Cleared Traditional

K903638 - GASTRO-INTESTINAL ACCU-CULSHURE TM (FDA 510(k) Clearance)

Class I Microbiology device.

K903638 · Medical Laboratory Automation Systems, Inc. · Microbiology device
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Jan 1991
Decision
158d
Days
Class 1
Risk

K903638 is an FDA 510(k) clearance for the GASTRO-INTESTINAL ACCU-CULSHURE TM. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Medical Laboratory Automation Systems, Inc. (Pleasantville, US). The FDA issued a Cleared decision on January 18, 1991 after a review of 158 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Medical Laboratory Automation Systems, Inc. devices

Submission Details

510(k) Number K903638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1990
Decision Date January 18, 1991
Days to Decision 158 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 102d · This submission: 158d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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.