Cleared Traditional

K040708 - STATUS FIRST STREP A

K040708 is an FDA 510(k) clearance for STATUS FIRST STREP A, manufactured by Princeton BioMeditech Corp.. The device is a Class 1 Microbiology device with product code GTY cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K040708 · Princeton BioMeditech Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
249d
Days
Class 1
Risk

K040708 is an FDA 510(k) clearance for the STATUS FIRST 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 November 22, 2004 after a review of 249 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K040708

510(k) Number K040708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2004
Decision Date November 22, 2004
Days to Decision 249 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
147d slower than avg
Panel avg: 102d · This submission: 249d
Pathway characteristics
Predicate-based equivalence.

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
Devices cleared under the same product code (GTY) and FDA review panel - the closest regulatory comparables to K040708.
CLEARVIEW ADVANCED STREP A , MODEL 737-430
K091489 · Binax, Inc. · Sep 2009
BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
K082661 · Princeton BioMeditech Corp. · Oct 2008
INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
K051638 · Unipath , Ltd. · Dec 2005
ACON STREP A RAPID TEST DEVICE
K031784 · ACON Laboratories, Inc. · Jul 2003
SAS STREPALERT
K023270 · Sa Scientific, Inc. · Oct 2002
SAS STREPALERT
K013379 · Sa Scientific, Inc. · Dec 2001