FDA product code GKL: Counter, Cell, Automated (Particle Counter)
GKL is the FDA product code for counter, cell, automated (particle counter). It is a Class II device, regulated under 21 CFR 864.5200 and reviewed by the Hematology panel. FDA has cleared 130 510(k) submissions under GKL, from 48 different applicants. The average 510(k) review took 84 days (median 71). FDA has posted 10 recalls for GKL devices.
Classification
| Field | Value |
|---|---|
| Device name | Counter, Cell, Automated (Particle Counter) |
| Device class | Class II |
| Regulation | 21 CFR 864.5200 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top GKL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Coulter Electronics, Inc. | 17 | 1989-02-22 |
| Toa Medical Electronics USA, Inc. | 15 | 1991-09-10 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 11 | 1992-09-22 |
| Technicon Instruments Corp. | 8 | 1987-08-28 |
| Abbott Diagnostics | 7 | 1985-03-26 |
43 more applicants have GKL clearances. See the full list in Caduvo.
Most recent GKL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K152776 | Advanced Instruments, Inc. | Glocyte Automated Cell Counter System | 2016-05-27 | 245 |
| K091539 | Iris Diagnostics | IQ 200 URINE ANALIZER BODY FLUIDS MODULE | 2010-08-31 | 462 |
| K071652 | Hemocue AB | HEMOCUE WBC SYSTEM | 2007-10-25 | 129 |
| K051693 | Bayer Healthcare, LLC | MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM | 2005-12-07 | 167 |
| K050235 | Iris International, Inc. | IQ 200 URINE ANALYZER BODY FLUIDS MODULE | 2005-03-23 | 50 |
Recalls for GKL devices
10 product recalls in 8 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-02-07.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code GKL?
GKL is the FDA product code for counter, cell, automated (particle counter). It is a Class II device, regulated under 21 CFR 864.5200 and reviewed by the Hematology panel.
What device class is GKL?
Class II, regulation 21 CFR 864.5200. Typical premarket route: 510(k).
How long does a 510(k) take for product code GKL?
Across 130 cleared submissions the average was 84 days from receipt to decision (median 71).
Which companies have the most GKL clearances?
Coulter Electronics, Inc. (17); Toa Medical Electronics USA, Inc. (15); Bd Becton Dickinson Vacutainer Systems Preanalytic (11); Technicon Instruments Corp. (8); Abbott Diagnostics (7).
Have GKL devices been recalled?
Yes: 10 product recalls across 8 recall events; the most recent began 2018-02-07.
Next steps
- Run an FDA pathway report with predicate devices for product code GKL
- Run a recall and safety report across every GKL manufacturer
- Watch product code GKL 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.