FDA product code LRG: Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
LRG is the FDA product code for instrument for auto reader & interpretation of overnight suscept. systems. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel. FDA has cleared 45 510(k) submissions under LRG, from 15 different applicants. The average 510(k) review took 111 days (median 60). FDA has posted 13 recalls for LRG devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Device class | Class II |
| Regulation | 21 CFR 866.1640 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LRG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 112 |
Compare with all 510(k) review times · Search every LRG clearance
Top LRG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dade Behring, Inc. | 23 | 2007-08-20 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 3 | 1990-03-15 |
| Thermo Fisher Scientific | 2 | 2019-11-06 |
| Siemens Healthcare Diagnostics, Inc. | 2 | 2011-08-04 |
| Siemens Healthcare Diagnostics | 2 | 2010-09-10 |
10 more applicants have LRG clearances. See the full list in Caduvo.
Most recent LRG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191918 | Thermo Fisher Scientific | Thermo Scientific Sensititre ARIS HiQ System | 2019-11-06 | 111 |
| K191914 | Thermo Fisher Scientific | Thermo Scientific Sensititre ARIS HiQ System | 2019-11-06 | 112 |
| K110583 | Trek Diagnostic Systems, Ltd. | SENSITITRE OPTIREAD | 2011-09-22 | 205 |
| K103532 | Trek Diagnostic Systems | AUTOREADER 2 | 2011-08-26 | 268 |
| K111677 | Siemens Healthcare Diagnostics, Inc. | MICROSCAN(R) MICROSTREP PLUS(R) | 2011-08-04 | 50 |
Recalls for LRG devices
13 product recalls in 5 recall events; 1 initiated in the last five years and 7 still open. Most recent: 2025-02-12.
| Year | Recalls |
|---|---|
| 2019 | 10 |
| 2020 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code LRG?
LRG is the FDA product code for instrument for auto reader & interpretation of overnight suscept. systems. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is LRG?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code LRG?
Across 45 cleared submissions the average was 111 days from receipt to decision (median 60).
Which companies have the most LRG clearances?
Dade Behring, Inc. (23); Bd Becton Dickinson Vacutainer Systems Preanalytic (3); Thermo Fisher Scientific (2); Siemens Healthcare Diagnostics, Inc. (2); Siemens Healthcare Diagnostics (2).
Have LRG devices been recalled?
Yes: 13 product recalls across 5 recall events; the most recent began 2025-02-12.
Next steps
- Run an FDA pathway report with predicate devices for product code LRG
- Run a recall and safety report across every LRG manufacturer
- Watch product code LRG 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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