Cleared Traditional

K894805 - RAPIDEC UR

K894805 is an FDA 510(k) clearance for RAPIDEC UR, manufactured by Dms Products, Inc.. The device is a Class 1 Microbiology device with product code JXA cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K894805 · Dms Products, Inc. · Microbiology device
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Sep 1989
Decision
60d
Days
Class 1
Risk

K894805 is an FDA 510(k) clearance for the RAPIDEC UR. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Dms Products, Inc. (Flemington, US). The FDA issued a Cleared decision on September 26, 1989 after a review of 60 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.

View all Dms Products, Inc. devices

FDA 510(k) Submission Details - K894805

510(k) Number K894805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1989
Decision Date September 26, 1989
Days to Decision 60 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 102d · This submission: 60d
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 13
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K894805.
URISCREEN
K981084 · Diatech Diagnostics,Inc. · Oct 1998
URINE SCREENING DEVICE
K972676 · Combact Diagnostic Systems , Ltd. · Feb 1998
BAC-T-SCREEN
K924218 · Biomerieux Vitek, Inc. · Feb 1993
GEN-PROBE PACE SYSTEM URINE SCREEN
K892216 · Gen-Probe, Inc. · Sep 1989
SLIDE CULTURE U 'EIKEN'
K861631 · Syn-Kit, Inc. · Jun 1986
URICHECK
K860905 · Difco Laboratories, Inc. · Apr 1986