(89 days)
Not Found
No
The device description details a chromogenic assay based on a two-step chemical reaction and absorbance measurement. There is no mention of AI, ML, or any computational methods beyond standard data analysis for accuracy and precision.
No
This device is an in-vitro diagnostic assay used to measure heparin activity in human plasma, which helps monitor antithrombotic therapy rather than providing direct therapeutic action.
Yes
The "Intended Use / Indications for Use" states that the device is for the "quantitative determination of heparin anti-X, activity in human plasma," which is a measurement used to aid in clinical diagnosis or monitoring.
No
The device description clearly outlines a chromogenic assay kit involving chemical reagents (Buffer Concentrate, FXa reagent, Substrate reagent, and AT-III reagent) and a two-step reaction process to measure heparin activity. This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of heparin anti-X, activity in human plasma." This indicates the device is used to test a biological sample (human plasma) in vitro (outside the body) to provide information about a patient's health status (heparin activity).
- Device Description: The description details a laboratory assay using reagents to measure a specific analyte (heparin anti-FXa activity) in a plasma sample. This is a hallmark of an in vitro diagnostic test.
- Performance Studies: The document includes performance studies (Accuracy and Precision) conducted on human plasma samples, further supporting its use as a diagnostic tool.
- Predicate Device: The mention of a predicate device (Stachrom® Heparin) with a K number (K925433) strongly suggests this device is undergoing regulatory review as an IVD, likely through the 510(k) pathway which requires comparison to a legally marketed predicate IVD.
N/A
Intended Use / Indications for Use
MDA™ Heparin anti-X, is achromgenic assay for the quantitative determination of heparin anti-X, activity in human plasma.
Product codes
Not Found
Device Description
Heparin is administered to prevent thrombotic comple, to prevent thrombosis following surgery) and to reduce or prevent the extension of existing thrombi (for example, in treatment of deep venous thrombosis). Heparin acts by binding to antithrombin III (AT-III), a plasma protein that inhibits coagulation enzymes including thrombin and FXa. Inhibition of these enzymes is greatly accelerated when AT-III is bound to heparin.
MDA Heparin anti-FXa measures the ability of heparin to accelerate AT-III inhibition of FXa using a chromogenic substrate. This substrate is a small peptide linked to a chromophore which is specifically cleaved by FXa to produce yellow color. The assay principle is based on the method of Teien and Lee (1,2) and uses a two-step reaction:
-
- Plasma containing heparin is mixed with buffer and AT-III, and incubated with FXa reagent for a fixed period of time. Some of the FXa is inactivated:
FXa + AT-III-Heparin (complex) ----------------------------------------------------------------------------------------------------------------------------------------------residual FXa
- Plasma containing heparin is mixed with buffer and AT-III, and incubated with FXa reagent for a fixed period of time. Some of the FXa is inactivated:
-
- Remaining active FXa cleaves chromogenic substrate to produce yellow color, monitored by measuring absorbance at 405 nm. The amount of color produced is proportional to the amount of FXa remaining and inversely proportional to the amount of heparin in the specimen plasma:
FXa + peptide-pNA -----------------> peptide + p-NO2-aniline (yellow) Reagents included in the assay kit include Buffer Concentrate, FXa reagent, Substrate reagent and AT-III
- Remaining active FXa cleaves chromogenic substrate to produce yellow color, monitored by measuring absorbance at 405 nm. The amount of color produced is proportional to the amount of FXa remaining and inversely proportional to the amount of heparin in the specimen plasma:
reagent.
Until recently, the heparins used for anticoagulant therapy were high-molecular weight (~15,000-30,000 daltons) sulfated polysaccharides that could be monitored using Activated Partial Thromboplastin Time (APTT, PTT) assay, chromogenic assays, or other methods (3). Recently, low molecular weight heparins (Mr
§ 864.7525 Heparin assay.
(a)
Identification. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
MAR 1 8 1997
MDA™ Heparin anti-X。
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and the final rule under 21 CFR 807.92 published December 14, 1994.
The submitter's name, address, telephone number, a contact person, and the date the summary (a) (1) was prepared;
Submitter's Name: Submitter's Address: Submitter's Telephone: Submitter's Contact: Date 510(k) Summmary Prepared:
Organon Teknika Corporation 100 Akzo Avenue, Durham, North Carolina 27712, USA (919) 620-2373 Ron Sanyal, M. Pharm, CQE, RAC Kam December 17, 1996
The name of the device, including the trade or proprietary name if applicable, the common or (a) (2) usual name, and the classification name, if known;
| Trade/Proprietary Name: | MDA™ Heparin anti-X |
|---|---|
| Common/ Usual Name: | Heparin assay |
| Classification Name: | Heparin assay |
An identification of the legally marketed device to which the submitter claims substantial (a) (3) equivalence.
Stachrom® Heparin (K925433) Device Equivalent to:
(a) (4) A description of the device(System)
Description of MDA Heparin anti-Xa
Heparin is administered to prevent thrombotic comple, to prevent thrombosis following surgery) and to reduce or prevent the extension of existing thrombi (for example, in treatment of deep venous thrombosis). Heparin acts by binding to antithrombin III (AT-III), a plasma protein that inhibits coagulation enzymes including thrombin and FXa. Inhibition of these enzymes is greatly accelerated when AT-III is bound to heparin.
MDA Heparin anti-FXa measures the ability of heparin to accelerate AT-III inhibition of FXa using a chromogenic substrate. This substrate is a small peptide linked to a chromophore which is specifically cleaved by FXa to produce yellow color. The assay principle is based on the method of Teien and Lee (1,2) and uses a two-step reaction:
-
- Plasma containing heparin is mixed with buffer and AT-III, and incubated with FXa reagent for a fixed period of time. Some of the FXa is inactivated:
FXa + AT-III-Heparin (complex) ----------------------------------------------------------------------------------------------------------------------------------------------residual FXa
- Plasma containing heparin is mixed with buffer and AT-III, and incubated with FXa reagent for a fixed period of time. Some of the FXa is inactivated:
-
- Remaining active FXa cleaves chromogenic substrate to produce yellow color, monitored by measuring absorbance at 405 nm. The amount of color produced is proportional to the amount of FXa remaining and inversely proportional to the amount of heparin in the specimen plasma:
FXa + peptide-pNA -----------------> peptide + p-NO2-aniline (yellow) Reagents included in the assay kit include Buffer Concentrate, FXa reagent, Substrate reagent and AT-III
- Remaining active FXa cleaves chromogenic substrate to produce yellow color, monitored by measuring absorbance at 405 nm. The amount of color produced is proportional to the amount of FXa remaining and inversely proportional to the amount of heparin in the specimen plasma:
reagent.
Until recently, the heparins used for anticoagulant therapy were high-molecular weight (~15,000-30,000 daltons) sulfated polysaccharides that could be monitored using Activated Partial Thromboplastin Time (APTT, PTT) assay, chromogenic assays, or other methods (3). Recently, low molecular weight heparins (Mr