Cleared Special

K031784 - ACON STREP A RAPID TEST DEVICE

K031784 is an FDA 510(k) clearance for ACON STREP A RAPID TEST DEVICE, manufactured by ACON Laboratories, Inc.. The device is a Class 1 Microbiology device with product code GTY cleared through the Special 510(k) pathway after a 34-day FDA review.

K031784 · ACON Laboratories, Inc. · Microbiology device
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Jul 2003
Decision
34d
Days
Class 1
Risk

K031784 is an FDA 510(k) clearance for the ACON STREP A RAPID TEST DEVICE. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on July 14, 2003 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031784

510(k) Number K031784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2003
Decision Date July 14, 2003
Days to Decision 34 days
Submission Type Special
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
68d faster than avg
Panel avg: 102d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

GTY Device Classification - Class 1, General Controls

Product Code GTY Antigens, All Groups, Streptococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
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 - GTY Antigens, All Groups, Streptococcus Spp.

All 43
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K031784 · ACON STREP A RAPID TEST DEVICE
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