Cleared Traditional

K193490 - SensiTox C. difficile Toxin Test (FDA 510(k) Clearance)

Class I Microbiology device.

K193490 · First Light Diagnostics, Inc. · Microbiology device
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Jul 2021
Decision
569d
Days
Class 1
Risk

K193490 is an FDA 510(k) clearance for the SensiTox C. difficile Toxin Test. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by First Light Diagnostics, Inc. (Chelmsford, US). The FDA issued a Cleared decision on July 8, 2021 after a review of 569 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all First Light Diagnostics, Inc. devices

Submission Details

510(k) Number K193490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2019
Decision Date July 08, 2021
Days to Decision 569 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
467d slower than avg
Panel avg: 102d · This submission: 569d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLH Reagents, Clostridium Difficile Toxin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 Consultant

MDC Associates, LLC
Fran White

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.