Cleared Traditional

K790366 - URINE CULTURE KIT

K790366 is an FDA 510(k) clearance for URINE CULTURE KIT, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Microbiology device with product code JTW cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K790366 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1979
Decision
41d
Days
Class 1
Risk

K790366 is an FDA 510(k) clearance for the URINE CULTURE KIT. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 4, 1979 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K790366

510(k) Number K790366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1979
Decision Date April 04, 1979
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 102d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

JTW Device Classification - Class 1, General Controls

Product Code JTW System, Transport, Aerobic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - JTW System, Transport, Aerobic

All 29
Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K790366.
CULSWAB CAT.#978 & 979
K802023 · Pollak (Intl.), Ltd. · Sep 1980
PDC 304 DOUBLE SWAB CULTURE COLLECTION
K791953 · Precision Dynamics Corp. · Oct 1979
PDC 104 SINGLE SWAB CULTURE COLLECTION
K791924 · Precision Dynamics Corp. · Oct 1979
CHAMBER, AEROBIC
K780440 · Marion Laboratories, Inc. · Apr 1978
CULTURE COLLEC. TRANS. SYS., SINGLE WET
K772207 · Precision Dynamics Corp. · Dec 1977
CULTURE COLLEC. TRANS. SYS., DOUBLE DRY
K772209 · Precision Dynamics Corp. · Dec 1977