Cleared Traditional

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

K971591 is an FDA 510(k) clearance for INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR ..., manufactured by David C. Bishop, Ph.D.. The device is a Class 1 Microbiology device with product code LSQ cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K971591 · David C. Bishop, Ph.D. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K971591

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 102d · This submission: 316d
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.