Cleared Traditional

K991074 - BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST

K991074 is an FDA 510(k) clearance for BARTELS LEGIONELLA URINARY ANTIGEN ELIS..., manufactured by Intracel Corp.. The device is a Class 2 Microbiology device with product code MJH cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K991074 · Intracel Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
265d
Days
Class 2
Risk

K991074 is an FDA 510(k) clearance for the BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST. Classified as Legionella, Spp., Elisa (product code MJH), Class II - Special Controls.

Submitted by Intracel Corp. (Rockville, US). The FDA issued a Cleared decision on December 21, 1999 after a review of 265 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3300 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intracel Corp. devices

FDA 510(k) Submission Details - K991074

510(k) Number K991074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1999
Decision Date December 21, 1999
Days to Decision 265 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 102d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJH Device Classification - Class 2, Special Controls

Product Code MJH Legionella, Spp., Elisa
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3300
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 Microbiology devices follow this clearance model.

Regulatory Peers - MJH Legionella, Spp., Elisa

Devices cleared under the same product code (MJH) and FDA review panel - the closest regulatory comparables to K991074.
ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
K191184 · Ssi Diagnostica A/S · Mar 2020
TRU Legionella
K163273 · Meridian Bioscience, Inc. · Feb 2017
TRU LEGIONELLA
K113190 · Meridian Bioscience, Inc. · Feb 2012
BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522
K982238 · Binax, Inc. · Aug 1998
BINAX LEGIONELLA URINARY ANTIGEN EIA
K934965 · Binax, Inc. · Sep 1994
LEGIONELLA STAT IGG/IGM TEST KIT
K911356 · Whittaker Bioproducts, Inc. · Jul 1992