Careside Aptt
by Careside Hemotology, Inc. 510(k)
Active
510(k) K014028
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK014028 | Date8 Feb 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GFO
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7925
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Careside APTT Cartridge is a single-use disposable device classified as an Activated Partial Thromboplastin Time (APTT) reagent cartridge. It is designed for in vitro diagnostic use to quantitatively measure activated partial thromboplastin time in citrated whole blood or plasma, aiding in the assessment of coagulation disorders and monitoring anticoagulant therapy.
This cartridge is intended for use exclusively with the Careside Analyzer in a clinical laboratory setting. Supplied as a sterile, single-use device, it requires no additional preparation beyond proper handling and insertion into the analyzer. The device holds an FDA 510(k) clearance (K014028) under product code GFO, adhering to regulatory standards for hematology diagnostics. Storage and handling must comply with manufacturer guidelines to maintain accuracy and sterility.
Questions
AI-generated answers, 18 Sep 2026
What clinical applications does the Careside APTT Cartridge support in a lab setting?
The Careside APTT Cartridge is designed for measuring activated partial thromboplastin time (APTT) in citrated whole blood or plasma, which helps clinicians assess coagulation disorders and monitor anticoagulant therapy. Since it is intended exclusively for use with the Careside Analyzer in a clinical laboratory, it aids in diagnosing bleeding risks, evaluating inherited clotting deficiencies, and tracking patients on treatments like heparin.
Is the Careside APTT Cartridge reusable or single-use, and how should it be handled?
The cartridge is explicitly labeled as a single-use disposable device, meaning it cannot be reused after one test. Proper handling involves ensuring sterility is maintained—no additional preparation is required beyond carefully inserting it into the Careside Analyzer. Discard it after use to avoid contamination or inaccurate results.
What storage requirements must be followed to preserve the cartridge’s sterility and performance?
While the exact storage conditions aren’t detailed here, the manufacturer’s guidelines (referenced in the device description) must be followed to maintain sterility and accuracy. Typically, this would include storing the cartridges in a clean, dry environment away from direct light or extreme temperatures until use. Always check the packaging for expiration dates or specific storage instructions.
How does the regulatory pathway for this device differ from other hematology diagnostics?
The Careside APTT Cartridge holds an FDA 510(k) clearance (K014028) under product code GFO, classified as substantially equivalent to a predicate device. This means it underwent a traditional review by the FDA’s Hematology (HE) advisory committee, demonstrating safety and effectiveness for its intended use—quantitative APTT measurement—without requiring a full premarket approval process. The clearance reflects compliance with FDA standards for in vitro diagnostics.