Cleared Traditional

K170481 - Strep B Carrot Broth Kit (FDA 510(k) Clearance)

Class I Microbiology device.

K170481 · Hardy Diagnostics · Microbiology device
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Optimized for regulatory review, auditing and printing
May 2017
Decision
89d
Days
Class 1
Risk

K170481 is an FDA 510(k) clearance for the Strep B Carrot Broth Kit. Classified as Gbs Culture Media, Selective And Differential (product code PQZ), Class I - General Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on May 16, 2017 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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.

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Submission Details

510(k) Number K170481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2017
Decision Date May 16, 2017
Days to Decision 89 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
13d faster than avg
Panel avg: 102d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PQZ Gbs Culture Media, Selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
Definition Culture Medium For Gbs Detection
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.