Cleared Traditional

K143118 - Human Microalbumin kit for use on SPAPLUS

K143118 is the FDA 510(k) clearance for Human Microalbumin kit for use on SPAPLUS by The Binding Site Group , Ltd.. It is a Class 2 Chemistry device (product code DCF) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K143118 · The Binding Site Group , Ltd. · Chemistry device
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May 2015
Decision
208d
Days
Class 2
Risk

K143118 is an FDA 510(k) clearance for the Human Microalbumin kit for use on SPAPLUS. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on May 26, 2015 after a review of 208 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5040 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all The Binding Site Group , Ltd. devices

Submission Details

510(k) Number K143118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2014
Decision Date May 26, 2015
Days to Decision 208 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 88d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCF Albumin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5040
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 - DCF Albumin, Antigen, Antiserum, Control

All 27
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K143118.
Optilite Low Level Albumin Kit
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