Cleared Traditional

K905633 - HUMAN C-REACTIVE PROTEIN RID KIT

K905633 is the FDA 510(k) clearance for HUMAN C-REACTIVE PROTEIN RID KIT by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code DCK) cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K905633 · The Binding Site, Ltd. · Immunology device
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Jul 1991
Decision
220d
Days
Class 2
Risk

K905633 is an FDA 510(k) clearance for the HUMAN C-REACTIVE PROTEIN RID KIT. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on July 22, 1991 after a review of 220 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - 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

Submission Details

510(k) Number K905633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1990
Decision Date July 22, 1991
Days to Decision 220 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 104d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 81
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K905633.
N/T RHEUMATOLOGY CONTROL SL/1, SL/2
K944375 · Behring Diagnostics, Inc. · Oct 1994
TINA-QUANT CRP
K930621 · Boehringer Mannheim Corp. · Mar 1993
VIGIL II
K920845 · Beckman Instruments, Inc. · Dec 1992
WAKO(TM) AUTOKIT CRP
K895598 · Wako Chemicals USA, Inc. · Sep 1989
TECHNICON DPA-1 (TM) CRP METHOD
K892198 · Technicon Instruments Corp. · May 1989
DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR
K884101 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1988