predicate device and precision assessment. Ground truth in the sense of expert consensus on qualitative interpretation is not relevant here. The "ground truth" for the method comparison is effectively the results generated by the predicate device.
Adjudication method for the test set:
- Not applicable. See point 2. No adjudication process for expert opinions or interpretations is mentioned or required for this type of quantitative comparison study.
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. This is not an MRMC study. This device is an automated in vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The performance data presented for correlation and precision are purely instrumental/algorithm-based, comparing the new device's output to the predicate device's output, and assessing its internal consistency. There is no human intervention in the result generation itself, beyond operating the instrument.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the method comparison study is the results obtained from the predicate device (IL Test™ α2-Antiplasmin K920012/B). For the precision study, the ground truth is statistical consistency over repeated measurements. There is no external "gold standard" pathology or outcomes data mentioned for establishing truth in these particular performance studies.
The sample size for the training set:
- Not applicable / Not specified. This document describes a traditional in vitro diagnostic device, not one based on machine learning or AI that would typically involve a separate "training set." The study focuses on validation using test samples.
How the ground truth for the training set was established:
- Not applicable. No training set, as per point 7.

Summary

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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):

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

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

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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: IL Test™ Plasmin Inhibitor

Indications for Ùse:

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)

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).