Cleared Traditional

B-STREP-TECT-II (K840160) - FDA 510(k) Clearance

Class I Microbiology device.

K840160 · Uti-Tect, Inc. · Microbiology device
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Mar 1984
Decision
49d
Days
Class 1
Risk

K840160 is an FDA 510(k) clearance for the B-STREP-TECT-II. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Uti-Tect, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1984 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Uti-Tect, Inc. devices

Submission Details

510(k) Number K840160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1984
Decision Date March 02, 1984
Days to Decision 49 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 102d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSI Culture Media, Selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSI Culture Media, Selective And Differential

All 59
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K840160.
NEOMYCIN BLOOD AGAR
K843492 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1984
MACCONKEY AGAR, PLUS
K842100 · Acumedia Manufacturers, Inc. · Jun 1984
COBA AGAR
K842101 · Acumedia Manufacturers, Inc. · Jun 1984
GROUP A SELECTIVE AGAR W/5% SHEEP BLOOD
K840294 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1984
FEELEY-GORMAN AGAR
K833301 · Acumedia Manufacturers, Inc. · Oct 1983
DEOXYCHOLATE LACTOSE AGAR
K833203 · Acumedia Manufacturers, Inc. · Oct 1983