Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
The Radioimmunoassay for Gentamicin (125-I) using Second Antibody Separation is a quantitative laboratory test that uses iodine-125-labeled gentamicin and a second antibody precipitation method to measure gentamicin concentrations in patient serum, supporting therapeutic drug monitoring of this aminoglycoside antibiotic. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3450 within the Clinical Toxicology specialty. The device qualifies for third-party 510(k) review.
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Basic Information
- Product Code
- DJB
- Device Class
- FDA class 2
- Regulation Number
- 862.3450
- 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 19 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K832792 | AMES TDA SISOMICIN TEST-CONTROL SERUM | Sep 29, 1983 | Substantially Equivalent | Miles Laboratories, Inc. |
| K831210 | GENTAMICIN TEST PACK-ACA | May 25, 1983 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K821669 | AMES TDA GENTAMICIN TEST | Dec 15, 1982 | Substantially Equivalent | Miles Laboratories, Inc. |
| K812394 | MRI GENTAMICIN RIA KIT | Sep 08, 1981 | Substantially Equivalent | Microanalytic Research, Inc. |
| K811844 | COAT-A-COUNT GENTAMICIN RIA KIT | Jul 10, 1981 | Substantially Equivalent | Diagnostic Products Corp. |
| K800537 | GAMMA STICK GENTAMICIN RIA KIT | Apr 24, 1980 | Substantially Equivalent | Alpha Gamma Laboratory |
| K791770 | QUANTIMUNE GENTAMICIN RIA GENTAMICIN | Oct 17, 1979 | Substantially Equivalent | Bio-Rad |
| K791547 | FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY | Oct 12, 1979 | Substantially Equivalent | Bio-Rad |
| K782049 | BIOASSAY SYSTEM, MS-2 SERUM | Aug 28, 1979 | Substantially Equivalent | Abbott Laboratories |
| K790584 | AMES TDA/GENTGMICIN | Jun 15, 1979 | Substantially Equivalent | Miles Laboratories, Inc. |
| K790829 | EMIT GENTAMICIN ASSAY | May 15, 1979 | Substantially Equivalent | Syva Co. |
| K782126 | RIA KIT, SISOMICIN | Feb 15, 1979 | Substantially Equivalent | Diagnostic Products Corp. |
| K781674 | MACRO-VUE TEST, GENTAMICIN | Nov 15, 1978 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K780516 | GENTAMICIN RIA KIT | Apr 28, 1978 | Substantially Equivalent | Antibodies, Inc. |
| K772116 | AMINOGLYCOSIDE TEST SYSTEM | Apr 28, 1978 | Substantially Equivalent | Nichols Institute Diagnostics |
| K780323 | QUANTITOPE 125-I GENTAMICIN RIA KIT | Mar 17, 1978 | Substantially Equivalent | Kallestad Laboratories, Inc. |
| K772425 | RIANEN GENTAMICIN RIA KIT | Jan 05, 1978 | Substantially Equivalent | New England Nuclear |
| K761157 | AMINOGLYCOSIDE (125I) RIA KIT | Mar 01, 1977 | Substantially Equivalent | Diagnostic Products Corp. |
| K760068 | KIT, RIA, GENTAMICIN SULF. | Jul 20, 1976 | Substantially Equivalent | New England Nuclear |