Cleared Traditional

K150031 - hemoFISH Masterpanel

K150031 is an FDA 510(k) clearance for hemoFISH Masterpanel, manufactured by Miacom Diagnostics GmbH. The device is a Class 1 Microbiology device with product code JSS cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K150031 · Miacom Diagnostics GmbH · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
266d
Days
Class 1
Risk

K150031 is an FDA 510(k) clearance for the hemoFISH Masterpanel. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Miacom Diagnostics GmbH (Dusseldorf, DE). The FDA issued a Cleared decision on October 1, 2015 after a review of 266 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Miacom Diagnostics GmbH devices

FDA 510(k) Submission Details - K150031

510(k) Number K150031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2015
Decision Date October 01, 2015
Days to Decision 266 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
164d slower than avg
Panel avg: 102d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

JSS Device Classification - Class 1, General Controls

Product Code JSS Kit, Identification, Enterobacteriaceae
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JSS Kit, Identification, Enterobacteriaceae

All 33
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K150031.
GRAM-NEGATIVE QUICKFISH BC
K123418 · Advandx, Inc. · Jul 2013
GNR TRAFFIC LIGHT PNA FISH
K101558 · Advandx, Inc. · Dec 2010
E.COLI/P. AERUGINOSA PNA FISH
K092236 · Advandx, Inc. · Dec 2009
EK/P. AERUGINOSA PNA FISH
K092393 · Advandx, Inc. · Sep 2009
E. COLI PNA FISH
K082068 · Advandx, Inc. · Jun 2009
EK/P. AERUGINOSA PNA FISH
K081433 · Advandx, Inc. · Mar 2009