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. 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.

Device Description

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. All plate wells contain antibody to PAI-1.

AI/ML Overview

The provided text describes a 510(k) summary for the IMUBIND® Plasma PAI-1 ELISA, a quantitative factor deficiency test. The summary focuses on demonstrating substantial equivalence to a predicate device rather than setting specific acceptance criteria and proving achievement through a detailed study with clinical endpoints.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy against a reference standard). Instead, it demonstrates substantial equivalence to a predicate device through method comparison and precision studies. The "performance" reported is primarily statistical correlation and variability.

Metric	Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (IMUBIND vs. Predicate or IMUBIND's own precision)
Method Comparison	Positive correlation comparable to the predicate device.	"The regression statistics in Table 1 indicate a positive correlation between the IMUBIND assay and the predicate device." (Specific regression equation and correlation coefficient are present in a table, but the values themselves are not fully rendered in the provided text for "regression" and "correlation").
Intra-Assay CV%	Low variability, comparable to typical ELISA performance.	Lot 1: 5.7%, 4.1% Lot 2: 5.7%, 4.2%
Inter-Assay CV%	Low variability, comparable to typical ELISA performance.	Lot 1: 5.1%, 2.1% Lot 2: 4.7%, 4.7%

Note: The table for "Method Comparison" in the original text is malformed and does not clearly present the regression equation or correlation coefficient values. It only states "Regression" and "And 100 Million," making it impossible to extract specific numerical performance for this section. The key takeaway from the text is that a positive correlation was observed.

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

Sample Size for Test Set: The document does not specify the exact number of samples (patients) used for the method comparison study. It only states that "Method comparison studies versus the predicate device were performed with one lot of IMUBIND Plasma PAI-1 ELISA." It also doesn't mention the number of runs for the method comparison.
Data Provenance: Not specified in the provided text. It does not mention the country of origin of the data or whether it was retrospective or prospective.

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

Not applicable. The study is a method comparison against a legally marketed predicate device, not a performance study against a clinical ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical adjudication process described for the test set, as it was a method comparison study.

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

Not applicable. This device is an in vitro diagnostic (ELISA) kit for measuring a biomarker, not an imaging or interpretive AI device that would involve human readers.

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

This refers to the performance of the assay itself. The performance data presented for "Method Comparison" and "Precision" describe the standalone performance of the IMUBIND® Plasma PAI-1 ELISA.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the method comparison study was the results obtained from the predicate device (TintElize® PAI-1). For precision, the "ground truth" was the expected value of the control samples.

8. The sample size for the training set

Not applicable. This device is an ELISA assay, not a machine learning or AI algorithm that requires a training set in the conventional sense.

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

Not applicable, as there is no "training set" for an ELISA assay.

In summary: The submission aims to establish substantial equivalence for the IMUBIND® Plasma PAI-1 ELISA to a predicate device (TintElize® PAI-1). It does so by showing similar method, performance characteristics (correlation, precision), intended use, reagents, storage, stability, specimen types, and limitations. The "study" proving the device meets the (implied) acceptance criteria is the method comparison and precision study, which demonstrated positive correlation with the predicate and acceptable intra- and inter-assay variability for the new device. A precise sample size for the method comparison study is not provided in the summary.

Summary

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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.

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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

LA LA LE RESIDENT LEA CHANNEL CAR		egression			ﺮ
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------		quationSeparation of Children of Children of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	And 100 Million------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	44.4Acres of the
MILEAR READ RANGER OF CStation 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 theMALE 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

IMUBINDPlasma PAI-1	Mean(ng/ml)	Intra-AssayCV%	Inter-AssayCV%
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 PlasmaPAI-1 ELISA	TintElize PAI-1
Intended Use	Similar	Similar
Principle andMethod	All plate wells containantibody to PAI-1	Half of the plate wells contain antibody (A-well) toPAI-1, half of the plate wells contain no antibody(N-well) providing a blank to be subtracted fromthe absorbance value for each sample
Reagents	Similar	Similar
Storage andStability	Similar	Similar
Specimen	Similar	Similar
Limitations	Similar	Similar
Expected Values	Similar	Similar
PerformanceCharacteristics	Similar	Similar

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

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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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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

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).