Cleared Traditional

K983185 - BOEHRINGER MANNHEIM TINA-QUANT IGE TEST

K983185 is an FDA 510(k) clearance for BOEHRINGER MANNHEIM TINA-QUANT IGE TEST, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K983185 · Boehringer Mannheim Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
62d
Days
Class 2
Risk

K983185 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM TINA-QUANT IGE TEST. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 12, 1998 after a review of 62 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K983185

510(k) Number K983185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1998
Decision Date November 12, 1998
Days to Decision 62 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
42d faster than avg
Panel avg: 104d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGC Device Classification - Class 2, Special Controls

Product Code DGC Ige, 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 - DGC Ige, Antigen, Antiserum, Control

All 84
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K983185.
RANDOX IGE
K010855 · Randox Laboratories, Ltd. · May 2001
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
K002560 · The Binding Site, Ltd. · Oct 2000
N LATEX IGE MONO REAGENT
K991787 · Dade Behring, Inc. · Jul 1999
AIA-PACK IGE II ASSAY
K972697 · Tosoh Medics, Inc. · Oct 1997
UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
K964152 · Pharmacia, Inc. · Apr 1997
HY-TEC TOTAL IGE ENZYME IMMUNOASSAY
K940183 · Hycor Biomedical, Inc. · May 1994