Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard ELISA assay for measuring a specific protein. There is no mention of AI, ML, or any computational analysis beyond basic statistical methods for performance evaluation.

Therapeutic

No
The device is an in vitro diagnostic (IVD) test for measuring PAI-1 antigen, used for diagnostic purposes and not for treating or preventing a disease or condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "This kit is for in vitro diagnostic use."

SaMD (Software as a Medical Device)

No

The device is an enzyme-linked immunosorbent assay (ELISA) kit, which is a laboratory test involving physical reagents and procedures, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "This kit is for in vitro diagnostic use."
Nature of the Test: The device is an ELISA (enzyme-linked immunosorbent assay) designed to measure a specific substance (PAI-1 antigen) in a human biological sample (plasma). This is a hallmark of in vitro diagnostics, which are tests performed on samples taken from the human body.
Clinical Relevance: The intended use mentions the association of high PAI-1 levels with deep vein thrombosis and myocardial infarction, indicating the test is intended to provide information for clinical purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in human plasma.
The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of human Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in plasma.
This kit is for in vitro diagnostic use.
High levels of PAI-1 antigen are known to be associated with deep vein thrombosis and myocardial infarction.

Product codes (comma separated list FDA assigned to the subject device)

GGP

Device Description

Not Found

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

Not Found

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

Not Found

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

Method comparison studies versus the predicate device were performed with one lot of IMUBIND Plasma PAI-1 ELISA. The regression statistics in Table 1 indicate a positive correlation between the IMUBIND assay and the predicate device.
Precision studies evaluated intra-assay and inter-assay variability with 2 control samples run in replicates of 4 over 10 runs (N=40 per control). Two lots were evaluated.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

BIOPOOL TintElize® PAI-1 K960438

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

Section 3

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IMUBIND® Plasma PAI-1 ELISA Quantitative Factor Deficiency Test (per 21CFR864.7290)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

Submitted by:

American Diagnostica Inc. 222 Railroad Avenue Greenwich, CT 06830 Phone: 203 661-0000 Fax: 203 661-7784

Contact:

Clare Santulli Field Trial Coordinator Phone: 203 661-0000

Summary Prepared:

August 12, 2001

Name of the Device:

IMUBIND® Plasma PAI-1 ELISA Product No. 822

Classification Name(s):

864.7290 Test, Quantitative Factor Deficiency GGP Hematology, Class II

Predicate Device:

BIOPOOL TintElize® PAI-1 K960438

Intended Use:

The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in human plasma.

1

Summary of Substantial Equivalence:

IMUBIND Plasma PAI-1 ELISA is substantially equivalent to the commercially available predicate device (TintElize PAI-1, manufactured by Biopool International, Ventura, CA) in performance and intended use.

Summary of Performance Data:

Method Comparison

Method comparison studies versus the predicate device were performed with one lot of IMUBIND Plasma PAI-1 ELISA. The regression statistics in Table 1 indicate a positive correlation between the IMUBIND assay and the predicate device.

	Table 1: Correlation (Y=IMUBIND, X=predicate device)
IMUBIND	Regression	Carlos	Sam

|

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------		quation
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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	44.4
Acres of the
MILEAR READ RANGER OF C
Station of the trial and the collect of the closed and the charges and the commission and the comments withing the contribution and the contribution and the contribution and
. BIR MILE LINE LIER RESER FREELER ANNUAL

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------- | month of the charge than the collection of the commission of the commission of the commission of the commission of the commended to the
MALE OF LEASE OF CHE OF CHEARTH | | B ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
.

-------------- |

Precision

Precision studies evaluated intra-assay and inter-assay variability with 2 control samples run in replicates of 4 over 10 runs (N=40 per control). Two lots were evaluated.

Table 2: Precision

| IMUBIND
Plasma PAI-1 | Mean
(ng/ml) | Intra-Assay
CV% | Inter-Assay
CV% |
|-------------------------|-----------------|--------------------|--------------------|
| Lot 1 | 11.5 | 5.7 | 5.1 |
| | 40.9 | 4.1 | 2.1 |
| Lot 2 | 11.3 | 5.7 | 4.7 |
| | 40.3 | 4.2 | 4.7 |

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Section 4

SUBSTANTIAL EQUIVALENCE COMPARISON

A comparison table of the relevant similarities and differences between IMUBIND Plasma PAI-1 ELISA and the predicate device:

| | IMUBIND Plasma
PAI-1 ELISA | TintElize PAI-1 |
|--------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Similar | Similar |
| Principle and
Method | All plate wells contain
antibody to PAI-1 | Half of the plate wells contain antibody (A-well) to
PAI-1, half of the plate wells contain no antibody
(N-well) providing a blank to be subtracted from
the absorbance value for each sample |
| Reagents | Similar | Similar |
| Storage and
Stability | Similar | Similar |
| Specimen | Similar | Similar |
| Limitations | Similar | Similar |
| Expected Values | Similar | Similar |
| Performance
Characteristics | Similar | Similar |

Similar performance and values were obtained with both devices suggesting that the method difference does not affect device equivalence.

IMUBIND Plasma PAI-1 ELISA is substantially equivalent to the commercially available predicate device (TintElize PAI-1, manufactured by Biopool International, Ventura, CA) in method, performance and intended use.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

7 2002 MAR

Mr. John Berryman Director of Regulatory Affairs American Diagnostica Inc. 222 Railroad Avenue Greenwich, CT 06830

Re: K013168

Trade/Device Name: IMUBIND® Plasma PAI-1 ELISA Regulation Number: 21 CFR 864.7290 Regulation Name: Factor deficiency test Regulatory Class: Class II Product Code: GGP Dated: January 8, 2002 Received: January 10, 2002

Dear Mr. Berryman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 regulation (21 CFR Part 801 and 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer 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 Butman

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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Section 2

STATEMENT OF INDICATIONS FOR USE

Applicant:

510(k) Number: _K013168

Device:

Indications for Use:

::

The IMUBIND® Plasma PAI-1 ELISA is an enzyme-linked immunosorbent assay for the measurement of human Plasminogen Activator Inhibitor Type-1 (PAI-1) antigen in plasma.

This kit is for in vitro diagnostic use.

High levels of PAI-1 antigen are known to be associated with deep vein thrombosis and myocardial infarction.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joachim Sauterki

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K013168