Cleared Traditional

K955431 - RIT LIVER, KIDNEY, STOMACH IFA KIT

K955431 is an FDA 510(k) clearance for RIT LIVER, manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with product code DBL cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K955431 · The Binding Site, Ltd. · Immunology device
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Apr 1996
Decision
147d
Days
Class 2
Risk

K955431 is an FDA 510(k) clearance for the RIT LIVER, KIDNEY, STOMACH IFA KIT. Classified as Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (product code DBL), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on April 23, 1996 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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, Ltd. devices

FDA 510(k) Submission Details - K955431

510(k) Number K955431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1995
Decision Date April 23, 1996
Days to Decision 147 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
42d slower than avg
Panel avg: 105d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBL Device Classification - Class 2, Special Controls

Product Code DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - DBL Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

All 18
Devices cleared under the same product code (DBL) and FDA review panel - the closest regulatory comparables to K955431.
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K953495 · Scimedx Corp. · Apr 1996
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K944191 · Light Diagnostics · Mar 1995
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K944192 · Light Diagnostics · Mar 1995