Cleared Traditional

K880752 - PHADEBACT SHIGELLA TEST

K880752 is an FDA 510(k) clearance for PHADEBACT SHIGELLA TEST, manufactured by Pharmacia, Inc.. The device is a Class 2 Microbiology device with product code GNB cleared through the Traditional 510(k) pathway after a 359-day FDA review.

K880752 · Pharmacia, Inc. · Microbiology device
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Feb 1989
Decision
359d
Days
Class 2
Risk

K880752 is an FDA 510(k) clearance for the PHADEBACT SHIGELLA TEST. Classified as Antisera, All Types, Shigella Spp. (product code GNB), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3660 - 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. Elevated predicate reliance profile. 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 Pharmacia, Inc. devices

FDA 510(k) Submission Details - K880752

510(k) Number K880752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1988
Decision Date February 17, 1989
Days to Decision 359 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
257d slower than avg
Panel avg: 102d · This submission: 359d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GNB Device Classification - Class 2, Special Controls

Product Code GNB Antisera, All Types, Shigella Spp.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.