Cleared Traditional

GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 (K972576) - FDA 510(k) Clearance

Class I Microbiology device.

K972576 · Accumed Intl., Inc. · Microbiology device
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Jan 1998
Decision
196d
Days
Class 1
Risk

K972576 is an FDA 510(k) clearance for the GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90. Classified as Gram Positive Identification Panel (product code LQL), Class I - General Controls.

Submitted by Accumed Intl., Inc. (Westlake, US). The FDA issued a Cleared decision on January 22, 1998 after a review of 196 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 Accumed Intl., Inc. devices

Submission Details

510(k) Number K972576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1997
Decision Date January 22, 1998
Days to Decision 196 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 102d · This submission: 196d
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.