Cleared Special

K082661 - BIOSTREP A

K082661 is an FDA 510(k) clearance for BIOSTREP A, manufactured by Princeton BioMeditech Corp.. The device is a Class 1 Microbiology device with product code GTY cleared through the Special 510(k) pathway after a 24-day FDA review.

K082661 · Princeton BioMeditech Corp. · Microbiology device
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Oct 2008
Decision
24d
Days
Class 1
Risk

K082661 is an FDA 510(k) clearance for the BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on October 6, 2008 after a review of 24 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.

View all Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K082661

510(k) Number K082661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2008
Decision Date October 06, 2008
Days to Decision 24 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
78d faster than avg
Panel avg: 102d · This submission: 24d
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 34
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