Cleared Traditional

K944876 - HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT

K944876 is an FDA 510(k) clearance for HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT, manufactured by Research Diagnostics, Inc.. The device is a Class 1 Immunology device with product code DAS cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K944876 · Research Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
73d
Days
Class 1
Risk

K944876 is an FDA 510(k) clearance for the HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT. Classified as Igg (fc Fragment Specific), Antigen, Antiserum, Control (product code DAS), Class I - General Controls.

Submitted by Research Diagnostics, Inc. (Flanders, US). The FDA issued a Cleared decision on December 15, 1994 after a review of 73 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5530 - 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 Research Diagnostics, Inc. devices

FDA 510(k) Submission Details - K944876

510(k) Number K944876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1994
Decision Date December 15, 1994
Days to Decision 73 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 105d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

DAS Device Classification - Class 1, General Controls

Product Code DAS Igg (fc Fragment Specific), Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5530
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DAS Igg (fc Fragment Specific), Antigen, Antiserum, Control

Devices cleared under the same product code (DAS) and FDA review panel - the closest regulatory comparables to K944876.
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
K982023 · Inova Diagnostics, Inc. · Sep 1998
HUMAN (IGG) SUBCLASS (EIA) KIT
K895600 · The Binding Site, Ltd. · Nov 1989
ANTISERUM TO HUMAN IG G FC FRAGMENTS
K790708 · Kent Laboratories, Inc. · Aug 1979
ANTISERUM TO HUMAN FC
K790715 · Kent Laboratories, Inc. · Aug 1979
AMINOGLYCOSIDE CONTROLS
K761156 · Supelco, Inc. · Dec 1976