Cleared Traditional

K970100 - TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL

K970100 is an FDA 510(k) clearance for TECH SIMPLE SYPHILIS POSITIVE SERUM CON..., manufactured by Simplicity Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code MJX cleared through the Traditional 510(k) pathway after a 59-day FDA review.

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

FDA 510(k) Submission Details - K970100

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 102d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

MJX Device Classification - Class 1, General Controls

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.

Regulatory Peers - MJX Kit, Serological, Positive Control

Devices cleared under the same product code (MJX) and FDA review panel - the closest regulatory comparables to K970100.
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