Cleared Traditional

K812581 - SENSI-TECT

K812581 is an FDA 510(k) clearance for SENSI-TECT, manufactured by Uti-Tect, Inc.. The device is a Class 2 Microbiology device with product code JTZ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K812581 · Uti-Tect, Inc. · Microbiology device
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Sep 1981
Decision
13d
Days
Class 2
Risk

K812581 is an FDA 510(k) clearance for the SENSI-TECT. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Uti-Tect, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - 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

FDA 510(k) Submission Details - K812581

510(k) Number K812581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1981
Decision Date September 23, 1981
Days to Decision 13 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 102d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTZ Device Classification - Class 2, Special Controls

Product Code JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth

All 45
Devices cleared under the same product code (JTZ) and FDA review panel - the closest regulatory comparables to K812581.
#19041-150X15MM MUELLER HINTON
K820792 · Biomedica, Inc. · Apr 1982
#1904L MUELLER HINTON W/5% SHEEP BLOOD
K820793 · Biomedica, Inc. · Apr 1982
#19012 CHOCOLATE MUELLER HINTON-150X15MM
K820794 · Biomedica, Inc. · Apr 1982
MUELLER HINTON AGAR
K811646 · Hardy Media · Jul 1981
MUELLER-HINTON
K811608 · Micro Media Laboratories · Jun 1981
MUELLER HINTON AGAR
K811471 · Biomedia, Inc. · Jun 1981