Cleared Traditional

INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) (K971591) - FDA 510(k) Clearance

Class I Microbiology device.

K971591 · David C. Bishop, Ph.D. · Microbiology device
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Mar 1998
Decision
316d
Days
Class 1
Risk

K971591 is an FDA 510(k) clearance for the INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIE.... Classified as Reagent, Rickettsia Serological (product code LSQ), Class I - General Controls.

Submitted by David C. Bishop, Ph.D. (Dowingtown, US). The FDA issued a Cleared decision on March 13, 1998 after a review of 316 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 David C. Bishop, Ph.D. devices

Submission Details

510(k) Number K971591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1997
Decision Date March 13, 1998
Days to Decision 316 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 102d · This submission: 316d
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.