Simplastin Excel
by Organon Teknika Corp. 510(k)
Active
510(k) K864283
Overview
The Simplastin Excel is a Test, Time, Prothrombin device classified under FDA regulation 864.7750, designed for use in hematology. It is intended for measuring prothrombin time (PT) in blood samples, a critical test for assessing coagulation function and monitoring anticoagulant therapy. The device operates by quantifying the time required for blood to clot in the presence of thromboplastin, providing clinical insights into bleeding risks or therapeutic efficacy of anticoagulants.
This device is supplied as a single-use reagent kit and requires no sterilization beyond manufacturer-provided packaging. It is intended for use in clinical laboratories and healthcare settings equipped for coagulation testing. The Simplastin Excel is classified as a Class II medical device under FDA regulations, with clearance granted through a 510(k) submission (K864283) as substantially equivalent to a predicate device. Storage conditions and expiration dates are specified on the packaging, and compliance with FDA guidelines ensures its regulatory standing.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864283 | Date4 Dec 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0629-03
Product is being recalled due to vial to vial variability of clotting time results.
Specification
- 510(k) Number
- FDA Product Code
- GJS
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7750
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Organon Teknika Corp.
Questions
What is the Simplastin Excel used for?
The Simplastin Excel is a single-use reagent kit designed specifically for measuring prothrombin time (PT) in blood samples. PT testing is critical for evaluating coagulation function and monitoring the effectiveness of anticoagulant therapy, such as warfarin. By quantifying the time it takes for blood to clot in the presence of thromboplastin, clinicians can assess bleeding risks or therapeutic efficacy.
How is the Simplastin Excel supplied and does it require sterilization?
The Simplastin Excel is supplied as a single-use reagent kit, meaning each unit is intended for one-time use only. The manufacturer-provided packaging ensures sterility, so no additional sterilization is required before use. This design minimizes contamination risks and ensures consistent performance for accurate PT measurements.
Is the Simplastin Excel intended for reuse or single-use?
The Simplastin Excel is explicitly designed for single-use only. This approach aligns with best practices in hematology testing to prevent cross-contamination, maintain accuracy, and ensure patient safety. Reusing the kit could compromise test reliability and introduce errors in coagulation assessment.
What storage conditions should be followed for the Simplastin Excel?
Storage conditions for the Simplastin Excel are detailed on the packaging, which must be followed to preserve the reagent’s integrity. Typically, such kits require protection from extreme temperatures, light exposure, and moisture. Always check the expiration date on the packaging and store the device in its original, sealed container until use to maintain accuracy and compliance with manufacturer guidelines.
What regulatory pathway was followed for the Simplastin Excel?
The Simplastin Excel was cleared through the FDA’s 510(k) pathway, specifically under the classification of Test, Time, Prothrombin (product code GJS). The device was determined to be substantially equivalent to a predicate device and received clearance with the 510(k) number K864283. This regulatory route ensures the device meets FDA standards for safety and effectiveness in measuring prothrombin time.