Cleared Traditional

K870731 - LYFO KWIK(TM) RUS KIT

K870731 is an FDA 510(k) clearance for LYFO KWIK(TM) RUS KIT, manufactured by Micro-Bio-Logics. The device is a Class 1 Microbiology device with product code JXA cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K870731 · Micro-Bio-Logics · Microbiology device
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Jun 1987
Decision
112d
Days
Class 1
Risk

K870731 is an FDA 510(k) clearance for the LYFO KWIK(TM) RUS KIT. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Micro-Bio-Logics (St. Cloud, US). The FDA issued a Cleared decision on June 17, 1987 after a review of 112 days - within the typical 510(k) review window.

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 - K870731

510(k) Number K870731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1987
Decision Date June 17, 1987
Days to Decision 112 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
10d slower than avg
Panel avg: 102d · This submission: 112d
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 43
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K870731.
RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST
K883385 · Los Alamos Diagnostics · Sep 1988
MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM
K881439 · Los Alamos Diagnostics · Apr 1988
ROUND 1
K873086 · Bioclinical Systems, Inc. · Aug 1987
N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE)
K864177 · Cls Co. · Feb 1987
UTISCREEN(R) BACTERIAL ATP TEST
K864202 · Los Alamos Diagnostics · Feb 1987
RAPID BACTERIURIA SCREEN (RBS)
K862195 · New Horizons Diagnostics Co. · Jun 1986
K870731 · LYFO KWIK(TM) RUS KIT
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