Cleared Traditional

K944528 - BBLCRYSTAL ANAEROBE ID SYSTEM

K944528 is the FDA 510(k) clearance for BBLCRYSTAL ANAEROBE ID SYSTEM by Becton Dickinson Microbiology Systems. It is a Class 1 Microbiology device (product code JSP) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K944528 · Becton Dickinson Microbiology Systems · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
173d
Days
Class 1
Risk

K944528 is an FDA 510(k) clearance for the BBLCRYSTAL ANAEROBE ID SYSTEM. Classified as Kit, Anaerobic Identification (product code JSP), Class I - General Controls.

Submitted by Becton Dickinson Microbiology Systems (Cockeysville, US). The FDA issued a Cleared decision on March 7, 1995 after a review of 173 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 Becton Dickinson Microbiology Systems devices

Submission Details

510(k) Number K944528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1994
Decision Date March 07, 1995
Days to Decision 173 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
71d slower than avg
Panel avg: 102d · This submission: 173d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSP Kit, Anaerobic Identification
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 - JSP Kit, Anaerobic Identification

All 9
Devices cleared under the same product code (JSP) and FDA review panel - the closest regulatory comparables to K944528.
VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION
K910666 · Vitek Systems, Inc. · Apr 1991
VITEK ANAEROBE IDENTIFICATION CARD
K900996 · Vitek Systems, Inc. · May 1990
DIAGNOSTIC REAGENT PET-RPLA
K855235 · Oxoid U.S.A., Inc. · Nov 1986
ANAEROBE KIT
K850052 · Austin Biological Laboratories · Mar 1985
AMS ANA CARD
K843686 · Vitek Systems, Inc. · Dec 1984
API ANAIDENT
K831032 · Analytical Products, Inc. · May 1983