FDA product code LDP: Colorimetry, Acetaminophen
LDP is the FDA product code for colorimetry, acetaminophen. It is a Class II device, regulated under 21 CFR 862.3030 and reviewed by the Clinical Toxicology panel. FDA has cleared 37 510(k) submissions under LDP, 2 in the last five years, from 27 different applicants. The average 510(k) review took 96 days (median 57); 88 days on average over the last three years. FDA has posted 12 recalls for LDP devices.
Classification
| Field | Value |
|---|---|
| Device name | Colorimetry, Acetaminophen |
| Device class | Class II |
| Regulation | 21 CFR 862.3030 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LDP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 315 |
| 2022 | 1 | 525 |
| 2026 | 1 | 88 |
Compare with all 510(k) review times · Search every LDP clearance
Top LDP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Chemicals , Ltd. | 4 | 2005-01-07 |
| Sekisui Diagnostics P.E.I., Inc. | 2 | 2022-02-18 |
| Dade Behring, Inc. | 2 | 2006-07-10 |
| Roche Diagnostics Corp. | 2 | 2002-01-08 |
| Beckman Coulter, Inc. | 2 | 2001-06-08 |
22 more applicants have LDP clearances. See the full list in Caduvo.
Most recent LDP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261364 | Siemens Healthcare Diagnostics, Inc. | Atellica CH Acetaminophen 2 (ACTM) | 2026-07-24 | 88 |
| K202644 | Sekisui Diagnostics P.E.I., Inc. | Acetaminophen | 2022-02-18 | 525 |
| K180835 | Sekisui Diagnostics P.E.I., Inc. | SEKURE Acetaminophen L3K Assay | 2019-02-08 | 315 |
| K110726 | Roche Diagnostics | ROCHE ACETAMINOPHEN ASSAY | 2011-12-23 | 282 |
| K100200 | Siemens Healthcare Diagnostics | ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 | 2010-08-02 | 189 |
Recalls for LDP devices
12 product recalls in 11 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-01-02.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
Frequently asked questions
What is FDA product code LDP?
LDP is the FDA product code for colorimetry, acetaminophen. It is a Class II device, regulated under 21 CFR 862.3030 and reviewed by the Clinical Toxicology panel.
What device class is LDP?
Class II, regulation 21 CFR 862.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code LDP?
Across 37 cleared submissions the average was 96 days from receipt to decision (median 57).
Which companies have the most LDP clearances?
Diagnostic Chemicals , Ltd. (4); Sekisui Diagnostics P.E.I., Inc. (2); Dade Behring, Inc. (2); Roche Diagnostics Corp. (2); Beckman Coulter, Inc. (2).
Have LDP devices been recalled?
Yes: 12 product recalls across 11 recall events; the most recent began 2018-01-02.
Next steps
- Run an FDA pathway report with predicate devices for product code LDP
- Run a recall and safety report across every LDP manufacturer
- Watch product code LDP 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.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times