FDA product code IDC: Acridine Orange
IDC is the FDA product code for acridine orange. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel. FDA has cleared 4 510(k) submissions under IDC, from 4 different applicants. The average 510(k) review took 30 days (median 30).
Classification
| Field | Value |
|---|---|
| Device name | Acridine Orange |
| Device class | Class I |
| Regulation | 21 CFR 864.1850 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IDC clearance
Top IDC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Advanced Medical Technology, Inc. | 1 | 1985-08-13 |
| Carr-Scarborough Microbiologicals, Inc. | 1 | 1981-09-01 |
| Remel Co. | 1 | 1981-02-12 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1981-02-12 |
Most recent IDC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K853187 | Advanced Medical Technology, Inc. | ACRIDINE ORANGE FLUORESCENT STAIN | 1985-08-13 | 14 |
| K812212 | Carr-Scarborough Microbiologicals, Inc. | ACRIDINE ORANGE STAIN | 1981-09-01 | 27 |
| K803304 | Remel Co. | ACRIDINE ORANGE STAIN | 1981-02-12 | 44 |
| K810040 | Bd Becton Dickinson Vacutainer Systems Preanalytic | ACRIDINE ORANGE STAIN | 1981-02-12 | 34 |
Recalls for IDC devices
openFDA lists no recalls for product code IDC.
Frequently asked questions
What is FDA product code IDC?
IDC is the FDA product code for acridine orange. It is a Class I device, regulated under 21 CFR 864.1850 and reviewed by the Pathology panel.
What device class is IDC?
Class I, regulation 21 CFR 864.1850. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IDC?
Across 4 cleared submissions the average was 30 days from receipt to decision (median 30).
Which companies have the most IDC clearances?
Advanced Medical Technology, Inc. (1); Carr-Scarborough Microbiologicals, Inc. (1); Remel Co. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IDC
- Run a recall and safety report across every IDC manufacturer
- Watch product code IDC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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