Amikacin Serum Assay
The Amikacin Serum Assay is an in vitro diagnostic device used in clinical toxicology laboratories to measure amikacin drug levels in patient serum samples, enabling therapeutic drug monitoring to maintain effective and safe concentrations of this aminoglycoside antibiotic during treatment. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KLP and it is regulated under 21 CFR 862.3035 in the Clinical Toxicology specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- KLP
- Device Class
- FDA class 2
- Regulation Number
- 862.3035
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K032279 | ONLINE TDM AMIKA | Oct 10, 2003 | Substantially Equivalent | Roche Diagnostics Corp. |
| K873426 | EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 | Oct 29, 1987 | Substantially Equivalent | Em Diagnostic Systems, Inc. |
| K790899 | BACTEC | May 23, 1979 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K780949 | BIO-MONITOR AMIKACIN | Aug 14, 1978 | Substantially Equivalent | Monitor Science Corp. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.