Cleared Traditional

K924218 - BAC-T-SCREEN

K924218 is an FDA 510(k) clearance for BAC-T-SCREEN, manufactured by Biomerieux Vitek, Inc.. The device is a Class 1 Microbiology device with product code JXA cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K924218 · Biomerieux Vitek, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
167d
Days
Class 1
Risk

K924218 is an FDA 510(k) clearance for the BAC-T-SCREEN. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on February 3, 1993 after a review of 167 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.

FDA 510(k) Submission Details - K924218

510(k) Number K924218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1992
Decision Date February 03, 1993
Days to Decision 167 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
65d slower than avg
Panel avg: 102d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

JXA Device Classification - Class 1, General Controls

Product Code JXA Kit, Screening, Urine
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 - JXA Kit, Screening, Urine

All 40
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K924218.
MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)
K950221 · Izon Business Products, Inc. · Mar 1995
MULTIPLE (IZON URINE COLLECTION KIT)
K950246 · Izon Business Products, Inc. · Mar 1995
CULTURIA MACCONKEY-MUG
K934759 · Clinical Convenience Products, Inc. · Sep 1994
DIASLIDE URINE CULTURING DEVICE
K921045 · Savyon Diagnostics , Ltd. · Sep 1992
URI-THREE(TM), MODIFICATION
K911846 · Culture Kits, Inc. · Oct 1991
QUALTURE
K903470 · Future Medical Technologies Intl., Inc. · Dec 1990
K924218 · BAC-T-SCREEN
Download PDF FDA Summary Biomerieux Vitek, Inc.