Cleared Traditional

K843571 - RIM-UREA

K843571 is an FDA 510(k) clearance for RIM-UREA, manufactured by Austin Biological Laboratories. The device is a Class 1 Microbiology device with product code JSS cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K843571 · Austin Biological Laboratories · Microbiology device
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Oct 1984
Decision
20d
Days
Class 1
Risk

K843571 is an FDA 510(k) clearance for the RIM-UREA. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Austin Biological Laboratories (Mchenry, US). The FDA issued a Cleared decision on October 1, 1984 after a review of 20 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K843571

510(k) Number K843571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1984
Decision Date October 01, 1984
Days to Decision 20 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
82d faster than avg
Panel avg: 102d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

JSS Device Classification - Class 1, General Controls

Product Code JSS Kit, Identification, Enterobacteriaceae
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 - JSS Kit, Identification, Enterobacteriaceae

All 48
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K843571.
IDS RAPID SS/U SYSTEM
K852871 · Innovative Diagnostic Systems, Inc. · Jul 1985
LYFO-KWIK OMI KIT
K851978 · Micro-Bio-Logics · Jun 1985
IDS RAPID E PLUS SYSTEM
K852110 · Innovative Diagnostic Systems, Inc. · Jun 1985
TITERTEK ENTEROBAC*
K834090 · Flow Laboratories, Inc. · Jan 1984
FLUOR-B. FRAG. DIRECT FLUORESCENT ANTI
K833612 · Petra Biomedical Products, Inc. · Dec 1983
FLUOR-B MEL A DIRECT FLUORESCENT ANTI
K833613 · Petra Biomedical Products, Inc. · Dec 1983
K843571 · RIM-UREA
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