Cleared Traditional

INDXTM DIP-S-TICKSTM (K920569) - FDA 510(k) Clearance

Class I Microbiology device.

K920569 · Intercare Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
368d
Days
Class 1
Risk

K920569 is an FDA 510(k) clearance for the INDXTM DIP-S-TICKSTM. 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 February 9, 1993 after a review of 368 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K920569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1992
Decision Date February 09, 1993
Days to Decision 368 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
266d slower than avg
Panel avg: 102d · This submission: 368d
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.