Cleared Traditional

QUANTA LITE INTRINSIC FACTOR ELISA (K061841) - FDA 510(k) Clearance

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

K061841 · Inova Diagnostics, Inc. · Immunology device
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Dec 2006
Decision
176d
Days
Class 2
Risk

K061841 is an FDA 510(k) clearance for the QUANTA LITE INTRINSIC FACTOR ELISA. Classified as Radioassay, Intrinsic Factor Blocking Antibody (product code LIG), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 22, 2006 after a review of 176 days - an extended review cycle.

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

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K061841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2006
Decision Date December 22, 2006
Days to Decision 176 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 104d · This submission: 176d
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 Immunology devices follow this clearance model.

Regulatory Peers - LIG Radioassay, Intrinsic Factor Blocking Antibody

All 7
Devices cleared under the same product code (LIG) and FDA review panel - the closest regulatory comparables to K061841.
Access Intrinsic Factor Ab
K240800 · Beckman Coulter, Inc. · May 2024
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
ABBOTT ARCHITECT B12
K984108 · Abbott Laboratories · Feb 1999
IMX B12
K903218 · Abbott Laboratories · Aug 1990