(116 days)
No
The device description details a standard ELISA assay kit, which relies on biochemical reactions and colorimetric measurement, not AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
This device is an in vitro diagnostic test kit used to quantify tPA antigen levels in plasma, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for the quantitative determination of tPA antigen, which is used in the assessment of a patient's fibrinolytic system following a thrombotic episode and to identify risks of myocardial infarction or vascular cerebral accident, all of which are diagnostic purposes.
No
The device description clearly outlines a test kit containing physical reagents (antibodies, buffers, etc.) and a microwell plate for performing an ELISA assay, which is a laboratory-based chemical process, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the kit is for the "quantitative determination of tissue-type plasminogen activator (tPA) antigen in citrated plasma". This involves testing a sample taken from the human body (plasma) in vitro (outside the body) to provide information about a patient's health status (assessment of the fibrinolytic system, risk of myocardial infarction or vascular cerebral accident, detection of hypofibrinolytic and hyperfibrinolytic states).
- Device Description: The description details a laboratory-based assay (ELISA) performed on a biological sample (plasma) using reagents provided in a kit. This is characteristic of an in vitro diagnostic device.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K934314) strongly indicates that this device is being submitted for regulatory clearance as a medical device, specifically an IVD, by comparing it to a previously cleared device of the same type.
Therefore, based on the provided information, the ASSERACHROM® tPA test kit clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GGP
Device Description
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).
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
§ 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).
0
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 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).
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