Sac-Cel
by Burroughs Wellcome Co. 510(k)
Active
510(k) K813508
Overview
The SAC-CEL is a Second Antibody (Species Specific Anti-Animal Gamma Globulin), classified under product code KTS and device class 2. This device is designed for immunology applications, specifically as a reagent to detect or neutralize animal-derived antibodies in biological samples, aiding in serological testing and diagnostic procedures. It functions by binding to animal gamma globulins, facilitating the identification of immune responses or cross-reactivity in assays.
SAC-CEL is supplied as a sterile reagent intended for single-use in laboratory settings. The device is regulated under FDA 510(k) clearance (K813508) and falls under the Second Antibody (Species Specific Anti-Animal Gamma Globulin) nomenclature, with no specified MRI safety or reusable components. Storage and handling must comply with standard laboratory protocols for reagents, ensuring sterility and stability until use. No additional regulatory approvals beyond the 1981 FDA clearance are referenced in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK813508 | Date29 Dec 1981 | 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- Withdrawn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
- KTS
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5510
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Burroughs Wellcome Co.
Questions
What is the SAC-CEL reagent used for in laboratory testing?
The SAC-CEL is designed as a second antibody reagent to detect or neutralize animal-derived gamma globulins in biological samples. It binds specifically to these antibodies, helping clinicians identify immune responses or cross-reactivity during serological testing, such as in allergy or autoimmune diagnostics.
How is the SAC-CEL supplied and intended for use?
SAC-CEL is supplied as a sterile reagent intended exclusively for single-use in controlled laboratory environments. Its sterile formulation ensures reliability in diagnostic assays, and it must be handled according to standard laboratory protocols to maintain sterility and stability until use.
Is the SAC-CEL reusable or does it require disposal after use?
The SAC-CEL is explicitly intended for single-use only. Reuse is not recommended or supported, as it could compromise sterility, accuracy, or the reagent’s ability to bind animal antibodies effectively in subsequent tests.
What storage conditions should be followed for SAC-CEL?
While specific storage temperatures or durations aren’t detailed, SAC-CEL must be stored and handled in accordance with standard laboratory practices for reagents. This includes protecting it from contamination, extreme temperatures, and light exposure to preserve its sterility and functional integrity until use.
What regulatory pathway does the SAC-CEL follow?
The SAC-CEL received FDA 510(k) clearance under the classification of Second Antibody (Species Specific Anti-Animal Gamma Globulin), categorized under product code KTS and device class 2. The clearance (K813508) was granted in 1981 by the Immunology (IM) advisory committee, confirming its compliance with U.S. regulatory standards for immunology reagents.