Radioassay, Intrinsic Factor Blocking Antibody
A radioassay for intrinsic factor blocking antibody is a laboratory test that uses radiolabeled reagents to detect antibodies that block the binding of vitamin B12 to intrinsic factor in patient serum, used in the diagnosis of pernicious anemia and other autoimmune conditions affecting vitamin B12 absorption. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It carries product code LIG and is regulated under 21 CFR 862.1810 within the Clinical Chemistry specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- LIG
- Device Class
- FDA class 2
- Regulation Number
- 862.1810
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240800 | Access Intrinsic Factor Ab | May 03, 2024 | Substantially Equivalent | Beckman Coulter, Inc. |
| K071346 | IMMULISA INTRINSIC FACTOR ANTIBODY ELISA | Sep 24, 2007 | Substantially Equivalent | Immco Diagnostics, Inc. |
| K061841 | QUANTA LITE INTRINSIC FACTOR ELISA | Dec 22, 2006 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K033603 | INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 | Dec 19, 2003 | Substantially Equivalent | Beckman Coulter, Inc. |
| K993251 | IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 | Nov 17, 1999 | Substantially Equivalent | Diagnostic Products Corp. |
| K984108 | ABBOTT ARCHITECT B12 | Feb 03, 1999 | Substantially Equivalent | Abbott Laboratories |
| K903218 | IMX B12 | Aug 23, 1990 | Substantially Equivalent | Abbott Laboratories |
| K811927 | 1F BLOCKING ANTIBODY(57 CO) RADIOASSAY | Apr 01, 1982 | Substantially Equivalent | Corning Medical & Scientific |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.