Cleared Traditional

K854150 - PHADIRECT STREP A TEST

K854150 is the FDA 510(k) clearance for PHADIRECT STREP A TEST by Pharmacia, Inc.. It is a Class 1 Microbiology device (product code GTZ) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K854150 · Pharmacia, Inc. · Microbiology device
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Oct 1985
Decision
12d
Days
Class 1
Risk

K854150 is an FDA 510(k) clearance for the PHADIRECT STREP A TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on October 23, 1985 after a review of 12 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K854150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1985
Decision Date October 23, 1985
Days to Decision 12 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
90d faster than avg
Panel avg: 102d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTZ Antisera, 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 - GTZ Antisera, All Groups, Streptococcus Spp.

All 61
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K854150.
DIFCO STREP A LATEX TEST
K854978 · Difco Laboratories, Inc. · Mar 1986
OXOID STREPTOCOCAL GROUPING KIT
K854929 · Oxoid U.S.A., Inc. · Mar 1986
ABBOTT STREP A P.S.D.
K852266 · Abbott Laboratories · Dec 1985
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.
K853073 · Marion Laboratories, Inc. · Aug 1985
QUIDEL QUEST STREP GROUP A TEST
K852806 · Quidel Corp. · Jul 1985
RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
K852841 · Smithkline Diagnostics, Inc. · Jul 1985