Cleared Traditional

K991157 - N LATEX STFR REAGENT

K991157 is an FDA 510(k) clearance for N LATEX STFR REAGENT, manufactured by Dade Behring, Inc.. The device is a Class 2 Immunology device with product code DDG cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K991157 · Dade Behring, Inc. · Immunology device
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Aug 1999
Decision
117d
Days
Class 2
Risk

K991157 is an FDA 510(k) clearance for the N LATEX STFR REAGENT. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on August 2, 1999 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5880 - 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K991157

510(k) Number K991157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1999
Decision Date August 02, 1999
Days to Decision 117 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 105d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDG Device Classification - Class 2, Special Controls

Product Code DDG Transferrin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5880
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 - DDG Transferrin, Antigen, Antiserum, Control

All 42
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K991157.
DIMENSION TRNF FLEX REAGENT CARTRIDGE
K994294 · Dade Behring, Inc. · Feb 2000
K-ASSAY TRANSFERRIN
K993537 · Kamiya Biomedical Co. · Nov 1999
WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
K993162 · Wako Chemicals USA, Inc. · Nov 1999
TRANSFERRIN SPQ III ANTIBODY REAGENT SET
K983880 · DiaSorin, Inc. · Dec 1998
TRF
K983167 · Abbott Laboratories · Nov 1998
N ANTISERUM TO HUMAN TRANSFERRIN
K972840 · Behring Diagnostics, Inc. · Oct 1997