Cleared Traditional

K844469 - PHARMACIA B2-MICRO EIA

K844469 is the FDA 510(k) clearance for PHARMACIA B2-MICRO EIA by Pharmacia, Inc.. It is a Class 2 Microbiology device (product code JZG) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K844469 · Pharmacia, Inc. · Microbiology device
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Feb 1985
Decision
87d
Days
Class 2
Risk

K844469 is an FDA 510(k) clearance for the PHARMACIA B2-MICRO EIA. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on February 14, 1985 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5630 - 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 K844469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1984
Decision Date February 14, 1985
Days to Decision 87 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
15d faster than avg
Panel avg: 102d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JZG System, Test, Beta-2-microglobulin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5630
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.

Regulatory Peers - JZG System, Test, Beta-2-microglobulin Immunological

All 41
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K844469.
IMX B2-MICROGLOBULIN
K890421 · Abbott Laboratories · Mar 1989
PHARMACIA B2-MICRO RIA
K880719 · Pharmacia, Inc. · Apr 1988
ABBOTT B2-MICROGLOBULIN RIA
K864130 · Abbott Laboratories · Nov 1986
ENZYGNOST BETA-2 MICROGLOBULIN TEST
K843967 · Behring Diagnostics, Inc. · Dec 1984
B2-MICRO CONTROL
K840601 · Pharmacia, Inc. · Apr 1984