IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma. This kit is for in vitro diagnostic use. Levels of tPA in plasma are known to be elevated in late stage pregnancy, myocardial infarction, atherosclerosis, and stroke.

Device Description

IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the IMUBIND® tPA ELISA device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of specific numeric thresholds for regression values or CV%. However, the study aims to demonstrate "substantial equivalence" to a predicate device. The performance data presented serves to support this claim by showing a high correlation and acceptable precision.

Acceptance Criterion (Implicit)	Reported Device Performance
Method Comparison:
Correlation with predicate device	Lot 1: Y=0.79x--0.6, R=0.904, Sy.x=4.42 ng/ml (Sample Range: 1.6-18.0 ng/ml) Lot 2: Y=0.83x+0.3, R=0.90, Sy.x=1.26 ng/ml (Sample Range: 3.1-23.2 ng/ml)
Precision:
Intra-Assay Variability (CV%)	Lot 1: 3.7% (6.8 ng/ml), 4.1% (15.4 ng/ml) Lot 2: 4.9% (6.5 ng/ml), 4.2% (14.9 ng/ml) Lot 3: 6.0% (5.6 ng/ml), 3.8% (14.6 ng/ml)
Inter-Assay Variability (CV%)	Lot 1: 8.9% (6.8 ng/ml), 9.0% (15.4 ng/ml) Lot 2: 8.2% (6.5 ng/ml), 4.0% (14.9 ng/ml) Lot 3: 6.7% (5.6 ng/ml), 2.3% (14.6 ng/ml)
Substantial Equivalence:	"Similar performance and values were obtained with both devices suggesting that the method difference does not affect device equivalence." (Based on comparison across intended use, principle, reagents, storage, specimen, limitations, expected values, and performance characteristics compared to the TintElize tPA predicate device.)

2. Sample Size Used for the Test Set and Data Provenance

Method Comparison (Test Set for Equivalence):
- Sample Size:
  - Lot 1: 286 samples
  - Lot 2: 75 samples
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The data appears to be from laboratory testing comparing the new device against the predicate.
Precision (Test Set for Repeatability/Reproducibility):
- Sample Size: N=20 per control (for both intra-assay and inter-assay, for each of the two control samples). This was across 10 runs with replicates of 4.
- Data Provenance: Not explicitly stated, but likely laboratory-generated data for internal validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The device is a quantitative immunoassay for an analyte (tPA antigen). The "ground truth" for its performance is established by comparing its measurements to a legally marketed predicate device (TintElize tPA) and by demonstrating acceptable analytical precision. There is no human interpretative component that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above. There is no human interpretation or decision-making that would require an adjudication process.

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

This is not applicable. The IMUBIND® tPA ELISA is an in vitro diagnostic assay, not an imaging or diagnostic device involving human reader interpretation or AI assistance in a clinical setting.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This is not applicable in the context of an algorithm. The IMUBIND® tPA ELISA is a laboratory assay. Its "standalone" performance is established by the analytical studies (method comparison and precision) without human interpretation as part of the measurement process.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurements obtained from the predicate device (TintElize tPA) for method comparison, and expected assay values/internal controls for precision studies.

8. The Sample Size for the Training Set

This is not applicable. The IMUBIND® tPA ELISA is a laboratory assay with established biochemical principles, not a machine learning model that requires a "training set" in the conventional sense. Its development would involve reagent optimization and assay design, but not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated above.

Summary

{0}------------------------------------------------

MAR 1 3 2002

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS IMUBIND® tPA 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: K013492

Submitted by:

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

Contact:

Clare Santulli Field Trial Coordinator Phone: 203 661-0000

Summary Revised:

January 4, 2002

Name of the Device:

IMUBIND® tPA ELISA Product No. 860

Classification Name(s):

Test, Quantitative Factor Deficiency 864.7290 GGP Hematology, Class II

Predicate Device:

TintElize® tPA K934314

Intended Use:

IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma. This kit is for in vitro diagnostic use.

{1}------------------------------------------------

Summary of Substantial Equivalence:

IMUBIND tPA ELISA is substantially equivalent to the commercially available predicate device (TintElize tPA, manufactured by Riopool International, Ventura, CA) in performance and intended use.

Summary of Performance Data:

Method Comparison

Method Comparison studies versus the predicate device were performed with two different lots of MUBIND tPA ELISA. The regression statistics in Table 1 indicate a positive correlation, between the IMUBIND tPA ELISA assay and the predicate device.

IMUBIND tPAELISA	N	Regression Equation	R	Sy.x(ng/ml)	Sample Range(ng/ml)
Lot 1	286	Y=0.79x--0.6	0.904	4.42	1.6-18.0
Lot 2	75	Y=0.83x+0.3	0.90	1.26	3.1-23.2

Table 1: Correlation (Y=IMUBIND. X=predicate device)

Precision

Precision studies evaluated intra-assay and inter-assay variability with 2 control samples run in replicates of 4 over 10 runs (N=20 per control). Assay results (ng/ml) were calculated using duplicate determinations. Three lots of IMUBIND tPA ELISA were evaluated.

Table 2: Precision

IMUBIND tPAELISA	Mean(ng/ml)	Intra-AssayCV%	Inter-AssayCV%
Lot 1	6.8	3.7	8.9
	15.4	4.1	9.0
Lot 2	6.5	4.9	8.2
	14.9	4.2	4.0
Lot 3	5.6	6.0	6.7
	14.6	3.8	2.3

{2}------------------------------------------------

Section 4

SUBSTANTIAL EQUIVALENCE COMPARISON

A comparison table of the relevant similarities and differences between IMUBIND tPA ELISA and the predicate device:

	IMUBIND tPA ELISA	TintElize tPA
Intended Use	Similar	Similar
Principle and Method	Similar	Similar
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 tPA ELISA is substantially equivalent to the commercially available predicate device (TintElize tPA, 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 seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its head turned to the right, and three lines extending from its neck, representing the department's focus on health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John B. Berryman Director of Regulatory Affairs American Diagnostica Inc. 222 Railroad Avenue P.O. Box 1165 Greenwich, Connecticut 06836-1165

Re: K013492

Trade/Device Name: IMUBIND® tPA ELISA Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GGP Dated: January 7, 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.

MAR 1 3 2002

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.

{4}------------------------------------------------

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 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 Sutman

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

{5}------------------------------------------------

Section 2

STATEMENT OF INDICATIONS FOR USE

Applicant:

510(k) Number:

Device: IMUBIND® tPA ELISA

Indications for Use:

IMUBIND® tPA ELISA is an enzyme-linked immunosorbent assay for the measurement of human tissue-type Plasminogen Activator (tPA) antigen in plasma.

This kit is for in vitro diagnostic use.

Levels of tPA in plasma are known to be elevated in late stage pregnancy, myocardial infarction, atherosclerosis, and stroke.

Angelini Battisti

(Division Sigh-Off Division of Clinical Laboratory Devices

510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

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).