FDA product code LGC: Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
LGC is the FDA product code for enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific. It is a Class II device, regulated under 21 CFR 866.3305 and reviewed by the Microbiology panel. FDA has cleared 38 510(k) submissions under LGC, from 21 different applicants. The average 510(k) review took 168 days (median 125). FDA has posted 7 recalls for LGC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific |
| Device class | Class II |
| Regulation | 21 CFR 866.3305 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LGC clearance
Top LGC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gull Laboratories, Inc. | 7 | 1999-02-26 |
| Baxter Diagnostics, Inc. | 4 | 1992-12-15 |
| Ortho Diagnostic Systems, Inc. | 3 | 1992-12-28 |
| Diagnostic Products Corp. | 2 | 2001-04-18 |
| Diamedix Corp. | 2 | 2000-11-28 |
16 more applicants have LGC clearances. See the full list in Caduvo.
Most recent LGC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K033059 | Trinity Biotech, Inc. | HERPES GROUP IGG | 2003-11-26 | 58 |
| K010878 | Diagnostic Products Corp. | MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 | 2001-04-18 | 30 |
| K002262 | Diamedix Corp. | DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM | 2000-11-28 | 126 |
| K000238 | Mrl Diagnostics | HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G | 2000-04-14 | 78 |
| K992166 | Zeus Scientific, Inc. | THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | 1999-09-03 | 70 |
Recalls for LGC devices
7 product recalls in 5 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-09-28.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code LGC?
LGC is the FDA product code for enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific. It is a Class II device, regulated under 21 CFR 866.3305 and reviewed by the Microbiology panel.
What device class is LGC?
Class II, regulation 21 CFR 866.3305. Typical premarket route: 510(k).
How long does a 510(k) take for product code LGC?
Across 38 cleared submissions the average was 168 days from receipt to decision (median 125).
Which companies have the most LGC clearances?
Gull Laboratories, Inc. (7); Baxter Diagnostics, Inc. (4); Ortho Diagnostic Systems, Inc. (3); Diagnostic Products Corp. (2); Diamedix Corp. (2).
Have LGC devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2022-09-28.
Next steps
- Run an FDA pathway report with predicate devices for product code LGC
- Run a recall and safety report across every LGC manufacturer
- Watch product code LGC 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times