Cleared Traditional

K113823 - HEVYLITE HUMAN IGM KAPPA AND HEVYLITE I...

K113823 is the FDA 510(k) clearance for HEVYLITE HUMAN IGM KAPPA AND HEVYLITE I... by The Binding Site Group , Ltd.. It is a Class 2 Immunology device (product code CFN) cleared through the Traditional 510(k) pathway after a 456-day FDA review.

K113823 · The Binding Site Group , Ltd. · Immunology device
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Mar 2013
Decision
456d
Days
Class 2
Risk

K113823 is an FDA 510(k) clearance for the HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT. Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on March 27, 2013 after a review of 456 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all The Binding Site Group , Ltd. devices

Submission Details

510(k) Number K113823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2011
Decision Date March 27, 2013
Days to Decision 456 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
352d slower than avg
Panel avg: 104d · This submission: 456d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFN Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CFN Method, Nephelometric, Immunoglobulins (g, A, M)

All 51
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