Cleared Traditional

PHADEBACT CSF POSITIVE CONTROLS (K840048) - FDA 510(k) Clearance

Class I Immunology device.

K840048 · Pharmacia, Inc. · Immunology device
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Mar 1984
Decision
56d
Days
Class 1
Risk

K840048 is an FDA 510(k) clearance for the PHADEBACT CSF 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 March 2, 1984 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3740 - the FDA immunology 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 K840048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1984
Decision Date March 02, 1984
Days to Decision 56 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 104d · This submission: 56d
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 43
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