FDA product code DKB: Calibrators, Drug Mixture
DKB is the FDA product code for calibrators, drug mixture. It is a Class II device, regulated under 21 CFR 862.3200 and reviewed by the Clinical Toxicology panel. FDA has cleared 94 510(k) submissions under DKB, from 33 different applicants. The average 510(k) review took 74 days (median 51). FDA has posted 9 recalls for DKB devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Calibrators, Drug Mixture |
| Device class | Class II |
| Regulation | 21 CFR 862.3200 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DKB clearance
Top DKB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 21 | 1999-12-21 |
| Roche Diagnostic Systems, Inc. | 10 | 1994-10-04 |
| Diagnostic Reagents, Inc. | 6 | 1998-11-05 |
| Microgenics Corp. | 5 | 2011-04-08 |
| Dade Behring, Inc. | 5 | 2006-09-14 |
28 more applicants have DKB clearances. See the full list in Caduvo.
Most recent DKB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K141928 | Roche Diagnostics Operations (Rdo) | COBAS C ACETAMINOPHEN GEN.2 ASSAY, ACET2 CALIBRATOR | 2014-11-25 | 132 |
| K133710 | Lin-Zhi International, Inc. | LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS | 2014-02-21 | 79 |
| K120936 | Microgenics Corporation | ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS | 2012-12-13 | 260 |
| K092266 | Randox Laboratories, Ltd. | RANDOX METHAMPHETAMINE ASSAY | 2011-05-09 | 650 |
| K101752 | Microgenics Corp. | THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS | 2011-04-08 | 290 |
Recalls for DKB devices
9 product recalls in 8 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2022-10-13.
| Year | Recalls |
|---|---|
| 2022 | 2 |
Frequently asked questions
What is FDA product code DKB?
DKB is the FDA product code for calibrators, drug mixture. It is a Class II device, regulated under 21 CFR 862.3200 and reviewed by the Clinical Toxicology panel.
What device class is DKB?
Class II, regulation 21 CFR 862.3200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DKB?
Across 94 cleared submissions the average was 74 days from receipt to decision (median 51).
Which companies have the most DKB clearances?
Syva Co. (21); Roche Diagnostic Systems, Inc. (10); Diagnostic Reagents, Inc. (6); Microgenics Corp. (5); Dade Behring, Inc. (5).
Have DKB devices been recalled?
Yes: 9 product recalls across 8 recall events; the most recent began 2022-10-13.
Next steps
- Run an FDA pathway report with predicate devices for product code DKB
- Run a recall and safety report across every DKB manufacturer
- Watch product code DKB 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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