Cleared Traditional

K962582 - OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT

K962582 is an FDA 510(k) clearance for OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT, manufactured by Olympus America, Inc.. The device is a Class 2 Immunology device with product code DBI cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K962582 · Olympus America, Inc. · Immunology device
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Oct 1996
Decision
109d
Days
Class 2
Risk

K962582 is an FDA 510(k) clearance for the OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), Class II - Special Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on October 18, 1996 after a review of 109 days - within the typical 510(k) review window.

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: 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 Olympus America, Inc. devices

FDA 510(k) Submission Details - K962582

510(k) Number K962582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1996
Decision Date October 18, 1996
Days to Decision 109 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
4d slower than avg
Panel avg: 105d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBI Device Classification - Class 2, Special Controls

Product Code DBI Complement C4, 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 - DBI Complement C4, Antigen, Antiserum, Control

All 27
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K962582.
C4
K983356 · Abbott Laboratories · Nov 1998
N-ASSAY TIA C4 TEST KIT
K964297 · Crestat Diagnostics, Inc. · Jul 1997
N-ASSAY TIA MULTI V-NL
K964300 · Crestat Diagnostics, Inc. · Jul 1997
QUANTEX C4
K962198 · Instrumentation Laboratory CO · Sep 1996
IL TEST COMPLEMENT 4
K920010 · Instrumentation Laboratory CO · Mar 1992
RAICHEM SPIA C4 REAGENT
K911899 · Reagents Applications, Inc. · May 1991