Cleared Traditional

INDX DIP S TICKS (K901597) - FDA 510(k) Clearance

Class I Microbiology device.

K901597 · Intercare Diagnostics, Inc. · Microbiology device
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Dec 1990
Decision
260d
Days
Class 1
Risk

K901597 is an FDA 510(k) clearance for the INDX DIP S TICKS. Classified as Reagent, Rickettsia Serological (product code LSQ), Class I - General Controls.

Submitted by Intercare Diagnostics, Inc. (Baltimore, US). The FDA issued a Cleared decision on December 21, 1990 after a review of 260 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3500 - 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 Intercare Diagnostics, Inc. devices

Submission Details

510(k) Number K901597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1990
Decision Date December 21, 1990
Days to Decision 260 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 102d · This submission: 260d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LSQ Reagent, Rickettsia Serological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3500
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.