Cleared Traditional

K832248 - PHADEBACT STREP POSITIVE CONTROLS

K832248 is the FDA 510(k) clearance for PHADEBACT STREP POSITIVE CONTROLS by Pharmacia, Inc.. It is a Class 1 Hematology device (product code GTY) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K832248 · Pharmacia, Inc. · Hematology device
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Sep 1983
Decision
52d
Days
Class 1
Risk

K832248 is an FDA 510(k) clearance for the PHADEBACT STREP POSITIVE CONTROLS. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Pharmacia, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 1, 1983 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.3740 - the FDA hematology 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 K832248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1983
Decision Date September 01, 1983
Days to Decision 52 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 113d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 28
Devices cleared under the same product code (GTY) and FDA review panel - the closest regulatory comparables to K832248.
ICON STREP B IMMUNOENZYMETRIC ASSAY
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ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
K864752 · Abbott Laboratories · Feb 1987
PHADEBACT CSF POSITIVE CONTROLS
K840048 · Pharmacia, Inc. · Mar 1984
MERITEC-STREP GROUP A BETA-HEMOLYTIC
K831599 · Meridian Diagnostics, Inc. · Aug 1983
BBL DIRECTIGEN TEST KIT
K812808 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1981