Cleared Traditional

K851541 - DART IMMUNOGLOBULINS REAGENT SYSTEM

K851541 is an FDA 510(k) clearance for DART IMMUNOGLOBULINS REAGENT SYSTEM, manufactured by Coulter Electronics, Inc.. The device is a Class 2 Immunology device with product code DEW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K851541 · Coulter Electronics, Inc. · Immunology device
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Jul 1985
Decision
90d
Days
Class 2
Risk

K851541 is an FDA 510(k) clearance for the DART IMMUNOGLOBULINS REAGENT SYSTEM. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on July 15, 1985 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Coulter Electronics, Inc. devices

FDA 510(k) Submission Details - K851541

510(k) Number K851541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1985
Decision Date July 15, 1985
Days to Decision 90 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
15d faster than avg
Panel avg: 105d · This submission: 90d
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 Immunology devices follow this clearance model.

Regulatory Peers - DEW Igg, Antigen, Antiserum, Control

All 57
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K851541.
PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS
K871352 · Helena Laboratories · Apr 1987
TINA-QUANT(R) IGG
K862764 · Boehringer Mannheim Corp. · Sep 1986
DAKO ITA SYSTEM
K861059 · Dako Corp. · Aug 1986
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT
K852589 · Abbott Laboratories · Jul 1985
AMER. HISTO-ID SYS PRIMARY IGG S7920-11
K842329 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
OPTIMATE IGG TEST
K841816 · Miles Laboratories, Inc. · Jun 1984