FDA product code LFR: Glucose Dehydrogenase, Glucose
LFR is the FDA product code for glucose dehydrogenase, glucose. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel. FDA has cleared 73 510(k) submissions under LFR, from 27 different applicants. The average 510(k) review took 137 days (median 118). FDA has posted 51 recalls for LFR devices.
Classification
| Field | Value |
|---|---|
| Device name | Glucose Dehydrogenase, Glucose |
| Device class | Class II |
| Regulation | 21 CFR 862.1345 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LFR clearance
Top LFR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics Corp. | 10 | 2005-09-02 |
| Boehringer Mannheim Corp. | 9 | 1999-02-05 |
| Eps Bio Technology Corp. | 6 | 2014-04-28 |
| Abbott Diabetes Care, Inc. | 5 | 2009-04-16 |
| Taidoc Technology Corporation | 4 | 2012-09-19 |
22 more applicants have LFR clearances. See the full list in Caduvo.
Most recent LFR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K152328 | Abott Laboratories | FreeStyle InsuLinx Blood Glucose Monotioring System | 2015-09-17 | 30 |
| K142089 | Roche Diagnostics Corporation | ACCU-CHEK AVIVA EXPERT SYSTEM | 2014-12-17 | 138 |
| K133537 | Eps Bio Technology Corp. | EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUCOSE SYSTEM | 2014-04-28 | 161 |
| K131727 | Ceragem Medisys, Inc. | CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM | 2014-02-28 | 261 |
| K131366 | Roche Diagnostics Operations, Inc. | ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM | 2013-10-11 | 151 |
Recalls for LFR devices
51 product recalls in 16 recall events; 0 initiated in the last five years and 2 still open. Most recent: 2021-07-28.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2021 | 2 |
Frequently asked questions
What is FDA product code LFR?
LFR is the FDA product code for glucose dehydrogenase, glucose. It is a Class II device, regulated under 21 CFR 862.1345 and reviewed by the Clinical Chemistry panel.
What device class is LFR?
Class II, regulation 21 CFR 862.1345. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFR?
Across 73 cleared submissions the average was 137 days from receipt to decision (median 118).
Which companies have the most LFR clearances?
Roche Diagnostics Corp. (10); Boehringer Mannheim Corp. (9); Eps Bio Technology Corp. (6); Abbott Diabetes Care, Inc. (5); Taidoc Technology Corporation (4).
Have LFR devices been recalled?
Yes: 51 product recalls across 16 recall events; the most recent began 2021-07-28.
Next steps
- Run an FDA pathway report with predicate devices for product code LFR
- Run a recall and safety report across every LFR manufacturer
- Watch product code LFR 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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