Cleared Traditional

K092283 - DIMENSION VISTA IMMUNOGLOBULIN IGG SUBC...

K092283 is an FDA 510(k) clearance for DIMENSION VISTA IMMUNOGLOBULIN IGG SUBC..., manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Immunology device with product code DFZ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K092283 · Siemens Healthcare Diagnostics · Immunology device
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Oct 2009
Decision
84d
Days
Class 2
Risk

K092283 is an FDA 510(k) clearance for the DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSI.... Classified as Igg (gamma Chain Specific), Antigen, Antiserum, Control (product code DFZ), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on October 21, 2009 after a review of 84 days - a notably fast clearance cycle.

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: 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 Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K092283

510(k) Number K092283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2009
Decision Date October 21, 2009
Days to Decision 84 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
20d faster than avg
Panel avg: 104d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFZ Device Classification - Class 2, Special Controls

Product Code DFZ Igg (gamma Chain Specific), 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 - DFZ Igg (gamma Chain Specific), Antigen, Antiserum, Control

Devices cleared under the same product code (DFZ) and FDA review panel - the closest regulatory comparables to K092283.
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE HITACHI 911/7070 TURBIDIMETRIC ANALYSER
K021081 · The Binding Site, Ltd. · Jun 2002
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K955906 · Boehringer Mannheim Corp. · Feb 1996
IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER
K940422 · The Binding Site, Ltd. · May 1994
AUTOMATED IMMUNOPRECIPITIN METHOD/ICG
K803272 · Icl Scientific · Jan 1981
ANTISERUM TO RABBIT IMMUNOGLOBULIN
K790709 · Kent Laboratories, Inc. · Aug 1979
ANTISERA TO RABBIT IMMUNOGLOBULIN
K790720 · Kent Laboratories, Inc. · Aug 1979