Statspin Mini-Plasma
510(k) K893613
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK893613 | Date28 Aug 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JKA
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1675
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Statspin Mini-Plasma is a centrifugal separator classified as a centrifuge for plasma separation under the FDA product code JKA. It is designed to isolate plasma from whole blood or other biological samples through high-speed centrifugation, facilitating laboratory analysis in clinical chemistry applications. The device leverages centrifugal force to separate plasma from cellular components, enabling precise sample preparation for diagnostic testing. Its compact design is optimized for use in clinical or research settings where efficient plasma separation is required.
This device is supplied as a reusable instrument intended for use in clinical chemistry laboratories. It operates under standard laboratory conditions and is not intended for MRI environments. The Statspin Mini-Plasma received FDA 510(k) clearance under the Traditional pathway, with a decision date of August 28, 1989, and is categorized under the Clinical Chemistry advisory committee. No specific sterility or single-use designation is noted in the regulatory data, though standard laboratory hygiene practices should be followed during operation.
Other devices from Statspin Technologies
Questions
AI-generated answers, 20 Sep 2026
What clinical applications is the Statspin Mini-Plasma intended for in a laboratory setting?
The Statspin Mini-Plasma is designed for clinical chemistry applications where precise plasma separation from whole blood or biological samples is required. It facilitates sample preparation for diagnostic testing by isolating plasma through high-speed centrifugation, making it useful in clinical or research environments where accurate plasma analysis is essential.
Is the Statspin Mini-Plasma a single-use or reusable device, and how should it be maintained?
The Statspin Mini-Plasma is supplied as a reusable instrument. While no explicit sterility designation is noted in the regulatory data, standard laboratory hygiene practices—such as cleaning and disinfection between uses—should be followed to ensure proper maintenance and prevent contamination.
What regulatory pathway was followed for the FDA clearance of the Statspin Mini-Plasma, and when was it approved?
The Statspin Mini-Plasma received FDA 510(k) clearance under the Traditional pathway, with a decision date of August 28, 1989. The device was determined to be substantially equivalent to a legally marketed predicate under the Clinical Chemistry advisory committee (CH).
Can the Statspin Mini-Plasma be used in environments with MRI equipment, and what are its operational conditions?
The Statspin Mini-Plasma is not intended for use in MRI environments. It operates under standard laboratory conditions, meaning it is designed for typical clinical or research lab settings where high-speed centrifugation for plasma separation is required.
What product code and advisory committee category does the Statspin Mini-Plasma fall under in the FDA registry?
The Statspin Mini-Plasma is classified under FDA product code JKA, which corresponds to centrifuges for plasma separation. Its regulatory submission was reviewed by the Clinical Chemistry (CH) advisory committee during the 510(k) clearance process.