FDA product code LIG: Radioassay, Intrinsic Factor Blocking Antibody
LIG is the FDA product code for radioassay, intrinsic factor blocking antibody. It is a Class II device, regulated under 21 CFR 862.1810 and reviewed by the Clinical Chemistry panel. FDA has cleared 8 510(k) submissions under LIG, 1 in the last five years, from 6 different applicants. The average 510(k) review took 101 days (median 64); 39 days on average over the last three years. FDA has posted 3 recalls for LIG devices.
Classification
| Field | Value |
|---|---|
| Device name | Radioassay, Intrinsic Factor Blocking Antibody |
| Device class | Class II |
| Regulation | 21 CFR 862.1810 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LIG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 39 |
Top LIG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 2 | 2024-05-03 |
| Abbott Laboratories | 2 | 1999-02-03 |
| Immco Diagnostics, Inc. | 1 | 2007-09-24 |
| Inova Diagnostics, Inc. | 1 | 2006-12-22 |
| Diagnostic Products Corp. | 1 | 1999-11-17 |
1 more applicants have LIG clearances. See the full list in Caduvo.
Most recent LIG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240800 | Beckman Coulter, Inc. | Access Intrinsic Factor Ab | 2024-05-03 | 39 |
| K071346 | Immco Diagnostics, Inc. | IMMULISA INTRINSIC FACTOR ANTIBODY ELISA | 2007-09-24 | 133 |
| K061841 | Inova Diagnostics, Inc. | QUANTA LITE INTRINSIC FACTOR ELISA | 2006-12-22 | 176 |
| K033603 | Beckman Coulter, Inc. | INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 | 2003-12-19 | 32 |
| K993251 | Diagnostic Products Corp. | IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 | 1999-11-17 | 50 |
Recalls for LIG devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-05-07.
Frequently asked questions
What is FDA product code LIG?
LIG is the FDA product code for radioassay, intrinsic factor blocking antibody. It is a Class II device, regulated under 21 CFR 862.1810 and reviewed by the Clinical Chemistry panel.
What device class is LIG?
Class II, regulation 21 CFR 862.1810. Typical premarket route: 510(k).
How long does a 510(k) take for product code LIG?
Across 8 cleared submissions the average was 101 days from receipt to decision (median 64).
Which companies have the most LIG clearances?
Beckman Coulter, Inc. (2); Abbott Laboratories (2); Immco Diagnostics, Inc. (1); Inova Diagnostics, Inc. (1); Diagnostic Products Corp. (1).
Have LIG devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2009-05-07.
Next steps
- Run an FDA pathway report with predicate devices for product code LIG
- Run a recall and safety report across every LIG manufacturer
- Watch product code LIG 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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