Cleared Traditional

K992488 - TOTAL HAEMOLYTIC COMPLEMENT RID KIT

K992488 is the FDA 510(k) clearance for TOTAL HAEMOLYTIC COMPLEMENT RID KIT by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code DAE) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K992488 · The Binding Site, Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
53d
Days
Class 2
Risk

K992488 is an FDA 510(k) clearance for the TOTAL HAEMOLYTIC COMPLEMENT RID KIT. Classified as Complement C9, Antigen, Antiserum, Control (product code DAE), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on September 17, 1999 after a review of 53 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

Submission Details

510(k) Number K992488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1999
Decision Date September 17, 1999
Days to Decision 53 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
51d faster than avg
Panel avg: 104d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DAE Complement C9, 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 - DAE Complement C9, Antigen, Antiserum, Control

Devices cleared under the same product code (DAE) and FDA review panel - the closest regulatory comparables to K992488.
Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator
K150412 · The Binding Site Group , Ltd. · Aug 2015
HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
K113349 · The Binding Site Group , Ltd. · Jul 2012
QUIDEL CH50 EQ EIA
K974111 · Quidel Corp. · Jul 1998
WAKO AUTOKIT CH50
K954145 · Wako Chemicals USA, Inc. · Dec 1995
COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)
K951639 · Incstar Corp. · Oct 1995