Cleared Traditional

K961968 - BBLCRYSTAL GRAM-POSITIVE ID SYSTEM (FDA 510(k) Clearance)

Class I Microbiology device.

K961968 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
260d
Days
Class 1
Risk

K961968 is an FDA 510(k) clearance for the BBLCRYSTAL GRAM-POSITIVE ID SYSTEM. Classified as Gram Positive Identification Panel (product code LQL), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Cockeysville, US). The FDA issued a Cleared decision on February 4, 1997 after a review of 260 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K961968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1996
Decision Date February 04, 1997
Days to Decision 260 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 102d · This submission: 260d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQL Gram Positive Identification Panel
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.