Cleared Traditional

K914388 - C1 RID KIT

K914388 is an FDA 510(k) clearance for C1 RID KIT, manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with product code DAK cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K914388 · The Binding Site, Ltd. · Immunology device
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Oct 1991
Decision
27d
Days
Class 2
Risk

K914388 is an FDA 510(k) clearance for the C1 RID KIT. Classified as Complement C1q, Antigen, Antiserum, Control (product code DAK), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on October 28, 1991 after a review of 27 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Binding Site, Ltd. devices

FDA 510(k) Submission Details - K914388

510(k) Number K914388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1991
Decision Date October 28, 1991
Days to Decision 27 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
78d faster than avg
Panel avg: 105d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAK Device Classification - Class 2, Special Controls

Product Code DAK Complement C1q, 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 - DAK Complement C1q, Antigen, Antiserum, Control

All 16
Devices cleared under the same product code (DAK) and FDA review panel - the closest regulatory comparables to K914388.
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IC MICROASSAY
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CORDIA IC
K844294 · Cordis Corp. · Feb 1985
ORTHO* SERUM ELISA TEST SYSTEM
K833636 · Ortho Diagnostic Systems, Inc. · Jun 1984