FDA product code LKQ: Antibody Igm,If, Cytomegalovirus Virus
LKQ is the FDA product code for antibody igm,if, cytomegalovirus virus. It is a Class II device, regulated under 21 CFR 866.3175 and reviewed by the Microbiology panel. FDA has cleared 18 510(k) submissions under LKQ, from 16 different applicants. The average 510(k) review took 147 days (median 106). FDA has posted 8 recalls for LKQ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Antibody Igm,If, Cytomegalovirus Virus |
| Device class | Class II |
| Regulation | 21 CFR 866.3175 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LKQ clearance
Top LKQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immuno Concepts, Inc. | 2 | 1989-07-25 |
| Whittaker Bioproducts, Inc. | 2 | 1987-04-14 |
| Siemens Healthcare Diagnostics | 1 | 2010-05-13 |
| Boston Biomedica, Inc. | 1 | 1997-08-22 |
| Biomerieux Vitek, Inc. | 1 | 1994-08-02 |
11 more applicants have LKQ clearances. See the full list in Caduvo.
Most recent LKQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100433 | Siemens Healthcare Diagnostics | IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, | 2010-05-13 | 86 |
| K972884 | Boston Biomedica, Inc. | ACCURUN 146 CMV IGM POSITIVE CONTROL | 1997-08-22 | 17 |
| K933549 | Biomerieux Vitek, Inc. | VIDAS CMV IGM ASSAY | 1994-08-02 | 376 |
| K922580 | Baxter Diagnostics, Inc. | BARTELS CYTOMEGALOVIRUS IGM EIA | 1993-04-08 | 316 |
| K914789 | Sclavo, Inc. | ELISA CMV IGM | 1992-03-04 | 133 |
Recalls for LKQ devices
8 product recalls in 6 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-02-09.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code LKQ?
LKQ is the FDA product code for antibody igm,if, cytomegalovirus virus. It is a Class II device, regulated under 21 CFR 866.3175 and reviewed by the Microbiology panel.
What device class is LKQ?
Class II, regulation 21 CFR 866.3175. Typical premarket route: 510(k).
How long does a 510(k) take for product code LKQ?
Across 18 cleared submissions the average was 147 days from receipt to decision (median 106).
Which companies have the most LKQ clearances?
Immuno Concepts, Inc. (2); Whittaker Bioproducts, Inc. (2); Siemens Healthcare Diagnostics (1); Boston Biomedica, Inc. (1); Biomerieux Vitek, Inc. (1).
Have LKQ devices been recalled?
Yes: 8 product recalls across 6 recall events; the most recent began 2022-02-09.
Next steps
- Run an FDA pathway report with predicate devices for product code LKQ
- Run a recall and safety report across every LKQ manufacturer
- Watch product code LKQ 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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