Cleared Traditional

K901597 - INDX DIP S TICKS

K901597 is an FDA 510(k) clearance for INDX DIP S TICKS, manufactured by Intercare Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code LSQ cleared through the Traditional 510(k) pathway after a 260-day FDA review.

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

FDA 510(k) Submission Details - K901597

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.

LSQ Device Classification - Class 1, General Controls

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.