Cleared Traditional

K100455 - SPAPLUS ANALYZER

K100455 is an FDA 510(k) clearance for SPAPLUS ANALYZER, manufactured by The Binding Site. The device is a Class 2 Immunology device with product code DBI cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K100455 · The Binding Site · Immunology device
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Sep 2010
Decision
198d
Days
Class 2
Risk

K100455 is an FDA 510(k) clearance for the SPAPLUS ANALYZER. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), Class II - Special Controls.

Submitted by The Binding Site (Los Angeles, US). The FDA issued a Cleared decision on September 3, 2010 after a review of 198 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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 The Binding Site devices

FDA 510(k) Submission Details - K100455

510(k) Number K100455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2010
Decision Date September 03, 2010
Days to Decision 198 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
94d slower than avg
Panel avg: 104d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBI Device Classification - Class 2, Special Controls

Product Code DBI Complement C4, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - DBI Complement C4, Antigen, Antiserum, Control

All 28
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K100455.
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
K012359 · Roche Diagnostics Corp. · Nov 2001
WAKO AUTOKIT C4
K010325 · Wako Chemicals USA, Inc. · Jun 2001
RANDOX COMPLEMENT C4
K000468 · Randox Laboratories, Ltd. · Mar 2000
DIMENSION C4 FLEX REAGENT CARTRIDGE
K994293 · Dade Behring, Inc. · Mar 2000
C4 MININEPH ANTISERUM
K981785 · The Binding Site, Ltd. · Dec 1999
K-ASSAY C4
K993481 · Kamiya Biomedical Co. · Nov 1999