Radioimmunoassay, Kanamycin
Radioimmunoassay, Kanamycin is an in vitro diagnostic device that uses radioisotope-labeled antibodies to quantify kanamycin antibiotic concentrations in patient serum or plasma, enabling therapeutic drug monitoring to ensure effective dosing while minimizing the risk of nephrotoxic and ototoxic adverse effects. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KJI, regulated under 21 CFR 862.3520, within the Clinical Toxicology medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- KJI
- Device Class
- FDA class 2
- Regulation Number
- 862.3520
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K832769 | AMES TDA KANAMYCIN TEST-CONTROL SERUM | Sep 29, 1983 | Substantially Equivalent | Miles Laboratories, Inc. |
| K823370 | ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY | Dec 03, 1982 | Substantially Equivalent | Syva Co. |
| K823062 | KENAMYCIN FLUORESCENT IMMUNOASSAY FIA | Nov 10, 1982 | Substantially Equivalent | American Diagnostic Corp. |
| K822808 | TDX KENAMYCIN | Oct 08, 1982 | Substantially Equivalent | Abbott Laboratories |
| K782125 | RIA KIT, KANAMYCIN | Jan 10, 1979 | Substantially Equivalent | Diagnostic Products Corp. |
| K772038 | KANAMYCIN RIA | Jan 12, 1978 | Substantially Equivalent | Monitor Science Corp. |