Cleared Traditional

K861575 - DIRECTATEX STREP A

K861575 is an FDA 510(k) clearance for DIRECTATEX STREP A, manufactured by Pacific Biotech, Inc.. The device is a Class 1 Microbiology device with product code GTY cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K861575 · Pacific Biotech, Inc. · Microbiology device
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Jun 1986
Decision
36d
Days
Class 1
Risk

K861575 is an FDA 510(k) clearance for the DIRECTATEX STREP A. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Pacific Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on June 3, 1986 after a review of 36 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. 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.

View all Pacific Biotech, Inc. devices

FDA 510(k) Submission Details - K861575

510(k) Number K861575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1986
Decision Date June 03, 1986
Days to Decision 36 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 102d · This submission: 36d
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 37
Devices cleared under the same product code (GTY) and FDA review panel - the closest regulatory comparables to K861575.
ICON STREP B IMMUNOENZYMETRIC ASSAY
K902991 · Hybritech, Inc. · Oct 1990
ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
K864752 · Abbott Laboratories · Feb 1987
RESPIRASTICK ENZYME IMMUNOASSAY TEST
K862475 · Orion Diagnostica, Inc. · Sep 1986
STREPTOCOCCUS GR. D
K840511 · Scientific Device Laboratory, Inc. · Mar 1984
STREPTOCOCCUS PNEUMONIAE CONTROL
K840512 · Scientific Device Laboratory, Inc. · Mar 1984
STREPTOCOCCUS GR. B CONTROL
K840513 · Scientific Device Laboratory, Inc. · Mar 1984