Cleared Traditional

K934324 - OT IGG SORBENT

K934324 is an FDA 510(k) clearance for OT IGG SORBENT, manufactured by Organon Teknika Corp.. The device is a Class 2 Microbiology device with product code DEW cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K934324 · Organon Teknika Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
230d
Days
Class 2
Risk

K934324 is an FDA 510(k) clearance for the OT IGG SORBENT. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on April 21, 1994 after a review of 230 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5510 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Organon Teknika Corp. devices

FDA 510(k) Submission Details - K934324

510(k) Number K934324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1993
Decision Date April 21, 1994
Days to Decision 230 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 102d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEW Device Classification - Class 2, Special Controls

Product Code DEW Igg, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 Microbiology devices follow this clearance model.

Regulatory Peers - DEW Igg, Antigen, Antiserum, Control

All 55
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K934324.
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR
K955798 · Randox Laboratories, Ltd. · Apr 1996
BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL
K951635 · Beckman Instruments, Inc. · May 1995
BEHRING NEPHELOMETER II
K943997 · Behring Diagnostics, Inc. · Oct 1994
RADIAS FERRITIN ENZYME IMMUNOASSAY
K933314 · Bio-Rad · Sep 1993
ZORBA(TM) IGG REMOVAL REAGENT
K924197 · Zeus Scientific, Inc. · Dec 1992
MODIFIED TECHNICON DPA-1(TM) SYSTEM
K900943 · Technicon Instruments Corp. · Apr 1990