MSI-PC Platelet Control Device
by Medical Specialties, Inc. 510(k)
Active
510(k) K880608
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK880608 | Date21 Mar 1988 | 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- Withdrawn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
- Full name
- Msi-Pc
- 510(k) Number
- FDA Product Code
- GJP
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.8625
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The MSI-PC Platelet Control Device is a Control, Platelet device classified under FDA regulation 864.8625, designed for use in hematology. It functions as a specialized instrument for managing platelet samples, ensuring precise control during laboratory procedures. This device is intended for in vitro diagnostic applications, adhering to strict regulatory standards for blood component handling.
This device is supplied as a single-use or reusable instrument, depending on manufacturer guidelines, and is intended for use in clinical or laboratory settings. It is not explicitly stated to be MRI-safe, and sterility requirements are not detailed in the provided data. The device is authorized under an FDA 510(k) clearance (K880608) and falls under the Hematology advisory committee classification. No additional storage or handling specifications are provided beyond standard laboratory protocols.
Other devices from Medical Specialties, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the MSI-PC Platelet Control Device used for?
The MSI-PC Platelet Control Device is designed specifically for hematology applications to manage platelet samples with precision during in vitro diagnostic procedures. It helps maintain accurate control over platelet counts and quality, ensuring reliable test results in clinical or laboratory settings.
Is the MSI-PC Platelet Control Device single-use or reusable?
The MSI-PC Platelet Control Device can be used either as a single-use or reusable instrument, depending on the manufacturer’s guidelines. This flexibility allows laboratories to choose the most suitable option based on their workflow, sterility protocols, and cost considerations.
What regulatory approval does the MSI-PC Platelet Control Device hold?
The MSI-PC Platelet Control Device holds FDA 510(k) clearance under the reference number K880608. This clearance confirms its substantial equivalence to a predicate device and compliance with FDA regulations for in vitro diagnostic use in hematology.
Does the MSI-PC Platelet Control Device require any special storage conditions?
The provided data does not specify any special storage requirements beyond standard laboratory protocols. Laboratories should follow general guidelines for maintaining cleanliness, temperature control, and protection from contamination to ensure optimal performance.
What classification does the MSI-PC Platelet Control Device fall under in the FDA’s regulatory system?
The MSI-PC Platelet Control Device is classified under FDA regulation 864.8625 as a Control, Platelet device. It was reviewed by the Hematology Advisory Committee (HE) and falls under the product code GJP, indicating its specific role in hematological diagnostics.