FDA product code DKC: Alcohol Control Materials
DKC is the FDA product code for alcohol control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel. FDA has cleared 11 510(k) submissions under DKC, from 8 different applicants. The average 510(k) review took 52 days (median 47). FDA has posted 5 recalls for DKC devices.
Classification
| Field | Value |
|---|---|
| Device name | Alcohol Control Materials |
| Device class | Class I |
| Regulation | 21 CFR 862.3280 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DKC clearance
Top DKC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sigma Diagnostics, Inc. | 2 | 1993-11-16 |
| Cala Diagnostics | 2 | 1991-08-12 |
| Syva Co. | 2 | 1981-03-06 |
| Medical Analysis Systems, Inc. | 1 | 2003-07-01 |
| Columbia Diagnostics, Inc. | 1 | 1994-03-22 |
3 more applicants have DKC clearances. See the full list in Caduvo.
Most recent DKC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K031392 | Medical Analysis Systems, Inc. | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL | 2003-07-01 | 60 |
| K935819 | Columbia Diagnostics, Inc. | QUALITY CONTROL MATERIAL (ASSAYED) | 1994-03-22 | 109 |
| K933425 | Sigma Diagnostics, Inc. | AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 | 1993-11-16 | 126 |
| K934467 | Beckman-Diagnostic Systems Group | BECKMAN CX AMMONIA/ALCOHOL CONTROL | 1993-10-27 | 47 |
| K932067 | Sigma Diagnostics, Inc. | ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III | 1993-06-16 | 48 |
Recalls for DKC devices
5 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-08-18.
| Year | Recalls |
|---|---|
| 2020 | 5 |
Frequently asked questions
What is FDA product code DKC?
DKC is the FDA product code for alcohol control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel.
What device class is DKC?
Class I, regulation 21 CFR 862.3280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DKC?
Across 11 cleared submissions the average was 52 days from receipt to decision (median 47).
Which companies have the most DKC clearances?
Sigma Diagnostics, Inc. (2); Cala Diagnostics (2); Syva Co. (2); Medical Analysis Systems, Inc. (1); Columbia Diagnostics, Inc. (1).
Have DKC devices been recalled?
Yes: 5 product recalls across 1 recall events; the most recent began 2020-08-18.
Next steps
- Run an FDA pathway report with predicate devices for product code DKC
- Run a recall and safety report across every DKC manufacturer
- Watch product code DKC 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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