Cleared Traditional

RAPIDEC STAPH (K891004) - FDA 510(k) Clearance

Class I Microbiology device.

K891004 · Dms Products, Inc. · Microbiology device
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Nov 1989
Decision
254d
Days
Class 1
Risk

K891004 is an FDA 510(k) clearance for the RAPIDEC STAPH. Classified as Gram Positive Identification Panel (product code LQL), Class I - General Controls.

Submitted by Dms Products, Inc. (Flemington, US). The FDA issued a Cleared decision on November 9, 1989 after a review of 254 days - an extended review 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: 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 Dms Products, Inc. devices

Submission Details

510(k) Number K891004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1989
Decision Date November 09, 1989
Days to Decision 254 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
152d slower than avg
Panel avg: 102d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQL Gram Positive Identification Panel
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.