Cleared Traditional

TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL (K970100) - FDA 510(k) Clearance

Class I Microbiology device.

K970100 · Simplicity Diagnostics, Inc. · Microbiology device
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Mar 1997
Decision
59d
Days
Class 1
Risk

K970100 is an FDA 510(k) clearance for the TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE .... Classified as Kit, Serological, Positive Control (product code MJX), Class I - General Controls.

Submitted by Simplicity Diagnostics, Inc. (Hatboro, US). The FDA issued a Cleared decision on March 10, 1997 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Simplicity Diagnostics, Inc. devices

Submission Details

510(k) Number K970100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1997
Decision Date March 10, 1997
Days to Decision 59 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
43d faster than avg
Panel avg: 102d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MJX Kit, Serological, Positive Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.