Freeze Dried Papain
by Biological Corp. of America
510(k) K810803
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810803 | Date21 Jul 1981 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KSK
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.9400
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
Freeze Dried Papain is a stabilized enzyme solution classified as a solution under FDA product code KSK. It is a proteolytic enzyme derived from papaya, primarily used in hematology for its ability to lyse red blood cells and facilitate blood sample processing. This enzyme aids in the preparation of blood smears and other hematological assays by breaking down cellular components, ensuring accurate diagnostic testing. Its classification aligns with FDA regulation 864.9400, which governs stabilized enzyme solutions intended for in vitro diagnostic use.
The device is supplied as a single-use, sterile freeze-dried powder intended for reconstitution with a compatible diluent prior to use. It is regulated under FDA 510(k) clearance (K810803) and falls under Class II medical devices, indicating a moderate risk level requiring special controls to ensure safety and effectiveness. Storage requires protection from moisture and extreme temperatures, as specified in the manufacturer’s instructions. No MRI safety information is provided, and the device is not intended for direct patient administration but rather for laboratory use in hematological diagnostics.
Other devices from Bca Biological Corp. of America
Questions
AI-generated answers, 1 Oct 2026
What is Freeze Dried Papain used for in hematology?
Freeze Dried Papain is a proteolytic enzyme derived from papaya, specifically designed to lyse (break down) red blood cells. This process facilitates the preparation of blood smears and other hematological assays by clearing cellular debris, ensuring precise and reliable diagnostic results in laboratory settings.
How is Freeze Dried Papain supplied and prepared for use?
The device is supplied as a single-use, sterile freeze-dried powder. Prior to use, it must be reconstituted with a compatible diluent as instructed by the manufacturer. This ensures proper enzyme activity for hematological applications.
Is Freeze Dried Papain sterile and intended for single-use?
Yes, Freeze Dried Papain is supplied in a sterile, single-use format to prevent contamination and ensure consistent performance. Each vial is designed for one-time use only, reducing the risk of cross-contamination in laboratory environments.
What storage conditions are required for Freeze Dried Papain?
To maintain stability and efficacy, Freeze Dried Papain must be stored protected from moisture and extreme temperatures. Adhering to these conditions prevents degradation of the enzyme and ensures reliable performance when reconstituted for use.
Is Freeze Dried Papain intended for direct patient administration?
No, Freeze Dried Papain is strictly for laboratory use in hematological diagnostics. It is not intended for direct administration to patients and should only be used in controlled clinical or diagnostic settings to process blood samples.