AllGrad 45 and 90 Cell Separation Media
by <Genx> Intl., Inc. 510(k)
Active
510(k) K022330
Overview
The AllGrad 45 and 90 Cell Separation Media is a density gradient solution designed for cell separation procedures. Classified under reproductive media, it facilitates the isolation of cells based on their density, commonly used in laboratory settings for assisted reproduction techniques. This device leverages a two-tiered density gradient (45% and 90%) to enable precise separation of cellular components, such as sperm or embryos, from biological samples.
Supplied as a sterile, single-use solution, the media is intended for use in clinical laboratories and reproductive medicine settings. It adheres to FDA regulatory standards, having received a 510(k) clearance under the classification of Media, Reproductive (product code MQL). Storage and handling must comply with standard sterile medical device protocols to maintain integrity. The device is authorized under regulation 884.6180 and is reviewed by the Obstetrics/Gynecology advisory committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK022330 | Date26 Aug 2002 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MQL
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.6180
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from <Genx> Intl., Inc.
Questions
What is the AllGrad 45 and 90 Cell Separation Media used for?
This media is designed for cell separation procedures in laboratory settings, particularly within reproductive medicine. It uses a two-tiered density gradient (45% and 90%) to isolate cells based on their density, commonly applied to separate sperm or embryos from biological samples during assisted reproduction techniques. The precise separation enables clinicians to isolate specific cell types for further analysis or treatment.
How is the AllGrad 45 and 90 Cell Separation Media supplied, and is it sterile?
The AllGrad 45 and 90 Cell Separation Media is supplied as a sterile, single-use solution. This ensures safety and consistency for clinical use, as it eliminates the risk of cross-contamination between patients or samples. Single-use also simplifies storage and handling, as each unit is intended for one procedure only.
Is this media reusable, or is it intended for single-use only?
The AllGrad 45 and 90 Cell Separation Media is explicitly designed for single-use only. This is a standard practice for sterile medical devices to prevent contamination and ensure patient safety. Reusing sterile medical devices can introduce risks of infection or compromise the integrity of the separation process, which is why single-use is recommended.
What storage and handling requirements apply to this media?
Since the AllGrad 45 and 90 Cell Separation Media is sterile and single-use, it must be stored and handled according to standard sterile medical device protocols. This includes maintaining the packaging integrity until use, storing in a clean, dry environment away from direct sunlight or extreme temperatures, and following manufacturer guidelines to prevent contamination. Proper storage ensures the media retains its efficacy for precise cell separation.
What regulatory approval does this device hold, and how was it reviewed?
The AllGrad 45 and 90 Cell Separation Media has received FDA 510(k) clearance under the classification of Media, Reproductive (product code MQL). The device was reviewed by the Obstetrics/Gynecology advisory committee and determined to be substantially equivalent to a predicate device. This regulatory pathway ensures that the media meets established safety and performance standards for use in reproductive medicine procedures.