The ASSERACHROM® tPA test kit is intended for the quantitative determination of tissue-type plasminogen activator (tPA) antigen in citrated plasma by the sandwich technique of enzyme immunoassay (EIA) known as enzyme-linked immunosorbent assay (ELISA).

The quantitative determination of tPA is generally performed during the assessment of the fibrinolytic system of a patient, for instance, following a thrombotic episode.

In addition, it has been reported that a high antigenic level of tPA is associated with a greater risk of myocardial infarction or vascular cerebral accident. Finally, quantitative tPA assays are useful in the detection of hypofibrinolytic and hyperfibrinolytic states.

Device Description

Mouse monoclonal anti-tPA antibody is coated on the inside wall of a plastic microwell. The plasma to be tested is allowed to incubate in the microwell for two hours at room temperature, during which any tPA present is captured by the monoclonal antibody. Next, a second (and different) mouse monoclonal anti-tPA antibody coupled with peroxidase is added to the microwell for another 2-hour incubation at room temperature; this antibody-enzyme conjugate binds to another antigenic determinant of the tPA molecule that is already bound to the microwell in the first incubation step. The bound enzyme is revealed by its action on orthophenylenediamine in the presence of hydrogen peroxide to produce a yellow color; after addition of a strong acid to stop the enzymatic action, the intensity of the color developed bears a direct relationship to the tPA level initially present in the test plasma.

The kit provides sufficient reagents to perform 96 tests in micro-ELISA plate format. Reagents in intact (unopened) kits remain stable for 18 months after their date of manufacture, when stored at 2°-8°C. Reconstituted reagent stabilities are as follows: Reagent ● (antibody-coated microwell strips) must be used immediately after opening of its package; Reagent @ (anti-tPA-Peroxidase), 24 hours at 2°-8°C; Reagent Oa (ortho-Phenylenediamine) dissolved together with Reagent Ob (Urea Peroxide), 1 hour at room temperature (18°-25°C); 1:10 diluted Reagent © (Dilution Buffer) and 1:20 diluted Reagent ® (Washing Solution), 15 days at 2°-8°C, when free of any contamination; both the Reagent ® (tPA Calibrator) and Reagent ® (tPA Control), 4 hours at 20°C.

The ASSERACHROM® tPA reagent system has a detection limit of 1 ng/ml; a working range from 1 ng/ml up to the tPA level of Reagent ® (tPA Calibrator, up to 50 ng/ml); intra-assay reproducibility of < 6.5%; inter-assay reproducibility of < 8%.

AI/ML Overview

The device concerned is the ASSERACHROM® tPA Test Kit, an ELISA-based assay for the quantitative determination of tissue-type plasminogen activator (tPA) antigen in citrated plasma.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Detection Limit	1 ng/ml
Working Range	1 ng/ml up to the tPA level of Reagent ® (tPA Calibrator, up to 50 ng/ml)
Intra-assay Reproducibility	< 6.5%
Inter-assay Reproducibility	< 8%

Study Information

The provided document, K971519, is a 510(k) premarket notification for the ASSERACHROM® tPA Test Kit. This notification outlines the device's characteristics and claims substantial equivalence to a predicate device.

Based on the provided text, a formal "study" proving the device meets the acceptance criteria in the sense of a clinical trial with human subjects is not detailed. Instead, the performance characteristics (detection limit, working range, and reproducibility) are stated as inherent properties of the assay and likely derived from internal validation studies conducted by the manufacturer. The document is a summary of these characteristics intended for regulatory submission.

Here's an analysis of the requested information based on the provided text:

Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for test sets used to determine the reported performance metrics (detection limit, working range, reproducibility).
- Data provenance is not provided (e.g., country of origin, retrospective or prospective). These performance specifications are typically derived from in-vitro laboratory experiments.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of in-vitro diagnostic device performance characterization. "Ground truth" for analytical performance metrics like detection limit and reproducibility is established through controlled laboratory experiments, not expert interpretation of results.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept is relevant for studies involving human interpretation or clinical outcomes, not for the analytical performance characteristics of an ELISA kit.
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 is an in-vitro diagnostic kit, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of "human readers improve with AI" are not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The reported performance metrics (detection limit, working range, reproducibility) are inherently "standalone" in the sense that they describe the algorithm/kit's analytical capabilities without human interpretative intervention in the measurement itself (though human operation is required). There is no "algorithm only" in the context of an ELISA kit, as it's a biochemical assay.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For analytical performance data like detection limit and reproducibility, the "ground truth" is defined by the known concentrations of standards or controls used in the assay and the statistical methods applied to the experimental results. It's based on biochemical and analytical principles, not clinical ground truth like pathology or outcomes.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The assay's parameters (reagent concentrations, incubation times, etc.) are developed through biochemical optimization, not statistical training on a data set in the AI sense.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an ELISA kit. The "ground truth" for optimizing the assay would be based on achieving optimal signal-to-noise ratios, linearity, sensitivity, and specificity through experimental design and validation using known concentrations of tPA.

In summary, the provided text describes the analytical performance characteristics of a laboratory test kit and its claim of substantial equivalence for regulatory purposes. It does not detail a clinical study with elements like human readers, AI, or specific patient sample sizes that would typically be seen in the context of medical imaging or AI-driven diagnostic devices.

Summary

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K97151.9

Page 33 of 33

AMERICAN BIOPRODUCTS COMPANY Premarket 510(k) Notification ASSERACHROM® tPA Test Kit

AUG / 9 1997

VIII. Safety and Effectiveness Summary

The ASSERACHROM® tPA test kit is claimed to be substantially equivalent to the predicate device TintElize® tPA test kit which is also an ELISA procedure for tPA available from Biopool (K934314).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Andrew Loc B. Le, Ph.D. Director, Requlatory Affairs and Quality Assurance American Bioproducts Company Five Century Drive Parsippany; New Jersey 07054 - --------

AUG 1 9 1997

K971519/S2 Re : Trade Name: ASSERACHROM® tPA Test Kit Requlatory Class: II Product Code: GGP Dated: August 5, 1997 Received: August 7, 1997

Dear Dr. Le:

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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Fart 320) 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

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 leqally 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 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

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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Page 1 of 1

Attachment A

K971519 510(k) Number (if known

Device Name: ___ ASSERACHROM® tPA Test Kit

Indications for Use:

The quantitative determination of tPA is generally performed during the assessment of the fibrinolytic system of a patient, for instance, following a thrombotic episode.

Umorre La. D. Montemayor
Division Sign-Off

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 971519

(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

Prescription Use
(Per 21 CFR 801.109)

510(k) Number

Over-The-Counter Use

(Optional Format 1-2-96)

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).