Cleared Traditional

ABBOTT ARCHITECT B12 (K984108) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K984108 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
78d
Days
Class 2
Risk

K984108 is an FDA 510(k) clearance for the ABBOTT ARCHITECT B12. Classified as Radioassay, Intrinsic Factor Blocking Antibody (product code LIG), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 3, 1999 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1810 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

Submission Details

510(k) Number K984108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1998
Decision Date February 03, 1999
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIG Radioassay, Intrinsic Factor Blocking Antibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1810
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LIG Radioassay, Intrinsic Factor Blocking Antibody

Devices cleared under the same product code (LIG) and FDA review panel - the closest regulatory comparables to K984108.
QUANTA LITE INTRINSIC FACTOR ELISA
K061841 · Inova Diagnostics, Inc. · Dec 2006
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999
K033603 · Beckman Coulter, Inc. · Dec 2003
IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6
K993251 · Diagnostic Products Corp. · Nov 1999
IMX B12
K903218 · Abbott Laboratories · Aug 1990