Cleared Traditional

K103824 - HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS (FDA 510(k) Clearance)

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

K103824 · The Binding Site · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
424d
Days
Class 2
Risk

K103824 is an FDA 510(k) clearance for the HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS. Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), Class II - Special Controls.

Submitted by The Binding Site (Birmingham West Midlands, GB). The FDA issued a Cleared decision on February 27, 2012 after a review of 424 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 devices

Submission Details

510(k) Number K103824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2010
Decision Date February 27, 2012
Days to Decision 424 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
320d slower than avg
Panel avg: 104d · This submission: 424d
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 60
Devices cleared under the same product code (CFN) and FDA review panel - the closest regulatory comparables to K103824.
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)
K233663 · Siemens Healthcare Diagnostics Products GmbH · Dec 2023
Immunoglobulin G (IgG)
K221114 · Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · Aug 2023
Human IgA liquid reagent kit for Use on SPAPlus
K192116 · The Binding Site Group , Ltd. · Sep 2019
Optilite IgA Kit
K191985 · The Binding Site Group , Ltd. · Aug 2019
Optilite IgM Kit
K191635 · The Binding Site Group , Ltd. · Jul 2019
Human IgM Kit for use on SPAPlus
K191465 · The Binding Site Group , Ltd. · Jun 2019