FDA product code LCO: Platelet Factor 4 Radioimmunoassay
LCO is the FDA product code for platelet factor 4 radioimmunoassay. It is a Class II device, regulated under 21 CFR 864.7695 and reviewed by the Hematology panel. FDA has cleared 13 510(k) submissions under LCO, 1 in the last five years, from 9 different applicants. The average 510(k) review took 109 days (median 92); 90 days on average over the last three years. FDA has posted 11 recalls for LCO devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Platelet Factor 4 Radioimmunoassay |
| Device class | Class II |
| Regulation | 21 CFR 864.7695 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LCO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 170 |
| 2020 | 2 | 62 |
| 2025 | 1 | 90 |
Compare with all 510(k) review times · Search every LCO clearance
Top LCO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Genetic Testing Institute | 3 | 2007-12-19 |
| Immucor Gti Diagnostics, Inc. | 2 | 2020-09-11 |
| Instrumentation Laboratory CO | 2 | 2017-09-08 |
| Instrumentation Laboratory (IL) Co. | 1 | 2025-01-28 |
| Hyphen Biomed | 1 | 2007-09-07 |
4 more applicants have LCO clearances. See the full list in Caduvo.
Most recent LCO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243374 | Instrumentation Laboratory (IL) Co. | HemosIL CL HIT-IgG(PF4-H) | 2025-01-28 | 90 |
| K201570 | Immucor Gti Diagnostics, Inc. | PF4 Enhanced assay | 2020-09-11 | 92 |
| K201311 | Immucor Gti Diagnostics, Inc. | PF4 IgG assay | 2020-06-18 | 31 |
| K170854 | Instrumentation Laboratory CO | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls | 2017-09-08 | 170 |
| K153137 | Instrumentation Laboratory CO | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls | 2016-07-08 | 252 |
Recalls for LCO devices
11 product recalls in 7 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-04-01.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2019 | 2 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LCO?
LCO is the FDA product code for platelet factor 4 radioimmunoassay. It is a Class II device, regulated under 21 CFR 864.7695 and reviewed by the Hematology panel.
What device class is LCO?
Class II, regulation 21 CFR 864.7695. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCO?
Across 13 cleared submissions the average was 109 days from receipt to decision (median 92).
Which companies have the most LCO clearances?
Genetic Testing Institute (3); Immucor Gti Diagnostics, Inc. (2); Instrumentation Laboratory CO (2); Instrumentation Laboratory (IL) Co. (1); Hyphen Biomed (1).
Have LCO devices been recalled?
Yes: 11 product recalls across 7 recall events; the most recent began 2026-04-01.
Next steps
- Run an FDA pathway report with predicate devices for product code LCO
- Run a recall and safety report across every LCO manufacturer
- Watch product code LCO 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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