Cleared Traditional

K843967 - ENZYGNOST BETA-2 MICROGLOBULIN TEST

K843967 is the FDA 510(k) clearance for ENZYGNOST BETA-2 MICROGLOBULIN TEST by Behring Diagnostics, Inc.. It is a Class 2 Microbiology device (product code JZG) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K843967 · Behring Diagnostics, Inc. · Microbiology device
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Dec 1984
Decision
53d
Days
Class 2
Risk

K843967 is an FDA 510(k) clearance for the ENZYGNOST BETA-2 MICROGLOBULIN TEST. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on December 3, 1984 after a review of 53 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K843967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1984
Decision Date December 03, 1984
Days to Decision 53 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
49d faster than avg
Panel avg: 102d · This submission: 53d
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.