Assay, Alpha-2-Antiplasmin
An alpha-2-antiplasmin assay is a hematology laboratory test used to measure the activity or concentration of alpha-2-antiplasmin, a key inhibitor of the fibrinolytic system, in patient plasma; it is used to evaluate bleeding disorders and conditions associated with abnormal fibrinolysis. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LGP and is regulated under 21 CFR 864.5425 within the Hematology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- LGP
- Device Class
- FDA class 2
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K864213 | IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY | Nov 25, 1986 | Substantially Equivalent | Instrumentation Laboratory CO |
| K850411 | GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY | May 08, 1985 | Substantially Equivalent | Warner-Lambert Co. |
| K833890 | COATEST ANTIPLASMIN | Jan 30, 1984 | Substantially Equivalent | Kabivitrum, Inc. |
| K803110 | PROTEOLYTIC ENZYME CONTROL | Feb 17, 1981 | Substantially Equivalent | American Dade |
| K802840 | ALPHA-ANTIPLASM ASSAY | Feb 17, 1981 | Substantially Equivalent | American Dade |