FDA product code CDT: Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
CDT is the FDA product code for lipase hydrolysis/glycerol kinase enzyme, triglycerides. It is a Class I device, regulated under 21 CFR 862.1705 and reviewed by the Clinical Chemistry panel. FDA has cleared 151 510(k) submissions under CDT, from 87 different applicants. The average 510(k) review took 62 days (median 45). FDA has posted 20 recalls for CDT devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides |
| Device class | Class I |
| Regulation | 21 CFR 862.1705 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CDT clearance
Top CDT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Em Diagnostic Systems, Inc. | 13 | 1993-08-25 |
| Data Medical Associates, Inc. | 6 | 1997-05-29 |
| Boehringer Mannheim Corp. | 6 | 1987-08-28 |
| Beckman Instruments, Inc. | 4 | 1992-01-28 |
| Trace Scientific , Ltd. | 4 | 1990-10-01 |
82 more applicants have CDT clearances. See the full list in Caduvo.
Most recent CDT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150819 | Randox Laboratories Limited | Triglycerides | 2015-08-06 | 132 |
| K133067 | Siemens Healthcare Diagnostics, Inc. | ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT | 2013-11-22 | 56 |
| K130332 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS TRIG SLIDES | 2013-05-31 | 109 |
| K113830 | Liposcience | VANTERA CLINICAL ANALYZER | 2012-08-30 | 247 |
| K102993 | Seppim S.A.S. | ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL | 2011-05-19 | 223 |
Recalls for CDT devices
20 product recalls in 16 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-01-27.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2021 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code CDT?
CDT is the FDA product code for lipase hydrolysis/glycerol kinase enzyme, triglycerides. It is a Class I device, regulated under 21 CFR 862.1705 and reviewed by the Clinical Chemistry panel.
What device class is CDT?
Class I, regulation 21 CFR 862.1705. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CDT?
Across 151 cleared submissions the average was 62 days from receipt to decision (median 45).
Which companies have the most CDT clearances?
Em Diagnostic Systems, Inc. (13); Data Medical Associates, Inc. (6); Boehringer Mannheim Corp. (6); Beckman Instruments, Inc. (4); Trace Scientific , Ltd. (4).
Have CDT devices been recalled?
Yes: 20 product recalls across 16 recall events; the most recent began 2023-01-27.
Next steps
- Run an FDA pathway report with predicate devices for product code CDT
- Run a recall and safety report across every CDT manufacturer
- Watch product code CDT 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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