Cleared Traditional

K890057 - SENSITITRE AUTO ID PLATE AP80 (FDA 510(k) Clearance)

Class I Microbiology device.

K890057 · Radiometer America, Inc. · Microbiology device
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Jun 1989
Decision
154d
Days
Class 1
Risk

K890057 is an FDA 510(k) clearance for the SENSITITRE AUTO ID PLATE AP80. Classified as Gram Negative Identification Panel (product code LQM), Class I - General Controls.

Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on June 9, 1989 after a review of 154 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 Radiometer America, Inc. devices

Submission Details

510(k) Number K890057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1989
Decision Date June 09, 1989
Days to Decision 154 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 102d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQM Gram Negative 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.