Cleared Traditional

K851225 - URINE DUO

K851225 is an FDA 510(k) clearance for URINE DUO, manufactured by Culture Kits, Inc.. The device is a Class 2 Microbiology device with product code JTZ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K851225 · Culture Kits, Inc. · Microbiology device
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Aug 1985
Decision
140d
Days
Class 2
Risk

K851225 is an FDA 510(k) clearance for the URINE DUO. Classified as Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth (product code JTZ), Class II - Special Controls.

Submitted by Culture Kits, Inc. (Norwich, US). The FDA issued a Cleared decision on August 13, 1985 after a review of 140 days - within the typical 510(k) review window.

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: 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 Culture Kits, Inc. devices

FDA 510(k) Submission Details - K851225

510(k) Number K851225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1985
Decision Date August 13, 1985
Days to Decision 140 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 102d · This submission: 140d
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 K851225.
MUELLER HINTON AGAR - SUPPLEMENTED
K864248 · Mds Laboratories, Inc. · Mar 1987
MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
K863821 · Gibco Laboratories Life Technologies, Inc. · Oct 1986
APL MUELLER HINTON AGAR
K853238 · Apl Medical Supplies · Aug 1985
MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS
K850291 · Remel Co. · May 1985
MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE
K851589 · Preferred Micro-Media · Apr 1985
MUELLER HINTON CHOCOLATE AGAR
K850843 · Micro Media Laboratories · Mar 1985